BPC January 04 update

Calithera CALA shares slide on disappointing data -45%; Offerings FATE MTNB NGM PRLD

Price and Volume Movers

Calithera Biosciences, Inc. (Nasdaq: CALA) shares closed down 45% to $2.72 following news its Phase 2 Cantata trial of telaglenastat in patients with advanced or metastatic renal cell carcinoma (RCC), did not meet the primary endpoint of improving progression free survival (PFS) in the study population when compared with cabozantinib. Median PFS was 9.2 months among patients treated with telaglenastat and cabozantinib as compared to 9.3 months with cabozantinib and placebo.

NGM Biopharmaceuticals, Inc. (NASDAQ:NGM) announced that it has commenced an underwritten public offering of $100m shares of its common stock. Shares are trading down 3% to $28.50 after hours.

Prelude Therapeutics Incorporated (NASDAQ:PRLD) also announced after hours a public offering of 1.75m shares of its common stock

Fate Therapeutics, Inc. (NASDAQ:FATE) announced after hours that it has commenced an underwritten public offering of $350m of shares of common stock. Shares are trading down 4% to $85.80 after hours.

Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB) shares closed up 28% to $1.74. Top-line data from its ENHANCE-IT head-to-head trial vs Vascepa are due this quarter.

Ocugen (NASDAQ:OCGN) shares closed up 68% to $3.07 on news its partner, Bharat Biotech, received an Emergency Use authorization (EUA) for its COVID-19 vaccine Covaxin in India.

Pandion Therapeutics (NASDAQ:PAND) shares closed up 48% to $21.94 on news its Phase 1a trial of PT101 in healthy volunteers met the safety goals of the trial. It plans to initiate a Phase 1b/2a clinical trial in patients with ulcerative colitis in mid-2021 and a Phase 2 clinical trial in patients with systemic lupus erythematosus in 2H 2021.

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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:

Jaguar Health, Inc. (JAGX): $1.78; +118%.

EyePoint Pharmaceuticals, Inc. (EYPT): $9.01; +37%.

Novan, Inc. (NOVN): $1.08; +33%.

Tiziana Life Sciences PLC (TLSA): $2.58; +28%.

Salarius Pharmaceuticals, Inc. (SLRX): $1.13; +24%.

DECLINERS:

PMV Pharmaceuticals, Inc. (PMVP): $49.25; -20%.

Sigilon Therapeutics, Inc. (SGTX): $39.25; -18%.

Denali Therapeutics Inc. (DNLI): $70.86%; -15%.

Codiak BioSciences, Inc. (CDAK): $27.35; -15%.

Silverback Therapeutics, Inc. (SBTX): $39.54; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARCT – Arcturus Therapeutics Holdings Inc.
LUNAR-COV19
COVID-19 vaccine

Phase 2 Phase 2 trial conducted in U.S. and Singapore. Interim data due early 2021. Phase 3 trial to commence 2Q 2021. Phase 1/2 data released December 28, 2020.
$1.6 billion

ATRA – Atara Biotherapeutics Inc.
ATA 129 (tab-cel) - ALLELE
Epstein-Barr virus (EBV-PTLD) after solid organ transplant (SOT)

BLA Filing Rolling BLA filing to be completed 3Q 2021.
$1.5 billion

AYLA – Ayala Pharmaceuticals Inc.
AL102
Desmoid tumors

Phase 2 Phase 2/3 trial to be initiated 1H 2021 with interim data from part 1 due mid-2022.
$167.4 million

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Troriluzole
Obsessive compulsive disorder (OCD)

Phase 3 Phase 2/3 top-line data did not meet primary endpoint - June 24, 2020. Phase 3 pivotal trial initiation announced January 4, 2021.
$4.7 billion

CALA – Calithera Biosciences Inc.
CB-839 + Cabozantinib (CANTATA)
Renal cell carcinoma

Phase 2 Phase 2 top-line data did not meet primary endpoint - January 4, 2020.
$206.7 million

DRNA – Dicerna Pharmaceuticals Inc.
DCR-PHXC - PHYOX2
Primary hyperoxaluria (PH)

Phase 2 Phase 2 pivotal top-line data due mid-2021.
$1.7 billion

FSTX – F-star Therapeutics Inc.
FS222
Advanced malignancies

Phase 1 Phase 1 commencement of dosing announced January 4, 2021.
$82.1 million

LIFE – aTyr Pharma Inc.
ATYR1923
COVID-19

Phase 2 Phase 2 data released January 4, 2021. Primary safety endpoint met. Median time to recovery of 5.5 days compared to 6 days in the placebo group.
$39.9 million

MEIP – MEI Pharma Inc.
Zandelisib (ME-401) - TIDAL
Relapsed/refractory Follicular Lymphoma (FL) Non Hodgkin Lymphoma

Phase 2 Phase 2 enrollment to be completed 1Q 2021 with top-line data due 4Q 2021.
$324.1 million

MEIP – MEI Pharma Inc.
Zandelisib (ME-401)
Relapsed/refractory Follicular Lymphoma/Chronic Lymphocytic Leukemia (CLL)

Phase 1b Phase 1b updates due mid-2021.
$324.1 million

OPK – Opko Health Inc.
Somatrogon (hGH-CTP)
Children - growth hormone deficiency

PDUFA BLA filing acceptance announced January 4, 2021. PDUFA date October 2021.
$2.9 billion

PAND – Pandion Therapeutics Inc.
PT101
Healthy volunteers

Phase 1 Phase 1a trial achieved primary objective of safety and tolerability - January 4, 2021. Phase 1a/2b trial in ulcerative colitis expected to start mid-2021 and Phase 2 clinical trial in systemic lupus erythematosus expected to start 2H 2021
$531.7 million

PASG – Passage Bio Inc.
PBGM01
GM1 gangliosidosis

Phase 1/2 Phase 1/2 dosing to be initiated 1Q 2021. Initial biomarker and safety data due mid-2021.
$1 billion

PRVB – Provention Bio Inc.
PRV-031 (teplizumab)
Type 1 diabetes

PDUFA priority review PDUFA date under priority review July 2, 2021. Advisory Committee scheduled for May 27, 2021.
$887.7 million