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.

-

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 data noted 50% (3 of 6) of evaluable patients from monotherapy arm and 1/1 patients on combo arm (Keytruda) showed stable disease - February 20, 2020.
$32.1 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

Approved FDA Approval announced February 14, 2020.
$161.9 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.
$22 million

BLCM – Bellicum Pharmaceuticals Inc.
BPX-601
Pancreatic cancer

Phase 1/2 Phase 1 Cohort 5C data due 2H 2020.
$22 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.
$578.9 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 2Q 2020.
$578.9 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.
$578.9 million

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

Phase 2 Phase 2 data due 2020.
$578.9 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.
$578.9 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.
$10.1 million

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

Phase 3 Phase 3 top-line data due summer 2020.
$347.2 million

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

Phase 2b Phase 2b data due summer of 2020.
$347.2 million

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

Phase 1/2 Phase 1/2 trial discontinued - noted July 16, 2019.
$1.1 billion

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

Phase 1/2 Phase 1/2 12-month overall survival data due June 2020, with 18-month data due 4Q 2020.
$1.1 billion

KRYS – Krystal Biotech Inc.
B-VEC (Beremagene Geperpavec) - KB103
Epidermolysis Bullosa

Phase 3 Phase 3 trial to commence 1H 2020.
$668.8 million

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

PDUFA Advisory Committee Meeting February 26, 2020 voted 6-5 in favor of a avorable benefit/risk profile.
$130.6 billion

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

Phase 2 Pivotal trial to be initiated mid-2020.
$7.9 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.
$219.2 million

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

Phase 3 Phase 3 data due 2Q 2020.
$219.2 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.
$219.2 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.
$219.2 million

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

Phase 2b Phase 2b data June 24, 2019 met primary endpoint.
$219.2 million

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

Phase 1/2 Phase 1 complete data to be presented 2H 2020.
$113.7 million

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

Phase 2a Phase 2a data presented at EHA June 16, 2019.
$113.7 million

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

Phase 1 Phase 1 complete dose escalation data due 2H 2020.
$113.7 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-060
Asthma

Phase 2 Phase 2 trial to be initiated 2H 2020.
$113.7 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.
$61.1 million

SYBX – Synlogic Inc.
SYNB1618
Phenylketonuria (PKU)

Phase 2 Phase 2 trial to be delayed due to COVID-19.
$53.2 million

SYBX – Synlogic Inc.
SYNB1020
Cirrhotic patients with elevated ammonia

Phase 1/2 Development to be discontinued due to lack of efficacy.
$53.2 million

TBPH – Theravance Biopharma Inc.
TD-1473
Ulcerative Colitis

Phase 2/3 Phase 2b data due late-2020.
$1.4 billion