BPC May 23 update

​Dynavax DVAX restructure to focus on hepatitis B -8% AH; IPO Pipeline updates BCYC IDYA

Price and Volume Movers

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that it will discontinue investment of its immuno-oncology portfolio and as a result will reduce its workforce by 37%. The company has been developing DV281 and SD-101 in Phase 1/2 trials as part of its cancer immunotherapy program and will now seek strategic alternatives for these programs, while focusing its resources towards its hepatitis B business. Dynavax also announced its CEO, Eddie Gray, will retire from his position. Shares are trading down 8% to $5.85 after hours.

Nektar Therapeutics (Nasdaq: NKTR) announced the formation of Inheris Biopharma, Inc., a wholly-owned subsidiary of Nektar. Inheris will be responsible for the commercialization of NKTR-181, an opioid for the treatment of lower back pain, currently under review with the FDA with a PDUFA date of August 29, 2019.

Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced that it intends to offer and sell American Depositary Shares (ADSs) in an underwritten public offering. Each ADS represents 40 ordinary shares. Data from its Phase 2 trial of IMM-124E for Alcoholic steatohepatitis (ASH) are due later this quarter.

Tocagen Inc. (Nasdaq: TOCA) shares, which closed Wednesday down 39%, fell a further 15% to $4.59. As previously noted, an Independent Data Monitoring Committee (IDMC) recommended that its Phase 3 Toca 5 trial evaluating Toca 511 and Toca FC in patients with recurrent high-grade glioma (HGG) not be stopped and continue through to final analysis.

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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:

Neon Therapeutics, Inc. (NTGN): $5.20; +13%.

Aerpio Pharmaceuticals, Inc. (ARPO): $1.11; +8%.

Evofem Biosciences, Inc. (EVFM): $5.21; +7%.

Oncolytics Biotech Inc. (ONCY): $1.87; +6%.

Soleno Therapeutics, Inc. (SLNO): $2.14; +5%.

DECLINERS:

Outlook Therapeutics, Inc. (OTLK): $1.96; -23%.

DelMar Pharmaceuticals, Inc. (DMPI): $2.25; -19%.

Novus Therapeutics, Inc. (NVUS): $1.71; -10%.

Cytokinetics, Incorporated (CYTK): $9.57; -10%.

Palatin Technologies, Inc. (PTN): $1.40; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
Odevixibat (A4250)
Biliary atresia

Phase 3 Phase 3 trial planned for 2020.
$227.8 million

AZRX – AzurRx BioPharma Inc.
MS1819-SD (OPTION)
Cystic fibrosis

Phase 2 Phase 2 negative data released September 25, 2019. Top-line data compared the coefficient of fat absorption (CFA) treatment phase, 56%, to the CFA of the porcine enzyme replacement therapies (PERT) treatment phase, 86%.
$16.9 million

BCYC – Bicycle Therapeutics plc
THR-149
Diabetic Macular Edema

Phase 1 Phase 1 safety and tolerability data released July 1, 2019.
$172.9 million

BCYC – Bicycle Therapeutics plc
BT1718
Solid tumors

Phase 1/2 Phase 1 initial data due 2H 2019. Phase 2 trial to also commence 2H 2019.
$172.9 million

DVAX – Dynavax Technologies Corporation
DV281
Non-small Cell Lung Cancer (NSCLC)

Phase 1 Announced May 23, 2019 that it will discontinue investment in this program.
$343.9 million

EARS – Auris Medical Holding Ltd.
AM-125
Vertigo

Phase 2 Phase 2 interim analysis due 4Q 2019 or 1Q 2020.
$6.5 million

EARS – Auris Medical Holding Ltd.
AM-201
Healthy volunteers

Phase 1b Phase 1b data from second part of trial due 1Q 2020.
$6.5 million

IDYA – IDEAYA Biosciences Inc.
IDE196
Solid tumors

Phase 1/2 Phase 1/2 initial data due 2Q/3Q 2020.
$130 million

ONCS – OncoSec Medical Incorporated
TAVO + epacadostat + KEYTRUDA (TRIFECTA)
Head and Neck Squamous Cell Carcinoma

Phase 2 Phase 2 initiation of dosing announced May 23, 2019.
$21.3 million

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-1300 (RBP-8000)
Cocaine intoxication

Phase 2 In-licensed - noted May 23, 2019.
$7 million

TYME – Tyme Technologies Inc.
SM-88
Ewing’s sarcoma

Phase 1/2 Phase 1/2 initiation announced May 23, 2019.
$159 million

XBIT – XBiotech Inc.
Bermekimab
Hidradenitis Suppurativa (HS)

Phase 2 Phase 2 trial to commence enrolment by the end of 2019.
$362.1 million