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 2 Phase 2 dosing has been initiated - noted November 19, 2019.
$173.8 million

AIM – AIM ImmunoTech Inc.
Ampligen, cisplatin and pembrolizumab
Ovarian cancer

Phase 2 Phase 2 interim data due around 4Q 2020.
$3.3 million

ALKS – Alkermes plc
ALKS 4230 ARTISTRY-1
Solid tumors

Phase 1 Phase 1/2 data at SITC November 2019 - 8/14 SD for monotherapy, 12/18 for combo (incl. 2 PRs).
$3.3 billion

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

Approved FDA Approval announced November 14, 2019.
$11.4 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.
$11.4 billion

HALO – Halozyme Therapeutics Inc.
HALO-301
Pancreatic cancer

Phase 3 Phase 3 data November 4, 2019 did not meet primary endpoint.
$2.8 billion

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

Phase 2 Phase 2 presentation at ASH December 8, 2019 at 6pm. Top-line data due 1H 2020.
$143.3 million

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

Phase 2 Phase 2 data due 2H 2020.
$582.3 million

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

Approved FDA Approval announced September 27, 2019.
$264.1 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.
$20.1 billion

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

Phase 3 Phase 3 data due 2H 2021.
$49.4 million

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

Phase 3 Phase 3 data June 12, 2019 did not meet primary endpoint. Noted October 2, 2019 that the FDA has recommended that a BLA not be filed. Open label data due 1Q 2020.
$46.2 million