BPC November 21 update

GlycoMimetics GLYC shares fall 17% on data delay; Intra-day offerings for ONTX and BPTH

Price and Volume Movers

AstraZeneca (NYSE: AZN) announced that the FDA has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

GlycoMimetics, Inc. (NASDAQ: GLYC) shares closed down 17% to $5.32 following an update that data from its Phase 3 clinical trial of uproleselan in relapsed/refractory AML, will now be released in 2021, a delay compared with previous guidance of a readout in 4Q 2020.

Onconova Therapeutics, Inc. (NASDAQ:ONTX) shares initially soared in early trading, up as much as 97%, following relatively insignificant news of a license agreement with Canadian-based Knight Therapeutics, where it obtains rights to commercialize rigosertib in Canada. However, the company took advantage of the price surge late-morning trading when it announced a public offering of 55m shares with accompanying common stock warrants, at a price of $0.20 for proceeds of $11m. Shares closed down 46% to $0.16.

Bio-Path Holdings, Inc., (NASDAQ:BPTH) shares saw similar price action when it announced pre-market that the FDA had given permission to commence a Phase 1 trial of its oncology candidate, BP1002. Shares traded up as high as 20% following the open, only to close down 22% to $7.62 after it also announced an intra-day registered direct offering of 808,080 shares and warrants to purchase up to 606,060 shares for gross proceeds of approximately $8m.

Enlivex Therapeutics Ltd. (NASDAQ:ENLV) announced that it has withdrawn its previously announced proposed underwritten public offering of ordinary shares due to market conditions.

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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:

Hepion Pharmaceuticals Inc (HEPA): $3.39; +38%.

Seneca Biopharma Inc (SNCA): $1.00; +30%.

Molecular Templates Inc (MTEM): $10.09; +22%.

Proteostasis Therapeutics Inc (PTI): $1.57; +16%.

Tyme Technologies Inc (TYME): $1.21; +15%.

DECLINERS:

Karuna Therapeutics Inc (KRTX): $79.36; -27%.

Iterum Therapeutics (ITRM): $1.70; -18%.

OptiNose Inc (OPTN): $9.40; -18%.

Aprea Therapeutics Inc (APRE): $24.62; -15%.

IGM Biosciences Inc (IGMS): $20.73; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AZN – Astrazeneca PLC
Calquence
Chronic lymphocytic leukaemia

Approved FDA Approval announced November 21, 2019.
$125.1 billion

BIIB – Biogen Inc.
BIIB111
Choroideremia

Phase 3 Phase completion of enrolment announced November 21, 2019 with data due 2H 2020.
$54.2 billion

BPTH – Bio-Path Holdings Inc.
BP1002
Refractory/relapsed lymphoma and chronic lymphocytic leukemia

Phase 1 Phase 1 trial to be initiated.
$22.9 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 INTREPID
Primary biliary cholangitis (PBC)

Phase 2 Phase 2 top-line data due 2Q 2020.
$1.3 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-305
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2b trial to be initiated 2Q 2020.
$1.3 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-938
Respiratory Syncytial Virus

Phase 2b Phase 2b trial has been initiated - noted November 21, 2019.
$1.3 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-514
Hepatitis B virus (HBV)

Phase 1 Phase 1 data due 1Q 2020.
$1.3 billion

ENTX – Entera Bio Ltd.
EB613
Osteoporosis

Phase 2 Phase 2 top-line data from interim (50%) 3-month biomarker endpoint due 2Q 2020.
$27.3 million

GLYC – GlycoMimetics Inc.
Uproleselan (GMI-1271)
Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer

Phase 3 Phase 3 data due 2021.
$259.7 million

IMRN – Immuron Limited
IMM-124E
Travelers’ Diarrhea

Phase 3 Phase 3 trial planned for 2020.
$17.7 million

IOVA – Iovance Biotherapeutics Inc.
LN-144 - lifileucel
Refractory metastatic melanoma

Phase 2 Phase 2 pivotal cohort enrolment to be completed 1Q 2020. Cohort 2 data noted 41% ORR in patients refractory to anti-PD1/L1 - November 21, 2019.
$3.1 billion

SNY – Sanofi
Sutimlimab (BIVV009) - Cardinal
Cold agglutinin disease

Phase 3 Phase 3 data to be presented at ASH December 10, 2019 at 7:45AM.
$115.3 billion

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-102 SL
Fibromyalgia

Phase 3 Phase 3 data September 6, 2016 did not meet primary endpoint - program discontinued. However new Phase 3 program initiated November 21, 2019.
$2.3 million

XERS – Xeris Pharmaceuticals Inc.
Continuous glucagon
Hypoglycemia-Associated Autonomic Failure

Phase 2a Phase 2 data showed no statistically significant differences between the treatment arms. Program to be discontinued - November 21, 2019.
$236.2 million