Acceleron Pharma Inc [XLRN] US$5,707 MM MCap

The com­pa­nies have mul­ti­ple Ph2 and Ph3 trials on­go­ing for chron­ic ane­mia in ad­di­tio­n­al pa­tient pop­u­la­tions of MDS and be­ta-tha­lassemia, as well as myelo­fi­bro­sis. The com­pany ex­pects to re­port to­p­line re­sults from Ph2 clin­i­cal trials in PAH (so­tater­cept) and CMT (ACE-083) in Q1 2020. [more in­for­ma­tion]

AcelRx Pharmaceuticals, Inc. [ACRX] US$82 MM MCap

Launched DSU­VIA (sufen­tanil sublin­gual tablet 30 mcg) in the US in 1Q19 for acute pain se­vere enough to re­quire opi­oid anal­gesic (adult pa­tients in cer­ti­fied med­i­cal­ly su­per­vised health­care sett­ings). Al­so de­vel­op­ing Za­lvi­so (Ph 3 com­plet­ed) in the US as an in­no­va­tive pa­tient-con­trolled anal­ge­sia sys­tem for mod­er­ate-to-se­vere acute pain in med­i­cal­ly su­per­vised sett­ings. [more in­for­ma­tion]

Achilles Therapeutics

cNeT (clo­n­al neoanti­gen) pro­cess builds on TILs, com­bined with abil­i­ty to iden­ti­fy pt-spe­cif­ic clo­n­al neoanti­gens and gen­er­ate per­so­n­al­ized T-cell ther­a­pies. Sep19 GBP100 mil­lion Se­ries B w/ RA, Syn­co­na, For­bion, In­vus, Per­cep­tive + Red­mile. [more in­for­ma­tion]

Adrenomed AG

Car­dio­vas­cu­lar and Sep­sis, Adre­cizumab Ph 2, bio­mark­er-guid­ed, mon­o­clo­n­al anti­body for sep­tic shock; to­p­li­nee da­ta re­leased late Feb. Adre­cizumab showed low­er all-cause mor­tal­i­ty for treat­ed pts com­pared to place­bo (28% mor­tal­i­ty rate in 28-day fol­low-up). De­tailed da­ta com­ing in fol­low­ing few months. [more in­for­ma­tion]

Affibody

Pro­pri­e­tary Af­fi­body® molecules and Al­bu­mod plat­forms. Lead can­di­date is an IL-17 with pos­i­tive Ph2 12wk da­ta in pso­ri­a­sis. Al­so has a Ph1 FcRn for b-cell au­toim­mune dis­eas­es part­nered with ALXN. Rev­enue gen­er­at­ing from ear­li­er li­censed as­sets. Backed by In­ves­tor AB. [more in­for­ma­tion]

Affimed N.V. [AFMD] US$323 MM MCap

NK cell en­gager AFM13 (CD30/CD16A) to en­ter a Phase 2 reg­is­tra­tion study in CD30-pos­i­tive pe­ripher­al T cell lym­pho­ma and an in­vesti­ga­tor-spon­sored study by MDACC of AFM13 com­bined with al­lo­gene­ic NK cells in re­lapsed/re­frac­to­ry CD30-pos­i­tive lym­pho­ma. [more in­for­ma­tion]

AM-Pharma B.V.

Treat­ing sep­sis as­so­ci­at­ed acute kid­ney in­jury (AKI) with pro­pri­e­tary re­com­bi­nant al­ka­line phos­pha­tase (re­cAP). Re­sults from Ph 2 trial in 300+ pts, de­mon­s­trat­ed rel­a­tive im­prove­ment of 40%+ OS in re­cAP group. Ini­ti­at­ing Ph 3 in Q3 2020 – in­ter­im look (n=400) exp Q3 2021 (P end­point: Day 28 all-cause mor­tal­i­ty). [more in­for­ma­tion]

Amarin Corporation [AMRN] US$2,553 MM MCap

Com­mer­cial­iz­ing Vas­ce­pa, the first and on­ly pure EPA ome­ga-3 fat­ty acid ap­proved to low­er trig­lyc­eride lev­els in adults. Pre­sent­ed (+) da­ta from RE­DUCE-IT CV Out­comes trial at AHA. 2019 gui­dance of $380-420M, or 66-83% high­er y/y. [more in­for­ma­tion]

Antev

Phase 3 ready, Tevere­lix, a long act­ing in­jectable pep­tide GnRH an­ta­g­on­ist. Lead in­di­ca­tion for pros­tate can­cer, fol­lowed by be­nign pro­stat­ic hy­per­pla­sia (BPH), acute uri­nary re­ten­tion (AUR), uterine fi­broids and en­dometrio­sis. Over 450 sub­jects have been dosed over 850 times to date with no se­ri­ous ad­verse re­ac­tions and good lo­cal tol­er­ance. [more in­for­ma­tion]

Apexigen

CD40 ag­on­ist mAb; 170+ pts dosed (mono & com­bi sett­ings). 7 on­go­ing Ph 2s, undis­closed oc­u­lar dis­ease pro­gram in Ph 3. AACR: Ph 1b da­ta (w/Park­er Inst); col­labs w/BMY, MDACC, Yale, et al [more in­for­ma­tion]

Aptorum Group [APM] US$99 MM MCap

Ap­to­rum is Hong Kong based, US list­ed com­pany (Mcap $100m) fo­cused on gen­er­at­ing late stage clin­i­cal can­di­dates by de­vel­op­ing al­ready ap­proved drugs for new or­phan in­di­ca­tions, as well as in­fec­tious dis­eas­es. Pipe­line – • SACT-1 for Neu­roblas­to­ma – ph2/3 trial planned for 2H’20 • SACT-COV­19 – COVID-19 treat­ment - pre­clin­i­cal [more in­for­ma­tion]

Arcellx

Clin­i­cal stage de­vel­op­ment of Anti­gen Re­cep­tor Com­plex T-cells (ARC-T) that are read­i­ly si­lenced, ac­ti­vat­ed and re­pro­grammed in vi­vo by ad­min­is­tra­tion of a tu­mo-tar­get­ing anti­gen pro­tean called a sparX. Backed by NEA, No­vo, SR One, Take­da, So­las­ta, Quan, Clough, Mi­rae, JVC and LG. [more in­for­ma­tion]

Ascentage Pharma [6855.HK]

As­cen­t­age Phar­ma has built a pipe­line of eight clin­i­cal drug can­di­dates, in­clud­ing a nov­el, high­ly po­tent Bcl-2/Bcl-xL in­hibi­tor, as well as can­di­dates aimed at IAP and MD­M2-p53 path­ways, and next-gen­er­a­tion ty­ro­sine ki­nase in­hibi­tors. The com­pany has been con­duct­ing 28 Phase I/II clin­i­cal trials to eval­u­ate the eight drug can­di­dates in the Unit­ed States, Aus­tralia, and Chi­na. [more in­for­ma­tion]

AsclepiX Therapeutics

AX­T107 de­mon­s­trat­ed ef­fi­ca­cy and dura­bil­i­ty in rab­bit and mouse mod­els that is su­pe­ri­or to stan­dard of care Eylea. [more in­for­ma­tion]

Assembly Biosciences, Inc. [ASMB] US$753 MM MCap

Tar­get­ing HBV w/ oral core in­hibi­tors - po­ten­tial to in­crease cure rates. Lead can­di­date 731 in Ph 2: +ive safe­ty and de­creas­es in cc­cD­NA pop with pts ex­pect­ed to be with­drawn from treat­ment in 2020 and fol­lowed for sus­tained vi­ral DNA sup­pres­sion off ther­a­py. [more in­for­ma­tion]

Aurinia Pharmaceuticals, Inc. [AUPH] US$1,657 MM MCap

**NOTE MEET­INGS AT ZEP­PELIN HO­TEL** Re­cent­ly an­nounced pos­i­tive AU­RO­RA Phase 3 trial re­sults de­mon­s­trat­ing Vo­clos­porin, a next gen­er­a­tion calcineurin in­hibi­tor, su­pe­ri­or­i­ty over stan­dard of care in Lu­pus Nephri­tis. [more in­for­ma­tion]

AxoGen [AXGN] US$436 MM MCap

Da­m­age or tran­sec­tion to pe­ripher­al nerves. Q1 revs $23.3M, 35% growth YoY; exp 2019 rev bt $109-$114M [more in­for­ma­tion]

Bellus Health [BLU] US$155 MM MCap

BEL­LUS' lead prod­uct can­di­date, BLU-5937, is be­ing de­vel­oped for the treat­ment of chron­ic cough (Phase II an­nounced Ju­ly 2020) and chron­ic pru­ri­tus (Phase II planned to be­gin 1H20). [more in­for­ma­tion]

BerGenBio [BGBIO:OS] NKr3,248 MM MCap

De­vel­op­ing first-in-class se­lec­tive Axl ki­nase in­hibi­tors for liquid and solid can­cers, lead can­di­date is bem­cen­tinib (BG­B324) in four com­pany-spon­sored trials. [more in­for­ma­tion]

Biohaven Pharmaceuticals, Inc [BHVN] US$4,246 MM MCap

NURTEC® ODT ap­proved in 1Q20. To­p­line re­sults ex­pect­ed 1Q20 in Ph 3 study of tro­r­ilu­zole for mi­graine pre­ven­tion. To­p­line re­sults ex­pect­ed 2Q20 in Ph 2/3 study of tro­r­ilu­zole for OCD. ~$600M to­tal in cash on hand, in­clud­ing re­cent $282.3M raise to sup­port NURTEC ODT launch. [more in­for­ma­tion]

BioShin

New­ly in­cor­po­rat­ed (Nov 2018), whol­ly owned sub­si­diary of Bio­haven Phar­ma­ceu­ti­cals. Shang­hai-based, led by ex-BMY ex­ec and Bio­haven’s Chief of Corp Strat­e­gy & BD, Don­nie Mc­Grath, Bioshin aims to de­vel­op and com­mer­cial­ize Bio­haven’s late-stage mi­graine and neu­rol­o­gy port­fo­lio in Chi­na and other APAC mar­kets. [more in­for­ma­tion]

BioXcel Therapeutics, Inc. [BTAI] US$1,050 MM MCap

BX­CL501 (sublin­gual dexmede­to­mi­dine): Phase 3 trials on­go­ing for the acute treat­ment of ag­i­ta­tion in pa­tients with schi­zophre­nia (SERENI­TY I) and bipo­lar di­s­or­der (SERENI­TY II). Phase 1b/2 trial (TRAN­QUIL­I­TY) on­go­ing for the acute treat­ment of ag­i­ta­tion as­so­ci­at­ed with ge­ri­a­tric de­men­tia. [more in­for­ma­tion]

CASI Pharmaceuticals Inc. [CASI] US$221 MM MCap

Launched EVOMELA® (mel­pha­lan for in­jec­tion, mul­ti­ple myelo­ma) in Au­gust 2019, on­ly mel­pha­lan com­mer­cial­ly avai­l­able in Chi­na; ad­vanc­ing de­vel­op­ment of an­ti-CD19 T-cell ther­a­py (CNC­T19) in B-NHL and B-ALL and an­ti-CD38 mAb (CID-103) in mul­ti­ple myelo­ma, fo­cused on be­com­ing Chi­na’s ma­jor he­ma­tol­o­gy on­col­o­gy com­pany; [more in­for­ma­tion]

Catabasis Pharmaceuticals Inc [CATB] US$117 MM MCap

Rare dis­ease pipe­line, with lead prod­uct Edasa­lonex­ent in Ph 3 trial in Duchenne mus­cu­lar dys­tro­phy re­gard­less of mu­ta­tion type. North Star Am­bu­la­to­ry As­sess­ment as the pri­mary end­point based on Phase 2 re­sults and FDA in­put. Top-line re­sults ex­pect­ed in 2020. [more in­for­ma­tion]

Catalyst Pharmaceuticals, Inc. [CPRX] US$490 MM MCap

Fir­dapse ap­proved for Lam­bert-Ea­ton Myas­thenic Syn­drome; 3Q19 rev of $30.9M, FY19 gui­dance of ~$102M and FY20 gui­dance of $135M-$155M. Mul­ti­ple key Fir­dapse trial read­outs in 1H20. [more in­for­ma­tion]

Celldex Therapeutics, Inc. [CLDX] US$433 MM MCap

I-O pipe­line of Abs, ADCs, im­mune sys­tem mo­d­u­la­tors and vaccines tar­get­ed to spe­cif­ic pa­tient pop­u­la­tions. STIC da­ta on an­ti-CD40; col­lab with Mer­ck. [more in­for­ma­tion]

CellMax Life

The com­pany is cur­rent­ly fo­cused on col­orec­tal can­cer (CRC) screen­ing us­ing the clin­i­cal­ly vali­dat­ed CMx plat­form, a blood biop­sy test plat­form that de­tects pre-can­cer­ous le­sions (ade­no­mas) in as lit­tle as two tea­spoons of blood (less than 10mL). [more in­for­ma­tion]

CerSci Therapeutics

De­vel­op­ing a new gen­er­a­tion of non-opi­oid medicines to treat acute post-op­er­a­tive and chron­ic neu­ro­path­ic pain. Lead pro­gram in Phase 1 (MAD/SAD/Food Ef­fect), CT-044, tar­get­ing re­ac­tive spe­cies that cause neu­ro­n­al ion chan­nel hy­per-sen­si­ti­za­tion, known to trig­ger pain. [more in­for­ma­tion]

CureVac AG

Cure­vac is a pri­vate Ger­man com­pany with mR­NA plat­form, di­ver­si­fied pipe­line, and three lead pro­grams in ph1: CV8102 (vari­ous can­cer in­di­ca­tions), CV9202 (NS­CLC) and CV7202 (Ra­bies). Last fi­nanc­ing round done at over $1bn. Other com­pa­nies in the space: MR­NA, TBIO, BN­TX. [more in­for­ma­tion]

DBV Technologies [DBVT] US$460 MM MCap

Vi­askin® Peanut is the Com­pany’s lead prod­uct can­di­date de­signed to po­ten­tial­ly re­duce the risk of life-threat­en­ing al­ler­g­ic re­ac­tions due to ac­ci­den­tal ex­po­sure to peanuts. An in­vesti­ga­tio­n­al non-in­va­sive, once-dai­ly, epi­cu­ta­neous patch, Vi­askin Peanut seeks to de­liv­er mi­cro­gram quan­ti­ties of peanut anti­gen to ac­ti­vate the im­mune sys­tem. [more in­for­ma­tion]

Enzo Biochem, Inc. [ENZ] US$128 MM MCap

$100m revs in F18. Pi­oneer in molec­u­lar di­ag­nos­tics (Dx), lead­ing con­ver­gence of clin­i­cal lab­o­ra­to­ries, life sci­ences and IP through de­vt of unique Dx plat­form tech­nolo­gies pro­vid­ing nu­mer­ous ad­van­tages over pre­vi­ous stan­dards. [more in­for­ma­tion]

Epigenomics AG [EPGNY] US$71 MM MCap

Blood-based can­cer de­tec­tion com­pany with DNA methy­la­tion bio­mark­er tech­nol­o­gy. De­vel­ops/com­mer­cial­izes Dx prod­ucts across mul­ti­ple can­cer in­di­ca­tions w/high med­i­cal need. Lead, Epi pro­Colon: blood-based screen­ing test de­tect­ing col­orec­tal can­cer. FDA ap­proved, mar­ket­ed in US, EU, Chi­na et al. [more in­for­ma­tion]

ESSA Pharma Inc. [EPIX] US$127 MM MCap

1Q20 IND sub­mis­sion for lead as­set, EPI-7386, a small molecule tar­get­ing n-ter­mi­nal do­main of an­dro­gen re­cep­tor for mCR­PC. First pa­tient dosed in EPI-7386 Phase 1 study in mCR­PC pa­tients fail­ing se­cond gen­er­a­tion an­tian­dro­gens by 2Q20. [more in­for­ma­tion]

Evofem Biosciences, Inc. [EVFM] US$234 MM MCap

Evofem Bio­s­ciences (EVFM) is de­vel­op­ing Am­pho­ra®, a Mul­ti­pur­pose Vag­i­nal pH Reg­u­la­tor (MVP-R) and non-hor­mo­n­al, on-de­mand, wo­m­an-con­trolled vag­i­nal gel for birth con­trol and the pre­ven­tion of uro­geni­tal ac­qui­si­tion of cer­tain STIs. PD­U­FA for con­tra­cep­tion of May 25, 2020. Phase 3 for ch­lamy­dia and gon­or­rhea ex­pect­ed to ini­ti­ate in 2020. [more in­for­ma­tion]

Faraday Pharmaceuticals

El­e­men­tal re­duc­ing agents for crit­i­cal care treat­ment to pre­vent car­di­ac and skele­tal mus­cle loss: lead can­di­date FDY-5301 Ph 3 (piv­o­tal) to ini­ti­ate mid-2020 for reper­fu­sion in­jury fol­low­ing heart at­tack (AMI); da­ta ear­ly 2023. SPA sub­mis­sion re­ceived by FDA Jan 22, 2020 and ini­tial feed­back re­ceived Feb 2020 - Type A meet­ing re­quest, like­ly in April 2020. Sig­ni­f­i­cant ad­di­tio­n­al treat­ment ap­pli­ca­tions with limit­ed to no com­pe­ti­tion. $57M raised to date from Arch Ven­ture Part­n­ers, Po­laris Part­n­ers, WRF, Osa [more in­for­ma­tion]

Forbius

Se­lec­tive in­hibi­tors of TGF Be­ta & EGFR path­ways. AACR: (+) Ph 1 da­ta. 3 on­go­ing Ph 2 trials (SCCHN, NS­CLC, TN­BC); ad­dl Ph 1 trials in IO, Sys­temic Scle­ro­sis & Myelo­fi­bro­sis [more in­for­ma­tion]

Freenome Holdings, Inc.

Biotech­nol­o­gy di­ag­nos­tics com­pany uti­l­iz­ing its deep ex­per­tise in molec­u­lar bi­ol­o­gy with ad­vanced com­pu­ta­tio­n­al bi­ol­o­gy and ma­chine learn­ing tech­niques; the com­pany pi­oneered a com­pre­hen­sive mul­ti­omics plat­form for ear­ly can­cer de­tec­tion through a rou­tine blood draw. At AS­CO GI 2020, de­mon­s­trat­ed a sen­si­tiv­i­ty of 94% and spe­ci­fic­i­ty of 94% for ear­ly-stage (I/II) col­orec­tal ade­no­car­ci­no­ma. [more in­for­ma­tion]

Galera Therapeutics [GRTX] US$182 MM MCap

Clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pany fo­cus­ing on trans­form­ing ra­dio­ther­a­py in can­cer. Lead as­set GC4419 is a po­tent, high­ly se­lec­tive small molecule dis­mu­tase mimet­ic be­ing de­vel­oped for se­vere oral mu­cosi­tis, cur­rent­ly in Phase 3 with Break­through Ther­a­py Desig­na­tion. To­p­line re­sults ex­pect­ed in 1H21. Top line re­sults in Phase 1b/2a in se­cond as­set, GC4419 in pan­cre­at­ic can­cer ex­pect­ed in 2H20. GC4419 ex­pect­ed to ini­ti­ate in Phase 1b/2a in lung can­cer in 2H20. [more in­for­ma­tion]

Genfit SA [GNFTF] US$213 MM MCap

$155m Mar 2019 US IPO; FDA BTD for Ela­fi­branor (4/19); (+) 36-mo DSMB rec for cont­in­u­a­tion of Ph 3 study in NASH; da­ta by YE [more in­for­ma­tion]

Geron Corporation [GERN] US$621 MM MCap

First-in-class telom­erase in­hibi­tor, ime­tel­s­tat. Start­ed Phase 3 trial Au­gust 2019 in low­er risk MDS. Top-line re­sults ex­pect­ed mid-year 2022. Se­cond po­ten­tial in­di­ca­tion in re­lapsed/re­frac­to­ry MF. Pre­par­ing for End of Phase 2 meet­ing by end of Q1 2020. Ex­pect de­ci­sion re­gard­ing whether to pur­sue po­ten­tial late-stage de­vel­op­ment in MF af­ter the FDA meet­ing. In-house ta­l­ent and cash re­sources suf­fi­cient to sup­port cur­rent de­vel­op­ment plans. [more in­for­ma­tion]

Glycotope

The lead can­di­date, Gatipo­tozumab, tar­gets TA-MUC1 and is in the clin­ic for the treat­ment of solid tu­mors in com­bi­na­tion with an an­ti-EGFR anti­body. Gly­co­tope’s tech­nol­o­gy pro­vides a plat­form for the de­vel­op­ment of ad­di­tio­n­al clin­i­cal and pre-clin­i­cal pro­grams with an ar­ray of modes of ac­tion pro­vid­ing a unique of­fer­ing in the im­muno-on­col­o­gy and on­col­o­gy space. [more in­for­ma­tion]

GW Pharmaceuticals PLC [GWPH] US$3,975 MM MCap

GW has estab­lished a world lead­ing po­si­tion in the de­vel­op­ment of plant-de­rived cann­abi­noid ther­a­peu­tics through its proven drug dis­cov­ery and de­vel­op­ment pro­cess­es, in­tel­lec­tu­al prop­er­ty port­fo­lio and reg­u­la­to­ry and man­u­fac­tur­ing ex­per­tise. GW has de­vel­oped an oral for­mu­la­tion of pu­ri­fied cann­abi­di­ol (CBD), ap­proved as Epi­di­olex® in the U.S. by the U.S. [more in­for­ma­tion]

HaemaLogiX

Pro­pri­e­tary, dif­fer­en­ti­at­ed B cell tar­gets en­gaged via anti­body and CAR-T pro­grams Kap­paMab & Lamb­daMab tar­get ac­ti­vat­ed plas­ma cell anti­gens (KMA/LMA); Kap­paMab plus RevDex vs. RevDex Ph 2b in MM, da­ta 1H20; Kap­pa CAR-T Ph 1 Q120 in MM; Ca­pac­i­ty for du­al-tar­get­ing via CD-19, BC­MA, etc; Lamb­daMab in pre­clin­i­cal for amy­loi­do­sis [more in­for­ma­tion]

Hutchison China MediTech Ltd ("Chi-Med") [HCM] US$1,862 MM MCap

Chi-Med has a port­fo­lio of 8 drugs in clin­i­cal de­vel­op­ment from own dis­cov­ery en­gine in its In­no­va­tion plat­form and a cash gen­er­at­ing Com­mer­cial plat­form with 2,500+ sales reps. Glob­al col­lab­o­ra­tion with As­traZene­ca in two reg­is­tra­tion en­abling studies with savol­i­tinib in Ta­gris­so re­frac­to­ry lung can­cer that is MET+ and EGFRm+ (glob­al) and MET Ex­on 14 dele­tion NS­CLC (Chi­na). [more in­for­ma­tion]

I-Mab Biopharma [IMAB] US$1,926 MM MCap

I-Mab Bio­phar­ma is a Chi­na based bio­phar­ma­ceu­ti­cal with fo­cus on de­vel­op­ing in­no­va­tive bi­o­log­ics in the ar­eas of im­muno-on­col­o­gy and au­toim­mune dis­ease for the glob­al mar­kets, in­clud­ing Chi­na; [more in­for­ma­tion]

Immatics NV [IMTX]

Im­mat­ics com­bines the dis­cov­ery of true tar­gets for can­cer im­munother­a­pies with the de­vel­op­ment of the right T cell re­cep­tors with the goal of en­abling a ro­bust and spe­cif­ic T cell re­sponse against th­ese tar­gets. We are com­mitt­ed to de­liv­er­ing the pow­er of T cells and to un­lock­ing new av­enues for pa­tients in their fight against can­cer. [more in­for­ma­tion]

Impact Therapeutics Inc

Based in Chi­na, IM­PACT is com­mitt­ed to the dis­cov­ery and de­vel­op­ment of best-in-class ther­a­peu­tics to treat can­cer and other life-threat­en­ing dis­eas­es. IM­PACT is a clin­i­cal-stage com­pany with a unique small-molecule drug dis­cov­ery and de­vel­op­ment plat­form tar­get­ing DDR. IM­PACT's lead­ing pro­gram, PARP in­hibi­tor IM­P4297, is cur­rent­ly un­der­go­ing phase I trials in Aus­tralia and Chi­na. [more in­for­ma­tion]

Innate Pharma [IPHA] US$487 MM MCap

Three-pronged ap­proach to on­col­o­gy treat­ment us­ing mAbs. 1) Im­mune Check­point In­hibi­tors: mo­n­al­izumab, an­ti-NKG2A (CD94) co-de­vel­oped with AZN for H&N and CRC in Ph2 de­vel­op­ment (en­ter­ing Ph3 in 2020); pre­clin­i­cal an­ti-Si­glec-9 al­so part­nered with AZN. 2) Tu­mor Anti­gen Tar­get­ing: Lu­mox­i­ti (CD22) ap­proved for HCL (com­mer­cial launch 2H19); Ph2 la­cu­tamab in S&ea­cute;zary Syn­drome (FTD); Ph2 la­cu­tamab in MF & PT­CL (up­dates ex­pect­ed 2H20); three ad­di­tio­n­al pre­clin­i­cal as­sets, two part­nered with AZN, one col­lab­o­ra­tion w [more in­for­ma­tion]

Iovance Biotherapeutics [IOVA] US$4,294 MM MCap

Late-stage cell ther­a­py com­pany uti­l­iz­ing pro­pri­e­tary au­tol­o­gous tu­mor in­fil­trat­ing lym­pho­cytes (TILs) to at­tack solid tu­mors. The com­pany is con­duct­ing piv­o­tal stage trials in me­tastat­ic me­lano­ma and ad­vanced cer­vi­cal can­cer with BLAs ex­pect­ed 2020. [more in­for­ma­tion]

Junshi Biosciences [1877:HK]

Fo­cused on de­vel­op­ing ther­a­pies in I-O, au­toim­mune and metabolic dis­eas­es. 13 pipe­line can­di­dates (7 in I-O, 2 in metabolic, 3 in au­toim­mune and 1 in neu­ro­log­i­cal dis­eas­es). JS001, or tori­pal­imab, is ap­proved by the NM­PA and the first mar­ket­ed an­ti-PD-1 mAb anti­body self-de­vel­oped by a PRC com­pany. For full year 2019, tori­pal­imab sales were ap­prox­i­mate­ly $11.1M / 135,525 bot­tles. [more in­for­ma­tion]

Kadmon Holdings, Inc. [KDMN] US$656 MM MCap

An­nounced pos. pri­mary anal­y­sis re­sults (May 2020) in piv­o­tal trial of ROCK in­hibi­tor-KD025 (Belu­mo­sudil) in cGVHD pts re­ceiv­ing 2+ pri­or ther­a­py lines; ORRs of 73% and 74% in 200mg QD and 200mg BID arms, re­spec­tive­ly. Belu­mo­sudil is be­ing re­viewed un­der Re­al-Time On­col­o­gy Re­view (RTOR) Pi­lot Pro­gram by the FDA; NDA sub­mis­sion exp Q4 2020. En­rolling pts in Ph 2 trial (sys. scle­ro­sis). [more in­for­ma­tion]

Kiadis Pharma N.V. [KDS-AMS]

NK-cell plat­form ad­min­is­tered as ad­junct I-O on top of HSCT. Launched FIH POC trial in r/r AML pa­tients (Feb 2020); set to launch ad­di­tio­n­al HSCT trial lat­er in 2020 w/in­ter­im da­ta exp 2021. Pre­sent­ing new da­ta on ex-vi­vo FC21 ex­pand­ed NK-cell ther­a­py in 13 pa­tients at EBMT in 2020. Estab­lished POC in 37 pa­tients to­tal. [more in­for­ma­tion]

Kineta Inc.

Kine­ta (Pri­vate) - whol­ly owned pre­clin­i­cal an­ti-VIS­TA (in­nate im­mune tar­get) anti­body re­pro­grams the tu­mor mi­croen­vi­ron­ment and is dif­fer­en­ti­at­ed from other im­munother­a­pies by block­ing sup­pres­sive cells in cold tu­mors. $520M deal with Pfiz­er for its small molecule RIG-I im­munother­a­py and $360M+ deal with Ge­nen­tech for KCP506, pre­clin­i­cal, non-opi­oid for chron­ic pain. [more in­for­ma­tion]

Klox Technologies, Inc.

Pro­pri­e­tary bio­pho­ton­ic sys­tem uti­l­izes mul­ti-LED ar­ray and chro­mophore con­vert­er gel to pro­mote skin re­pair. Acne & skin re­ju­ve­na­tion in­di­ca­tion ap­proved in EU and Ca­na­da, on­go­ing trials in wound heal­ing. [more in­for­ma­tion]

Landos Biopharma

Based on ex­ten­sive pre­clin­i­cal studies, Lan­dos has vali­dat­ed a unique mech­anism of ac­tion in­volv­ing LAN­CL2 that ex­erts po­tent an­ti-in­flam­ma­to­ry ef­fects with an out­s­tand­ing safe­ty pro­file. Lead as­set BT-11 Phase 2 in­ter­im read out in mid-2020 in UC. [more in­for­ma­tion]

Lineage Cell Therapeutics [LCTX] US$114 MM MCap

Cell ther­a­py com­pany with 3 cl­ni­cal pro­grams 1) OpRe­gen, an RPE tran­s­plant ther­a­py in Ph1/2a de­vel­op­ment for the treat­ment of dry-AMD. 2) OPC1, an oli­go­den­dro­cyte pro­gen­i­tor cell ther­a­py for acute spi­nal cord in­juries with Or­phan and RMAT desig­na­tions. 3) VAC2, an al­lo­gene­ic can­cer im­munother­a­py of anti­gen-pre­sent­ing den­drit­ic cells cur­rent­ly in a Ph 1 for NS­CLC con­duct­ed by CRUK. [more in­for­ma­tion]

Marker Therapeutics [MRKR] US$81 MM MCap

A clin­i­cal-stage im­muno-on­col­o­gy com­pany with the po­ten­tial to sig­ni­f­i­cant­ly dis­rupt the cur­rent cell ther­a­py land­s­cape. Mark­er's cur­rent Mul­ti­TAA cell ther­a­py is look­ing to ini­ti­ate a Phase II study in AML in 2020 with en­roll­ment com­ple­tion an­ti­ci­pat­ed in 2H20. The com­pany al­so has a T-cell vaccine pro­gram, cur­rent­ly be­ing studied in breast can­cer. [more in­for­ma­tion]

Medivir AB [MVIR B:ST] SKr936 MM MCap

Nu­cleotide-pro­drug plat­form: MIV-818, an oral pro­drug of the clin­i­cal­ly ef­fec­tive troxac­itabine, for HCC and MIV-828 for AML. Ad­vanced clin­i­cal pro­grams for part­ner­ing: Birini­pant, a bi­va­lent SMAC mimet­ic; Remeti­no­s­tat for CT­CL and Ph 3 ready MIV-711 for OA. [more in­for­ma­tion]

MEI Pharma, Inc. [MEIP] US$348 MM MCap

4 clin­i­cal-stage on­o­cl­o­gy can­di­dates, in­clud­ing pra­ci­no­s­tat (oral HDAC in­hibi­tor) in an on­go­ing glob­al reg­is­tra­tion trial, and ME-401 (oral PI3K del­ta in­hibi­tor) en­ter­ing a Ph 2 clin­i­cal trial which the com­pany in­tends to sub­mit to the FDA to sup­port an ac­cel­er­at­ed ap­pro­val mar­ket­ing ap­pli­ca­tion [more in­for­ma­tion]

Microbiotica

Well­come Sanger In­sti­tute spi­nout; lead­er in mi­cro­biome ther­a­peu­tics and bio­mark­er dis­cov­ery, pipe­line in­cludes LBTs for UC and I-O, bio­mark­ers for IBD and I-O. £12m equi­ty raised to date; $534m IBD deal with Ge­nen­tech (June 2018); lead­ing mi­cro­biome in­ves­tor Sev­en­ture (joined Oc­to­ber 2018) [more in­for­ma­tion]

Minoryx Therapeutics

Oral PPAR&gam­ma; ag­on­ist, MIN-102, in Piv­o­tal Ph 2/3 for X-linked ALD and Ph 2 Frie­drich’s Ataxia; da­ta for both ex­pect­ed by end of 2020. VC in­ves­tors in­clude Kur­ma, Ysios, Fund+, Roche, Id­in­vest, etc [more in­for­ma­tion]

Nanobiotix SA [NANO:PA] €156 MM MCap

Nano­bi­otix is a lead­ing, clin­i­cal-stage nanomedicine com­pany pi­oneer­ing new ap­proach­es to sig­ni­f­i­cant­ly change pa­tient out­comes by bring­ing nano­physics to the heart of the cell. Nano­bi­otix’s Im­muno-On­col­o­gy pro­gram has the po­ten­tial to bring a new di­men­sion to can­cer im­munother­a­pies. [more in­for­ma­tion]

Neoleukin Therapeutics [NLTX] US$426 MM MCap

Lead pro­gram NL-201: cy­tokine mimet­ic (ne­oleukin) to ac­ti­vate im­mune cells for can­cer im­munother­a­py; first de no­vo pro­tein ther­a­peu­tic ev­er cre­at­ed. IND planned for 2020. Po­ten­tial for best-in-class IL-2/IL-15. [more in­for­ma­tion]

NeuroRx

De­vel­op­ing the first Glx tar­get­ed an­tide­pres­sant to ad­dress sui­ci­dal­i­ty in bipo­lar de­pres­sion. Lead can­di­date, NRX-101 is in Phase 2b/3 de­vel­op­ment, ini­ti­at­ed in Ju­ly 2019 (Break­through, SPA and Fast Track by FDA) for Se­vere Bipo­lar De­pres­sion in pts w Acute Sui­ci­dal Idea­tion and Be­havior. Re­port­ed Phase 2 ef­fi­ca­cy and safe­ty da­ta for NRX-011 in De­cem­ber 2018. [more in­for­ma­tion]

NexImmune, Inc.

Mul­ti-anti­gen-spe­cif­ic T cell ther­a­py. Syn­thet­ic nano­par­ti­cles de­c­o­rat­ed w a com­bo of mul­ti­ple tu­mor rel­e­vant anti­gens and co-sti­m­u­la­to­ry sig­nals en­gag­ing di­rect­ly w tar­get­ed T cells. Two Ph 1's on­go­ing. [more in­for­ma­tion]

NorthSea Therapeutics

First-in class, oral, struc­tu­ral­ly en­gi­neered fat­ty acids [SE­FAs] ad­dress­ing NASH and as­so­ci­at­ed metabolic di­s­or­ders via unique tar­get­ing of path­ways reg­u­lat­ing metabolism, oxida­tive stress, in­flam­ma­tion, and fi­bro­sis. $40m Se­ries B (Jan 2020) with ven­Bio Part­n­ers (lead) and Sofin­no­va In­vest­ments. [more in­for­ma­tion]

Oncimmune [ONC:LN] £80 MM MCap

Oncim­mune's pro­pri­e­tary plat­form is un­der­pinned by rapid bio­mark­er dis­cov­ery and a com­pre­hen­sive im­muno­genic pro­tein li­brary of over 8,000 anti­genic pro­teins. [more in­for­ma­tion]

Oncopeptides AB [ONCO:ST] SKr7,866 MM MCap

Melflufen (Yga­lo): alky­lat­ing pep­tide se­lec­tive­ly tar­gets MM; su­pe­ri­or ef­fi­ca­cy vs. SOC. In­ter­im da­ta at EHA (2018) from on­go­ing Ph2 study in late stage r/r MM showed ORR of ~32%. Fil­ing for AA ex­pect­ed in H1'20. [more in­for­ma­tion]

PAION AG [PAIOF] US$206 MM MCap

Remi­ma­zo­lam: short-act­ing anes­thet­ic. Ph 3 study in pro­ce­du­ral se­da­tion in US. Safe­ty da­ta in ASA III/IV pa­tients in Ph 3 colonos­copy study and Ph 3 bron­chos­copy study. US ap­pro­val filed by part­n­er Cos­mo Phar­ma­ceu­ti­cals in June 2019. Ini­ti­at­ed Ph 3 in gen­er­al anes­th­e­sia in EU in Ju­ly 2018, exp com­ple­tion 2020. [more in­for­ma­tion]

Paradigm BioPharma [PBIGF] US$537 MM MCap

Launch­ing Ph 3 in 2020 in OA pts w/bone mar­row ede­ma le­sions (BML). Pos­i­tive Ph2b re­sults in sub­jects w/OA & BML - stat sig im­prove­ment on pain re­duc­tion & BML vol­ume/grade re­duc­tions on MRI. Q12020: ini­tial da­ta from com­pas­sio­nate use trial (ex-NFL sub­jects w/OA) and joint IND sub­mis­sion to FDA/EMA for piv­o­tal trial in Mu­copolysacchari­do­sis. Exp AUS rev-gen in Q3 20. [more in­for­ma­tion]

PharmaMar SA [PHM:ES]

Yon­delis (soft tis­sue sar­co­ma and ovarian can­cer) com­mer­cial­ized with di­rect sales-force in EU and part­n­er­ship in US with Janssen. Signed li­cens­ing agree­ment with Jazz Phar­ma for Lur­binecte­din in the US - up­front pay­ment of $200M, $100mm on ap­pro­va­land up to $550M sales mile­s­tones. Jazz to launch Zepzel­ca in US Ju­ly 2020. [more in­for­ma­tion]

Pharming Group NV [PHARM:AS] €727 MM MCap

RU­CON­EST (rhC1INH), the on­ly re­com­bi­nant en­zyme re­place­ment ther­a­py mar­ket­ed for acute Hered­i­tary An­gioede­ma (HAE) at­tacks and be­ing de­vel­oped for large un­met in­di­ca­tions. [more in­for­ma­tion]

Pharvaris

Phar­varis is fo­cused on bring­ing an oral bradykinin B2 re­cep­tor an­ta­g­on­ist to pa­tients for use as an al­ter­na­tive to in­ject­ed ther­a­pies for hered­i­tary an­gioede­ma (HAE) and other B2 re­cep­tor-me­di­at­ed in­di­ca­tions. Phar­varis us­es small molecules to ad­vance po­tent, oral­ly avai­l­able com­pounds tar­get­ing HAE. [more in­for­ma­tion]

Photocure ASA [PHO:OS] NKr1,800 MM MCap

Pho­to­cure is a rev­enue-gen­er­at­ing com­mer­cial stage com­pany fo­cused on urol­o­gy. Lead prod­uct Hexvix/Cysview is an op­ti­cal imag­ing agent for im­proved de­tec­tion, re­duced dis­ease re­cur­rence and pro­gres­sion rates of blad­der can­cer. [more in­for­ma­tion]

Pieris Pharmaceuticals, Inc. [PIRS] US$153 MM MCap

An­ti­calins (en­gi­neered lipo­calin pro­teins) for re­sp & on­co dis­eas­es. Im­mi­nent da­ta for AZN-part­nered PRS-060 in­haled IL4 for mod-to-se­vere asth­ma. Cash of $128MM in the bank as of March 2019. [more in­for­ma­tion]

Pliant Therapeutics, Inc. [PLRX] US$861 MM MCap

Pliant has de­vel­oped a port­fo­lio of ful­ly-owned de­vel­op­ment can­di­dates fo­cused on in­hibit­ing the TGFb path­way through in­te­grin in­hi­bi­tion. Pliant has a strate­g­ic li­cens­ing and col­lab­o­ra­tion agree­ment with No­var­tis cov­er­ing the de­vel­op­ment and com­mer­cial­iza­tion of our pre­clin­i­cal liv­er fi­bro­sis pro­gram, PLN-1474 and up to three ad­di­tio­n­al ear­ly stage in­te­grin tar­gets. [more in­for­ma­tion]

Protagonist Therapeutics [PTGX] US$542 MM MCap

PTG-300 in­jectable hep­cidin mimet­ic Ph 2 trials on­go­ing in be­ta-tha­lassemia, hered­i­tary he­mochro­ma­to­sis, po­ly­cythemia ve­ra, and MDS; Phase 2 re­sults and first in­di­ca­tion choice for piv­o­tal study ex­pect­ed 2020. PN-943 oral GI-re­strict­ed al­pha-4-be­ta-7 an­ta­g­on­ist Ph 2 in ul­cer­a­tive coli­tis to be­gin ear­ly 2020; PTG-200, part­nered w/ Janssen, oral GI-re­strict­ed IL-23R an­ta­g­on­ist Ph 2 Crohn’s dis­ease study on­go­ing. [more in­for­ma­tion]

Pulse Biosciences, Inc. [PLSE] US$247 MM MCap

Med-tech; bio­elec­tric medicine plat­form com­pany bring­ing to mar­ket its pro­pri­e­tary CellFX Sys­tem plat­form har­ness­ing its unique Nano-Pulse Sti­m­u­la­tion tech­nol­o­gy. Com­pany filed for 510(k) clear­ance with the FDA dur­ing 2019 based on strong clin­i­cal da­ta from mul­ti­ple ap­pli­ca­tion clin­i­cal studies in its first ap­pli­ca­tion area, aes­thet­ic der­ma­tol­o­gy. Clear­ance is ex­pect­ed dur­ing the first quar­ter of 2020 with com­mer­cial­iza­tion fol­low­ing prompt­ly. [more in­for­ma­tion]

Rigel Pharmaceuticals [RIGL] US$364 MM MCap

Fo­cused on in­hibit­ing path­ways re­lat­ed to im­mune-me­di­at­ed and in­flam­ma­to­ry dis­ease. In April 2018, Rigel launched its first com­mer­cial prod­uct, TA­VALISSE (fos­ta­ma­tinib) in­to a $1 bil­lion US mar­ket for im­mune throm­bo­cy­tope­nia (ITP), a rare he­ma­to­log­i­cal di­s­or­der. TA­VALISSE is al­so in a piv­o­tal Phase 3 trial for an warm au­toim­mune he­mo­lyt­ic ane­mia (wAI­HA), a he­ma­to­log­ic di­s­or­der with no FDA-ap­proved ther­a­py. [more in­for­ma­tion]

Ryvu Therapeutics [RVU:WAR]

Po­ten­tial first in class CD­K8 in­hibi­tor for leukemias, lym­pho­mas, and solid tu­mors in Ph1b in AML and high-risk MDS, PIM/FLT3 ki­nase in­hibi­tor in Ph 1/2 in AML (part­nered w Me­nari­ni). Da­ta in 2020. Ear­ly stage pipe­line ad­dress­ing emerg­ing solid tu­mor tar­gets. [more in­for­ma­tion]

Savara Inc. [SVRA] US$108 MM MCap

Or­phan lung dis­ease; Mol­gradex, Ph 3, in­haled GM-CSF: au­toim­mune pul­mo­nary alve­o­lar pro­tei­no­sis (aPAP), Ph 2a: non­tu­ber­cu­lous my­cobac­te­ria (NTM) lung in­fec­tion [more in­for­ma­tion]

Secarna Pharmaceuticals GmbH

Se­car­na's unique­ly ef­fi­cient LNA­plus™ dis­cov­ery pro­cess is fu­eled by their pro­pri­e­tary and stream­lined Oli­go­fy­er™ bioin­for­mat­ics sys­tems large in-house cell li­brary and own in vit­ro screen­ing as­says. [more in­for­ma­tion]

Selecta Biosciences, Inc. [SELB] US$207 MM MCap

Im­mune tol­er­ance plat­form (Imm­TOR) de­vel­oped in com­bo with rare dis­ease ther­a­pies. SEL-212 (chron­ic re­frac­to­ry gout) in COM­PARE Ph 2 trial vs KRYS­TEXXA®; to­p­line da­ta mid-2020. Gene tx pipe­line in pre­clin­i­cal de­vel­op­ment with Imm­TOR where re-dos­ing re­quire. Ask­Bio col­lab. [more in­for­ma­tion]

Seneca Biopharma [SNCA] US$13 MM MCap

Stream­lined rab­bit anti­body plat­form fo­cused on im­muno­log­i­cal dis­eas­es. Lead pro­gram is a fast fol­low­er to Dupix­ent in Asth­ma and Atopic Der­mati­tis, en­ter­ing the clin­ic late 2020 in Chi­na and ear­ly 2021 in the US. [more in­for­ma­tion]

Sigilon Therapeutics, Inc.

Plat­form cell ther­a­py com­pany fo­cus­ing on sev­er­al chron­ic dis­eas­es (he­mophilia, T1D, ly­so­so­mal stor­age di­s­or­ders); 5 INDs exp in the next 2 years; 1st IND in Jan 2020 (He­mophilia A). Eli Lil­ly col­lab­o­ra­tion in T1D ($75m ini­tial com­mit­ment, $410 mile­s­tones & sin­gle to dou­ble dig­it roy­al­ties). En­gi­neer­ing cells to pro­duce cru­cial pro­teins/en­zymes/etc; en­cap­su­late cells in al­gi­nate sphere co­va­lent­ly bond­ed w/coat­ing that pre­vents fi­bro­sis & re­jec­tion; coat­ing dev'd at Bob Langer's Lab at MIT. Flag­ship Pi­oneeri [more in­for­ma­tion]

Sol-Gel Technologies Ltd. [SLGL] US$184 MM MCap

Com­mer­cial­iz­ing brand­ed gener­ic top­i­cal drug prod­ucts (skin dis­eas­es). Two pos­i­tive Phase 3 pro­grams in rosacea and acne, with NDAs ex­pect­ed in 1H20 and 2H20, re­spec­tive­ly. Ad­di­tio­n­al brand­ed pipe­line as­sets in­clude SGT-210, er­lo­tinib, for the treat­ment of punc­tu­ate pal­mo­plan­tar ker­a­to­der­ma, and pre­clin­i­cal as­set tap­i­narof and rof­lu­mi­last. Sol-Gel al­so has rev­enue from sev­er­al gener­ic col­lab­o­ra­tions. [more in­for­ma­tion]

Solebury Capital

Sole­bury Cap­i­tal LLC is a glob­al ad­vi­so­ry firm and reg­is­tered bro­k­er deal­er ex­clu­sive­ly fo­cused on the equi­ty cap­i­tal mar­kets. We pro­vide our cor­po­rate and fi­nan­cial spon­sor clients with in­de­pen­dent ad­vice, ex­pe­ri­enced judg­ment and tran­s­ac­tion ma­n­age­ment ser­vices – em­pow­er­ing them to make more ful­ly in­formed de­ci­sions at all points in the un­der­writ­ing pro­cess. [more in­for­ma­tion]

Solebury Trout

With al­most two de­cades of ex­pe­ri­ence in the biotech­nol­o­gy, phar­ma­ceu­ti­cal, med­i­cal tech­nol­o­gy and life sci­ence tech­nol­o­gy sec­tors, the Trout Group of­fers its clients the knowl­edge base need­ed to clar­i­fy in­vest­ment themes and lev­er­age key re­la­tion­ships for in­creased ex­po­sure to the prop­er au­di­ence. [more in­for­ma­tion]

Sonnet Biotherapeutics, Inc. [SONN] US$31 MM MCap

Son­net's in­ter­leukin-based can­di­date has been shown to en­hance pK (up to 10 fold) and im­prove tu­mor de­liv­ery with an in­crease in in vi­vo ef­fi­ca­cy (30 fold) as de­mon­s­trat­ed in a mice tu­mor mod­el. The Son­net plat­form de-risks the use of in­ter­leukins by great­ly ex­tend­ing their in vi­vo half-life, while al­so im­prov­ing their spe­ci­fic­i­ty to tu­mor tis­sue. [more in­for­ma­tion]

SphingoTec GmbH

The tests are be­ing im­ple­ment­ed on the Com­pany’s own point-of-care im­munoas­say an­a­lyz­er plat­form ac­quired form Sam­sung in 2018 that is ful­ly de­vel­oped and was orig­i­nal­ly launched in 2012 and was sold more than 1,800 times since then. [more in­for­ma­tion]

Stemline Therapeutics, Inc. [STML] US$621 MM MCap

EL­ZON­RIS, a com­mer­cial tar­get­ed ther­a­py di­rect­ed to IL-3 re­cep­tor (CD123), ap­proved for BPD­CN and on­go­ing trials in other in­di­ca­tions; SL-801 an oral small molecule re­v­ersi­ble in­hibi­tor of XPO1 in Ph 1 trial; and SL-701 an im­munother­a­peu­tic that com­plet­ed Ph 2 trial in pts w/2nd line GBM [more in­for­ma­tion]

sterna biologicals

By tar­get­ing tran­scrip­tion fac­tors that play a cen­tral role in reg­u­lat­ing Th1- and Th2-driv­en in­flam­ma­to­ry mech­anisms, the Com­pany’s pro­pri­e­tary DNAzyme-based drug can­di­dates can in­ter­vene with up­stream in­flam­ma­to­ry pro­cess­es to ad­dress re­lat­ed dis­eas­es more ef­fec­tive­ly. Ster­na cur­rent­ly has four pro­grams in phase 2 de­vel­op­ment. [more in­for­ma­tion]

STRATEC SE [SBS:FF] €1,122 MM MCap

Au­to­ma­tion sys­tems and soft­ware for di­ag­nos­tics in­dus­try. In­s­talled base of >13,000 sys­tems across 20 fam­i­lies in­clud­ing PAN­THER (Ho­log­ic), Li­a­son XL (Di­a­Sorin), VI­DAS (BioMerieux) and AD­VIA (Sie­mens). Rev gen­er­at­ing and pro­f­itable; growth drivers in­cl prod­uct launch­es/ramp-ups, new tests; de­mo­graph­ics and out­sourc­ing in IVD in­dus­try. [more in­for­ma­tion]

Strongbridge Biopharma [SBBP] US$180 MM MCap

Rare dis­eas­es; Keveyis for PPP revs ~21.7M for 2019 and $26 - $27M for 2020. Re­cor­lev for en­doge­nous Cush­ing's syn­drome Ph 3 pub­lished with to­p­line place­bo-con­trolled Ph 3 3Q20. [more in­for­ma­tion]

Sutro Biopharma [STRO] US$324 MM MCap

FolR&al­pha;-tar­get­ing ADC (STRO-002) Phase 1, ad­di­tio­n­al dose es­ca­la­tion da­ta in 1H 2020. CD74-tar­get­ing ADC (STRO-001) Phase 1, ad­di­tio­n­al dose es­ca­la­tion da­ta in 2H 2020. BMS col­lab­o­ra­tion Phase 1 clin­i­cal de­vel­op­ment up­date for CC-99712 (BC­MA-tar­get­ing ADC). Mer­ck col­lab­o­ra­tion up­date in 2020 on first cy­tokine deri­va­tive pro­gram. [more in­for­ma­tion]

Targovax [TRVX:OS] NKr498 MM MCap

Pre­lim­i­nary Ph1b da­ta of OV ON­COS-102+che­mo in me­sothe­lio­ma re­sults: com­bo mPFS=8.4 mos. vs. con­trol mPFS=6.8 mos.; 1L pts mPFS-8.9 mos. Up­com­ing mile­s­tones: up­dat­ed clin­i­cal & im­mune da­ta in Ph2 me­sothe­lio­ma (1H20); pre­clin­i­cal da­ta on next-gen OV w/ dou­ble trans­genes (1H20); and clin­i­cal da­ta from Ph1 me­lano­ma study, part 2 with ex­tend­ed dos­ing (2H20). [more in­for­ma­tion]

Tessa Therapeutics

On­go­ing Ph III (na­sopha­ryn­geal can­cer), up­com­ing piv­o­tal Ph II (Hodgkin lym­pho­ma), and mul­ti­ple other clin­i­cal-stage pro­grams. GMP fa­cil­i­ty un­der con­struc­tion. Key col­lab­o­ra­tions: Bay­lor, Park­er Inst., St. Jude Chil­dren’s, and JV in Chi­na. [more in­for­ma­tion]

Urovant Sciences [UROV] US$289 MM MCap

Re­port­ed pos­i­tive long-term da­ta for lead prod­uct can­di­date, vibe­gron, an oral, once-dai­ly small molecule be­ta-3 ag­on­ist be­ing eval­u­at­ed for over­ac­tive blad­der (OAB). 12-week piv­o­tal phase 3 EM­POWUR study de­mon­s­trat­ed a fa­vor­able long-term safe­ty and tol­er­a­bil­i­ty pro­file and fur­ther im­proved treat­ment ben­e­fit over the 40-week ex­ten­sion. Al­so eval­u­at­ing vibe­gron in a phase 3 study for the treat­ment of OAB in men with be­nign pro­stat­ic hy­per­pla­sia and in a phase 2a study for ab­dom­i­nal pain as­so­ci­at­ed with irr [more in­for­ma­tion]

Vaccitech Limited

Pro­pri­e­tary ChA­dOx (prime) and MVA (boost) tech­nol­o­gy plat­form in­duces and main­tains CD8+ T-cells at the max­i­mum lev­els pub­lished to date. Ph1/2 da­ta for HPV and HBV im­munother­a­pies ex­pect­ed 2H20. En­cour­ag­ing pros­tate can­cer, 5T4 im­munother­a­peu­tic da­ta re­cent­ly re­leased. Ph1/2 NS­CLC MAGE-NYE­SO im­munother­a­peu­tic en­ters clin­ic in Q1 2021. ChA­dOx COVID-19 vaccine out-li­censed to Ox­ford Uni/As­traZene­ca with post-pan­dem­ic rev­enue stream. $150M fund­ing at Jen­n­er In­sti­tute and com­pany raised $48M since for­ma­tion [more in­for­ma­tion]

Vericel Corporation [VCEL] US$724 MM MCap

Mar­ket­ing MA­CI (car­ti­lage re­pair) and Epi­cel (skin re­place­ment) in TAMs of $2b+. FY19 rev­enue of $117.9M in­creased 30% over 2018; FY20 gui­dance of $141M-$146M. Exp mid-20 sub­mis­sion of Nexo­Brid BLA. [more in­for­ma­tion]

Verrica Pharmaceuticals [VRCA] US$227 MM MCap

Ver­ri­ca Phar­ma­ceu­ti­cals is a der­ma­tol­o­gy ther­a­peu­tics com­pany de­vel­op­ing med­i­ca­tions for vi­ral skin dis­eas­es re­quir­ing med­i­cal at­ten­tion. Lead prod­uct, VP-102 for mol­lus­cum con­ta­gio­sum has a PD­U­FA date of Ju­ly 13, 2020. Phase 2 da­ta in ex­ter­nal geni­tal warts ex­pect­ed in 2H20. Ini­ti­a­tion of Phase 3 in com­mon warts in 1H20 and ini­ti­a­tion of Phase 2 in plan­tar warts in mid-2020. [more in­for­ma­tion]

Viela Bio [VIE] US$1,956 MM MCap

BLA for lead can­di­date, ine­bi­l­izumab (an­ti-CD19 mAb), is un­der FDA re­view for the treat­ment of neu­romyeli­tis op­ti­ca spec­trum di­s­or­der (NMOSD); PD­U­FA date June 11, 2020. VIB7734, an­ti-ILT7 mAb, Phase 1b in­ter­im da­ta 1H20. Ad­di­tio­n­al trials with ine­bi­l­izumab ex­pect­ed to ini­ti­ate in 2020, in­clud­ing myas­the­nia gravis and Ig­G4-re­lat­ed dis­ease. [more in­for­ma­tion]

vTv Therapeutics, Inc. [VTVT] US$147 MM MCap

June 2019 pos­i­tive da­ta for TT­P399 as an add-on ther­a­py to in­sulin ther­a­py in a 12 week phase 1/2 trial in pa­tients with T1D. Re­sults from the se­cond part of the Ph2 study ex­pect­ed Q1 2020.&nb­sp;Re­cent­ly an­nounced the first pa­tient has been screened for the Ph2 proof of con­cept study eval­u­at­ing the safe­ty and ef­fi­ca­cy of azeli­ra­gon in pa­tients with mild Alzheimer's dis­ease and Type 2 Di­a­betes. [more in­for­ma­tion]

Vyome Therapeutics Inc.

$22M fund raise Jan '19. Ad­vanced lead as­set VB-1953 to Ph 2 for mod­er­ate to se­vere acne. Pipe­line DART - du­al ac­tion over­com­ing an­timi­cro­bial re­sis­tance - and MRT - pa­tent­ed an­ti­fun­gal plat­form. Treat drug-re­sis­tant skin patho­gens. [more in­for­ma­tion]

Wave Life Sciences Ltd. [WVE] US$345 MM MCap

Top-line da­ta from first 3 clin­i­cal pro­grams, 1 in DMD and 2 in Hunt­ing­ton’s dis­ease, exp 2019. Da­ta read­outs from ad­dl pro­grams in DMD, ALS, and fron­totem­po­ral de­men­tia exp in 2020. Lev­er­ag­ing plat­form to ad­vance pro­grams across oph­thal­mol­o­gy and he­p­a­tol­o­gy. [more in­for­ma­tion]

Yichang Humanwell and Soehngen Consult

Yichang Hu­man­well is lead­ing in sev­er­al ther­a­peu­tic ar­eas, es­pe­cial­ly in anes­thet­ics and pain ma­n­age­ment in Chi­na, and is one of the largest providers of anes­thet­ics medicines in Asia. It ac­counts for 68% of the mar­ket share of nar­cot­ic drugs in 2018 in Chi­na, and its core prod­ucts in­clude in­jecta­bles of Fen­tanyl, Sufen­tanil, Remifen­tanil and Hy­dro­mor­phone. [more in­for­ma­tion]

Yisheng Biopharma

De­vl bio­ther­a­peu­tics for can­cers and in­fec­tious dis­ease. Prod­ucts in de­vt in­clude Ph 1 IO prod­uct tar­get­ing solid tu­mors Ph 3 PI­KA vaccine tar­get­ing hep B and ra­bies in­fec­tions. [more in­for­ma­tion]

Zentalis [ZNTL] US$1,410 MM MCap

In ad­di­tion to its lead pro­gram, ZN-c5, an oral SERD for es­tro­gen re­cep­tor pos­i­tive, HER2-neg­a­tive breast can­cer, the Com­pany is de­vel­op­ing a broad pipe­line of on­col­o­gy can­di­dates, tar­get­ing ar­eas of ma­jor un­met med­i­cal need. [more in­for­ma­tion]