BPC May 09 update

ADC Therapeutics ADCT -29% CEO and Earnings; Redhill RDHL ​​-27% Offering

Price and Volume Movers

ADC Therapeutics SA (NYSE: ADCT) reported financial results for the first quarter noting an adjusted loss of $0.36 per share, with revenue of $46.5 million. ADC also announced that its CEO Chris Martin, DPhil has stepped down and will be replaced by Ameet Mallik. Shares closed down 29% at $7.81.

Novavax, Inc. (NASDAQ: NVAX) shares are currently down 18% during after hours trading after it reported earnings for the first quarter. Revenue was $704 million, lower than the $845.2 million estimate, and earnings per share was $2.56, also lower than the $2.69 estimate.

Mereo BioPharma Group plc (NASDAQ: MREO) released topline data from its Phase 2 ASTRAEUS study of alvelestat (MPH-966) to treat severe alpha-1 antitrypsin deficiency-(AATD) associated emphysema. Data for the high dose was statistically significant for all three biomarker endpoints. Shares closed down 31% at $0.40.

RedHill Biopharma Ltd. (NASDAQ: RDHL) announced a registered direct offering of 10,563,380 American Depositary Shares (ADS) for gross proceeds of approximately $15 million. Shares closed down 27% at $1.08.

The FDA lifted its hold on LogicBio Therapeutics, Inc’s (NASDAQ: LOGC) Investigational New Drug Application (IND) for LB-001, allowing for enrollment to resume in its 1/2 SUNRISE trial to treat pediatric patients with methylmalonic acidemia. Shares closed up 34% at $0.67.

BMO Capital maintained its Market Perform rating of Endo International (NASDAQ: ENDP) and lowered its price target from $4 to $2. Shares closed down 15% at $1.20.

Notable earnings from today:

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)

Avadel Pharmaceuticals plc (NASDAQ: AVDL)

Surface Oncology (NASDAQ: SURF)

Advancers

CompanyPriceChange
GOVX
GeoVax Labs Inc.
 $1.01 +1.01  +100%
SIGA
SIGA Technologies Inc.
 $1.01 +1.01  +100%
NNVC
NanoViricides Inc.
 $1.01 +1.01  +100%
TXMD
TherapeuticsMD Inc.
 $1.01 +1.01  +100%
IMMX
Immix Biopharma Inc.
 $1.01 +1.01  +100%
TNYA
Tenaya Therapeutics Inc.
 $1.01 +1.01  +100%
FHTX
Foghorn Therapeutics Inc.
 $1.01 +1.01  +100%
AEMD
Aethlon Medical Inc.
 $1.01 +1.01  +100%
TPST
Tempest Therapeutics Inc.
 $1.01 +1.01  +100%
CNTX
Context Therapeutics Inc.
 $1.01 +1.01  +100%

Decliners

CompanyPriceChange
BGXX
Bright Green Corporation
 $1.01 -1.01  -100%
NURO
NeuroMetrix Inc.
 $1.01 -1.01  -100%
PTE
PolarityTE Inc.
 $1.01 -1.01  -100%
MGTA
Magenta Therapeutics Inc.
 $1.01 -1.01  -100%
INAB
IN8bio Inc.
 $1.01 -1.01  -100%
NVCT
Nuvectis Pharma Inc.
 $1.01 -1.01  -100%
FREQ
Frequency Therapeutics Inc.
 $1.01 -1.01  -100%
CABA
Cabaletta Bio Inc.
 $1.01 -1.01  -100%
IMAB
I-MAB
 $1.01 -1.01  -100%
CINC
CinCor Pharma Inc.
 $1.01 -1.01  -100%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ACHL – Achilles Therapeutics plc
ATL001 - (THETIS)
Melanoma
$2.52
+0.11  +5% 		Phase 1/2 Phase 1/2a update reported stable disease in 63% (5 of 8) in the initial, low-dose cohort noted November 12, 2021. Phase 1/2a cohort B enrollment initiated, noted May 9, 2022. Phase 1/2a data due in 2H 2022.
$102.7 million

ALKS – Alkermes plc
Nemvaleukin (ALKS 4230) - (ARTISTRY-1)
Solid tumors
$30.00
+0.52  +2% 		Phase 1/2 Phase 1/2 data presented at ASCO June 4, 2021. 2/6 patients in melanoma monotherapy cohort showed partial responses. Phase 1/2 final data set to be presented at ASCO June 4, 2022.
$4.9 billion

CLNN – Clene Inc.
CNM-Au8 - (HEALEY ALS Platform Trial)
Amyotrophic Lateral Sclerosis
$2.50
+0.09  +4% 		Phase 2/3 Phase 2/3 enrollment completed, noted November 15, 2021. Phase 2/3 data due 3Q 2022, NDA filing planned.
$158.1 million

CLNN – Clene Inc.
CNM-Au8 - (REPAIR-MS)
Multiple Sclerosis
$2.50
+0.09  +4% 		Phase 2 Phase 2 trial met primary endpoint - August 5, 2021. Phase 2 second cohort initiated, noted May 9, 2022.
$158.1 million

DTIL – Precision BioSciences Inc.
PBCAR0191
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia and R/R non-hodgkin lymphoma
$1.71
-0.02  -1% 		Phase 1/2 Phase 1/2 updated safety and efficacy data showed no ≥ Grade 3 cytokine release syndrome (CRS), yielded an overall response rate of 73% and a complete response rate of 59% using a 3 x 106 cells/kg cell dose. 4 of 17 evaluable subjects reached Day 180 durability assessment, noted December 11, 2021. Phase 1/2 clinical update in June 2022.
$106.3 million

EGRX – Eagle Pharmaceuticals Inc.
Landiolol
Supraventricular tachycardia (SVT) - atrial fibrillation and atrial flutter
$46.71
+1.04  +2% 		NDA Filing NDA filing due May 2022.
$593.2 million

ELDN – Eledon Pharmaceuticals Inc.
Tegoprubart (AT-1501)
IgA nephropathy (IgAN)
$3.20
+0.08  +3% 		Phase 2a Phase 2a dosing initiated, noted May 9, 2022. Phase 2a initial data due 2H 2022.
$44 million

FULC – Fulcrum Therapeutics Inc.
FTX-6058
Sickle Cell Disease
$8.51
-0.13  -2% 		Phase 1b Phase 1b trial initiated, noted January 10, 2022. Phase 1b initial data to be presented at the EHA 2022 Congress on June 10, 2022
$347.6 million

IMGO – Imago BioSciences Inc.
Bomedemstat w/ atezolizumab
Small cell lung cancer (SCLC)
$13.98
+0.32  +2% 		Phase 1/2 First patient dosed in Phase 1/2 trial, noted May 9, 2022.
$471.6 million

LOGC – LogicBio Therapeutics Inc.
LB-001 - (SUNRISE)
Methylmalonic Acidemia (MMA)
$0.44
+0.01  +2% 		Phase 1/2 Phase 1/2 trial clinical hold lifted, noted May 9, 2022. SAE in fourth patient has been resolved, noted March 4, 2022. Phase 1/2 interim data due in 2Q 2022.
$14.4 million

LPCN – Lipocine Inc.
LPCN 1144 - (LiFT)
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)
$0.90
+0.01  +1% 		Phase 2 Phase 2 top-line change in liver fat data met primary endpoint January 12, 2021. OLE extension study results reported that treatment was well-tolerated with liver injury markers reduced, noted May 12, 2022. Phase 3 trial and NDA submission planned.
$80 million

MDGL – Madrigal Pharmaceuticals Inc.
Resmetirom (MGL-3196) - (MAESTRO-NAFLD-1)
Non-Alcoholic Fatty Liver Disease
$66.71
-1.17  -2% 		Phase 3 Phase 3 52-week top-line data reported that trial met primary endpoint and hierarchically-controlled secondary endpoints, noted January 31, 2022. Subpart H submission for FDA expected. Phase 3 52-week primary data analysis to be presented at the EASL's International Liver Congress on June 25.
$1.1 billion

MREO – Mereo BioPharma Group plc
Alvelestat - (ASTRAEUS)
Severe alpha-1 antitrypsin deficiency
$0.53
+0.04  +9% 		Phase 2 Phase 2 study have shown good safety to-date and the study has now recruited 99 patients and per protocol, enrollment has been biased towards the high dose, noted December 27, 2021. Phase 2 study demonstrated to be statistically significant inhibition of blood neutrophil elastase activity of up to 90% in patients in both high and low dose groups throughout the 12-week dosing period, noted May 9, 2022.
$62.3 million

RARE – Ultragenyx Pharmaceutical Inc.
DTX301 - (Enh3ance)
Ornithine Transcarbamylase (OTC) Deficiency
$48.55
+1.55  +3% 		Phase 1/2 Phase 3 study expected to initiate in mid-2022. Phase 1/2 trial safety and efficacy data reported that in the prophylactic steroid cohort, one of two patients demonstrated a complete response, noted May 19, 2022.
$3.4 billion