BPC November 12 update

Earnings week 4 and near term catalysts; Biotech week in review

Weekly watchlist

This upcoming week wraps up earnings, concluding a reporting season that was so eventful. This week we highlight the final notable earnings releases set for the coming week and focus on near-term catalysts. Next week, we look forward to the remainder of the quarter and comprise a watchlist with catalysts we are still waiting for.

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

CLINICAL UPDATES:

Oncorus, Inc. (NASDAQ: ONCR) released data from its Phase 1 trial of ONCR-177 to treat solid tumors, noting one partial response, one Investigator-reported clinical response, and one patient with stable disease. Shares closed the week down 47% at $6.04.

Catalyst Biosciences, Inc. (NASDAQ: CBIO) has halted the development of its hemophilia assets, including MarzAA. Catalyst will focus resources on the development of CB 4332, with a planned Investigational New Drug (IND) application upcoming. Shares closed the week down 45% at $1.71.

Aditxt, Inc. (NASDAQ: ADTX) announced that its Phase 3 trial of Avigan and Reeqonus (favipiravir) failed to meet the primary endpoint. Shares closed the week down 32%% at $1.39.

Compass Pathways plc (NASDAQ: CMPS) reported data from its Phase 2b trial of COMP360 psilocybin for treatment-resistant depression. The release reported that the 25mg dosage met the primary endpoints, however, Treatment Emergency Serious Adverse events were more frequent in this dosage cohort. The 10mg and 1mg dosages did not meet the primary endpoints. Shares closed the week down 28% at $35.39.

Cortexyme, Inc. (NASDAQ: CRTX) presented data from its Phase 2/3 GAIN trial of atuzaginstat to treat Alzheimer’s disease. Data noted that the 40 mg dose reported better efficacy compared to 80 mg however, benefits were not seen on ADCS-ADL at either dose. Shares closed the week down 16%% at $14.26.

OTHER:

Shattuck Labs, Inc. (NASDAQ: STTK) and Takeda Pharmaceutical Co Ltd (NYSE: TAK) have terminated their collaboration deal for SL-279252 and SL-115154. Shattuck shares closed the week 33%% at $12.48.

EARNINGS

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

Monday: RMTI PLX URGN JAGX ACRX SNDX EVFM CLSN ATHX STAB TRVN

Tuesday: MDWD NRXP

Wednesday: BFRA

Thursday: CALT

Drug Price Stage Catalyst Market Cap

BYSI – BeyondSpring Inc.
Plinabulin + G-CSF Combination
Chemotherapy-induced neutropenia (CIN)

$14.35
+1.07  +8%
PDUFA priority review PDUFA date under priority review November 30, 2021.
$437.6 million

CMRX – Chimerix Inc.
ONC201
H3 K27M-mutant Glioma

$5.90
-0.33  -5%
Phase 2 Phase 2 data demonstrated an ORR of 20%, median duration of response was 11.2 months and the median time to response was 8.3 months. Also PFS reached a 35% and 30% at 6 and 12 months respectively, OS 57% at 12 months, noted November 19, 2021.
$512.5 million

CTIC – CTI BioPharma Corp.
Pacritinib
Myelofibrosis

$2.48
+0.14  +6%
PDUFA priority review PDUFA date under priority review November 30, 2021.
$239.8 million

FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-Induced Hearing Loss

$9.64
-0.21  -2%
PDUFA CRL announced August 10, 2020. NDA resubmitted with new PDUFA date of November 27, 2021.
$250.7 million

RCUS – Arcus Biosciences Inc.
AB680 + Zimberelimab (AB122) - (ARC-8)
Pancreatic Cancer

$46.36
-2.10  -4%
Phase 1 Phase 1 further data due in 2022
$3.3 billion

SYBX – Synlogic Inc.
SYNB1618 - (SynPheny-1)
Phenylketonuria (PKU)

$2.59
-0.05  -2%
Phase 2 Phase 2 interim analysis demonstrated clinically meaningful reductions of phenylalanine (Phe) at several dose levels, across multiple time points, September 20, 2021. Phase 2 data reported a 40% reduction in D5-Phe absorption after a meal challenge, a 20% reduction in mean fasting plasma Phe across all subjects, and a >250 µM mean reduction in fasting plasma Phe, noted November 23, 2021. Additional Phase 2 data due in 1H 2022.
$180.5 million