BPC December 19 update

​Catalyst CBIO and Selecta SELB shares rally on respective license agreements

Price and Volume Movers

Catalyst Biosciences, Inc. (Nasdaq: CBIO) announced it has entered into a global license and collaboration agreement with Biogen Inc. (Nasdaq: BIIB) for the development of CB 2782 for the potential treatment of geographic atrophy (GA) associated dry age-related macular degeneration (dry AMD). Catalyst will receive a $15 million upfront payment and is eligible to receive up to $340m in milestone payments plus royalties on any net sales. Shares closed up 66% to $7.91.

Selecta Biosciences, Inc. (NASDAQ: SELB) shares closed up 45% to $2.12 following a number of announcements including news that it has entered into an agreement where Asklepios BioPharmaceutical, Inc. will license rights to develop its immune tolerance platform, ImmTOR, for use in adeno-associated virus (AAV) gene therapy for the treatment of Pompe disease. Selecta is eligible to receive upfront and milestone payments of over $240m plus royalties on product sales. No mention was made of the amount of the actual upfront payment. The company also announced a private placement for gross proceeds of $70m.

Bausch Health Companies Inc. (NYSE: BHC) announced that the FDA has approved the New Drug Application for Arazlo (tazarotene) Lotion, for the topical treatment of acne vulgaris in patients nine years of age and older.

Abeona Therapeutics Inc. (NASDAQ:ABEO) shares closed normal trading hours up 27% to $5.00. Shares of the company have risen from $2.36 just one month ago. The company took advantage of the recent gains when it announced after hours that it intends to offer and sell shares and pre-funded warrants in lieu of common stock, in an underwritten public offering. Great Point Partners, an existing holder has indicated its intention to purchase up to $33m in the offering. Shares are trading down 21% to $3.96 after hours.

UroGen Pharma Ltd. (Nasdaq: URGN) announced the FDA has granted priority review for its New Drug Application (NDA) for UGN-101 (mitomycin gel) as a potential treatment for patients with low-grade upper tract urothelial cancer (LG UTUC). The PDUFA date is April 18, 2020.

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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:

PLx Pharma Inc. (PLXP): $4.75; +41%.

Paratek Pharmaceuticals, Inc. (PRTK): $3.90; +32%.

Inovio Pharmaceuticals, Inc. (INO): $3.44; +31%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $6.14; +30%.

Abeona Therapeutics Inc. (ABEO): $5.00; +27%.

DECLINERS:

Minerva Neurosciences, Inc. (NERV): $5.66; -18%.

Rubius Therapeutics, Inc. (RUBY): $11.78; -17%.

BioNTech SE (BNTX): $29.34; -16%.

Proteostasis Therapeutics, Inc. (PTI): $1.34; -13%.

ASLAN Pharmaceuticals Limited (ASLN): $2.24; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGEN – Agenus Inc.
AGEN1181 - 2nd gen CTLA
Advanced cancer

Phase 1 Phase 1 data presented at Investor Day February 20, 2020.
$461.5 million

AGN – Allergan plc
ABP 798
RITUXAN biosimilar - non-Hodgkin lymphoma

BLA Filing BLA filing announced December 19, 2019.
$65.2 billion

ALDX – Aldeyra Therapeutics Inc.
ADX-2191
Proliferative vitreoretinopathy (PVR)

Phase 3 Phase 3 commencement of enrolment announced December 19, 2019 with initial data due 2020.
$135.3 million

ATOS – Atossa Therapeutics Inc.
Endoxifen - oral
Mammographic breast density (MBD)

Phase 2 Phase 2 trial to commence 1Q or 2Q 2020.
$12.1 million

BHC – Bausch Health Companies Inc.
IDP-123
Acne

Approved FDA Approval announced December 19, 2019.
$9.2 billion

CTMX – CytomX Therapeutics Inc.
PROCLAIM-CX-072-002
Solid tumors

Phase 2 Phase 2 final data from monotherapy expansion trials and initial combo data in melanoma due 2020.
$329.4 million

CTXR – Citius Pharmaceuticals Inc.
Mino-Lok
Catheter related blood stream infection

Phase 3 Phase 3 75% interim analysis for superior efficacy expected 1H 2020.
$26.6 million

GLPG – Galapagos NV
Filgotinib
Rheumatoid arthritis (RA)

NDA Filing NDA filing announced December 19, 2019.
$15.9 billion

IONS – Ionis Pharmaceuticals Inc.
AKCEA-APOCIII-LRx
Hyperlipoproteinemia and established cardiovascular disease

Phase 2 Phase 2 data met primary and secondary endpoints - January 22, 2020.
$8 billion

JNCE – Jounce Therapeutics Inc.
Vopratelimab JTX-2011
Solid tumors - Cancer

Phase 1/2 Phase 1/2 data to be presented at ASCO-SITC Clinical Immuno-Oncology Symposium Annual Meeting on February 6, 2020.
$191.4 million

MGNX – MacroGenics Inc.
Margetuximab
Metastatic breast cancer

BLA Filing BLA filing announced December 19, 2019.
$542 million

OTLK – Outlook Therapeutics Inc.
NORSE 1 (ONS-5010-001)
Wet age-related macular degeneration (wet AMD)

Phase 3 Phase 3 data due August 2020.
$38.8 million

URGN – UroGen Pharma Ltd.
MitoGel - UGN-101
Urothelial Carcinoma

PDUFA priority review PDUFA date under priority review April 18, 2020.
$615.3 million