BPC October 22 update

Earnings and biotech catalysts to watch; Biotech week in review

Weekly watchlist

With the earnings season underway, we turn our focus to key companies reporting next week. The majority of biotech and pharmaceutical companies covered by BioPharmCatalyst are in the clinical trial phase of drug development and have little revenue, so one normally sees little share price impact from earnings reports. However, for large-cap companies that are fortunate to have drugs on the market, earnings season presents a major catalyst.

We list top revenue-earning companies set to report next week below, as well as highlight near-term catalysts. First, however, let’s review the week that was with price-moving events.

CLINICAL UPDATES:

Radius Health, Inc. (NASDAQ: RDUS) released top-line data from its Phase 3 EMERALD study of elacestrant to treat ER+/HER2- advanced or metastatic breast cancer (mBC), noting that the trial met both primary endpoints. Shares closed the week up 33% at $20.10.

Atea Pharmaceuticals, Inc. (NASDAQ: AVIR) released that its Phase 2 trial of AT-527 to treat COVID-19 did not meet its primary endpoint. Due to the trial failure, Atea is modifying its Phase 3 MORNINGSKY study. Shares closed the week down 68% at $12.73.

Galera Therapeutics, Inc. (NASDAQ: GRTX) announced data from its Phase 3 ROMAN trial of vasopasem manganese to treat severe oral mucositis (SOM) in patients with head and neck cancer (HNC). The data release revealed that the study did not meet its primary endpoint. Shares closed the week down 76% at $1.82.

Metacrine, Inc. (NASDAQ: MTCR) released data Friday from its Phase 2a trial of MET642 to treat non-alcoholic steatohepatitis (NASH), noting that it will halt the future development in the NASH indication to focus on MET642 to treat IBD. Shares closed the week down 53% at $1.63.

Ocular Therapeutix, Inc. (NASDAQ: OCUL) announced that its Phase 2 clinical trial of OTX-CSI to treat dry eye disease (DED) failed to meet the primary endpoint. Shares closed the week down 39% at $6.91.

Agenus (NASDAQ: AGEN) withdrew its Biologics License Application (BLA) for balstilimab to treat cervical cancer, following the approval of pembrolizumab. Shares closed the week down 23% at $4.01.


EARNINGS

Selection of top revenue earning companies scheduled to report earnings week of October 25-19, 2021 (PREMIUM members see BioPharmCatalyst earnings calendar for full list and details)

Tuesday: NVS LLY

Wednesday: GSK BMY TEVA BMRN ALKS

Thursday: MRK SNY GILD SGEN BPMC NVCR ALNY

Friday: ABBV

Drug Price Stage Catalyst Market Cap

ANGN – Angion Biomedica Corp.
ANG-3777
Acute kidney injury (AKI) / Delayed Graft Function

$3.75
-0.23  -6%
Phase 3 Phase 3 trial did not met the primary endpoint, noted October 26, 2021.
$112.3 million

CLSD – Clearside Biomedical Inc.
XIPERE (Suprachoroidal CLS-TA)
Macular edema associated with uveitis

$3.95
-0.09  -2%
Approved Approved October 25, 2021.
$235.7 million

CRTX – Cortexyme Inc.
Atuzaginstat - GAIN
Alzheimer’s disease

$12.03
-0.19  -2%
Phase 2/3 Phase 2/3 top-line data reported that the trial did not meet its co-primary endpoints, noted October 26, 2021. Phase 2/3 data reported that the 40 mg demonstrated equivalent or better efficacy compared 80 mg, as well as a superior safety profile. Benefits were shown in ADAS-Cog11, CDR-SB, MMSE, and NPI, with increasing separation from placebo throughout the study consistent with disease modification. Benefits were not seen on ADCS-ADL at either dose, noted November 11, 2021.
$359.4 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

EYEN – Eyenovia Inc.
MydCombi
Mydriasis - pupil dilation

$3.74
0.00  0%
CRL CRL issued October 25, 2021.
$106.2 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

RAPT – RAPT Therapeutics Inc.
RPT193
Atopic dermatitis

$31.16
-1.58  -5%
Phase 1b Phase 1b top-line data released June 14, 2021 - 42.9% of patients treated with RPT193 achieved a 50% improvement in EASI score (EASI-50) compared with 10.0% in the placebo group. Phase 1b top-line data displayed at Day 29 clear benefit over placebo with EASI-50, vIGA 0/1 (clear or almost clear skin), body surface area (BSA), and pruritis NRS-3 and 4 (3 and 4 point reduction on the numerical rating scale for itch). By Day 43, continued improvement in the EASI, EASI-50, EASI-75, EASI-90, vIGA 0/1, and BSA was displayed. No serious adverse events were reported, noted September 30, 2021. Additional clinical efficacy data presented at the 4th Inflammatory Skin Disease Summit November 3, 2021.
$920.7 million