BPC June 12 update

​Savara SVRA shares plunge on late-stage fail; Synlogic SYBX +25% on collaboration

Price and Volume Movers

Savara Inc. (Nasdaq: SVRA) shares have slumped after hours, currently trading down 74% to $2.72 on the release of data from its Phase 3 clinical trial evaluating Molgradex, for the treatment of autoimmune pulmonary alveolar proteinosis. An average A-aDO2(alveolar-arterial oxygen) improvement of 12.1 mmHg was observed in the continuous dosing arm, compared to 8.8 mmHg in the placebo arm. With an estimated 4.6 mmHg treatment difference (p=0.17), the study did not meet its primary endpoint.

Seres Therapeutics, Inc. (Nasdaq: MCRB) shares are trading down 15% to $2.80 after hours following its announcement that it is commencing an underwritten registered public offering of $60m of shares of its common stock.

Synlogic, Inc. (Nasdaq: SYBX) shares closed up 25% to $7.85 on news of a collaboration with Ginkgo Biowork and its cell programming platform. As part of the agreement, Ginkgo has purchased 6,340,771 shares of Synlogic common stock as well as pre-funded warrants to purchase up to 2,548,117 shares, both at a price of $9per share for gross proceeds of approximately $80m.

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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:

Hemispherx Biopharma, Inc. (HEB): $6.76; +22%.

Tocagen Inc. (TOCA): $5.94; +16%.

BeyondSpring Inc. (BYSI): $20.34; +15%.

Immuron Limited (IMRN): $3.55; +15%.

Capricor Therapeutics, Inc. (CAPR): $3.75; +14%.

DECLINERS:

Jaguar Health, Inc. (JAGX): $7.78; -23%.

Oncternal Therapeutics, Inc., (Nasdaq: ONCT): $4.86; -17%.

ContraVir Pharmaceuticals, Inc. (CTRV): $7.95; -16%.

Epizyme, Inc. (EPZM): $12.10; -14%.

Navidea Biopharmaceuticals, Inc (NAVB): $1.01; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AFMD – Affimed N.V.
AFM13
CD30-positive peripheral T cell lymphoma (PTCL)

Phase 1/2 Phase 2 interim efficacy data due mid-2020. Top-line data due 2021.
$169.8 million

ALKS – Alkermes plc
ALKS 4230 ARTISTRY-1
Solid tumors

Phase 1 Phase 1/2 data due 2H 2019.
$3.4 billion

BGNE – BeiGene Ltd.
Zanubrutinib (BGB-3111)
Relapsed or refractory mantle cell lymphoma (MCL)

Phase 2 Phase 2 updated data at ICML June 19, 2019 - ORR was 83.7%; CR rate 77.9%.
$8.7 billion

BGNE – BeiGene Ltd.
Zanubrutinib and Obinutuzumab
Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

Phase 1b Phase 1b data presented at ICML June 20, 2019 noted ORR 72-100%. Phase 2 trial is ongoing.
$8.7 billion

CNCE – Concert Pharmaceuticals Inc.
CTP-692
Schizophrenia

Phase 1 Phase 2 trial to be initiated 4Q 2019. Phase 1 data to be presented at the ECNP Annual Congress, September 7-10, 2019.
$248.9 million

HALO – Halozyme Therapeutics Inc.
HALO-301
Pancreatic cancer

Phase 3 Phase 3 data due by December 2019.
$2.4 billion

HEB – Hemispherx BioPharma Inc.
Ampligen, cisplatin and pembrolizumab
Ovarian cancer

Phase 2 Phase 2 initiation of patient dosing announced June 12, 2019 with data due 2021.
$4.2 million

IMV – IMV Inc.
DPX-Survivac and pembrolizumab
Diffuse Large Cell Lymphoma

Phase 2 Phase 2 top-line data due 1H 2020. Update due 2H 2019.
$157.4 million

KNSA – Kiniksa Pharmaceuticals Ltd.
Mavrilimumab
Giant cell arteritis (GCA)

Phase 2 Phase 2 data due 2H 2020.
$548 million

RHHBY – Roche Holding Ltd ADR (Sponsored)
MabThera/ Rituxan (rituximab)
Granulomatosis with polyangiitis (GPA) / microscopic polyangiitis (MPA)

PDUFA priority review PDUFA date under priority review, sBLA accepted June 12, 2019. No PDUFA date released. Estimate October 11, 2019 assuming sBLA was filed two months prior to acceptance.
$237.6 billion

SGEN – Seattle Genetics Inc.
ADCETRIS and Opdivo CM-744
Relapsed/Refractory Classical Hodgkin Lymphoma

Phase 2 Phase 2 presentation at EHA June 15, 2019.
$12.8 billion

SMMT – Summit Therapeutics plc
Ridinilazole
C. difficile infection (CDI)

Phase 3 Phase 3 data due 2H 2021.
$40.8 million

SVRA – Savara Inc.
Molgradex - IMPALA
Autoimmune pulmonary alveolar proteinosis (PAP)

Phase 3 Phase 3 data June 12, 2019 did not meet primary endpoint.
$90.6 million