BPC August 13 update

​Deciphera DCPH soars 80% on positive late-stage data

Price and Volume Movers

Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) shares soared to close up 80% to $35.90 on the release of two sets of data from its trials of ripretinib in patients with gastrointestinal stromal tumors (GIST). Its Phase 3 Invictus trial in patients with fourth-line and fourth-line plus GIST achieved its primary endpoint of improved progression free survival (PFS), exhibiting a median PFS of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (HR of 0.15, p<0.0001) compared to placebo. The trial did not meet the key secondary endpoint of objective response rate (ORR), with an ORR of 9.4% shown compared with 0% for placebo (p-value=0.0504). The company also released data from its ongoing Phase 1 trial of ripretinib, in patients with second-line through fourth-line plus GIST. The data showed ORRs of 22% (second-line), 13% (third-line) and 8% (fourth-line). Deciphera took advantage of the price surge by announcing after hours a registered underwritten public offering of $200m of shares of its common stock.

Blueprint Medicines Corporation (NASDAQ: BPMC), which is developing Avapritnib also for GIST, saw its shares close down 4% to $85.76 on the data released by Deciphera.

Oncolytics Biotech Inc. (NASDAQ:ONCY) announced that it intends to offer common shares and warrants to purchase common shares in an underwritten public offering. Shares are trading down 22% to $0.70 after hours.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the FDA has approved the Prior-Approval Supplement (PAS) for the Eylea Injection prefilled syringe. The 2 mg, single-dose provides physicians with a new way to administer Eylea that requires fewer preparation steps compared to vials. Eylea is indicated to treat neovascular (wet) age-related macular degeneration (Wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).

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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:

Atreca, Inc. (BCEL): $14.49; +26%.

Mustang Bio, Inc. (MBIO): $3.55; +23%.

G1 Therapeutics, Inc. (GTHX): $37.28; +19%.

Foamix Pharmaceuticals Ltd. (FOMX): $3.08; +15%.

Fortress Biotech, Inc. (FBIO): $1.50; +13%.

DECLINERS:

Xenetic Biosciences, Inc. (XBIO): $1.86; -12%.

Neurotrope, Inc. (NTRP): $5.30; -12%.

Aptinyx Inc. (APTX): $3.22; -11%.

Solid Biosciences Inc. (SLDB): $5.17; -11%.

Evolus, Inc. (EOLS): $16.00; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ATOS – Atossa Genetics Inc.
Endoxifen - oral
Mammographic breast density (MBD)

Phase 2 Phase 2 trial to commence 4Q 2019 with completion due mid-2020.
$19.9 million

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

Phase 2 Phase 2 data due September 2019.
$25.8 million

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Progressive Multiple Sclerosis

Phase 2 Phase 2 top-line data due mid-2020.
$81.6 million

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line

NDA Filing Phase 3 data met PFS primary endpoint - August 13, 2019. Secondary ORR endpoint not achieved. NDA filing due 1Q 2020.
$1.4 billion

DMAC – DiaMedica Therapeutics Inc.
DM199
Chronic Kidney Disease (African Americans) APOL1

Phase 2 Phase 2 initiation expected 2H 2019 with interim analysis 1Q 2020.
$30.7 million

DMPI – DelMar Pharmaceuticals Inc.
VAL-083
MGMT-unmethylated newly diagnosed Glioblastoma Multiforme (GBM)

Phase 2 Phase 2 initial data noted 53% of patients have achieved compete response. Trial to be completed around mid-2020.
$3.2 million

INNT – Innovate Biopharmaceuticals Inc.
INN-202
Celiac disease

Phase 3 Phase 3 initiation of dosing announced August 13, 2019.
$28.9 million

MIST – Milestone Pharmaceuticals Inc.
Etripamil - NODE-301
Paroxysmal supraventricular tachycardia (PSVT)

Phase 3 Phase 3 top-line data due 1H 2020.
$430.5 million

MTNB – Matinas Biopharma Holdings Inc.
MAT2203
Vulvovaginal candidiasis (VVC)

Phase 2 Phase 2 trial to be initiated 4Q 2019.
$113.6 million

ONCY – Oncolytics Biotech Inc.
Pelareorep and Tecentriq - AWARE-1
Breast cancer

Phase 1b Phase 1b interim data due 4Q 2019.
$12.8 million

PHAS – PhaseBio Pharmaceuticals Inc.
PB2452
Reversal agent for ticagrelor

Phase 2a Phase 2a trial to be completed 4Q 2019. Phase 2b trial to be initiated 4Q 2019. Phase 3 trial to commence 1Q 2020.
$212.1 million

SLGL – Sol-Gel Technologies Ltd.
TWIN
Acne

Phase 3 Phase 3 data due 4Q 2019.
$161.1 million

SNGX – Soligenix Inc.
SGX942 (dusquetide)
Oral Mucositis in Patients with Head & Neck Cancer

Phase 3 Phase 3 interim analysis due September 2019 with top-line data due 1H 2020.
$22.3 million

VCNX – Vaccinex Inc.
Pepinemab (VX15) and avelumab
Non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1/2 full enrolment has been achieved - August 13, 2019. Top-line data due 1H 2020.
$74.2 million