BPC February 13 update

Biotech week ahead: PDUFA dates, presentations and earnings; Biotech week in Review

Weekly watchlist

This week we look ahead at data presentations, regulatory decisions and key companies reporting fourth quarter earnings over the coming week. Markets are closed Monday for President’s Day.

A reminder that key catalysts for the quarter as a whole can be viewed in our previous Phase 1/2, Phase 3, and PDUFA lists, which will be refreshed from next week.

First, let’s review the week that was, which was relatively quiet in terms of price-moving clinical data newsflow.

BioXcel Therapeutics, Inc. (NASDAQ: BTAI) shares closed up 55% to $36.97 following a significant upgrade from analysts at Suntrust, which increased their price target from $24 to $150.

ImmunoGen, Inc. (NASDAQ: IMGN), the big earnings mover of the week, reported fourth quarter earnings of $44.9m compared with $13.4m for the same period in 2018 and well ahead of estimates of $29.3m. Forecast revenues for the current year of $60-$65m were also well ahead of consensus of around $45m. Shares closed up Friday 27% to $6.80.

Acasti Pharma Inc (NASDAQ:ACST) shares closed the week down 25% to $0.57 on news that the release of data from its second Phase 3 trial, TRILOGY 2, for the treatment of severe hypertriglyceridemia, will now be delayed until 3Q 2020, compared with earlier guidance of a release this month. The company noted that it intends to request a meeting with the FDA in 2Q 2020 to discuss the failed TRILOGY 1 trial prior to unblinding data from TRILOGY 2.

vTv Therapeutics Inc. (Nasdaq: VTVT) announced that data from Part 2 of the Phase 2 Simplici-T1 trial evaluating TTP399 as an oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D) achieved its primary objective by demonstrating statistically significant improvements in HbA1c (long-term blood sugar) compared to placebo at week 12 (p=0.03). Shares closed the week up 38% to $2.90.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) shares closed down 12% to $45.33 after announcing its Phase 3 trial of troriluzole compared to placebo did not meet the primary endpoint for the treatment of patients with Generalized Anxiety Disorder (GAD). Of more importance to investors, however, is their Phase 3 migraine trial which is slated to release data shortly this quarter.

LogicBio Therapeutics, Inc. (Nasdaq:LOGC) announced that the FDA has placed a clinical hold on the Investigational New Drug (IND) submission for LB-001 for the treatment of methylmalonic acidemia (MMA) pending the resolution of certain clinical and nonclinical questions. Shares closed the week down 37% to 8.01.

XBiotech Inc. (NASDAQ: XBIT) shares closed Thursday down 24% to $16.53 following the release of results of its “modified Dutch auction” tender offer following its announcement in January that it would return $420m to investors via a Dutch auction from proceeds of the sale of its drug bermekimab to Johnson and Johnson. A total of 41,164,725 common shares were tendered for by investors. However, the company announced this amount would be prorated so that investors receive payment for only 31.9% of shares tendered.

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Key earnings dates for the week ahead:

Mon: President’s Day (markets closed)

Tue: BCLI

Wed: BHC GMAB RETA

Thur: ANIK EBS GLPG PBYI RGEN

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Regulatory events and data presentations slated for the upcoming week:

Drug Stage Catalyst Market Cap

ADXS – Advaxis Inc.
ADXS-HOT 503
Non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1 data noted 50% (3 of 6) of evaluable patients from monotherapy arm and 1/1 patients on combo arm (Keytruda) showed stable disease - February 20, 2020.
$35.1 million

AGEN – Agenus Inc.
Balstilimab (AGEN2034) anti-PD-1
Cervical cancer

BLA Filing Phase 1 data from interim analysis noted ORR of 11.4% - February 20, 2020. BLA filing 2020.
$643.5 million

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

Approved FDA Approval announced February 20, 2020.
$62 million

CLRB – Cellectar Biosciences Inc.
CLR 131 - CLOVER-1
Various lymphoma

Phase 2 Phase 2 data update February 19, 2020. Non-Hodgkin’s lymphoma (NHL) - 42% ORR.
$35.8 million

CLRB – Cellectar Biosciences Inc.
CLR 131
Multiple myeloma

Phase 1 Phase 1 trial has been completed - February 19, 2020.
$35.8 million

ESPR – Esperion Therapeutics Inc.
Bempedoic acid
Hypercholesterolemia

Approved FDA Approval announced February 21, 2020.
$1.4 billion

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

Phase 2 Phase 2 completion of enrolment announced June 29, 2020. Further interim data due 2H 2020.
$42.8 million