BPC May 01 update

Biotech earnings season continues; Biotech stock catalysts for May

Weekly watchlist

Earnings season ramps up this week with a large number of small and mid-cap companies on the calendar. We note a selection of key revenue-earning firms reporting, while we look ahead at likely catalysts scheduled for May.

Let’s first review the week that was starting with COVID-19 related news.

AstraZeneca PLC (NYSE:AZN) announced a development and distribution agreement with the University of Oxford for a potential vaccine aimed at preventing COVID-19. Initial data from their Phase 1 trial are due in May.

Gilead Sciences. Inc. (NASDAQ:GILD) announced that a Phase 3 placebo-controlled, double blinded trial of its antiviral remdesivir for the treatment of COVID-19 met the primary endpoint. The treatment aided in the recovery of patients, but mortality benefit did not show statistical significance. While by no means a silver bullet for patients with COVID-19, it is encouraging that at least one treatment can be listed on the board. Shares, which initially rose on the news, pulled back later in the week when analysts issued downgrades following notice, ironically, a non-profit model will be used in the distribution of remdesivir.

Moderna, Inc., (NASDAQ:MRNA) announced a 10-year collaboration agreement with Lonza Ltd to enable larger scale manufacture of its mRNA vaccine (mRNA-1273) for COVID-19. The companies intend to manufacture the first batches in July 2020 and manufacture up to 1 billion doses per year. A Phase 2 trial is slated to commence later this quarter.

AVEO Oncology (NASDAQ:AVEO) announced that the final overall survival analysis from its pivotal Phase 3 TIVO-3 trial comparing tivozanib to sorafenib in 3rd and 4th line renal cell carcinoma, will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program on May 29, 2020. Shares closed the week up 76% to $7.27.

Blueprint Medicines Corporation (NASDAQ:BPMC) shares closed the week down 19% to $57.15 following news top-line data from its Phase 3 Voyager trial of avapritinib in patients with locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) did not meet the primary endpoint of an improvement in progression-free survival (PFS) versus regorafenib.

Syndax Pharmaceuticals (NASDAQ:SNDX) shares closed the week up 55% to $18.16. The company announced initial Phase 1 data from its trial of SNDX-5613 in patients harboring an MLL gene rearrangement. Two of three patients showed a response, with one partial and one complete response.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) shares closed the week up 18% to $90.13 following news its Phase 2/3 ADVANCE-1 trial met the primary endpoint, significantly improving agitation in patients with Alzheimer’s disease as compared to placebo.

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15 key companies reporting 1Q earnings. Further companies available on the BioPharmCatalyst Earnings Calendar for premium members:

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Other biotech events slated for May (excludes events slated for 2Q):

Drug Stage Catalyst Market Cap

ADVM – Adverum Biotechnologies Inc.
ADVM-022 (OPTIC)
Wet age-related macular degeneration (Wet-AMD)

Phase 1 Pivotal trial to commence mid-2021.
$1.4 billion

AVEO – AVEO Pharmaceuticals Inc.
Tivozanib
Third line treatment of patients with renal cell cancer

PDUFA PDUFA date March 31, 2021.
$149.5 million

AZN – AstraZeneca PLC
Tagrisso (ADAURA)
Non-small Cell Lung Carcinoma

PDUFA priority review PDUFA date under priority review (sNDA) 1Q 2021 - estimate February 20, 2020 based on 4-mth timeline from acceptance date.
$138.5 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).
$138.5 billion

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

Approved FDA Approval announced May 15, 2020.
$559.6 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 INTREPID
Primary biliary cholangitis (PBC)

Phase 2 Phase 2 top-line data did not meet primary endpoint - May 6, 2020.
$840.5 million

EVFM – Evofem Biosciences Inc.
Amphora - AMPOWER
contraceptive vaginal gel

Approved FDA Approval announced May 22, 2020.
$178.8 million

GNFT – GENFIT S.A.
Elafibranor - RESOLVE-IT
Non-alcoholic steatohepatitis (NASH)

Phase 3 Phase 3 data did not meet primary endpoint - May 11, 2020.
$207.9 million

IOVA – Iovance Biotherapeutics Inc.
LN-144 - lifileucel
Refractory metastatic melanoma

BLA Filing BLA filing due 2021.
$6.1 billion

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

NDA Filing NDA filing announced November 30, 2020.
$36.2 million

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

Phase 3 Phase 3 data did not meet primary endpoint - June 1, 2020.
$36.2 million

MRSN – Mersana Therapeutics Inc.
XMT-1536
Ovarian Cancer, Non Small Cell Lung Cancer

Phase 1 Phase 1 interim update September 17, 2020 noted 34% objective response rate and 79% disease control rate.
$1.6 billion

TRIL – Trillium Therapeutics Inc.
TTI-622
Refractory lymphoma or multiple myeloma

Phase 1b Phase 1 presentation at due at ASH December 5, 2020.
$1.6 billion