BPC July 15 update

Phase 1/2 biotech stock events to watch during 3Q 2021: Biotech week in Review

Weekly watchlist

We conclude our preview of biotech stock events to watch this quarter with notable Phase 1 and 2 trial readouts of interest. This follows from previous previews of regulatory catalysts (PDUFA and Advisory Committee meetings) and Phase 3 readouts due this quarter.

First, let’s review the week that was with price moving events that hit the wires.

REGULATORY:

FibroGen (NASDAQ:FGEN) shares closed Friday down 42% to $14.35 following news an FDA Advisory Committee delivered negative votes for its regulatory application for roxadustat for the treatment of anemia of chronic kidney disease. The committee voted 12-2 against recommending approval in patients on dialysis and 13-1 against approval for patients not on dialysis.

CLINICAL UPDATES:

Galapagos NV (NASDAQ:GLPG) shares closed down 13% to $57.23 following the release of negative data from two of three readouts late-Wednesday of its pipeline candidate GLPG3970. While promising signs were noted from its trial in patients with psoriasis, both rheumatoid arthritis and ulcerative colitis patients saw no differentiation from placebo in their respective trials. Shares closed the week down 14% to $50.30.

Celldex Therapeutics, Inc. (NASDAQ:CLDX) shares closed the week up 25% to $40.64. following the release of updated data the previous week from its Phase 1b trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism. 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a marked partial response.

CohBar, Inc. (NASDAQ:CWBR) announced the release of data from its Phase 1a/1b trial of CB4211 for the potential treatment of nonalcoholic steatohepatitis and obesity has been delayed. Initially slated for release during early-July 2021, the company now expects data to be available sometime prior to Labor Day (September 6, 2021). Shares dropped 28% for the week to close down at $1.05.

OTHER:

PLx Pharma Inc. (NASDAQ:PLXP) announced a deal with Walmart that will see its product VAZALORE, an approved liquid-filled aspirin capsule, available in over 4,500 stores across the United States in mid-August. Stock closed the week up 30% to $16.70.


Phase 1/2 events to watch during 3Q 2021:

Drug Price Stage Catalyst Market Cap

ALEC – Alector Inc.
AL001 (INFRONT-2)
Frontotemporal Dementia

$24.04
-0.04  -0%
Phase 2 Phase 2 open-label data presented at AAIC meeting July 29 2021 - slowed clinical progression by 47%.
$1.9 billion

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

$34.43
-9.07  -21%
Phase 2 Phase 2 full data September 2021. Negative data released July 28, 2021 - patients on the placebo saw improved cognitive impairment compared with Posiphen.
$278.9 million

APRE – Aprea Therapeutics Inc.
Eprenetapopt (APR-246) and Vidaza (azacitidine)
TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) - post transplant

$4.23
-0.11  -3%
Phase 2 Phase 2 data released July 21, 2021. 58% relapse free survival at 1 year post-transplant; 79% overall survival at 1 year post-transplant.
$89.6 million

ASLN – ASLAN Pharmaceuticals Limited
ASLAN004
Atopic dermatitis

$2.77
-0.06  -2%
Phase 1 Phase 1 top-line data due 3Q 2021. Phase 2b trial to be initiated 2H 2021.
$192.6 million

BCEL – Atreca Inc.
ATRC-101
Solid tumors

$5.49
+0.58  +12%
Phase 1b Phase 1b initial data released July 29, 2021. 20/50 (40%) of patients exhibited stable disease.
$202.5 million

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

$37.51
+0.36  +1%
Phase 2 Phase 2 pivotal top-line data due mid-2021.
$2.9 billion

EDIT – Editas Medicine Inc.
AGN-151587 (EDIT-101) - BRILLIANCE
Leber Congenital Amaurosis type 10 (LCA10).

$41.86
-0.04  -0%
Phase 1/2 Phase 1/2 initial data due to be presented at the International Symposium on Retinal Degeneration planned for September 27 – October 2, 2021.
$2.8 billion

EVLO – Evelo Biosciences Inc.
EDP1815
Mild to moderate psoriasis

$9.21
-0.90  -9%
Phase 2b Phase 2b data due 3Q 2021.
$491.6 million

FATE – Fate Therapeutics Inc.
FT596
B-Cell Chronic Lymphoma, chronic lymphocytic leukemia

$82.80
-3.24  -4%
Phase 1 Phase 1 interim data to be highlighted at virtual event August 19, 2021.
$7.8 billion

INFI – Infinity Pharmaceuticals Inc.
Eganelisib (IPI-549) + TECENTRIQ (atezolizumab) and ABRAXANE (nab-paclitaxel) and IPI-549 + TECENTRIQ (atezolizumab) and AVASTIN (Bevacizumab) - (MARIO-3)
Front-line triple negative breast cancer (TNBC); Renal cell cancer (RCC)

$2.12
-0.21  -9%
Phase 2 Phase 2 updated data released July 27, 2021. Overall response rate 55% in patients. PFS was extended as compared to benchmark data for atezolizumab and nab-paclitaxel alone, increasing from 7.2 months to 7.4 months.
$188.1 million

INMB – INmune Bio Inc.
XPro1595
Alzheimer’s disease

$15.22
-0.60  -4%
Phase 2 Phase 2 trial planned with data due 2H 2023.
$241.1 million

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

$7.10
+0.11  +2%
Phase 2b Phase 2b trial did not meet primary endpoint - July 22, 2021.
$650.9 million

SAVA – Cassava Sciences Inc.
Simufilam (PTI-125)
Alzheimer’s disease

$69.53
-33.82  -33%
Phase 2 Phase 2b trial did not meet primary endpoint - May 15, 2020. Noted improvements in biomarkers of disease pathology September 14, 2020. Phase 2 open-label data 9-month data released July 29, 2021. Separate Cognition Maintenance Study (CMS) trial ongoing. Phase 3 trial to be initiated Fall 2021.
$2.8 billion

TBPH – Theravance Biopharma Inc.
Izencitinib
Ulcerative Colitis

$12.98
-0.18  -1%
Phase 2/3 Phase 2b data due 3Q 2021.
$934.3 million

XENE – Xenon Pharmaceuticals Inc.
XEN1101 (X-TOLE)
Adult Focal Epilepsy

$17.27
-0.34  -2%
Phase 2 Phase 2b completion of enrollment announced July 7, 2021. Top-line data due late-September to mid-October 2021.
$707.5 million