BPC October 29 update

Earnings week 2 and biotech catalysts to watch; Biotech week in review

Weekly watchlist

Earnings season is in full swing, and this week we continue to highlight upcoming earnings releases and spotlight some upcoming catalysts set for the next two weeks. Next week we will focus on remaining earning readouts and notable presentations at the Society for Immunotherapy of Cancer (SITC) and The Liver Meeting set for November 12-15, 2021.

First, however, let’s review the week that was with price-moving events.

REGULATORY UPDATES:

HCW Biologics Inc. (NASDAQ: HCWB) received clearance from the FDA to initiate its Phase 1b trial of HCW9218 to treat advanced pancreatic cancer. Shares closed the week up 83% at $4.47.

DBV Technologies S.A. (NASDAQ: DBVT) released its third-quarter earnings this week noting that its Viaskin Peanut (mVP) development program and STAMP trial initiation are further delayed as DBV awaits FDA review. Shares closed the week down 42% at $3.03.

CLINICAL UPDATES:

Cortexyme, Inc. (NASDAQ: CRTX) reported top-line results on Tuesday from its Phase 2/3 GAIN trial of atuzaginstat (COR388) to treat Alzheimer's disease, noting that the trial did not meet its co-primary endpoints. Shares closed the week down 78% at $13.20.

Rafael Holdings, Inc. (NYSE: RFL) announced that its AVENGER 500 Phase 3 clinical trial failed after noting that its study of CPI-613 (devimistat) to treat metastatic adenocarcinoma of the pancreas did not meet its primary endpoint. Shares closed the week down 76% at $7.56.

Angion Biomedica Corp. (NASDAQ: ANGN) and Vifor Pharma also announced a clinical failure as its Phase 3 trial of ANG-3777 to treat delayed graft function (DGF) after a kidney transplant did not meet its primary endpoint. Shares closed the week down 52% at $4.14.

OTHER:

CohBar, Inc. (NASDAQ: CWBR) announced a proposed public offering of shares of its common stock and accompanying warrants. The offering is set at $0.72 per share for aggregate gross proceeds of approximately $15.0 million. Shares closed the week down 31% at $0.62.

EARNINGS

Selection of top revenue earning companies scheduled to report earnings week of November 1-6, 2021 (PREMIUM members see BioPharmCatalyst earnings calendar for full list and details)

Monday: NBIX

Tuesday: PFE BHC INCY AMGN EXAS EXEL

Wednesday: AMRX HZNP NVO IONS SRPT

Thursday: REGN MRNA EBS NVAX ENDP


Drug Price Stage Catalyst Market Cap

CALA – Calithera Biosciences Inc.
CB-280
Cystic fibrosis

$0.90
+0.01  +1%
Phase 1b Phase 1b clinical data showed that treatment was well-tolerated at all dosage levels, with no reported discontinuations. Treatment also demonstrated pharmacodynamic effects, with rapid and significant dose-proportional increases in plasma arginine. There was a trend toward increased FeNO and decreased sweat chloride in CB-280 treated subjects, noted November 1, 2021. To complete Phase 1b enrollment by end of 2021 with additional cohort enrollment in 2022.
$67.5 million

EQ – Equillium Inc.
Itolizumab (EQ001) - (EQUALISE)
Systemic lupus erythematosus (SLE) and lupus nephritis (LN)

$5.41
+0.02  +0%
Phase 1b Phase 1b interim safety data for Type A portion of study released noted decreases in proteinuria and albuminuria. SLE patients with UPCR > 100 mg/g, > 30 mg/g and > 200 mg/g reported a decrease of 34%, 54% and 42%, respectively. Treatment was well tolerated at doses ranging from 0.4 to 2.4 mg/kg, noted November 5, 2021. Additional data expected mid-2022.
$159 million

ETON – Eton Pharmaceuticals Inc.
EPRONTIA (topiramate) - Oral Solution
Seizures/migraine

$4.22
-0.10  -2%
Approved FDA Approval November 8, 2021.
$103.8 million

GRAY – Graybug Vision Inc.
GB-102 (ALTISSIMO)
Wet age-related macular degeneration

$2.70
-0.09  -3%
Phase 2b Phase 2b data released March 9, 2021. BCVA approx 9 letters lower across all time points than that observed in the control (aflibercept) arm. Extension trial top-line data noted 55% of patients maintained visual acuity and central retinal thickness. In addition, the injection burden was reduced by 73%, noted September 28, 2021. Additional Phase 2b data reported that the anatomical control was similar to aflibercept over 18 months with BCVA maintained in extension study, noted November 15, 2021.
$57.6 million

KDNY – Chinook Therapeutics Inc.
BION-1301
IgA nephropathy

$15.38
-1.04  -6%
Phase 1/2 Additional data from Phase 1/2 trial expected 1H 2022. Phase 1/2 data reported that treatment was well tolerated. Treatment demonstrated a >50% geometric mean reduction in 24-hour urine protein creatinine ratio (UPCR) after three to six months, with further reductions in two patients with IgAN through one year of treatment, noted November 4, 2021.
$839.9 million

LQDA – Liquidia Corporation
YUTREPIA (treprostinil)
Pulmonary arterial hypertension

$4.11
-0.07  -2%
Approved Tentative approval November 8, 2021. Final approval due in October 2022 or earlier upon resolution of on-going litigation.
$213.6 million