BPC March 12 update

​Bio-Path BPTH offering +8%; LLY meets NSCLC primary endpoint

Price and Volume Movers

Bio-Path Holdings, Inc., (Nasdaq: BPTH) announced a registered direct offering for institutional investors of 712,910 shares of its common stock, at a purchase price of $25.95 per share, for aggregate gross proceeds of approximately $18.5m. Shares closed up 8% to $35.13.

Eli Lilly and Company (NYSE: LLY) announced that its Phase 3 RELAY study of Cyramza (ramucirumab) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC), met its primary endpoint of progression-free survival (PFS).

Zafgen, Inc. (Nasdaq:ZFGN) shares closed down 37% to $2.89 following news late-Monday that it will suspend plans to file an investigational new drug (IND) application for ZGN-1258, its pipeline candidate for Prader-Willi syndrome (PWS), based on findings in muscle tissue in rodent toxicology studies.

Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced it will be acquired by Smith & Nephew plc (LSE:SN, NYSE:SNN) for $19 per share in cash, representing a total equity value of approximately $660m, a marginal premium compared with Monday's close, with shares closing up just 1% to $19.06.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

Aileron Therapeutics, Inc. (ALRN): $2.12; +51%.

Seelos Therapeutics, Inc. (SEEL): $3.85; +20%.

Jounce Therapeutics, Inc. (JNCE): $6.51; +19%.

Dova Pharmaceuticals, Inc. (DOVA): $9.34; +17%.

Aslan Pharmaceuticals Limited (ASLN): $4.38; +17%.

DECLINERS:

Tonix Pharmaceuticals Holding Corp. (TNXP): $2.97; -12%.

Matinas BioPharma Holdings, Inc. (MTNB): $1.17; -9%.

TrovaGene, Inc. (TROV): $4.44; -8%.

Crinetics Pharmaceuticals, Inc. (CRNX): $23.51; -8%.

Corvus Pharmaceuticals, Inc. (CRVS): $4.07; -8%.

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADXS – Advaxis Inc.
ADXS-HOT 503
Non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1/2 immune response data from Part A monotherapy due 1Q 2020.
$42.2 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

PDUFA CRLs issued 2013 and 2017. New PDUFA extended by three months to February 16, 2020. Advisory Committee Meeting October 30, 2019 voted 14 to 1 in favor.
$238.4 million

BLCM – Bellicum Pharmaceuticals Inc.
BPX-501 Rivo-cel
Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) - cancer

Phase 1/2 Phase 2 pediatric top-line data met primary endpoint of event free survival - July 8, 2019.
$80.4 million

BLCM – Bellicum Pharmaceuticals Inc.
BPX-601
Pancreatic cancer

Phase 1/2 Phase 1 Cohort 5C data due 2H 2020.
$80.4 million

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) oral
Stage 3-4 Chronic Kidney Disease-Associated Pruritus

Phase 2 Phase 2 data met primary endpoint but secondary missed - December 3, 2019. Phase 3 trial to be initated 2H 2020.
$758.1 million

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) injection - KALM-2 global
Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus

Phase 3 Phase 3 enrolment to be completed 4Q 2019.
$758.1 million

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) injection - KALM-1
Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus

Phase 3 Phase 3 data met primary endpoint - May 29, 2019.
$758.1 million

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) oral
Chronic Liver Disease-Associated Pruritus

Phase 2 Phase 2 data due 2H 2020.
$758.1 million

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) oral
Atopic dermatitis patients with moderate-to-severe pruritus

Phase 2 Phase 2 interim analysis 2Q 2020. Top-line data 2H 2020.
$758.1 million

CNAT – Conatus Pharmaceuticals Inc.
Emricasan
NASH cirrhosis - ENCORE-PH trial

Phase 2 Phase 2b data released December 5, 2018 did not meet primary endpoint.
$13.2 million

CRBP – Corbus Pharmaceuticals Holdings Inc.
Resunab - RESOLVE-1
Systemic Sclerosis

Phase 3 Phase 3 top-line data due summer 2020.
$432 million

CRBP – Corbus Pharmaceuticals Holdings Inc.
Anabasum (Resunab)
Cystic Fibrosis

Phase 2b Phase 2b data due summer of 2020.
$432 million

INO – Inovio Pharmaceuticals Inc.
INO-5401 and atezolizumab
Bladder cancer

Phase 1/2 Phase 1/2 trial discontinued - noted July 16, 2019.
$549.1 million

INO – Inovio Pharmaceuticals Inc.
INO-5401 + cemiplimab
Glioblastoma (GBM)

Phase 1/2 Phase 1/2 overall survival data due 2020.
$549.1 million

KRYS – Krystal Biotech Inc.
KB103
Epidermolysis Bullosa

Phase 2 Phase 3 trial to commence 1H 2020.
$998.7 million

LLY – Eli Lilly and Company
Ramucirumab
Non-small cell lung cancer

Phase 3 Phase 3 PFS primary endpoint met - March 12, 2019.
$133.1 billion

NBIX – Neurocrine Biosciences Inc.
Crinecerfont (NBI-74788)
Congenital Adrenal Hyperplasia (CAH) - adults

Phase 2 Pivotal trial to be initiated mid-2020. Phase 2 data to be presented at at ENDO March 28–31, 2020.
$9.1 billion

NERV – Minerva Neurosciences Inc
MIN-117
Major Depressive Disorder

Phase 2b Phase 2b data failed to meet endpoints - December 18, 2019. Development to be discontinued in MDD.
$320.2 million

NERV – Minerva Neurosciences Inc
Roluperidone (MIN-101)
Schizophrenia

Phase 3 Phase 3 data due 2Q 2020.
$320.2 million

NERV – Minerva Neurosciences Inc
MIN-202 (seltorexant)
Major Depressive Disorder

Phase 2 Phase 2b data May 13, 2019 noted p-value was 0.083.
$320.2 million

NERV – Minerva Neurosciences Inc
MIN-202 (seltorexant) vs quetiapine
Major Depressive Disorder

Phase 2 Phase 2b data noted quantitative advantage but no statistical separation between two arms. Company noted trial was not designed to detect statistical significance.
$320.2 million

NERV – Minerva Neurosciences Inc
MIN-202 (seltorexant)
Primary insomnia

Phase 2b Phase 2b data June 24, 2019 met primary endpoint.
$320.2 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-343
HER2-positive solid tumors

Phase 1/2 Phase 1 complete data due 2020.
$166 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-080
Anemia of chronic disease

Phase 2a Phase 2a data presented at EHA June 16, 2019.
$166 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-343 and atezolizumab (Tecentriq)
HER2-positive solid tumors

Phase 1 Phase 1 complete dose escalation data due 2020.
$166 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-060
Asthma

Phase 1 Phase 1 presentation at European Respiratory Society International Congress, October 1, 2019.
$166 million

PSTI – Pluristem Therapeutics Inc.
PLX-R18
Incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT)

Phase 1 Phase 1 DSMB approval given to continue to the final cohort - March 12, 2019.
$57.7 million

SYBX – Synlogic Inc.
SYNB1618
Phenylketonuria (PKU)

Phase 2 Phase 2 trial to commence 1H 2020.
$84 million

SYBX – Synlogic Inc.
SYNB1020
Cirrhotic patients with elevated ammonia

Phase 1/2 Development to be discontinued due to lack of efficacy.
$84 million

TBPH – Theravance Biopharma Inc.
TD-1473
Ulcerative Colitis

Phase 2/3 Phase 2b data due late-2020.
$1.5 billion