BPC October 05 update

Annovis ANVS -13% Phase 2 data; Johnson & Johnson JNJ EUA amendment for COVID-19 Booster

Price and Volume Movers

Annovis Bio, Inc. (NASDAQ: ANVS) announced Phase 2 efficacy data of ANVS401 to treat Parkinson’s disease. The trial displayed statistically significant improvements in speed and motor function in PD patients. Based on the MDS-Unified Parkinson's Disease Scale, ANVS401 showed improvement of ~16% and ~15.5%, in the 10mg and 20mg doses. Shares rallied in the premarket session but closed down 13% at $26.35.

Johnson & Johnson (NYSE: JNJ) announced the submission of an Emergency Use Authorization (EUA) amendment to the FDA to support the booster shot of its COVID-19 vaccine. The amendment included additional data from its Phase 3 trial that found a booster shot povided 100 percent protection against severe/critical COVID-19.

Kaleido Biosciences, Inc. (NASDAQ: KLDO) announced top-line data from its non-IND/CTA clinical study evaluating KB295 to treat ulcerative colitis (UC). Data noted a meaningful reduction in three key biomarkers: FCP, fecal lactoferrin, and FimH. The trial was originally designed for 30 subjects, however, due to COVID-19 related enrollment impacts, 12 subjects were enrolled. The trial met its primary endpoint and Kaleido plans for a Phase 2 trial in the first half of 2022. Shares closed down 10% at $5.26.

UNITY Biotechnology, Inc. (NASDAQ: UBX) released 12-week data from its Phase 1 trial of UBX1325 to treat diabetic macular edema (DME) and wet age-related macular degeneration (AMD). Data reported that 8 of 12 patients showed an increase in ETDRS letters from baseline. Across all doses, 6 of 10 patients had a decrease in CST, excluding two patients who received anti-VEGF rescue therapy following the progression of the underlying disease. Shares closed down 4% at $2.66.

Advancers

CompanyPriceChange
PROG
Progenity Inc.
$3.02+0.52  +20.89%
ATHA
Athira Pharma Inc.
$10.76+1.13  +11.73%
CNTX
Context Therapeutics Inc.
$6.89+0.72  +11.72%
RPTX
Repare Therapeutics Inc.
$24.63+1.87  +8.22%
CABA
Cabaletta Bio Inc.
$13.98+1.03  +7.99%
KALA
Kala Pharmaceuticals Inc.
$2.05+0.15  +7.89%
CMPS
COMPASS Pathways Plc
$37.80+2.49  +7.05%
PTPI
Petros Pharmaceuticals Inc.
$1.80+0.1  +5.88%
EYEN
Eyenovia Inc.
$6.31+0.34  +5.70%
MRTX
Mirati Therapeutics Inc.
$187.21+9.91  +5.59%

Decliners

CompanyPriceChange
MTCR
Metacrine Inc.
$1.64-2.19  -57.05%
OCUL
Ocular Therapeutix Inc.
$6.95-3.88  -35.87%
AGEN
Agenus Inc.
$3.90-1.24  -24.07%
SIOX
Sio Gene Therapies Inc.
$2.03-0.33  -13.98%
STAB
Statera Biopharma Inc.
$3.33-0.54  -13.95%
RNLX
Renalytix AI plc
$24.41-2.99  -10.91%
APLT
Applied Therapeutics Inc.
$13.98-1.71  -10.87%
XFOR
X4 Pharmaceuticals Inc.
$4.43-0.52  -10.51%
GRCL
Gracell Biotechnologies Inc.
$10.50-1.22  -10.41%
GRTX
Galera Therapeutics Inc.
$1.80-0.2  -10.20%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ADAP – Adaptimmune Therapeutics plc
Afami-cel (ADP-A2M4)
Solid tumors

$5.20
-0.07  -1%
Phase 1 Phase 1 data at American Society for Radiation Oncology (ASTRO) October 24-27, 2021. Additional Phase 1 data update to be presented at SITC November 12-14, 2021.
$810.9 million

ADAP – Adaptimmune Therapeutics plc
Afami-cel - (SPEARHEAD‑1)
Synovial sarcoma or myxoid/round cell liposarcoma (MRCLS)

$5.20
-0.07  -1%
Phase 2 Phase 2 initial data at ASCO June 4-8, 2021. Abstract noted overall response rate was 39.3% (13/33), 41.4% (12/29) for synovial sarcoma; 25.0% (1/4) for MRCLS. Phase 2 data update due at CTOS meeting November 12, 2021
$810.9 million

ADTX – Aditxt Inc.
Avigan Reeqonus Qifenda (favipiravir)
Covid-19

$1.60
-0.12  -7%
Phase 3 Phase 3 trial completed enrollment. Phase 3 top-line data due in less than 60 days (from October 5, 2021).
$43.2 million

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

$28.58
-0.81  -3%
Phase 2a Phase 2a completion of dosing announced August 11, 2021. Phase 2a data showed improvements in cognition in AD patients by 4.4 points compared to placebo at 3.3. WAIS coding in AD patients show a statistically-significant 23% improvement and PD patients a statistically-significant 24% improvement compared with placebo, noted September 2021. Phase 2a of PD patients noted statistically significant improvements in WAIS coding scores, in the UPDRS 2, 3, 4, and in total MDS-UPDRS test compared to baseline, noted October 5, 2021. Phase 3 trial to be initiated 1Q 2022.
$231.5 million

AZN – AstraZeneca PLC
AZD7442 (PROVENT)
COVID-19

$61.81
+0.59  +1%
Phase 3 Phase 3 trial met primary endpoint - August 20, 2021. 77% reduced risk of developing symptomatic COVID-19. EUA application filed to FDA October 5, 2021.
$191.5 billion

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Namodenoson (CF102)
Non-alcoholic steatohepatitis (NASH)

$1.55
-0.02  -1%
Phase 2b Phase 2b trial to commence patient enrollment 4Q 2021.
$29.6 million

JNJ – Johnson & Johnson
JNJ-78436735 (Ad26.COV2-S) - (ENSEMBLE-2)
COVID-19 vaccine - two-dose regimen

$163.61
+0.21  +0%
Phase 3 Phase 3 data showed 100 percent protection against severe/critical COVID-19 – at least 14 days post-final vaccination. 75 percent protection against symptomatic (moderate to severe/critical) COVID-19 globally. 94 percent protection against symptomatic COVID-19 in the U.S, September 21, 2021. An additional Phase 1/2a data showing that when a booster of the vaccine was given 6 months after the single shot, antibody levels increased nine-fold 1 week after the booster and continued to climb to 12-fold higher 4 weeks after the booster. EUA amendment submitted to FDA - October 5, 2021. EUA for second dose for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine, noted October 20, 2021.
$430.7 billion

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone (RESET)
Established status epilepticus (SE)

$11.09
-0.02  0%
Phase 2 Phase 2 patient first patient enrollment due 1Q 2022.
$407.4 million

TSHA – Taysha Gene Therapies Inc.
AAV9/CLN7
CLN7 Disease

$16.15
-0.34  -2%
Phase 1 Phase 1 trial currently enrolling, October 5, 2021. Phase 1 data due by year-end 2021.
$620 million

UBX – Unity Biotechnology Inc.
UBX1325
Diabetic macular edema / Age-related macular degeneration

$2.23
-0.03  -1%
Phase 2a Phase 2a 12-week data due 1H 2022.
$123.2 million

UBX – Unity Biotechnology Inc.
UBX1325
Diabetic macular edema (DME) / wet age-related macular degeneration (AMD)

$2.23
-0.03  -1%
Phase 1 Phase 1 data released July 6, 2021 - favorable safety and tolerability profile. Phase 1 12-week data noted overall 8 of 12 patients showed a gain in ETDRS letters, and in the high dose groups 5 of 6 patients showed a gain in ETDRS letters. Overall 6 of 10 patients had a decrease in CST, excluding two patients who received anti-VEGF rescue therapy following progression of underlying disease, noted October 5, 2021. Phase 1 24-week data and 8-week data from wet AMD cohort due year end 2021.
$123.2 million

URGN – UroGen Pharma Ltd.
VesiGel UGN-102 - ATLAS
Low grade non-muscle invasive bladder cancer (LG-NMIBC)

$16.97
+0.30  +2%
Phase 3 Phase 3 trial ongoing. Phase 2b results showed a significant treatment response with sustained durability in non-surgical chemoablation of LG IR-NMIBC. 65% (41/63) of patients that received a dose achieved a complete response (CR) three months after the start of therapy, of whom 39 (95%), 30 (73%), and 25 (61%) remained disease-free at 6, 9, and 12 months after treatment initiation, respectively, noted October 5, 2021.
$379.5 million

ZYME – Zymeworks Inc.
Zanidatamab and Evorpacept (ALX148)
HER2 Breast cancer and solid tumors

$22.77
-0.59  -3%
Phase 1/2 Phase 1b/2 first patient dosed, October 5, 2021.
$1.1 billion