BPC January 06 update

​Imara IMRA shares fall on disappointing sickle cell data -38%; Offerings ALRN ATOS CLSD HARP RGNX

Price and Volume Movers

Imara Inc. (NASDAQ:IMRA) shares closed down 38% to $14.72 following the release of data from its Phase 2a trial of IMR-687 in adult patients with sickle cell disease (SCD). While the monotherapy arm showed a 25% lower rate of vaso-occlusive crises/sickle cell-related pain crises (VOCs/SCPCs), it recorded decreases in fetal hemoglobin (HbF) levels of 1.1.% compared with baseline. The combination arm of IMR-687 and hydroxyurea saw no meaningful differences in VOCs/SCPCs.

Clearside Biomedical, Inc. (NASDAQ:CLSD) announced a registered direct offering for the sale of 4,209,050 shares at a price of $2.851 per share for gross proceeds of approximately $12m. Shares closed down 11% to $3.45.

Atossa Therapeutics, Inc. (NASDAQ:ATOS) shares fell 19% to $0.92 on news of a registered direct offering of 23,850,000 shares and warrants to purchase 17,887,500 shares at a combined purchase price for one share and .75 warrants to purchase one share of common stock of $1.055.

Aileron Therapeutics, Inc. (NASDAQ:ALRN) also announced a registered direct offering for the sale of 32,630,983 of its shares of common stock at a purchase price of $1.10 per share for gross proceeds of $35.9m. Shares closed down 5% to $1.23.

EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) announced a private placement of shares and warrants at a combined price of $5.225 per share and warrant for gross proceeds of $8m. Shares closed up 5% to $5.34.

Harpoon Therapeutics, Inc. (NASDAQ:HARP) shares are trading down 6% to $17.35 after hours on news it has commenced an underwritten public offering of its common stock.

REGENXBIO Inc. (NASDAQ:RGNX) also announced after hours that it intends to offer $175m of its common stock in an underwritten public offering. Shares have pulled back 3% to $47.00 after hours after closing normal trading hours up 8%.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

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

ADVANCERS:

Orchard Therapeutics plc (ORTX): $6.50; +33%.

9 Meters Biopharma, Inc. (NMTR): $1.37; +28%.

DBV Technologies S.A. (DBVT): $3.62; +27%.

NeuroBo Pharmaceuticals, Inc. (NRBO): $6.68; +20%.

Radius Health, Inc. (RDUS): $21.60; +16%.

DECLINERS:

Brickell Biotech, Inc. (BBI): $1.08; -11%.

Sigilon Therapeutics, Inc. (SGTX): $33.60; -11%.

Lumos Pharma, Inc. (LUMO): $21.29; -9%.

Pandion Therapeutics, Inc. (PAND): $18.88; -8%.

Genocea Biosciences, Inc. (GNCA): $2.45; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
Reproxalap (TRANQUILITY)
Dry eye syndrome

Phase 3 Phase 3 data due 2H 2021.
$538.4 million

AUTL – Autolus Therapeutics plc
AUTO1-AL1
B-Cell Acute Lymphoblastic Leukemia

Phase 1/2 Phase 1/2 full data due 2022.
$439.3 million

AZN – AstraZeneca PLC
Farxiga (Dapa-CKD)
Chronic Kidney Disease

PDUFA priority review PDUFA date under priority review 2Q 2021. Estimate May 6, 2021.
$138 billion

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
Spinal Muscular Atrophy (SMA) Type 3

Phase 2 Phase 2 trial met primary endpoint. Secondary endpoints not met. Will not pursue development further.
$380.4 million

CRNX – Crinetics Pharmaceuticals Inc.
CRN04777
Congenital hyperinsulinism (HI)

Phase 1 Phase 1 trial to commence February 2021.
$493.8 million

INFI – Infinity Pharmaceuticals Inc.
IPI-549 + Nivolumab (MARIO-275)
Urothelial cancer

Phase 2 Phase 2 data to be presented at ASCO Genitourinary Cancers Symposium February 11, 2021 8:00 AM - 6:30 PM EST.
$245.3 million

INFI – Infinity Pharmaceuticals Inc.
IPI-549 + Tecentriq and Abraxane and IPI-549 + Tecentriq and Avastin (MARIO-3)
Front-line triple negative breast cancer (TNBC); Renal cell cancer (RCC)

Phase 2 Phase 2 progression-free survival and updated overall response rate data for will be presented in 1H and 2H of 2021.
$245.3 million

MCRB – Seres Therapeutics Inc.
SER-287
Mild-to-Moderate Ulcerative Colitis

Phase 2b Phase 2b top-line data due 2H 2021.
$2.2 billion

NRBO – NeuroBo Pharmaceuticals Inc.
ANA-001
COVID-19

Phase 2 Phase 2 data due 3Q 2021.
$98.7 million

RDUS – Radius Health Inc.
RAD011
Prader-Willi syndrome

Phase 2/3 Phase 2/3 trial to commence 2H 2021.
$1 billion

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

NDA Filing NDA filing due 1Q 2021.
$194.3 million

SEEL – Seelos Therapeutics Inc.
SLS-005 (IV trehalose) - HEALEY ALS Platform Trial
Amyotrophic lateral sclerosis

Phase 2/3 Phase 2/3 trial to commence 1H 2021.
$118 million

SPRB – Spruce Biosciences Inc.
Tildacerfont
Pediatric Classic Congenital Adrenal Hyperplasia

Phase 2 Phase 2 trial to be initiated 2H 2021.
$485.9 million

TRVN – Trevena Inc.
TRV027
COVID-19

Phase 1b Phase 1b top-line data due 1Q 2021.
$339.2 million