BPC June 05 update

Biotech week in Review; Biotech catalysts to watch in June

Weekly watchlist

Our list of events to watch over the next three weeks remains largely unchanged following a relatively quiet week of clinical readouts and regulatory events. Noted price moving and other news events from the week that was are noted below:

The White House announced as part of its Warp Speed program, five COVID vaccines that it sees as most likely to succeed. The five companies that have been selected are Moderna (MRNA), Astrazeneca (AZN), Johnson & Johnson (JNJ), Merck & Co. (MRK) and Pfizer (PFE). Notable companies not on the list that have made headlines recently include Inovio Pharmaceuticals, Inc. (NASDAQ:INO), Novavax, Inc. (NASDAQ: NVAX) and Sanofi (NASDAQ: SNY). Bloomberg did report later, however, that the White House is having discussions with an additional two companies. The Warp Speed program is reportedly aiming to have ready 300 million doses by the end of this year.

Mereo BioPharma Group plc (NASDAQ: MREO) announced Thursday the completion of a $70m private placement with institutional and accredited investors. The fundraising was led by healthcare fund, Orbimed. Mereo also announced plans to advance etigilimab (Anti-TIGIT) into a Phase 1b trial in 4Q 2020. Shares of the micro-cap company closed the week up 121% to $2.81.

Iterum Therapeutics plc (NASDAQ:ITRM) shares slumped to close the week down 64% to $1.53 on news its Phase 3 trial of sulopenem did not achieve statistical non-inferiority relative to ertapenem in its trial in patients with complicated urinary tract infection (cUTI). Data from its trial in uncomplicated urinary tract infection (uUTI) are due later this month.

Ocugen, Inc. (NASDAQ: OCGN) shares closed the week down 19% to $0.25 following its announcement to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. Host Disease (oGVHD) due to results of interim analysis which indicated the trial was unlikely to meet its co-primary endpoints.

Novus Therapeutics, Inc. (NASDAQ:NVUS) announced top-line data from its Phase 2a clinical trial of OP0201 in acute otitis media (study C-006) did not meet the primary endpoint. Shares slid to close the week down 58% to $0.53.

Biotech catalysts to watch in June:

Drug Stage Catalyst Market Cap

AKRO – Akero Therapeutics Inc.
AKR-001
Nonalcoholic steatohepatitis (NASH)

 Phase 2a Phase 2a dose groups all met primary endpoint - March 31, 2020. Further data released June 30, 2020 noted 48% of patients achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis.
$946.8 million

AZN – Astrazeneca PLC
AZD1222 (ChAdOx1 nCoV-19)
COVID-19 vaccine

 Phase 1 Phase 1 data due July 2020. Phase 3 data due August/September 2020.
$141.2 billion

BLU – BELLUS Health Inc.
BLU-5937
Chronic cough

 Phase 2 Phase 2 data due July 2020.
$724.2 million

BYSI – BeyondSpring Inc.
Plinabulin + TAC (Trial 106)
Chemotherapy-induced neutropenia (CIN)

 Phase 3 Phase 3 interim top-line data due met primary endpoint - June 15, 2020. Final analysis expected in 2H 2020
$444.7 million

CNST – Constellation Pharmaceuticals Inc.
CPI-0610 and ruxolitinib - Manifest
Myelofibrosis

 Phase 2 Phase 2 update due at EHA June 12, 2020. 19 of 30 evaluable patients (63%) achieved SVR35 at 24 weeks.
$1.2 billion

EPZM – Epizyme Inc.
Tazemetostat
Follicular lymphoma

 Approved FDA approval announced June 18, 2020.
$1.6 billion

EVOK – Evoke Pharma Inc.
Gimoti - EVK-001
Diabetic gastroparesis

 Approved FDA Approval announced June 19, 2020.
$91.9 million

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

 CRL CRL announced June 29, 2020.
$1.4 billion

INO – Inovio Pharmaceuticals Inc.
INO-4800
Coronavirus COVID-19 vaccine

 Phase 1 Phase 1 interim data released June 30, 2020. 94% of Phase 1 trial participants demonstrated overall immune responses at Week 6 but no data on how many patients produced antibodies. Phase 2/3 trial to commence July/August 2020.
$3.4 billion

OBSV – ObsEva SA
Linzagolix OBE2109 - PRIMROSE 1
Uterine fibroids

 Phase 3 Phase 3 data due July 6, 2020.
$274.2 million

OPK – Opko Health Inc.
Somatrogon (hGH-CTP)
Children - growth hormone deficiency

 Phase 3 Phase 3 data met primary endpoint.
$2.4 billion

REGN – Regeneron Pharmaceuticals Inc.
Kevzara (Sarilumab)
Coronavirus COVID-19

 Phase 3 Phase 3 trial did not meet primary endpoint - July 2, 2020.
$63.9 billion

SLNO – Soleno Therapeutics Inc.
Diazoxide Choline Controlled-Release (DCCR) - DESTINY PWS
Prader-Willi syndrome (PWS)

 Phase 3 Phase 3 trial did not meet its primary endpoint - June 8, 2020.
$173.4 million

SRPT – Sarepta Therapeutics Inc.
MYO-101 (SRP-9003)
Limb-girdle Muscular Dystrophy Type 2E (LGMD2E)

 Phase 1/2 Phase 1/2 one-year functional results from the low dose cohort presented June 8, 2020. Three patients showed improvement in functional mobility of 4,6 and 7 points.
$12.7 billion

ZGNX – Zogenix Inc.
FINTEPLA (ZX008)
Dravet syndrom

 Approved FDA approval announced June 25, 2020.
$1.6 billion

ZYNE – Zynerba Pharmaceuticals Inc.
Zygel ZYN002
Fragile X syndrome

 Phase 2/3 Phase 2/3 trial did not meet primary endpoint - June 30, 2020.
$87.3 million