BPC January 15 update

Phase 1 and 2 data readouts to watch for the first quarter; Biotech week in Review

Weekly watchlist

The final part of our first quarter preview of biotech stock events to watch rounds out this week with Phase 1/2 catalysts. Previously a list of PDUFA dates for small and mid-cap companies and Phase 3 data readouts were published.

First, let’s review the week that was with notable price-moving news.

Eli Lilly and Company (NYSE:LLY) shares closed Monday up 12% to $185.94 following the release of data from its Phase 2 trial of Donanemab for the treatment of Alzheimer's Disease. The trial met the primary endpoint, slowing the decline of patients on the Integrated Alzheimer's Disease Rating Scale (iADRS) by 32% relative to placebo.

Biogen Inc (NASDAQ:BIIB) shares followed the move made by Lilly, closing the week up 9% to $275.84. The FDA is currently reviewing its regulatory application for marketing approval of its candidate for Alzheimer’s, Aducanumab, with a decision due by March 7. An FDA Advisory Committee voted last year in November that the treatment was not effective.

Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced it will sell its Inbrija manufacturing operations to Catalent for $80m in cash. Catalent will manufacture Inbrija for Acorda. The company expects that combined savings from the sale, restructuring and other operating cost reductions will reduce annual operating expenses by approximately $40m. Shares closed the week up 63% to $6.70.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. government will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients. Under the new agreement, the government will purchase all finished doses, up to 1.25m, of antibody cocktail delivered by June 30, 2021, in addition to the current supply of doses to treat 300,000 people under a previous agreement. Shares closed the week up 4% to $517.93.

Cardiff Oncology, Inc. (NASDAQ:CRDF) shares fell Friday 31% to $13.46 following the release of updated data from its Phase 1b trial of Onvansertib in patients with colorectal cancer. Of the 12 Phase 1b patients evaluable for efficacy 5 (42%) achieved a partial response (PR) and 8 (67%) have shown a durable response ranging from 6.1 to 13.7 months. At a previous update at the ESMO conference in September the company noted a partial response rate of 45% (5/11 patients).

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Phase 1 and 2 data readouts to watch for the first quarter:

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

AMGN – Amgen Inc.
AMG 510 - sotorasib (CodeBreak 100)
Non-small cell lung cancer (NSCLC)

PDUFA priority review PDUFA date under priority review August 16, 2021.
$130.4 billion

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

ASLN – ASLAN Pharmaceuticals Limited
ASLAN004
Atopic dermatitis

Phase 1 Phase 1 interim data released March 1, 2021. Full data due mid-2021.
$163.7 million

CNCE – Concert Pharmaceuticals Inc.
CTP-692
Schizophrenia

Phase 2 Phase 2 data did not meet primary endpoint - February 1, 2021.
$212.3 million

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

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

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

MTNB – Matinas Biopharma Holdings Inc.
MAT9001 (ENHANCE-IT)
Severe hypertriglyceridemia

Phase 2 Phase 2 data released February 1, 2021. Primary endpoint not met.
$255.5 million

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

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

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide (basket)
POMC Heterozygous Deficiency Obesity, Alstrom Syndrome, POMC Epigenetic Disorders

Phase 2 Phase 2 data released January 26, 2021. 12 of 35 patients (34.3 percent) achieved the primary endpoint. Further data due 1H 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

VXRT – Vaxart Inc.
VXA-CoV2-1
COVID-19 Vaccine

Phase 2 Phase 2 trial to be initiated 2Q 2021.
$781.6 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

ZYME – Zymeworks Inc.
ZW49
HER2-Expressing Cancers

Phase 1 Phase 1 update January 27, 2021. 2/6 partial responses in the high dose three week dosing cohorts.
$1.7 billion