BPC February 18 update

Biotech earnings week ahead; Phase 1/2 data readouts to watch for the remainder of 1Q 2021

Weekly watchlist

Following on from last week’s rundown of Phase 3 readouts to watch, we continue this week with a look ahead at Phase 1/2 notable events slated for data release this quarter. First, let’s review the week that was, which was notably quieter due to the shortened trading week.

Cortexyme, Inc. (NASDAQ:CRTX) shares closed the week down 32% to $32.47 on news the FDA has placed a partial clinical hold on atuzaginstat (COR388) in patients with Alzheimer's disease. As a result, the open-label extension part of its Phase 2/3 trial has stopped. Patients in the placebo-controlled randomized part of the trial will continue to be dosed, with top-line data still slated for 4Q 2021.

bluebird bio, Inc. (Nasdaq: BLUE) announced its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) trials of LentiGlobin gene therapy for sickle cell disease (SCD) (bb1111) have been placed on a temporary suspension due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML). A patient that was treated with LentiGlobin more than five years ago has been recently diagnosed with AML. The company is investigating the cause of the patient’s AML in order to determine if there is any relationship with the use of a lentiviral vector in the manufacture of its LentiGlobin gene therapy. Shares slumped to close the week down 42% to $26.68.

AVROBIO, Inc. (Nasdaq: AVRO) shares fell in sympathy to the fall by bluebird, closing the week down 27% to $11.84. The company also has a clinical-stage gene therapy platform, with its most advanced, a lentiviral gene therapy for Fabry disease currently in Phase 2 trials.

GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) announced they have expanded their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. Vir receives $225m upfront and a further equity investment of $120m. Data from the first of their Phase 3 COVID-19 antibody candidates are due this quarter. Vir shares closed Wednesday up 19% to $80.03, before pulling back almost half of its gains to close the week up 10% to $76.58.

Evolus (NASDAQ:EOLS) shares closed Friday up 72% to $12.29 on news of a settlement agreement with AbbVie (NYSE:ABBV) and Medytox to resolve outstanding litigation related to Jeuveau, a treatment for wrinkles approved for Evolus, a competitor of Abbvie’s Botox. AbbVie will grant a license to Evolus to continue to commercialize Jeuveau in return of milestone and royalty payments from Evolus and the issuance of Evolus common stock to Medytox. The litigation was previously initiated on claims Evolus had stolen trade secrets from Abbvie's South Korean partner to manufacture Jeuveau.

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Selection of biotech earnings next week (15) – full list for premium members

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Phase 1/2 data readouts to watch for the remainder of 1Q 2021.

Drug Stage Catalyst Market Cap

ALT – Altimmune Inc.
T-COVID
COVID-19

Phase 1/2 Phase 1/2 data due 2Q 2021.
$585.4 million

ANAB – AnaptysBio Inc.
ANB019 - POPLAR
Palmo-plantar pustular psoriasis

Phase 2 Phase 2 data due 1Q 2021.
$754.3 million

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

Phase 2 Phase 2 initial data due 1Q 2021.
$195.9 million

ARNA – Arena Pharmaceuticals Inc.
Olorinab
Irritable Bowel Syndrome

Phase 2b Phase 2b trial did not meet primary endpoint - March 2, 2021.
$4.6 billion

AZRX – AzurRx BioPharma Inc.
MS1819 - OPTION 2
Cystic fibrosis

Phase 2b Phase 2b top line data due in 1Q 2021.
$74.3 million

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Progressive Multiple Sclerosis

Phase 2 Phase 2 top-line data due 1Q 2021.
$142.5 million

DVAX – Dynavax Technologies Corporation
Biological E. vaccine with CpG 1018
COVID-19 vaccine

Phase 1/2 Phase 1/2 data due March 2021.
$951.9 million

IMTX – Immatics N.V.
IMA201 (ACTengine)
Solid tumors

Phase 1 Phase 1 initial data due 1Q 2021.
$707.7 million

PLRX – Pliant Therapeutics Inc.
PLN-1474
Liver fibrosis associated with NASH

Phase 1 Phase 1 data due 1Q 2021.
$1.3 billion

VBIV – VBI Vaccines Inc.
BRII-179 (VBI-2601)
Hepatitis B

Phase 2 Phase 1b/2a interim data from low dose cohort released November 18, 2020. Boosting of hepatitis B surface antigen antibodies observed in 60% (6/10) and 67% (6/9) of evaluable patients. Phase 2 combination study to assess VBI-2601 (BRII-179) and BRII-835 (VIR-2218) to be initiated 1Q 2021.
$803.6 million

WVE – Wave Life Sciences Ltd.
WVE-120101 (PRECISION-HD1)
Huntington’s disease

Phase 1/2 Phase 1b/2a top line data 1Q 2021.
$522.2 million