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 safety, tolerability and immune correlative data due by the end of June 2019.
$40.9 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

NDA Filing CRL issued 2013. Further CRL issued December 22, 2017. Resubmission due 2Q 2019.
$66.6 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 paediatric top-line data due 2Q 2019.
$153.8 million

BLCM – Bellicum Pharmaceuticals Inc.
BPX-601
Pancreatic cancer

Phase 1 Phase 1 initial data released December 14, 2018 at ESMO noted 2/6 patients had tumor shrinkage >20%. Further data due 1H and 2H 2019.
$153.8 million

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

Phase 2 Phase 2 data due 2H 2019.
$725.7 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 data due 2H 2019.
$725.7 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 due 2Q 2019.
$725.7 million

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

Phase 2 Phase 2 trial to be initiated 2Q 2019.
$725.7 million

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

Phase 2 Phase 2 trial to be initiated mid-2019.
$725.7 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. Late breaker at EASL April 13, 2019, 4:00 p.m. CEST. 48-week liver function data due mid-2019.
$39.6 million

CRBP – Corbus Pharmaceuticals Holdings Inc.
Resunab
Systemic Sclerosis

Phase 3 Phase 3 data due 2020.
$463 million

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

Phase 2b Phase 2b data due 2020.
$463 million

FBIO – Fortress Biotech Inc.
IV Tramadol
Post-operative Pain

Phase 3 Phase 3 data due mid-2019.
$111.2 million

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

Phase 1/2 Phase 1/2 interim readout due 2019.
$352 million

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

Phase 1/2 Phase 1/2 interim readout due 2019.
$352 million

KRYS – Krystal Biotech Inc.
KB103
Epidermolysis Bullosa

Phase 2 Phase 2 top-line data due 1H 2019.
$392 million

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

Phase 3 Phase 3 PFS primary endpoint met - March 12, 2019.
$134.2 billion

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

Phase 2a Phase 2a positive interim data released March 12, 2019.
$7.7 billion

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

Phase 2b Phase 2b data due mid-2019.
$298.2 million

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

Phase 2b Phase 2b data due mid-2019.
$298.2 million

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

Phase 2 Phase 2b data due 2Q 2019.
$298.2 million

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

Phase 3 Phase 3 data due mid-2019.
$298.2 million

NERV – Minerva Neurosciences Inc
MIN-117
Major Depressive Disorder

Phase 2a Phase 2b data due 1H 2019.
$298.2 million

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

Phase 1 Phase 1 data due 2019.
$150.4 million

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

Phase 2a Phase 2a data due 1H 2019.
$150.4 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-060
Healthy subjects

Phase 1 Phase 1 initial data due at upcoming meeting.
$150.4 million

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

Phase 1/2 Phase 1 data due 2019.
$150.4 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.
$111.5 million

RCKT – Rocket Pharmaceuticals Inc.
RP-L102
Fanconi Anemia (FA)

Phase 1 Phase 1 dosing of first patient announced March 12, 2019. Initial data due by end of 2019.
$776.4 million

SYBX – Synlogic Inc.
SYNB1020
Cirrhotic patients with elevated ammonia

Phase 1/2 Phase 1b/2a data due mid-2019.
$190.8 million

SYBX – Synlogic Inc.
SYNB1618
Phenylketonuria (PKU)

Phase 1 Phase 1/2 top-line data due mid-2019.
$190.8 million

TBPH – Theravance Biopharma Inc.
TD-1473
Ulcerative Colitis

Phase 2/3 Phase 2b/3 initiation of dosing announced March 12, 2019.
$1.3 billion