BPC March 19 update

COVID-19 stocks pull back on recent gains; NovaBay NBY surges on launch of face masks

Price and Volume Movers

Soligenix, Inc. (Nasdaq: SNGX) shares closed up 19% to $1.88. The company announced preliminary top-line data from its Phase 3 trial evaluating SGX301 in the treatment of cutaneous T-cell lymphoma (CTCL) showed a statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. 12 week (Cylce 2) data are expected to be announced in June 2020.

NovaBay Pharmaceuticals, Inc. (NYSE: NBY) shares surged to close up 394% to $1.50. Investors appear to be reacting to news that its Avenova website has recently commenced selling KN95 face masks https://patients.avenova.com/kn95-mask/.

BioNTech SE (Nasdaq: BNTX) shares, which had seen a three-day 197% gain up until today, saw its shares pull back 36% to $59.30. A Phase 1 trial of its mRNA vaccine candidate BNT162 for the prevention of COVID-19, is due to commence in late April 2020.

Other COVID-19 related stocks that have seen upward moves in recent weeks also retraced, with iBio, Inc. (IBIO) $1.32 and Vaxart, Inc. (VXRT) $1.92 shares both falling 18%.

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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:

Precigen, Inc. (PGEN): $2.56; +57%.

Arbutus Biopharma Corporation (ABUS): $1.75; +46%.

ADMA Biologics, Inc. (ADMA): $2.11; +41%.

Verona Pharma plc (VRNA): $2.96; +37%.

Arcutis Biotherapeutics, Inc. (ARQT): $25.23; +36%.

DECLINERS:

Entasis Therapeutics Holdings Inc. (ETTX): $2.75; -51%.

Acer Therapeutics Inc. (ACER): $1.39; -31%.

Neon Therapeutics, Inc. (NTGN): $2.20; -18%.

Mesoblast Limited (MESO): $3.71; -16%.

IMV Inc. (IMV): $1.98; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BTAI – BioXcel Therapeutics Inc.
BXCL501 (SERENITY I)
Schizophrenia - Agitation

Phase 3 Phase 3 data due mid-2020.
$493.1 million

CRIS – Curis Inc.
Fimepinostat (CUDC-907) and venetoclax
Diffuse-large B-cell lymphoma (DLBCL)

Phase 1b Development to be discontinued - noted March 19, 2020.
$25.9 million

CRIS – Curis Inc.
CA-4948
Relapsed or Refractory Non-Hodgkin Lymphoma

Phase 1 Phase 1 data due later in 2020.
$25.9 million

GILD – Gilead Sciences Inc.
Epclusa (sofosbuvir /velpatasvir)
Hepatitis C

Approved sNDA FDA Approval announced March 19, 2020.
$91.7 billion

HOOK – HOOKIPA Pharma Inc.
HB-101
Cytomegalovirus (CMV)

Phase 2 Phase 2 safety and immunogenicity data due 1H 2020, with efficacy data due 2H 2020.
$202.7 million

MYOK – MyoKardia Inc.
Mavacamten (MYK-461) - MAVERICK-HCM
Hypertrophic cardiomyopathy (HCM)

Phase 2 Phase 2 top-line data met primary endpoint. Data to be presented at the American College of Cardiology/World Cardiology Congress joint meeting March 30, 2020, 10:30 a.m – 10:40 a.m CDT.
$2.5 billion

NK – NantKwest Inc.
haNK + avelumab + N-803 (QUILT-3.063)
Merkel cell carcinoma (MCC)

Phase 2 Phase 2 dosing of first patient announced March 19, 2020.
$310.2 million

PHAT – Phathom Pharmaceuticals Inc.
Vonoprazan PHALCON-EE
Erosive esophagitis / Gastroesophageal reflux disease (GERD)

Phase 3 Phase 3 new patient randomization paused due to COVID-19. Top-line data due 2021.
$714 million

PHAT – Phathom Pharmaceuticals Inc.
Vonoprazan PHALCON-HP
H. pylori

Phase 3 Phase 3 trial has temporarily paused new patient randomization due to COVID-19. Top-line data due in 2021.
$714 million

RHHBY – Roche Holding Ltd ADR (Sponsored)
Tocilizumab (COVACTA)
Coronavirus COVID-19

Phase 3 Phase 3 trial initiation announced March 18, 2020.
$266.8 billion

SAVA – Cassava Sciences Inc.
PTI-125
Alzheimer’s disease

Phase 2b Phase 2b top-line data due mid-2020.
$73.4 million

SNGX – Soligenix Inc.
SGX301 (synthetic hypericin)
Cutaneous T-Cell Lymphoma (CTCL) cancer

Phase 3 Phase 3 top-line data met primary endpoint - March 19,2020. Cycle 2 data due June 2020.
$37.6 million

TFFP – TFF Pharmaceuticals Inc - Ordinary Shares
Voriconazole Inhalation Powder
Invasive Pulmonary Aspergillosis (IPA)

Phase 1 Phase 1 MAD 6-month toxicology studies complete by the end of 4Q 2020.
$66.4 million

VBLT – Vascular Biogenics Ltd.
VB-111
Recurrent platinum resistant ovarian cancer

Phase 3 Phase 3 interim analysis noted that the DSMC recommended that the study proceed without modification. Overall CA-125 response rate in the first 60 randomized evaluable patients was 53%.
$47.7 million

VXRT – Vaxart Inc.
Norovirus vaccine
Norovirus vaccine

Phase 1b Phase 2 trial planned. Initiation placed on hold with focus to be placed on COVID-19 vaccine.
$123.1 million