BPC February 08 update

Small-cap biotech stocks surge on little news; Erytech ERYP falls on interim trial review

Price and Volume Movers

A significant number of stocks saw speculative upward price moves today, with little to no news in the sector seeing extraordinary price moves lately. Refer to the Advancers list for the big movers of the day.

Ocugen, Inc. (NASDAQ:OCGN) surged to close up 201% to $15.81. The company announced a registered direct offering of 3m shares of its common stock at a purchase price of $7.65 per share for gross proceeds of approximately $23m.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) shares closed up 22% to $1.55 on news that it intends to initiate clinical trials of TNX-2100, a skin test to measure COVID-19 exposure. Intra-day, the company announced the pricing of a direct offering priced at $1.20 per share for gross proceeds of $70m.

Alterity Therapeutics Limited (NASDAQ: ATHE) shares are trading up 27% after hours to $2.52 following an Australian market press release which noted funding of US$495,000 for primate testing to determine the optimal dose of ATH434 in future Parkinson’s disease clinical trials.

Baudax Bio, Inc. (NASDAQ:BXRX) shares closed up 6% to $1.70, trading as high as $2 late in the session, before falling following news of an offering of 11m shares at a purchase price of $1.60 per share in a registered direct for proceeds of approximately $17.6m.

Erytech Pharma S.A. (NASDAQ: ERYP) shares closed down 15% to $9.55 following news that its Phase 3 TRYbeCA-1 trial in patients with second-line pancreatic cancer, will continue through to final analysis following interim analysis by an Independent Data Monitoring Committee (IDMC). There was potential for the trial to be stopped early if there were sufficient efficacy, which investors were hopeful of. However, the committee deemed that the trial should continue through to final analysis expected in the fourth quarter of 2021.

Autolus Therapeutics plc (NASDAQ:AUTL) announced after hours that it has commenced an underwritten public offering of up to $100m of its American Depositary Shares (ADSs), each ADS representing one ordinary share.

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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:

Aeterna Zentaris Inc. (AEZS): $3.34; +201%.

Zosano Pharma Corporation (ZSAN): $1.93; +75%.

Outlook Therapeutics, Inc. (OTLK): $3.31; +52%.

Marker Therapeutics, Inc. (MRKR): $3.19; +48%.

Purple Biotech Ltd. (PPBT): $6.99; +47%.

DECLINERS:

Pliant Therapeutics, Inc. (PLRX): $31.35; -8%.

Seagen Inc. (SGEN): $177.15; -7%.

VistaGen Therapeutics, Inc. (VTGN): $1.89; -7%.

Progenity, Inc. (PROG): $5.79; -7%.

Bicycle Therapeutics plc (BCYC): $28.24; -7%.

I-Mab (IMAB): $57.98; -6%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

CORT – Corcept Therapeutics Incorporated
Relacorilant plus nab-paclitaxel (RELIANT)
Pancreatic cancer

Phase 3 Phase 3 data from first 40 patients due 1H 2021.
$2.9 billion

CUE – Cue Biopharma Inc.
CUE-101 and Keytruda - KEYNOTE-A78
HPV16+ head and neck cancer

Phase 1 Phase 1 initiation of dosing announced February 8, 2021.
$393.6 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-514
Hepatitis B virus (HBV) - viremic chronic

Phase 1b Phase 1b initial data due 2Q 2021.
$1 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 ARGON-2
Non-alcoholic steatohepatitis (NASH)

Phase 2b Phase 2b interim analysis due mid-2021.
$1 billion

ERYP – Erytech Pharma S.A.
Eryaspase (Trybeca-1)
Pancreatic cancer

Phase 3 Phase 3 interim analysis February 8, 2021. Trial to continue through to final analysis due 4Q 2021.
$181.5 million

FIXX – Homology Medicines Inc.
HMI-203
Hunter syndrome (MPS II)

Phase 1/2 Phase 1/2 trial planned for later in 2021.
$477.5 million

FRLN – Freeline Therapeutics Holdings plc
FLT180a
Hemophilia B

Phase 1/2 Phase 1/2 data due by end of 2022. Phase 3 trial to be initiated mid-2023.
$519.8 million

GMTX – Gemini Therapeutics Inc.
GEM103
Wet Age-Related Macular Degeneration (AMD)

Phase 2a Phase 2a top-line data due 2H 2021.
$725.3 million

GMTX – Gemini Therapeutics Inc.
GEM103 (ReGAtta)
Dry Age-related Macular Degeneration / Geographic Atrophy

Phase 2 Phase 2 data due 1H 2021.
$725.3 million

NAVB – Navidea Biopharmaceuticals Inc.
NAV3-32 (TC99m-tilmanocept)
Rheumatoid arthritis

Phase 2b Phase 2b commencement of US site enrollment announced February 8, 2021. Phase 3 trial planned.
$65.2 million

OPNT – Opiant Pharmaceuticals Inc.
OPNT003
Opioid Overdose

NDA Filing NDA to be filed in 2021. Data from PK trial due June 2021.
$56.2 million

QURE – uniQure N.V.
AMT-130
Huntington's disease

Phase 1/2 Phase 1/2 enrollment to be completed mid-2021.Initial biomarker and imaging data due towards end of 2021.
$1.6 billion

SUPN – Supernus Pharmaceuticals Inc.
SPN-812 (pediatric)
ADHD

PDUFA CRL announced November 9, 2020. NDA filing resubmitted February 8, 2021. PDUFA date two month review - estimate April 8, 2021.
$1.3 billion

VERU – Veru Inc.
VERU-111
COVID-19 / Severe Acute Respiratory Syndrome

Phase 3 Phase 3 trial to commence April 2021 with data due 4Q 2021.
$1.1 billion