BPC November 11 update

Moderna MRNA COVID-19 vaccine update - analysis due soon

Price and Volume Movers

Moderna, Inc., (Nasdaq: MRNA) announced that it has completed case accrual for the first interim analysis of the Phase 3 COVE trial of mRNA-1273, its COVID-19 vaccine candidate. Moderna noted that it has seen a significant increase in the rate of case identification across sites in the last week. As a result, it expects the first interim analysis will include substantially more than 53 cases, the targeted trigger point for the analysis. The data on these cases is being prepared for submission to the independent Data Safety Monitoring Board (DSMB) for analysis and recommendation, which likely puts the release of the analysis sometime over the next week. Shares closed up 8% to $82.21, in part following comments reported by the Financial Times that leading infectious disease expert, Anthony Fauci, expects positive data would be released soon.

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) shares closed up 235% to $17.88 on the back of news released late-Tuesday that its Phase 2 FIGHT trial comparing mFOLFOX6 chemotherapy in combination with bemarituzumab, met the primary efficacy endpoints in patients with front-line advanced gastric or gastroesophageal junction (GEJ) cancer. The company announced after hours that it plans to sell 5m shares of its common stock in an underwritten public offering. Shares are trading up a further 19% after hours to $21.40.

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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:

Tracon Pharmaceuticals, Inc. (TCON): $7.46; +35%.

Equillium, Inc. (EQ): $5.04; +45%.

Genfit SA (GNFT): $5.10; +29%.

Immuron Limited (IMRN): $8.40; +24%.

Arcturus Therapeutics Holdings Inc. (ARCT): $48.84; +24%.

DECLINERS:

Ideaya Biosciences, Inc. (IDYA): $13.03; -8%.

Applied Genetic Technologies Corporation (AGTC): $5.19; -8%.

Phathom Pharmaceuticals, Inc. (PHAT): $38.20; -8%.

Harmony Biosciences Holdings, Inc. (HRMY): $47.47; -8%.

Osmotica Pharmaceuticals plc (OSMT): $5.49; -7%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGTC – Applied Genetic Technologies Corporation
AGTC-501 (VISTA)
X-linked Retinitis Pigmentosa (XLRP)

Phase 2/3 Phase 2/3 trial to be initiated 1Q 2021 with 6-month interim analysis 3Q 2022.
$114.9 million

BTAI – BioXcel Therapeutics Inc.
BXCL501 (SERENITY I)
Schizophrenia - Agitation

NDA Filing NDA filing due 1Q 2021.
$1.1 billion

DCPH – Deciphera Pharmaceuticals Inc.
DCC-3014
Solid tumors / Tenosynovial Giant Cell tumor

Phase 1/2 Phase 1 update at CTOS meeting November, 2020. ORR 41%.
$3.5 billion

DCTH – Delcath Systems Inc.
Melphalan/HDS - FOCUS
Liver-dominant ocular melanoma

Phase 3 Phase 3 top-line data due early-2021.
$69 million

INBX – Inhibrx Inc.
INBRX-109
Chondrosarcoma and mesothelioma

Phase 1 Phase 1 interim data released November 11, 2020. 2/12 partial responses. Initial data from combination cohorts due 1H 2021. Initiation of registration-enabling trials in 2021.
$1 billion

LCTX – Lineage Cell Therapeutics, Inc.
OpRegen
Dry age-related macular degeneration (AMD)

Phase 1/2 Phase 1/2 updated presented at AAO meeting November 15, 2020.
$214.5 million

MESO – Mesoblast Limited
Remestemcel-L
COVID-19

Phase 3 Phase 3 trial to continue following recommendation from the independent Data Safety Monitoring Board (DSMB) following second interim analysis.
$1.8 billion

ONCR – Oncorus Inc.
ONCR-177
Solid tumors

Phase 1 Phase 1 interim data due 2H 2021 through to 2H 2022.
$635.1 million

ONCY – Oncolytics Biotech Inc.
Pelareorep with Keytruda (NU 18I01)
Pancreatic cancer

Phase 2 Phase 2 final data due 1H 2021.
$145.4 million

ONCY – Oncolytics Biotech Inc.
Pelareorep and atezolizumab (Tecentriq) - GOBLET
Colorectal and advanced anal cancers

Phase 1/2 Phase 1/2 initiation of dosing due 1H 2021.
$145.4 million

PYPD – PolyPid Ltd.
D-PLEX100 - SHILED I
Abdominal (soft tissue) sternal surgical site infections

Phase 3 Phase 3 trial initiation announced July 1, 2020 with data due 2H 2021.
$219.9 million

SLRX – Salarius Pharmaceuticals Inc.
Seclidemstat
Ewing sarcoma

Phase 1 Phase 1/2 trial is completing dose escalation, expected to advance into Phase 2 dose-expansion in 1Q 2021.
$13.5 million

TRVI – Trevi Therapeutics Inc.
Nalbuphine ER - PRISM
Prurigo Nodularis

Phase 2/3 Phase 2b/3 enrolment to be completed in 3Q 2021 with top-line data due 4Q 2021.
$56.1 million