BPC January 04 update

HOTH +85% Alzheimer non-clinical data; NLS Pharmaceutics NLSP +26% Patent

Price and Volume Movers

Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced proof-of-concept data generated using an Alzheimer's disease mouse model of HT-ALZ. The initial data reported a significant decrease in Aβ with HT-ALZ, compared to placebo. Shares closed up 85% at $1.30.

NLS Pharmaceutics Ltd. (NASDAQ: NLSP) announced that the United States Patent and Trademark Office (USPTO) granted Patent No. 11207271 covering oral formulations containing mazindol and their use in treating attention deficit disorders (ADD or ADHD). Shares closed up 26% at $1.50.

Gritstone bio, Inc. (NASDAQ: GRTS) released Phase 1 clinical data from the first cohort of its CORAL-BOOST study. Treatment demonstrated both a neutralizing antibody response to Spike and robust CD8+ T cell responses. Shares closed down 42% at $7.02.

AVROBIO, Inc. (NASDAQ: AVRO) announced that it is deprioritizing its Fabry disease program due to data showing variable engraftment patterns, increasingly challenging market and regulatory environment for Fabry disease. Shares closed down 37% at $2.56.

Oncternal Therapeutics, Inc. (NASDAQ: ONCT) announced that the company and the FDA agreed on elements of its Phase 3 trial of zilovertamab to treat mantle cell lymphoma (MCL). The trial is to be initiated in the second quarter of 2022. Shares are currently trading up 16% after-hours at $2.71.

Advancers

CompanyPriceChange
ARDS
Aridis Pharmaceuticals Inc.
$1.60+0.27  +20.30%
CINC
CinCor Pharma Inc.
$18.20+2.13  +13.25%
RVLP
RVL Pharmaceuticals plc
$1.20+0.11  +10.09%
ITCI
Intra-Cellular Therapies Inc.
$42.66+3.79  +9.75%
GMDA
Gamida Cell Ltd.
$3.24+0.28  +9.46%
HILS
Hillstream BioPharma Inc.
$3.36+0.23  +7.35%
KPTI
Karyopharm Therapeutics Inc.
$8.28+0.55  +7.12%
CNTX
Context Therapeutics Inc.
$2.10+0.13  +6.60%
LABD
Direxion Daily S&P Biotech Bear 3X Shares
$45.71+2.71  +6.30%
BDSI
BioDelivery Sciences International Inc.
$3.36+0.18  +5.66%

Decliners

CompanyPriceChange
IMMX
Immix Biopharma Inc.
$4.51-0.91  -16.79%
ACXP
Acurx Pharmaceuticals Inc.
$3.64-0.7  -16.13%
CGTX
Cognition Therapeutics Inc.
$3.50-0.64  -15.46%
HOOK
HOOKIPA Pharma Inc.
$1.50-0.26  -14.77%
CVAC
CureVac N.V.
$18.73-3.12  -14.28%
BFRI
Biofrontera Inc.
$3.47-0.53  -13.25%
BSGM
BioSig Technologies Inc.
$1.80-0.27  -13.04%
HCWB
HCW Biologics Inc.
$2.02-0.3  -12.93%
VRPX
Virpax Pharmaceuticals Inc.
$2.30-0.34  -12.88%
APM
Aptorum Group Limited
$1.48-0.21  -12.43%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
ADX-2191 - (GUARD)
Proliferative vitreoretinopathy (PVR)

$3.25
-0.22  -6%
Phase 3 Phase 3 part 1 completion of enrollment, noted January 4, 2022. Top-line results expected 2H 2022.
$188.8 million

ALNA – Allena Pharmaceuticals Inc.
Reloxaliase (ALLN-177) - (URIROX-2)
Enteric Hyperoxaluria

$0.38
-0.01  -4%
Phase 3 Phase 3 interim analysis due late 1Q 2022.
$32.9 million

ALNA – Allena Pharmaceuticals Inc.
ALLN-346-202
Gout in chronic kidney disease (CKD)

$0.38
-0.01  -4%
Phase 2a Phase 2a first patient dosed September 29, 2021. Phase 2a initial data due 1Q 2022. Two additional cohorts to be initiated during 2Q 2022.
$32.9 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

ASMB – Assembly Biosciences Inc.
ABI-H3733
Healthy volunteers

$1.70
-0.06  -3%
Phase 1b Phase 1b trial planned for 1H 2022, initial data due in 2H 2022.
$81.4 million

AVEO – AVEO Pharmaceuticals Inc.
FOTIVDA (Tivozanib) and IMFINZI (Durvalumab) - (DEDUCTIVE)
Hepatocellular carcinoma (HCC)

$3.42
-0.18  -5%
Phase 1/2 Phase 1b/2 trial has moved to Phase 2 part of trial - May 29, 2020. Phase 1b data presented at ASCO GI January 15, 2021. 29% partial response (PR) rate. Phase 1b/2 data reported a 27.8% partial response (PR) rate and disease control rate (PR + stable disease) of 67.8%, with a median PFS of 7.3 months and a 1-year OS of 76%, noted January 20, 2022.
$117.6 million

AVRO – AVROBIO Inc.
AVR-RD-02
Gaucher disease

$1.83
-0.03  -2%
Phase 1/2 Phase 1/2 safety data reported no SAEs and no AEs for more than 14 months post-treatment, noted October 19, 2021. Company plans to provide a full program update 1H 2022.
$79.9 million

AYLA – Ayala Pharmaceuticals Inc.
AL101 - (ACCURACY)
Adenoid cystic carcinoma

$6.74
-0.01  0%
Phase 2 Preliminary Phase 2 data had a disease control rate (DCR) of 70% (23/33 patients), partial responses (PR) in 3 patients (9%), stable disease (SD) in 20 patients (61%). Progressive disease (PD) was observed in 8 patients (24%), noted September 16, 2021. Final data from the 4 mg and additional data from the 6 mg cohort which includes 42 subjects are expected to be announced during 2022.
$93.9 million

CNTB – Connect Biopharma Holdings Limited
CBP-201
Atopic dermatitis

$4.90
-0.13  -3%
Phase 2b Phase 2b data met primary endpoint all three doses achieving significant improvements. Also reported for key secondary endpoints including other measures of skin clearance and itch with a 300mg dose every two weeks (Q2W) arm, noted November 18, 2021. Additional Phase 2b analyses demonstrated a potential competitive therapeutic profile for 300mg administered every two weeks (Q2W) or every four weeks (Q4W), noted January 5, 2022. Phase 3 trial to be initiated 2H 2022. Additional data to be presented at the 18th Annual Maui Derm meeting, January 24-28, 2022.
$281.7 million

EVLO – Evelo Biosciences Inc.
EDP1815 - (TACTIC-E)
COVID-19

$4.90
-0.08  -2%
Phase 2/3 Phase 2/3 interim safety and futility analysis due in 1H 2022.
$262 million

GNCA – Genocea Biosciences Inc.
GEN-011 - (TITAN)
Various tumors

$0.96
-0.05  -5%
Phase 1/2 Phase 1/2 initiation of dosing announced July 13, 2021, with initial data due in early 2Q 2022.
$55.1 million

INBX – Inhibrx Inc.
INBRX-106
Solid Tumors

$28.06
+0.06  +0%
Phase 1 Phase 1 dose escalation data reported 2 partial responses, noted January 4, 2022. Phase 1 dose expansion data due by year end 2022.
$1.1 billion

PRQR – ProQR Therapeutics N.V.
Sepofarsen (QR-110) - (ILLUMINATE)
Leber's Congenital Amaurosis (LCA) - Genetic blindness

$5.07
-0.45  -8%
Phase 2/3 Phase 2/3 top-line data due 1Q 2022.
$373.7 million

ZYNE – Zynerba Pharmaceuticals Inc.
Zygel (ZYN002) - (INSPIRE)
22q11.2 Deletion Syndrome

$2.37
-0.01  0%
Phase 2 Phase 2 top-line data due in mid-2022.
$97.7 million