BPC January 29 update

Biotech Stock Earnings Preview; Biotech week in Review

Weekly watchlist

After a smattering of calls this previous week, the first full week of earnings commences this coming week. While the vast majority of pharma and biotech companies tracked by BioPharmCatalyst struggle to turn a profit, the first full week of earnings typically sees the big revenue companies reporting, and accordingly making each report a key catalyst.

Our watch list for this week focuses on key companies reporting full year earnings.

First, let’s review the week that was with a week full of COVID-19 vaccine news.

Novavax, Inc. (NASDAQ:NVAX) shares closed Friday up 65% to $220.94 following the release of interim data from its Phase 3 UK trial of its COVID-19 vaccine NVX-CoV2373. Further upward price movement was also seen as investors compared its efficacy to data of J&J released on Friday.

Overall efficacy of 89.3% was recorded with 56 cases of COVID-19 recorded in the placebo group and 6 cases in the NVX-CoV2373 group. When broken down into effectiveness by strain, efficacy of 95.6% was recorded against the original COVID-19 strain, slightly higher than earlier data released from Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) / BioNTech (NASDAQ:BNTX). The UK variant strain showed an efficacy rate of 85.6%. In the South Africa Phase 2b trial efficacy rates of 60% were recorded in HIV-negative patients with 29 cases observed in the placebo group and 15 in the vaccine group. Following the inclusion of HIV-positive patients, efficacy in the overall population was 49.4%. Sequencing to date has shown 92.6% of cases were infected with the South African variant. The company noted it initiated development against the emerging strains in early January and expects to select ideal candidates for a booster and/or combination bivalent vaccine for the new strains in the coming days and will initiate clinical testing of these new vaccines in the second quarter of this year.

Johnson & Johnson (NYSE:JNJ) also announced data from their Phase 3 single-dose COVID-19 vaccine trial. Among all participants the vaccine was 66% effective in preventing moderate to severe COVID-19, 28 days after vaccination. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination. The vaccine candidate was 85% effective in preventing severe disease across all regions. Shares fell Friday by 4% to $163.13.

Vaxart, Inc. (NASDAQ: VXRT) shares rose ahead of its Phase 1 data release slated for next week of its COVID-19 vaccine pill, closing Friday up 34% to $11.98.

Merck (NYSE:MRK) announced that it is discontinuing development of its COVID-19 vaccine candidates, V590 and V591, and plans to focus its COVID-19 research strategy on advancing two therapeutic candidates, MK-4482 and MK-7110. The decision follows Merck's review of findings from Phase 1 trials for the vaccines, which showed immune responses were inferior to those seen following natural infection and those reported for other COVID-19 vaccines.

Biogen (Nasdaq: BIIB) announced that the FDA has extended the review period by three months for the Biologics License Application (BLA) for aducanumab for the treatment for Alzheimer’s disease. The new PDUFA date is June 7, 2021. The extension is due to the submission of a response to an information request by the FDA, including additional analyses and clinical data, which the FDA will require additional time for review. An FDA Advisory Committee voted in November 2020 that the treatment was ineffective. Shares closed Friday up 5% to $282.61.

Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM) shares closed Friday up 21% to $4.65 following news the FDA has lifted the clinical hold on patient enrollment and dosing of its Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer.

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Biotech Earnings (15 earnings dates to watch) – full calendar for premium members:

Mon: HZNP VRTX

Tue: AMGN PFE

Wed: ABBV BIIB GSK NVO

Thu: ALXN BMY GILD MRK REGN SNY TEVA

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Selection of Covid stocks with near-term catalysts:

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

ARCT – Arcturus Therapeutics Holdings Inc.
LUNAR-COV19
COVID-19 vaccine

Phase 2 Phase 2 trial conducted in U.S. and Singapore. Interim data due early 2021. Phase 3 trial to commence 2Q 2021. Phase 1/2 data released December 28, 2020.
$1.4 billion

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

Phase 3 Phase 3 initial data met primary endpoint. 70% efficacy (90% and 60% across two dosing regimens) - UK and Brazil trial. Data from U.S. trial due 1Q 2021.
$125.3 billion

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

GSK – GlaxoSmithKline PLC
VIR-7831 / GSK418213 (COMET-ICE)
COVID-19 antibody

Phase 3 Phase 3 data due 1Q 2021.
$85.8 billion

HGEN – Humanigen Inc.
Lenzilumab
COVID-19

Phase 3 Phase 3 data due March 2021.
$973 million

RIGL – Rigel Pharmaceuticals Inc.
Fostamatinib
COVID-19

Phase 2 Phase 2 data due April 2021.
$727.5 million

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

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