BPC July 10 update

Phase 3 small/mid-cap readouts to watch slated for the third quarter; Biotech week in Review

Weekly watchlist

Last week we previewed events to watch due either in July or mid-2020. This week, our focus turns towards the quarter as a whole, as we look ahead at key Phase 3 clinical trial readouts for small and mid-cap companies slated for release this quarter. Let us first review the week that was with notable biotech stock news.

COVID-19:

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the initiation of trials evaluating REGN-COV2, its antibody cocktail for the treatment and prevention of COVID-19. A Phase 3 trial will evaluate the ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient. Additionally, Phase 2/3 trials in hospitalized and non-hospitalized patients have also been initiated with initial data due this summer.

Novavax, Inc. (Nasdaq: NVAX) shares rallied to close the week up 16% to $94.34 following news it has been selected to participate in Operation Warp Speed (OWS), a U.S. government program to deliver vaccines for COVID-19. Novavax has been awarded $1.6 billion to complete development and deliver 100m doses of its vaccine candidate.

CLINICAL:

Immunomedics, Inc. (NASDAQ: IMMU) shares closed the week up 10% to $41.32 following the release of Phase 3 data of Trodelvy (sacituzumab govitecan) in patients with Triple-Negative Breast Cancer. The trial met its primary endpoint demonstrating a statistically significant improvement in progression free survival (PFS) compared to chemotherapy, with a hazard ratio of 0.41 and median PFS of 5.6 months compared to 1.7 months for chemo.

Otonomy, Inc. (Nasdaq: OTIC) announced top-line data from its Phase 1/2 clinical trial of OTO-313 in patients with persistent tinnitus exhibited responder rates of 43% at both Day 29 and Day 57 compared to 13% of placebo patients. Shares closed the week up 33% to $4.20.

Bellus Health Inc. (Nasdaq: BLU) shares slumped to close Monday down 72% to $3.40 on news top-line data from its Phase 2 trial of BLU-5937 in patients with refractory chronic cough failed to meet the primary endpoint.

ObsEva SA (NASDAQ: OBSV) announced its Phase 3 PRIMROSE 1 trial of linzagolix in women with heavy menstrual bleeding due to uterine fibroids, met the primary endpoint, showing a statistically significant reduction in menstrual blood loss compared to placebo. However, shares fell to close the week down 57% to $2.66 on data which noted lower placebo adjusted responder rates than in previous trials by competitors Abbvie and Myovant.

REGULATORY:

Biogen (Nasdaq: BIIB) announced that it has completed its Biologics License Application (BLA) filing for aducanumab for the treatment of Alzheimer’s disease. Biogen has requested Priority Review for the application. Shares closed Wednesday up 4% to $280.19.

Osmotica Pharmaceuticals (NASDAQ:OSMT) shares closed the week up 36% to $8.77. It announced Thursday that the FDA approved Upneeq, for the treatment of acquired blepharoptosis.

OTHER:

Intersect ENT, Inc. (NASDAQ:XENT) shares closed Wednesday up 29% to $17.98 reports by Bloomberg that medical device company Medtronic (NYSE:MDT) has made an offer to acquire Intersect.

Unum Therapeutics Inc. (NASDAQ:UMRX) announced the acquisition of Kiq LLC, a biotech focused on precision kinase inhibitors. Unum also entered into a private placement for proceeds of $104.4m. Shares soared to close the week up 655% to $3.32.

Phase 3 small/mid-cap readouts to watch slated for the third quarter:

Drug Stage Catalyst Market Cap

ACAD – ACADIA Pharmaceuticals Inc.
Pimavanserin - CLARITY-2 and CLARITY-3
Adjunctive Treatment in Patients With Major Depressive Disorder

Phase 3 Phase 3 trial did not meet primary endpoint - July 20, 2020.
$6.2 billion

AKBA – Akebia Therapeutics Inc.
Vadadustat - PRO2TECT
Non-dialysis patients with anemia related to CKD (NDD-CKD)

Phase 3 Phase 3 data due early-September 2020.
$1.5 billion

ALBO – Albireo Pharma Inc.
Odevixibat (A4250) - PEDFIC- 1
Progressive familial intrahepatic cholestasis (PFIC)

Phase 3 Phase 3 top-line data due mid-2020.
$374.3 million

BTAI – BioXcel Therapeutics Inc.
BXCL501 (SERENITY I)
Schizophrenia - Agitation

Phase 3 Phase 3 data met primary and secondary endpoints - July 20, 2020.
$1.1 billion

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
MuSK-antibody positive myasthenia gravis (MuSK-MG)

Phase 3 Phase 3 trial did not meet primary endpoint - August 10, 2020.
$340.9 million

CRBP – Corbus Pharmaceuticals Holdings Inc.
Resunab - RESOLVE-1
Systemic Sclerosis

Phase 3 Phase 3 top-line data due summer 2020.
$577.7 million

ITCI – Intra-Cellular Therapies Inc.
Lumateperone ITI-007-402
Bipolar depression

Phase 3 Phase 3 top-line data due mid-September 2020.
$1.3 billion

MCRB – Seres Therapeutics Inc.
SER-109 - ECOSPOR III
Recurrent C. Difficile infection

Phase 3 Phase 3 data met primary endpoint - August 10, 2020.
$1.6 billion

MESO – Mesoblast Limited
MPC-06-ID
Chronic low back pain

Phase 3 Phase 3 data mid-2020.
$1.4 billion

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)

Phase 3 Phase 3 top-line data due 3Q 2020.
$213.8 million

ODT – Odonate Therapeutics Inc.
Tesetaxel - CONTESSA
Metastatic breast cancer (MBC)

Phase 3 Phase 3 top-line data due 3Q 2020.
$1.3 billion

OTLK – Outlook Therapeutics Inc.
NORSE 1 (ONS-5010-001)
Wet age-related macular degeneration (wet AMD)

Phase 3 Phase 3 data due August 2020.
$165 million

SBBP – Strongbridge Biopharma plc
COR-003 (levoketoconazole) - LOGICS
Endogenous Cushing’s syndrome

Phase 3 Phase 3 top-line data expected September 2020.
$204.4 million

SPRO – Spero Therapeutics Inc.
SPR994 (ADAPT-PO)
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data due 3Q 2020.
$266.9 million