BPC July 18 update

A look ahead at the first big week of 2Q earnings; Biotech Week in Review

Weekly watchlist

Second quarter biotech earnings commenced last week, with Johnson & Johnson (NYSE: JNJ), Seattle Genetics, Inc. (NASDAQ: SGEN) and Novartis AG (NYSE: NVS) heading the season off. The overwhelming majority of companies covered by BioPharmCatalyst bring in limited revenue, and as such, earnings releases typically have limited impact on their respective stock prices. However, for mid and large cap companies with established revenue streams from marketable drugs, such dates should be considered as potential price moving catalysts. Seattle Genetics, Inc. (+19%) and Novarits (+4%) are examples of the importance of such data.

Below we list TEN significant earnings releases coming up next week, while also look at regulatory and clinical readouts slated for July. Note that the list does not include catalysts slated for “mid-2019”, which were highlighted three weeks ago. We will refresh this list next week.

Galapagos NV (Euronext & NASDAQ: GLPG) shares closed the week up 35% to $162.70 on news of a global research and development collaboration with Gilead Sciences, Inc. (NASDAQ: GILD). Galapagos will receive a $3.95b upfront payment and a $1.1b equity investment, where Gilead will increase its holding from 12% to 22%.

AVROBIO, Inc. (NASDAQ: AVRO) announced Monday promising data from its two ongoing clinical trials of its AVR‑RD‑01 investigational gene therapy in Fabry disease. To date, eight patients have been dosed in the trials - three patients in the Phase 2 FAB-201 trial and five patients in the Phase 1 FACTs trial. The first Phase 2 patient had an 87% reduction in plasma lyso-Gb3 at one year, while the first four Phase 1 patients have seen their plasma lyso-Gb3 levels reduced between 33% and 41% versus their ERT pre-treatment levels. Shares closed the week up 54% to $21.99.

scPharmaceuticals Inc. (Nasdaq: SCPH) shares closed the week up 45% to $5.21. The company announced that the FDA has advised the company that further clinical safety, efficacy, or pharmacology trials will not be required as part of the resubmission of its New Drug Application (NDA) for Furoscix for the treatment of congestion in patients with heart failure. It expects to resubmit the NDA in mid-2020.

Amarin Corporation plc (NASDAQ: AMRN) announced a public offering of $400m of its American Depositary Shares. Shares closed the week down 17% to $18.08. Other companies to announce offerings included AzurRx BioPharma (NASDAQ: AZRX), Xenetic Biosciences, Inc. (NASDAQ: XBIO), Atara Biotherapeutics, Inc. (Nasdaq:ATRA), AVROBIO, Inc. (NASDAQ: AVRO), Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), Forty Seven, Inc. (Nasdaq: FTSV) and Immuron Limited (NASDAQ: IMRN).


Key companies reporting 2Q earnings next week:

T: BIIB

W: ALXN GSK MDCO

Th: ALKS AZN BMY GLPG LNTH

F: ABBV


Biotech events left for July (not including catalysts listed as "mid-2019").

Drug Stage Catalyst Market Cap

EVOK – Evoke Pharma Inc.
Gimoti - EVK-001
Female diabetic gastroparesis

NDA Filing CRL issued April 2, 2019. NDA to be resubmitted 4Q 2019.
$21.2 million

ITCI – Intra-Cellular Therapies Inc.
Lumateperone
Schizophrenia

PDUFA PDUFA date extended by three months to December 27, 2019.
$502.1 million

LPTX – Leap Therapeutics Inc.
DKN-01 + KEYTRUDA
Esophagogastric adenocarcinoma

Phase 1/2 Phase 1/2 data August 6, 2019 noted 50% ORR.
$35.1 million

SAGE – Sage Therapeutics Inc.
SAGE-217 - ARCHWAY
Bipolar depression

Phase 2 Phase 2 Part A data July 24, 2019 noted MADRS score of 15.5 points at Day 15 (n=23; p<0.0001) - secondary endpoint.
$8.4 billion

TLSA – Tiziana Life Sciences plc
Milciclib
Hepatocellular carcinoma (HCC)

Phase 2a Phase 2a objective tumor assessments due September 2019.
$94.8 million