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 (NASDAQ:ENLV) announced that it has withdrawn its previously announced proposed underwritten public offering of ordinary shares due to market conditions.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.
$144.3 billion

BIIB – Biogen Inc.
BIIB111
Choroideremia

Phase 3 Phase 3 data due towards the end of 2020.
$49.4 billion

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

Phase 1 Phase 1 trial to be initiated in 1H 2020.
$20.3 million

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

Phase 2 Phase 2 top-line data did not meet primary endpoint - May 6, 2020.
$1 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 ARGON-2
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2b trial initiation has been delayed due to COVID-19 - March 26, 2020.
$1 billion

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

Phase 2b Phase 2b data due 3Q 2021.
$1 billion

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

Phase 1b Phase 1b trial to be initiated 2Q 2020.
$1 billion

ENTX – Entera Bio Ltd.
EB613
Osteoporosis

Phase 2 Phase 2 six-month and biomarker data due 3Q 2020.
$34.7 million

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

Phase 3 Phase 3 data due 2021.
$123.3 million

IMRN – Immuron Limited
IMM-124E
Travelers’ Diarrhea

Phase 3 Phase 3 trial initiation postponed due to COVID-19.
$9.6 million

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

Phase 2 Phase 2 new cohort 2 interim data presented at ASCO May 29, 2020. 36.4% Overall Response Rate (ORR) maintained
$4.1 billion

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

PDUFA priority review PDUFA date under priority review November 13, 2020.
$124.2 billion

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

Phase 3 Phase 3 interim analysis due September 2020. Top-line data due 1Q 2021.
$34.3 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.
$172.2 million