BPC February 10 update

​Galapagos GLPG shares fall on late-stage fail; Companies continue to push through offerings

Price and Volume Movers

Galapagos NV NASDAQ:GLPG) shares fell 18% to $89.90 on news their Phase 3 ISABELA trial with Gilead Sciences (NASDAQ:GILD) of ziritaxestat in patients with idiopathic pulmonary fibrosis has been discontinued due to insufficient efficacy shown following a review by the Independent Data Monitoring Committee (IDMC).

Bio-Path Holdings, Inc., (NASDAQ:BPTH) shares closed up 126% to $11.77 following its announcement that it received a patent for its platform technology for DNAbilize, its RNAi nanoparticle drugs.

Cassava Sciences, Inc. (NASDAQ:SAVA) shares fell 14% to $49.29 on news of a registered direct offering of 4,081,633 shares of its common stock, at a purchase price per share of $49, for gross proceeds of $200m.

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Numerous other companies continued to raise cash in the form of direct and public offerings of stock, taking advantage of the current speculative environment. Brief details below:

Iterum Therapeutics plc (NASDAQ:ITRM) - direct offering of 17.5m shares at $2 per share for gross proceeds of $35m.

Assertio Holdings, Inc. (NASDAQ:ASRT) - direct offering of 35m shares at a price of $0.98 per share, for gross proceeds of $34.3m.

Stealth BioTherapeutics Corp (NASDAQ:MITO) – direct offering of 2.339m American Depositary Shares ("ADSs") at $2 per ADS, for gross proceeds of $4.7m.

Travere Therapeutics, Inc. (NASDAQ:TVTX) - public offering of $150m of common stock.

TherapeuticsMD, Inc. (NASDAQ:TXMD) - public offering of common stock.

Onconova Therapeutics, Inc. (NASDAQ:ONTX) - public offering of common stock.

Applied Therapeutics, Inc. (NASDAQ:APLT) - public offering of 3m shares of common stock.

Kadmon Holdings, Inc. (NASDAQ:KDMN) – private offering of $150m of convertible senior notes.

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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:

Anchiano Therapeutics Ltd. (ANCN): $7.96; +184%.

Zynerba Pharmaceuticals, Inc. (ZYNE): $8.75; +47%.

Intec Pharma Ltd (NTEC): $7.85; +33%.

Pulmatrix, Inc. (PULM): $2.65; +33%.

PLx Pharma Inc. (PLXP): $8.75; +27%.

DECLINERS:

Panbela Therapeutics Inc. (PBLA): $6.02; -27%.

Enlivex Therapeutics Ltd. (ENLV): $19.18; -20%.

Ocugen, Inc. (OCGN): $10.25; -19%.

PDS Biotechnology Corporation (PDSB): $5.61; -18%.

aTyr Pharma, Inc. (LIFE): $6.21; -16%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ATOS – Atossa Therapeutics Inc.
AT-301 Nasal Spray
COVID-19

Phase 1 Phase 1 final data released February 25, 2021 - safe and well tolerated.
$194 million

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

BPTS – Biophytis SA
Sarconeos (BIO101) - SARA-INT
Sarcopenia

Phase 2 Phase 2 top-line data due 2Q 2021.
$175 million

GLPG – Galapagos NV
ISABELA - Ziritaxestat GLPG1690
Idiopathic pulmonary fibrosis

Phase 3 Phase 3 trial to be discontinued due to lack of efficacy - February 10, 2021.
$5.5 billion

GMTX – Gemini Therapeutics Inc.
GEM103 (ReGAtta)
Dry Age-related Macular Degeneration / Geographic Atrophy

Phase 2 Phase 2 data due 1H 2021.
$725.3 million

OBSV – ObsEva SA
Linzagolix (OBE2109) - EDELWEISS 3
Endometriosis

Phase 3 Phase 3 data due 4Q 2021.
$251.3 million

PYPD – PolyPid Ltd.
D-PLEX100 - SHIELD I
Abdominal (soft tissue) sternal surgical site infections

Phase 3 Phase 3 data due end of 2021.
$217.5 million

RGLS – Regulus Therapeutics Inc.
RGLS4326
Autosomal dominant polycystic kidney disease (ADPKD)

Phase 1b Phase 1 completion of enrollment of first cohort announced February 10, 2021.
$89.6 million

SGEN – Seagen Inc.
Tisotumab Vedotin
Cervical Cancer

BLA Filing BLA filing announced February 10, 2021.
$27.8 billion

VERU – Veru Inc.
Tadalafil and Finasteride combo
Benign prostatic hyperplasia (BPH)

NDA Filing NDA filing announced February 23, 2021.
$1.1 billion

VERU – Veru Inc.
VERU-111
COVID-19 / Severe Acute Respiratory Syndrome

Phase 3 Phase 3 trial to commence April 2021 with data due 4Q 2021.
$1.1 billion

VNDA – Vanda Pharmaceuticals Inc.
Tradipitant
Gastroparesis

Phase 3 Phase 3 enrollment to be completed 1H 2021.
$985.1 million

VNDA – Vanda Pharmaceuticals Inc.
HETLIOZ (tasimelteon)
Delayed sleep phase disorder (DSPD)

Phase 2 Phase 3 trial to be initiated 1Q 2021.
$985.1 million

YMTX – Yumanity Therapeutics Inc.
YTX-7739
Parkinson’s Disease

Phase 1b Phase 1b preliminary results expected by mid-year 2021.
$182.5 million