BPC January 30 update

Key healthcare companies reporting earnings this coming week; Biotech week in Review

Weekly watchlist

Fourth quarter earnings season gets into full flow this coming week with a large number of mid and large cap companies set to report. The vast majority of companies covered by BioPharmCatalyst do not have marketed drugs and next to little or no revenue, meaning earnings releases have little effect on their stock prices. However, for mid and large cap revenue earning companies, earnings season is a key catalyst to gauge whether or not they have been able to live up to the hype generated during development phases of their drugs.

We list below key earnings dates to look out for over the next week, while also continuing to look ahead at catalysts that are likely to occur over the next 2-3 weeks.

First, let’s review the week that was.

Aimmune Therapeutics, Inc. (Nasdaq: AIMT) announced late-Friday that the FDA approved Palforzia, the first approved treatment for patients with peanut allergy. Initial dose escalation may be administered to patients aged 4 through 17 years. Shares closed the after-hours session on Friday up 17% to $36.19.

Acceleron Pharma Inc. (NASDAQ:XLRN) shares closed the week up 74% to $90.78 following news that its Phase 2 trial of sotatercept met its primary and key secondary endpoints in patients with pulmonary arterial hypertension (PAH).

miRagen Therapeutics, Inc. (NASDAQ: MGEN) announced updated data from its Phase 1 clinical trial of cobomarsen in patients with Adult T-Cell Leukemia/Lymphoma (ATLL). The company noted progression free survival (PFS) of 12.5 months compared with 5.4 months in a historical cohort and a median survival time (MST) of 26 months compared with 7.4 months in a historical cohort. Shares closed the week up 80% to $1.75.

Spring Bank Pharmaceuticals, Inc. (NASDAQ:SBPH) discontinued development of inarigivir soproxil, which was in Phase 2 development for the treatment of chronic hepatitis B virus (HBV). This decision was made following the occurrence of serious adverse events, including one patient death, in its Phase 2b Catalyst trial. Shares closed the week down 32% to $1.25.

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) announced that entered into an agreement with five life sciences investors for the purchase of common stock at $8 per share for gross proceeds of $35m. The pricing represented a premium of 20% to the share price as of market close on Thursday, January 30, which investors reacted positively to, sending shares up Friday 41% to $9.38.

Principia Biopharma Inc. (NASDAQ: PRNB) shares closed the week down 8% to $52.65 following a short report by Kerrisdale Capital, a private investment manager with a short position in the company, which noted misleading data and that its drugs do not work and that the data from its Phase 2 trials in the autoimmune diseases pemphigus and immune thrombocytopenia ("ITP") indicate likely failure in Phase 3.

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Key earnings dates for the week ahead:

Tu: GILD NBIX

We: GSK MRK NVO

Th: ALNY BMY REGN SNY LGND SGEN

Fr: ABBV

Upcoming biotech events to watch over the next 2-3 weeks:

Drug Stage Catalyst Market Cap

ACST – Acasti Pharma Inc.
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia

Phase 3 Phase 3 TRILOGY 1 data did not meet primary endpoint - January 13, 2020. TRILOGY 2 data due 3Q 2020.
$47.7 million

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

Phase 1 Phase 1 data February 8, 2020 - Cohort 1: 6 of 6 patients remain rescue-injection-free at median 50 weeks, with 3 patients at 52 weeks. Cohort 2 - 4 of 6 patients remain rescue-injection-free at 24 weeks at the lower dose.
$888.4 million

ADXS – Advaxis Inc.
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer

Phase 1/2 Phase 1 presentation at ASCO Genitourinary Cancers Symposium February 13, 2020 noted median overall survival (95% CI) of 33.7 months.
$54.5 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

Approved FDA Approval announced February 14, 2020.
$212.9 million

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Rimegepant
Migraine - preventative

Phase 3 Phase 3 top-line data due 1Q 2020.
$2.5 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
TRORILUZOLE
Generalized anxiety disorder (GAD)

Phase 3 Phase 3 trial did not meet primary endpoint - February 10, 2020.
$2.5 billion

BXRX – Baudax Bio Inc.
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery

Approved FDA Approval announced February 20, 2020.
$84.4 million

CBIO – Catalyst Biosciences Inc.
Dalcinonacog alfa – DalcA
Hemophilia B

Phase 2b Phase 2b final data due 2Q 2020.
$76.7 million

CRVS – Corvus Pharmaceuticals Inc.
CPI-444
Solid tumors - cancer

Phase 1b Phase 1b/2 updated data at the ASCO Genitourinary Cancers Symposium (GU) February 13, 2020 noted 1/35 partial responses.
$121.6 million

EXEL – Exelixis Inc.
Cabozantinib + atezolizumab (TECENTRIQ) COSMIC-021
Solid tumors

Phase 1b Phase 1b data at ASCO GU noted ORR 32%.
$6.1 billion

IMMP – Immutep Limited
Eftilagimod alpha and Keytruda - TACTI-002
Non-small cell lung cancer; Head and neck cancer

Phase 2 Phase 2 data released February 19, 2020 noted initial overall response rate of 47% for 1st line NSCLC ; 33% for 2nd line HNSCC patients.
$98.3 million

KOD – Kodiak Sciences Inc
KSI-301
Diabetic macular edema (DME)

Phase 1b Phase 1b data February 8, 2020 - 55% of wet AMD eyes extended to six months and 64% of DME eyes extended to six months or longer before first retreatment.
$2.7 billion

TROV – TrovaGene Inc.
Onvansertib (PCM-075) and Zytiga
Prostate cancer

Phase 2 Phase 2 biomarker data to be presented at AACR April 24-29, 2020.
$12.1 million

XXII – 22nd Century Group Inc.
VLN cigarettes
MRTP application

NDA Filing FDA Tobacco Products Scientific Advisory Committee (TPSAC) to met February 14, 2020, regarding MRTP application.
$128.2 million