BPC February 09 update

​KalVista KALV surges 115% on positive data; Genfit GNFT spikes 95% after hours on old data

Price and Volume Movers

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) shares closed up 115% to $33.50 following its announcement of positive top-line data from its Phase 2 trial of KVD900 as an oral on-demand treatment for hereditary angioedema (HAE) attacks. Attacks treated with KVD900 significantly reduced use of rescue treatment (p=0.001), with 15% of KVD900 treated attacks rescued compared to 30% on placebo at 12 hours. This efficacy benefit of KVD900 was maintained at 24 hours (p=0.0005). The company also announced after hours it intends to sell 4.5m shares in an underwritten public offering.

PDS Biotechnology Corporation (NASDAQ:PDSB) shares closed up 53% to $6.81 on no news. The company has mentioned that it is planning to initiate clinical trials of its COVID-19 vaccine during the first half of this year.

Heat Biologics, Inc. (NASDAQ:HTBX) shares closed up 50% on the back of updated data from its Phase 2 trial of HS-110, in combination with Opdivo (nivolumab) in advanced non-small cell lung cancer (NSCLC). In previously treated, checkpoint inhibitor naïve patients with advanced NSCLC, median progression free survival (PFS) of 1.8 months and a median overall survival (OS) of 24.6 months was observed.

Genfit (NASDAQ:GNFT) shares are trading up 97% after hours to $10.23 on news that data from its Phase 2 clinical trial evaluating elafibranor in patients with Primary Biliary Cholangitis (PBC) have been published in the Journal of Hepatology. Importantly, however, these data are not new and were released in April 2019 (press release).

Several companies announced public offerings. Brief details below:

Oncorus, Inc. (NASDAQ:ONCR) – Public offering of 3m shares.

Genprex, Inc. (NASDAQ:GNPX) - Registered direct offering of 4m at a purchase price of $6.25 per share for proceeds of $25m.

Codiak BioSciences, Inc. (NASDAQ:CDAK) - Public offering of 2.5m shares.

Adicet Bio, Inc. (NASDAQ:ACET) - Public offering of its common stock.

SQZ Biotechnologies Company (NYSE:SQZ) - Public offering of 3m shares.

Mereo BioPharma Group plc (NASDAQ:MREO) – Public offering of American Depositary Shares.

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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:

Heat Biologics, Inc. (HTBX): $12.54; +50%.

Iterum Therapeutics plc (ITRM): $2.27; +47%.

Veru Inc. (VERU): $19.27; +38%.

Evoke Pharma, Inc. (EVOK): $4.41; +38%.

Rockwell Medical, Inc. (RMTI): $1.93; +30%.

DECLINERS:

Aeterna Zentaris Inc. (AEZS): $2.20; -34%.

Infinity Pharmaceuticals, Inc. (INFI): $4.19; -22%.

Ocugen, Inc. (OCGN): $12.61; -20%.

Summit Therapeutics Inc. (SMMT): $9.35; -16%.

Translate Bio, Inc. (TBIO): $29.27; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGEN – Agenus Inc.
AGEN1181 and balstilimab (anti-PD-1)
Colon cancer

Phase 1/2 Phase 1/2 data announced February 9, 2021 - six confirmed responses.
$695.9 million

AZRX – AzurRx BioPharma Inc.
Oral niclosamide
COVID-19

Phase 2 Phase 2 trial to commence 1H 2021.
$74.3 million

CRIS – Curis Inc.
CA-4948 and ibrutinib
Non-Hodgkin Lymphoma (NHL)

Phase 1 Phase 1 initiation of dosing announced February 9, 2021. Initial data due 4Q 2021.
$894.7 million

CYTH – Cyclo Therapeutics Inc.
Trappsol Cyclo
Niemann-Pick Disease Type C

Phase 1/2 Phase 1/2 top-line data due 1Q 2021. Phase 3 trial to be initiated early 2021.
$38.3 million

DCPH – Deciphera Pharmaceuticals Inc.
Vimseltinib (DCC-3014)
Solid tumors / Tenosynovial Giant Cell tumor

Phase 1/2 Phase 1 updated data due 2H 2021.
$2.6 billion

DCPH – Deciphera Pharmaceuticals Inc.
DCC-2618 - INTRIGUE
Gastrointestinal Stromal Tumors (GIST) - second-line

Phase 3 Phase 3 top-line data due 2H 2021.
$2.6 billion

DCPH – Deciphera Pharmaceuticals Inc.
Rebastinib and paclitaxel
Solid tumors

Phase 1/2 Phase 1b/2 updated data in the endometrial cancer cohort due 2Q 2021, and the platinum-resistant ovarian cancer cohort in 2H 2021.
$2.6 billion

HTBX – Heat Biologics Inc.
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 data announced February 9, 2021 - median progression free survival (PFS) of 1.8 months and median overall survival (OS) of 24.6 months.
$179.7 million

INCY – Incyte Corporation
Parsaclisib INCB50465 (CITADEL-203)
Follicular lymphoma

NDA Filing NDA filing due 2H 2021.
$17.3 billion

INCY – Incyte Corporation
Ruxolitinib - TRuE-V
Vitiligo

Phase 3 Phase 3 initial data due 1H 2021.
$17.3 billion

KALV – KalVista Pharmaceuticals Inc.
KVD900
Hereditary Angioedema (HAE)

Phase 2 Phase 2 positive data released February 9, 2021. Significantly reduced use of rescue (p=0.001), with 15% of KVD900 treated attacks rescued compared to 30% on placebo at 12 hours.
$780.2 million

MRK – Merck & Company Inc. (new)
Keytruda KN-522
Triple negative breast cancer (TNBC)

PDUFA PDUFA date March 29, 2021. Advisory Committee meeting advised that the date should be extended pending further data.
$184.3 billion

REGN – Regeneron Pharmaceuticals Inc.
Libtayo
Basal cell carcinoma (BCC)

Approved FDA approval announced February 9, 2021.
$48.7 billion

SIOX – Sio Gene Therapies Inc.
AXO-AAV-GM1
GM1 gangliosidosis

Phase 1/2 Phase 1/2 12-month data from low-dose cohort due 2H 2021.
$157.5 million