BPC February 10 update

Acasti ACST data delay - shares fall 25%; LogicBio LOGC IND placed on clinical hold

Price and Volume Movers

Acasti Pharma Inc (NASDAQ:ACST) shares fell 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 and will seek their guidance about how to conduct the analysis of the TRILOGY 2 data prior to unblinding 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 up 52% to $3.20.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) shares closed down 8% to $47.06 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).

Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced that the FDA accepted its New Drug Application (NDA) for Libervant (diazepam) Buccal Film for the management of seizure clusters. The PDUFA date is September 27, 2020. While the news was expected, shares still closed up 18% to $4.67.

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 are trading down 27% to $7.60 after hours.

Mereo BioPharma Group plc (NASDAQ: MREO) announced a $5m convertible equity financing with Novartis Pharma and concurrently entered into a securities purchase agreement to issue up to $28m of its ordinary shares. Shares closed up 27% to $2.00.

Adverum Biotechnologies, Inc. (NASDAQ:ADVM) shares, which closed up 18% to $12.05, announced after hours it has commenced an underwritten public offering of $100m of its common stock.

Theravance Biopharma, Inc. (NASDAQ:TBPH) announced that it intends to offer $150m of ordinary shares in an underwritten public offering. Shares are trading down 5% to $29.00 after hours.

Xeris Pharmaceuticals, Inc. (NASDAQ:XERS) also announced that it has commenced an underwritten public offering of 6m shares of its common stock. Shares are trading after hours down 7% to $5.70.

Revance Therapeutics, Inc. (NASDAQ:RVNC) announced that it intends to offer $200m of convertible senior notes in a private placement. Shares are trading down 5% to $25.50 after hours.

Moderna, Inc. (Nasdaq: MRNA) shares are trading down 6% to $22.30 after hours after it also announced that it has commenced an underwritten public offering of $500m in shares of common stock.

Can-Fite BioPharma Ltd. NYSE:CANF) shares dropped sharply late in the trading session after it announced an offering of shares and warrants priced at $1.50 for gross proceeds of $5m. Shares closed down 43% to $1.20.

Collegium Pharmaceutical, Inc. (NASDAQ:COLL) shares fell 15% to $21.62 after it announced it will offer $125m of convertible senior notes in a public offering.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Kezar Life Sciences, Inc. (KZR): $5.02; +35%.

Advaxis, Inc. (ADXS): $1.07; +29%.

Stoke Therapeutics, Inc. (STOK): $34.15; +22%.

Lineage Cell Therapeutics, Inc. (LCTX): $1.47; +18%.

Bellicum Pharmaceuticals, Inc. (BLCM): $11.35; +17%.

DECLINERS:

Monopar Therapeutics Inc. (MNPR): $11.58; -26%.

Benitec Biopharma Limited (BNTC): $5.56; -25%.

Alector, Inc. (ALEC): $29.26; -17%.

PDS Biotechnology Corporation (PDSB): $2.03; -11%.

Liquidia Technologies Inc (LQDA): $5.39; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABUS – Arbutus Biopharma Corporation
AB-452
Hepatitis B

Phase 1 Program to be discontinued - February 10, 2020.
$191.7 million

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

AQST – Aquestive Therapeutics Inc.
Libervant - AQST-203
Epileptic seizures

PDUFA PDUFA date September 27, 2020.
$135.4 million

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

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel - (ZUMA-2)
Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancer

PDUFA priority review PDUFA date under priority review August 10, 2020.
$92.2 billion

LLY – Eli Lilly and Company
Solanezumab
Inherited Alzheimer's disease

Phase 2/3 Phase 3 trial did not meet primary endpoint - February 10, 2020.
$132.1 billion

LOGC – LogicBio Therapeutics Inc.
LB-001
Methylmalonic Acidemia (MMA)

Phase 1/2 Phase 1/2 IND placed on clinical hold - February 10, 2020.
$195.1 million

MRNA – Moderna Inc.
mRNA-1647
CMV vaccine (Cytomegalovirus Infection)

Phase 2 Phase 2 interim data due 3Q 2020.
$6.3 billion

TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain

NDA Filing CRL issued November 2, 2018. NDA resubmission announced February 10, 2020.
$68 million

VTVT – vTv Therapeutics Inc.
TTP399
Type 1 Diabetes

Phase 1/2 Phase 2 Part 2 data met primary endpoint - February 10, 2020.
$228.8 million