BPC April 17 update

Key biotech reporting season gets underway; Biotech week in Review

Weekly watchlist

Biotech earnings season gets underway this coming week, in what will be one of the most closely watched reporting seasons in recent times. This coming week sees a few major companies reporting with most large-cap companies set to report the week after. Eyes will be on how the COVID-19 pandemic has affected first quarter earnings together with second quarter guidance.

While some companies have already signalled clinical trial timelines will be extended, many have yet to give specific details regarding such delays, so expect a plateful of updates to be released in their reports. The season covers four weeks, with key companies and their respective earnings dates noted in the weekly watch list from this week.

Before we preview the list and other key events for this month, let’s first review the week that was with price-moving events.

Arcus Biosciences Inc (NASDAQ: RCUS) shares closed the week up 76% to $28.11 following reports by Bloomberg that Gilead is in talks to acquire a stake in the company.

Gilead Sciences, Inc. (NASDAQ: GILD) shares closed Friday up 10% to $83.99 following a report by STAT News of promising responses from patients with COVID-19 treated with Remdesivir. Phase 3 data in severe patients are due at the end of April, while initial data will be released from a placebo-controlled NIAID trial as well as in patients with moderate symptoms, both later in May.

Oragenics, Inc. (NYSE American: OGEN) announced Wednesday its Phase 2 trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients did not meet the primary endpoint. Shares closed the week down 47% to $0.40.

MEI Pharma, Inc. (NASDAQ: MEIP) announced an agreement with Kyowa Kirin Co., Ltd. to further develop ME-401, for the treatment of B-cell malignancies. MEI will receive all revenue from U.S. sales, while Kyowa Kirin has rights outside of the U.S. MEI will receive a $100m upfront payment and is also eligible to receive up to $582.5m in additional payments. Shares closed the week up 42% to $2.42.

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COVID-19 vaccine timeline updates from the past week:

Sanofi (NASDAQ: SNY) / GlaxoSmithKline plc (NYSE:GSK): Vaccine to enter clinical trials in 2H 2020 and available in 2H 2021.

Johnson & Johnson (NYSE:JNJ): Clinical trials to be initiated in September. Data due December. First batches for emergency use will be available in early 2021.

Moderna, Inc., (NASDAQ:MRNA): Phase 1 safety data due 2Q 2020. Phase 2 trial to also commence 2Q 2020, with Phase 3 development to commence fall of 2020.

Sinovac Biotech Ltd (NASDAQ: SVA): Phase 1 enrolment has commenced in China.

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Key companies reporting 1Q earnings:

We: BIIB

Th: LLY

Fr: SNY

Other likely biotech events over the next ~3 weeks:

Drug Stage Catalyst Market Cap

ASND – Ascendis Pharma A/S
TransCon
Hypoparathyroidism

Phase 2 Phase 2 six-month data from the open-label extension portion due 3Q 2020. Phase 3 trial to commence 4Q 2020.
$7 billion

AXSM – Axsome Therapeutics Inc.
AXS-05 ADVANCE-1
Agitation in patients with Alzheimer’s disease (AD)

Phase 2/3 Phase 2/3 top-line met primary endpoint - April 27, 2020.
$2.9 billion

BPMC – Blueprint Medicines Corporation
Avapritinib - Voyager
Gastrointestinal stromal tumors (GIST)

Phase 3 Phase 3 data did not meet primary endpoint - April 28, 2020.
$3.5 billion

CLVS – Clovis Oncology Inc.
Rubraca (rucaparib)
Castrate-resistant prostate cancer (mCRPC)

Approved FDA Approval announced May 15, 2020.
$608.9 million

GILD – Gilead Sciences Inc.
Remdesivir
Coronavirus / COVID-19 - severe patients

Phase 3 Phase 3 data from open-label trial released April 29, 2020 - 10-day course achieved similar improvement compared to 5-day course.
$97.6 billion

ITRM – Iterum Therapeutics plc
Sulopenem
Uncomplicated urinary tract infections (uUTI)

Phase 3 Phase 3 data due May 2020.
$62.6 million

ITRM – Iterum Therapeutics plc
Sulopenem
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data due 2Q 2020.
$62.6 million

KNSA – Kiniksa Pharmaceuticals Ltd.
KPL-716
Prurigo nodularis

Phase 2a Phase 2a trial met primary endpoint - April 22, 2020.
$1.2 billion

MYOV – Myovant Sciences Ltd.
Relugolix - SPIRIT 1
Endometriosis-associated pain

Phase 3 Phase 3 data 2Q 2020.
$1.1 billion

NBIX – Neurocrine Biosciences Inc.
Opicapone
Parkinson's disease

Approved FDA Approval announced April 27, 2020.
$11.6 billion

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

Phase 3 Phase 2/3 initial data noted trial to continue with patients with critical disease only ("severe" cohort discontinued due to no benefit). Phase 3 data due June 2020.
$69 billion

UTHR – United Therapeutics Corporation
Trevyent
Pulmonary Arterial Hypertension (PAH)

CRL CRL announced April 29, 2019.
$5.2 billion