BPC December 23 update

Final 4Q biotech catalysts to watch; Biotech week in review

Weekly watchlist

Happy holidays to our readers from the team at BioPharmCatalyst. In the final week of 2021 we highlight the remaining 4Q catalysts on our list. Next week we will provide a recap of market moving events and a look back at the biggest gainers of 2021.

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

CLINICAL UPDATES:

Allakos Inc. (NASDAQ: ALLK) released data from two of its trials of lirentelimab, ENIGMA 2 a Phase 3 study and KRYPTOS a Phase 2/3 study. Both studies met their histologic co-primary endpoints but did not meet the patient-reported symptomatic co-primary endpoint. Shares closed the week down 87% at $10.45.

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) reported that its Phase 3 TRANQUILITY trial of reproxalap ophthalmic solution (reproxalap) to treat dry eye disease did not meet its primary endpoint. Shares closed the week down 40% at $4.17.

Can-Fite BioPharma Ltd. (NYSE: CANF) reported that the last patient treated in its Phase 2 trial of Namodenoson to treat hepatocellular carcinoma (HCC) had a complete response. Can-Fite also announced an exercise of warrants totaling $10 million in cash. Shares closed the week down 43% at $1.37.

CytomX Therapeutics, Inc. (NASDAQ: CTMX) released preliminary data from its Phase 2 results of CX-2029 to treat lung, head and neck cancer. The objective response rate (ORR) was 18.8%. Shares closed the week down 33% at $4.22.

OTHERS:

BiondVax Pharmaceuticals Ltd (NASDAQ: BVXV) entered into an 5-year agreement to license its COVID-19 VHH antibody candidates. Shares closed the week up 75% at $2.78.

Qualigen Therapeutics, Inc. (NASDAQ: QLGN) was featured on a Seeking Alpha blog post Friday noting the companies’ valuation and revenue increase of 38% year over year. Shares closed the week up 36% at $1.29.


Drug Price Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
ADX-629
Psoriasis / atopic asthma / COVID-19

$3.25
-0.22  -6%
Phase 2 Phase 2 top-line data due by 1Q 2022.
$188.8 million

ANNX – Annexon Inc.
ANX005
Huntington’s disease

$7.50
-0.38  -5%
Phase 2 Phase 2 data reported that treatment was generally well-tolerated, noted January 4, 2022. Full Phase 2 data due in 1H 2022.
$287.8 million

BBIO – BridgeBio Pharma Inc.
Acoramidis (AG10) - (ATTRibute-CM)
ATTR-CM

$10.30
-1.16  -10%
NDA Filing Phase 3 top-line reported that trial did not meet its primary endpoint, noted December 27, 2021. NDA filing expected in 2022. Part B data due 2023.
$1.5 billion

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

CFRX – ContraFect Corporation
Exebacase - (DISRUPT)
Serious infections caused by Staph aureus including MRSA

$2.36
-0.08  -3%
Phase 3 Phase 3 interim futility analysis delayed due to COVID-19 until 1H 2022.
$92.8 million

EQ – Equillium Inc.
Itolizumab (EQ001) - (EQUIP)
Asthma

$3.95
+0.07  +2%
Phase 1b Phase 1b interim data reported mean ACQ-6 of 2.5, which decreased to 1.5 at Day 29, and maintained this level 30 days after the last dose of itolizumab at Day 85. Mean FEV-1 was 2.1 on Day 1, which increased to 2.4 at Day 29 and maintained at Day 85, noted November 5, 2021. Phase 1b trial met primary endpoint, noted January 4, 2021.
$116.1 million

FBIO – Fortress Biotech Inc.
Cosibelimab (CK-301)
Cutaneous squamous cell carcinoma (CSCC)

$2.05
-0.05  -2%
Phase 1 Phase 1 pivotal top-line data expected in 1Q 2022. BLA submission due in 2022.
$204.2 million

IMV – IMV Inc.
Maveropepimut-S (DPX-Survivac) and KEYTRUDA (pembrolizumab) - basket trial
Solid tumors

$1.20
-0.03  -2%
Phase 2 Phase 2 trial update 1Q 2022.
$98.6 million

JAGX – Jaguar Health Inc.
Crofelemer (Mytesi)
Chronic Idiopathic Diarrhea in Non-HIV Patients

$0.81
-0.06  -7%
Phase 3 Phase 4 trial ongoing.
$37.2 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

RVMD – Revolution Medicines Inc - Ordinary Shares
RMC-4630 and Sotorasib (AMG 510)
Solid tumors

$22.71
-0.55  -2%
Phase 1b Phase 1b preliminary data due in 2H 2022
$1.7 billion

SWTX – SpringWorks Therapeutics Inc.
Nirogacestat (DeFi)
Desmoid tumors

$54.24
-0.38  -1%
Phase 3 Phase 3 top-line data due early 2022.
$2.7 billion

TCON – TRACON Pharmaceuticals Inc.
TRC102
Mesothelioma cancer

$2.13
-0.12  -5%
Phase 2 Phase 2 data reported that 9 patients reported stable disease as best response with Grade 3 TRAEs including lymphopenia (4) and anemia (1), noted October 7, 2021.
$41.4 million

TSHA – Taysha Gene Therapies Inc.
TSHA-120
Giant axonal neuropathy (GAN)

$7.93
-0.24  -3%
Phase 1/2 Phase 1/2 data due in January 2022.
$305.1 million