BPC February 17 update

Processa PCSA financing +33%; VIR expands collaboration with GSK +19%

Price and Volume Movers

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) shares closed up 33% to $10.76 on news it has executed a securities purchase agreement to raise gross proceeds of $10.2m resulting from the sale of 1,321,132 shares through a private investment in public equity (PIPE) financing at a price of $7.75 per share.

GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) announced they have expanded their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. Under the terms of the agreement, GSK will make an upfront payment of $225m and a further equity investment in Vir of $120m. Data from the first of their Phase 3 COVID-19 antibody candidates are due this quarter. Vir shares closed up 19% to $80.03.

Oncolytics Biotech Inc. (NASDAQ:ONCY) shares closed up 18% to $3.56 following the initiation of coverage by analysts at HC Wainwright, with a Buy rating and a price target of $15.

Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) announced a registered direct offering for the sale of 50,830,566 shares and accompanying warrants to purchase 25,415,283 shares at a purchase price of $1.505 per share and accompanying warrant, for gross proceeds of $76.5m. Shares closed down 12% to $1.49.

Molecular Templates, Inc. (NASDAQ:MTEM) shares are trading down 5% to $12.89 after hours on news that it has commenced an underwritten public offering of its common stock.

Veru Inc. (NASDAQ:VERU) also announced after hours that it intends to sell shares of its common stock in an underwritten public offering. Shares are trading down 4% after hours following a 13% drop during the normal trading session to $17.21.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Advaxis, Inc. (ADXS): $1.41; +25%.

Onconova Therapeutics, Inc. (ONTX): $1.51; +24%.

Auris Medical Holding Ltd. (EARS): $4.45; +23%.

Hoth Therapeutics, Inc. (HOTH): $3.04; +22%.

Evofem Biosciences, Inc. (EVFM): $4.88; +22%.

DECLINERS:

Immunic, Inc. (IMUX): $20.29; -20%.

Timber Pharmaceuticals, Inc. (TMBR): $2.46; -20%.

Akers Biosciences, Inc. (AKER): $4.02; -17%.

Aeterna Zentaris Inc. (AEZS): $1.55; -14%.

Veru Inc. (VERU): $17.21; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AZN – AstraZeneca PLC
Lynparza - OlympiA
BRCAm adjuvant breast cancer

Phase 3 Phase 3 trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) versus placebo - February 17, 2021.
$125.3 billion

BGNE – BeiGene Ltd.
Zanubrutinib (BGB-3111)
Waldenström’s macroglobulinemia

PDUFA PDUFA date October 18, 2021.
$28 billion

BPMC – Blueprint Medicines Corporation
Avapritinib
Advanced Systemic mastocytosis (SM)

PDUFA priority review PDUFA date under priority review of June 16, 2021.
$5.7 billion

BPTS – Biophytis SA
Sarconeos (BIO101) - COVA
COVID-19

Phase 2 Phase 2 interim analysis due 1Q 2021 with top-line data due 2Q 2021.
$175 million

CHRS – Coherus BioSciences Inc.
CHS-1420
Psoriasis

PDUFA BsUFA date December, 2021.
$1.1 billion

IMUX – Immunic Inc.
IMU-838 CALVID-1
COVID-19

Phase 2 Phase 2 top-line data released February 17, 2021 - low rates of COVID-19 prevented the primary endpoint from being evaluable. Final analysis 2Q 2021.
$331.1 million

PRVB – Provention Bio Inc.
PRV-3279
Systemic Lupus Erythematosus (SLE) and Lupus nephritis (LN)

Phase 2a Phase 2a portion to commence 2H 2021.
$772.3 million

PTCT – PTC Therapeutics Inc.
PTC299 (FITE19)
COVID-19

Phase 2/3 Phase 2/3 data due 2H 2021.
$3.9 billion

RDHL – Redhill Biopharma Ltd.
RHB-107 (upamostat)
COVID-19 (outpatients)

Phase 2/3 Phase 2/3 initiation of dosing announced February 17, 2021.
$324.4 million

SELB – Selecta Biosciences Inc.
SEL-399
Healthy volunteers

Phase 1 Phase 1 initiation announced February 17, 2021. Interim data due 4Q 2021.
$455.9 million

VKTX – Viking Therapeutics Inc.
VK2809 VOYAGE
Non-alcoholic steatohepatitis (NASH) and fibrosis

Phase 2b Phase 2b enrolment to be completed 2H 2021.
$508.6 million

VKTX – Viking Therapeutics Inc.
VK0214
X-linked adrenoleukodystrophy

Phase 1 Phase 1 trial to be completed 1H 2021.
$508.6 million

VRCA – Verrica Pharmaceuticals Inc.
VP-102
Molluscum contagiosum

PDUFA CRL announced July 14, 2020. NDA resubmitted with new PDUFA date June 23, 2021.
$368.8 million

VTVT – vTv Therapeutics Inc.
HPP737
Psoriasis

Phase 1 Phase 1 trial to be completed 2Q 2021. Phase 2 trial also planned by partner.
$189.5 million