BPC December 31 update

Biotech week in review; 2021 Advancers: A Catalist

Weekly watchlist

Happy New Year and a warm welcome to 2022 to all readers from the team at BioPharmCatalyst. This week, we will provide a recap of market-moving events and a look back at the biggest gainers of 2021. To see the Top 10 Catalist click the link below.

Top 10 Catalist

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

REGULATORY

Novavax Inc (NASDAQ: NVAX) announced that it submitted data to the FDA for emergency use authorization (EUA) of its COVID-19 vaccine, with the company expecting to submit a formal request in one month. Shares closed the week down 15% at $143.07.

CLINICAL UPDATES:

BridgeBio Pharma, Inc. (NASDAQ: BBIO) announced top-line results from its ATTRibute-CM Phase 3 study of acoramidis to treat symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The trial did not meet its primary endpoint at Month 12. Shares closed the week up 32% at $16.68.

OTHERS:

Baudax Bio, Inc. (NASDAQ: BXRX) entered into a direct offering of 42,289.3 shares of convertible preferred stock and warrants for gross proceeds of $4.2 million. Shares closed the week down 35% at $0.22.

Aditxt Inc. (NASDAQ: ADTX) signed a share exchange agreement to acquire AiPharma Global Holdings LLC. In a series of two closings with payments of $250,000, Aditxt will acquire the equity interest of AiPharma. Shares closed the week down 25% at $0.54.

Altamira Therapeutics Ltd. (NASDAQ: CYTO) announced that Bentrio is available in Germany on the Amazon platform. Altamira and Wellesta Holdings Pte Ltd, Singapore, also entered into a definite marketing and distribution agreement for six Asian countries - India, Indonesia, Malaysia, Singapore, Taiwan, and Vietnam. Shares closed the week up 38% at $1.82.

Biofrontera Inc. (NASDAQ: BFRI) announced that through the exercise of outstanding warrants the majority ownership of Biofrontera AG was diluted below 50%. As a result, Biofrontera Inc. is no longer considered a subsidiary of Biofrontera AG. Shares closed the week down 43% at $7.52.

Drug Price Stage Catalyst Market Cap

AVXL – Anavex Life Sciences Corp.
ANAVEX2-73-AD-004
Mild to moderate Alzheimer’s disease

$12.38
-0.27  -2%
Phase 2/3 Phase 2b/3 upon review of safety interim data, the DSMB recommendation is to continue the studies without modification. Top-line data due 2H 2022.
$941.1 million

BCYC – Bicycle Therapeutics plc
BT8009
Solid tumors

$46.21
-0.38  -1%
Phase 1/2 Phase 1 trial in monotherapy cohorts, 4 out of 11 urothelial patients had partial responses; dose escalation remains ongoing, with no dose limiting toxicities (DLTs) yet observed. - noted October 7, 2021. Phase 1/2 update reported 4 confirmed partial responses with one becoming a complete response, noted January 5, 2022.
$1.4 billion

DVAX – Dynavax Technologies Corporation
VLA2001-301 + alum and CpG 1018 (COV-COMPARE)
COVID-19 vaccine

$12.86
-0.29  -2%
Phase 3 Phase 3 top-line data reported that trial met both co-primary endpoints, noted October 18, 2021.
$1.5 billion

GRTS – Gritstone bio Inc.
COVID-19 vaccine - (CORAL)
COVID-19 vaccine

$5.00
-0.20  -4%
Phase 1 Phase 1 data from first cohort (10 µg dose) demonstrated both strong neutralizing antibody responses to spike and robust CD8+ T cell responses. The vaccine was well-tolerated in these subjects, with no grade 3 or 4 adverse events observed, noted January 4, 2022. Omicron cohorts to be initiated in 2Q 2022. Additional phase 1 data expected 1H 2022.
$339.9 million

OPNT – Opiant Pharmaceuticals Inc.
OPNT003
Opioid Overdose

$25.64
+0.42  +2%
Phase 1 Phase 1 PD data due 1Q 2022.
$121 million

ORMP – Oramed Pharmaceuticals Inc.
ORMD-0801
Non-alcoholic steatohepatitis (NASH)

$8.91
-1.00  -10%
Phase 2 Phase 2 trial top-line data due in 2H 2022. Over 50% enrollment September 15, 2021. Phase 2 enrollment to be complete by 1H 2022.
$341.3 million

PDSB – PDS Biotechnology Corporation
PDS0101 - (VERSATILE-002)
Head and neck cancer

$5.71
-0.36  -6%
Phase 2 Phase 2 achieved its preliminary safety benchmark in its first 12 patients September 20, 2021. Phase 2 completion of enrollment announced October 4, 2021. Phase 2 initial data to be presented at the Multidisciplinary Head and Neck Cancers Symposium February 24-26, 2022.
$162.4 million

PFE – Pfizer Inc.
Comirnaty (BNT162b2)
COVID-19 Vaccine (Booster)

$52.79
-1.26  -2%
Approved FDA EUA approval announced for 65 and older, or those 18 and older at high risk September 22, 2021. EUA approval expanded to include all individuals 18 years of age and older, noted November 19, 2021. EUA approval expanded to include adolescents 12 through 15 years of age, noted January 3, 2022.
$296.3 billion

PRTA – Prothena Corporation plc
PRX004
ATTR-cardiomyopathy

$35.23
-0.20  -1%
Phase 1 Phase 2/3 trial to be initiated 1H 2022.
$1.6 billion

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

$36.33
-1.08  -3%
Phase 3 First Phase 3 trial safety and efficacy 52-week study initiated in 750 Patients with AD - October 6, 2021. Second Phase 3 trial initiated November 18, 2021.
$1.5 billion