BPC November 05 update

Earnings week 3 with SITC and Liver Meeting catalysts; Biotech week in review

Weekly watchlist

Soon commences the Society for Immunotherapy of Cancer (SITC) and The Liver Meeting conferences, where many notable companies will provide updates and release data. In this watchlist, we highlight upcoming earnings releases as well as presentations of relevance. Next week will wrap up our earnings season overview and we will focus on other upcoming catalysts.

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

CLINICAL UPDATES:

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) released top-line data from its Phase trial of QINLOCK to treat gastrointestinal stromal tumors (GIST), noting that the study did not meet the primary endpoint. Shares closed the week down 73% at $8.82.

Sangamo Therapeutics (NASDAQ: SGMO) reported data from its Phase 1/2 trial of isaralgagene civaparvovec to treat Fabry disease. The treatment produced alpha-galactosidase A activity 2-fold to 15-fold above mean normal, allowing one patient to withdraw from enzyme replacement therapy. Shares closed the week up 35% at $10.97.

OTHER:

The U.S. government canceled its $180 million contract with Emergent Biosolutions Inc. (NYSE: EBS) after its Baltimore facilities caused months-long delays in Johnson & Johnson COVID-19 vaccine production. These delays were caused by contamination in batches, soiling millions of doses. Production will continue at Emergent’s Bayview facility. Shares closed the week down 30% at $33.11.

Cardiol Therapeutics Inc. (NASDAQ: CRDL) will conduct a public offering of 16,350,000 units, comprised of one Class A common share and warrant. The units are priced at $3.07 per unit, for gross proceeds of $50,194,500. Shares closed the week down 31% at $2.55.

Petros Pharmaceuticals, Inc. (NASDAQ: PTPI) announced a 476% growth year-over-year of STENDRA tablet sales as part of an exclusive digital health marketing agreement with Hims & Hers Health, Inc. Shares closed the week up 45% at $2.29.

EARNINGS

Selection of top revenue earning companies scheduled to report earnings week of November 8-12, 2021 (PREMIUM members see BioPharmCatalyst earnings calendar for full list and details)

Monday: ACAD CHRS AMPH RDUS RCUS EDIT

Tuesday: JAZZ INO BNTX FOLD ACOR EGRX DRNA

Wednesday: ASNH GMAB

Drug Price Stage Catalyst Market Cap

ALGS – Aligos Therapeutics Inc.
ALG-000184
Hepatitis B

$16.27
-0.03  0%
Phase 1 Phase 1 safety, pharmacokinetics, and antiviral activity data noted that ALG-000184 administration was associated with similar rapid, substantial reductions in HBV DNA and RNA through the 28-day period, with ≥75% and 100% of evaluable subjects achieving HBV DNA and RNA reductions below the lower limit of quantitation (LLOQ), respectively, noted November 12, 2021.
$693.4 million

BNTX – BioNTech SE
BNT211
Solid tumors

$348.00
+43.24  +14%
Phase 1/2 Phase 1/2 data showed a favorable safety profile at doses tested and encouraging signs of efficacy, noted November 9, 2021.
$84.4 billion

CMPI – Checkmate Pharmaceuticals Inc.
Vidutolimod (CMP-001) and KEYTRUDA (pembrolizumab)
Melanoma

$3.58
-0.16  -4%
Phase 1b Phase 1b final analysis demonstrated clinical activity in 159 patients with an ORR of 23.5% per RECIST v1.1, including 7.1% (7/98) of patients with a complete response, noted November 12, 2021. Data readout expected 2022.
$77.4 million

NXTC – NextCure Inc.
NC318
Solid tumors

$6.02
-0.18  -3%
Phase 2 Combined Phase 1 and Phase 2 data reported one complete response (CR) and one partial response (PR), with disease control rate across all tumors in both studies was 37% and a median progression-free survival (PFS) of 5.0 months, noted November 13, 2021.
$166.3 million

ONCR – Oncorus Inc.
ONCR-177
Solid tumors

$5.57
-0.28  -5%
Phase 1 Phase 1 initial data reported one partial response, one Investigator-reported clinical response and one patient with stable disease. Additional surface lesion monotherapy expansion data due in mid-2022; initial surface lesion combination ONCR-177 + KEYTRUDA (pembrolizumab) expansion and visceral (hepatic) lesion monotherapy dose escalation due in late 2022.
$143.8 million

VIR – Vir Biotechnology Inc.
VIR-3434
Hepatitis B

$36.00
+3.98  +12%
Phase 1 Phase 1 data reported that a single dose of 6 to 75 mg of VIR-3434 resulted in rapid HBsAg reductions of >1 log10 IU/mL in most participants within approximately 1 week post-dose. The largest (>2 log10 IU/mL) and most sustained reductions in HBsAg were observed in the 75 mg cohort, noted November 12, 2021. Phase 2 trial planned for 2H 2021.
$4.7 billion