BPC October 03 update

​Arbutus ABUS discontinues early-stage hepatitis B trial - shares fall 24% after hours

Price and Volume Movers

Arbutus Biopharma Corporation (Nasdaq: ABUS) shares are trading after hours down 24% to $1.08 on news it will discontinue the development of AB-506 for the treatment of chronic hepatitis B. The decision follows two cases of acute hepatitis in a Phase 1a clinical trial in healthy volunteers.

PDS Biotechnology Corporation (Nasdaq: PDSB) shares closed up 31% to $3.94. The company announced a modification of the clinical trial collaboration agreement with a subsidiary of Merck to evaluate PDS0101, with Merck's Keytruda. The planned Phase 2 clinical trial will now evaluate the efficacy and safety of the combination as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection and is expected to be initiated in 1Q 2020.

Gilead Sciences, Inc. (NASDAQ: GILD) announced that the FDA approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF), to reduce the risk of sexually acquired HIV-1 infection.

Tocagen Inc. (Nasdaq: TOCA) announced it will reduce its workforce by approximately 65%. Shares closed up 20% to $0.70.

Mesoblast Limited (Nasdaq: MESO) announced a placement of 37.5m shares priced at A$2 per share for a total raise of A$75m. This placement will result in the issue of 37.5 million new fully-paid ordinary shares at a price of A$2.00 per share.

Heron Therapeutics, Inc. (NASDAQ: HRTX) announced after hours it intends to offer and sell shares of its common stock in an underwritten registered public offering. Shares are trading down 7% to $17.97.

Ovid Therapeutics Inc. (Nasdaq: OVID) shares are trading down 14% to $2.81 after hours following news it also intends to offer and sell shares of its common stock and preferred stock in two public offerings.

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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:

Catalyst Biosciences, Inc. (CBIO): $6.18; +25%.

Sorrento Therapeutics, Inc. (SRNE): $2.32; +19%.

Endo International plc (ENDP): $3.86; +13%.

TCR2 Therapeutics Inc. (TCRR): $15.74; +12%.

BioLineRx Ltd. (BLRX): $2.97; +12%.

DECLINERS:

Enlivex Therapeutics Ltd. (ENLV): $11.18; -44%.

Jaguar Health, Inc. (JAGX): $1.04; -21%.

Neuralstem, Inc. (CUR): $1.45; -9%.

Adaptimmune Therapeutics plc (ADAP): $1.28; -9%.

Paratek Pharmaceuticals, Inc. (PRTK): $3.84; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABUS – Arbutus Biopharma Corporation
AB-506
Hepatitis B (HBV)

Phase 1 Development to be discontinued - noted October 3, 2019.
$58 million

APVO – Aptevo Therapeutics Inc.
APVO210
Healthy volunteers

Phase 1 Development terminated - noted October 3, 2019.
$25.4 million

CBIO – Catalyst Biosciences Inc.
Dalcinonacog alfa – DalcA
Hemophilia B

Phase 2b Phase 2b final data due 1H 2020.
$64 million

CRVS – Corvus Pharmaceuticals Inc.
CPI-006
Solid tumors

Phase 1b Phase 1/1b updated data due at SITC November 8, 2019 from 3:45 pm ET.
$95.8 million

GILD – Gilead Sciences Inc.
F/TAF (Descovy)
Pre-exposure prophylaxis

Approved FDA Approval announced October 3, 2019.
$82.7 billion

JAGX – Jaguar Health Inc.
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)

Phase 2 Phase 2 interim analysis is still pending - noted October 3, 2019. Enrolment to be completed November 2019. Final data due 1Q 2020 as per CC October 3, 2019.
$4.3 million

KZR – Kezar Life Sciences Inc.
KZR-616
Autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP)

Phase 2 Phase 2 interim analysis 4Q 2020 with final data due mid-2021.
$60.3 million

KZR – Kezar Life Sciences Inc.
KZR-616
Dermatomyositis and polymyositis

Phase 2 Phase 2 data due 2H 2021.
$60.3 million

MEIP – MEI Pharma Inc.
ME-401
Relapsed/refractory Follicular Lymphoma/Chronic Lymphocytic Leukemia (CLL)

Phase 1b Phase 1b updated data noted ORR 89% for CLL/SLL and 78% for FL.
$123 million

MIST – Milestone Pharmaceuticals Inc.
Etripamil - NODE-303
Paroxysmal supraventricular tachycardia (PSVT)

Phase 3 Phase 3 open label commencement of dosing announced October 3, 2019.
$447.9 million

NGM – NGM Biopharmaceuticals Inc.
NGM282
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 cohort 4 data noted statistically significant change in liver fat content (LFC) of -7.9% compared to -2.0% increase for placebo. Top-line data from full cohort due 1Q 2020.
$658.4 million

PDSB – PDS Biotechnology Corporation
PDS0101 and Keytruda
Head and neck cancer / human papillomavirus-16 (HPV16) infection

Phase 2 Phase 2 trial planned for 1Q 2020.
$17.8 million

SIGA – SIGA Technologies Inc.
TPOXX - IV
Smallpox

NDA Filing NDA filing due 2020.
$445.8 million

SPRO – Spero Therapeutics Inc.
SPR994 (ADAPT-PO)
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data due 3Q 2020.
$204.8 million