BPC June 22 update

Vaccitech VACC +36% Phase 1/2 EASL poster; Applied APLT -33% AH Offering

Price and Volume Movers

Athira Pharma, Inc. (NASDAQ: ATHA) shares tumbled down 66% at $2.85 after it announced that its Phase 2 ACT-AD trial of fosgonimeton (ATH-1017) to treat Alzheimer's disease (AD) failed to reach its primary endpoint.

Vaccitech plc (NASDAQ: VACC) presented a poster at the 2022 EASL International Liver Congress with updated efficacy data from its Phase 1/2 HBV002 study to treat Hepatitis B. From the monotherapy reductions of HBsAg were seen in all three patients with baseline HBsAg under 50 IU/mL. Shares closed up 36% at $6.21.

Applied Therapeutics, Inc. (NASDAQ: APLT) announced a public offering of stock or pre-funded warrants. Shares are currently trading down 33% at $0.72.

Xenon Pharmaceuticals Inc. (NASDAQ: XENE) announced open label data from its Phase 2b X-TOLE trial of XEN1101 to treat focal epilepsy, noting that seizure reduction exceeded 70% at 3 months and exceeded 80% at 12 months. Xenon also announced a public offering of stocks. Shares are currently trying down 9% at $31.45 during after hours trading.

BioSig Technologies, Inc. (NASDAQ: BSGM) announced it has entered an agreement with Cleveland Clinic to have them participate in a 60-day evaluation of BioSig's PURE EP(TM) System. Shares closed up 21% at $0.88.

Summit Therapeutics Inc. (NASDAQ: SMMT) announced that its Board of Directors has approved a rights offering of common stock at $1.08 per share. Shares are currently trading down 17% at $0.90.

Advancers

CompanyPriceChange
OMER
Omeros Corporation
$1.01 +1.01  +100%
CLVS
Clovis Oncology Inc.
$1.01 +1.01  +100%
MREO
Mereo BioPharma Group plc
$1.01 +1.01  +100%
BLTE
Belite Bio Inc
$1.01 +1.01  +100%
INDP
Indaptus Therapeutics Inc.
$1.01 +1.01  +100%
TYRA
Tyra Biosciences Inc.
$1.01 +1.01  +100%
BLCM
Bellicum Pharmaceuticals Inc.
$1.01 +1.01  +100%
CRTX
Cortexyme Inc.
$1.01 +1.01  +100%
AUPH
Aurinia Pharmaceuticals Inc
$1.01 +1.01  +100%
ELYM
Eliem Therapeutics Inc
$1.01 +1.01  +100%

Decliners

CompanyPriceChange
TALS
Talaris Therapeutics Inc.
$1.01 -1.01  -100%
AKUS
Akouos Inc.
$1.01 -1.01  -100%
FEMY
Femasys Inc.
$1.01 -1.01  -100%
CLDX
Celldex Therapeutics Inc.
$1.01 -1.01  -100%
PRVB
Provention Bio Inc.
$1.01 -1.01  -100%
EPIX
ESSA Pharma Inc.
$1.01 -1.01  -100%
ADIL
Adial Pharmaceuticals Inc
$1.01 -1.01  -100%
CDAK
Codiak BioSciences Inc.
$1.01 -1.01  -100%
LABD
Direxion Daily S&P Biotech Bear 3X Shares
$1.01 -1.01  -100%
PPBT
Purple Biotech Ltd.
$1.01 -1.01  -100%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALGS – Aligos Therapeutics Inc.
ALG-055009
Nonalcoholic steatohepatitis (NASH)

$1.25
+0.04  +3%
Phase 1 Phase 1 trial initiated in healthy volunteers December 9, 2021. Phase 1 initial data reported no serious adverse events, noted June 22, 2022. Top-line data expected 3Q 2022.
$53.4 million

ANIP – ANI Pharmaceuticals Inc.
Clorazepate Dipotassium Tablets
Tranxene generic

$31.54
+1.86  +6%
Approved Approved June 22, 2022.
$543.9 million

ATHA – Athira Pharma Inc.
ATH-1017 - (ACT-AD)
Mild-to-moderate Alzheimer's disease

$3.22
+0.17  +6%
Phase 2 Phase 2 top-line results reported that trial did not meet primary endpoint, noted June 22, 2022. Fully analysis of results to be presented at AAIC July 31 to August 31, 2022.
$121.2 million

AURA – Aura Biosciences Inc.
AU-011 (IVT administration)
Indeterminate lesions (ILs) and choroidal melanoma (CM)

$14.21
+0.04  +0%
Phase 1/2 Phase 1b/2 12-month safety and efficacy data noted a statistically significant reduction in the tumor growth rate, a 64% tumor control rate, and visual acuity preservation rate of 71%, noted November 15, 2021. Phase 1b/2 reported results from retrospective matched case control study, treatment achieved statistically significant vision preservation compared current standard of care, noted June 22, 2022.
$415.8 million

BBIO – BridgeBio Pharma Inc.
BBP-812 - (CANaspire)
Canavan Disease

$9.92
+0.84  +9%
Phase 1/2 Phase 1/2 data from first two patients reported that after 6 months, patient 1 had a 77% lowering of NAA in the CSF, 15% reduction in NAA in brain white matter by magnetic resonance spectroscopy (MRS) imaging, and ~50% decrease in urine NAA. At 3 months patient two had a 89% reduction of NAA in CSF, >50% decrease in NAA in brain white matter by MRS imaging, and 81% drop in urine NAA. Additional Phase 1/2 data expected in 2022.
$1.5 billion

BMEA – Biomea Fusion Inc.
BMF-219 - (COVALENT-101)
Acute myeloid leukemia (AML) / acute lymphocytic leukemia (ALL) / Diffuse large B-cell lymphoma (DLBCL) / Multiple myeloma (MM)

$11.15
-0.83  -7%
Phase 1 Phase 1 trial first patient dosed in the MM cohort, noted June 22, 2022.
$325.2 million

CBAY – CymaBay Therapeutics Inc.
Seladelpar - (RESPONSE)
Primary biliary cholangitis (PBC)

$2.77
-0.18  -6%
Phase 3 Phase 3 data to be presented at EASL demonstrated that treatment of 50 patients for 2 years resulted in a mean (SD) change from baseline in GLOBE score of -0.417 (0.269), resulting in a corresponding hazard ratio of 0.66 for transplantation or death compared to no prior treatment. The improvement in GLOBE score and predicted survival did not depend on age. However, an analysis of subpopulations of high risk patients by GLOBE score (> 0.3) revealed that while patients of all ages improved, the younger patients tended to have numerically greater improvements, although these differences did not achieve significance, noted June 22, 2022.
$234.6 million

CYBN – Cybin Inc.
CYB003
Major Depressive Disorder (MDD) and Alcohol use disorder (AUD)

$0.56
0.00  +1%
Phase 1/2 Phase 1/2a trial initiated June 27, 2022. Phase 1/2a study initial data expected in 4Q 2022.
$94.1 million

KRYS – Krystal Biotech Inc.
B-VEC - (GEM-3)
Epidermolysis Bullosa

$67.47
+1.81  +3%
BLA Filing Phase 3 trial met its primary endpoint and secondary endpoint, noted November 29, 2021. BLA submitted June 22, 2022.
$1.7 billion

MDNA – Medicenna Therapeutics Corp.
MDNA11 - (ABILITY)
Solid tumors

$1.18
+0.02  +2%
Phase 1/2 Phase 1/2 data reported that levels of Ki67+ expression by CD8+ T cells and NK cells increased by 17-fold and 10-fold, respectively, in the third cohort, noted May 2, 2022. New data show that treatment boosted the lymphocyte population by 2-fold without inducing significant increases in eosinophils (associated with toxicity), noted May 11, 2022. Phase 1/2 data showed that tumor control achieved following treatment in 3/8 patients enrolled in first 3 dose escalation cohorts, noted June 22, 2022.
$66.4 million

MRK – Merck & Company Inc.
VAXNEUVANCE (V114-029) - (PNEU-PED)
Pneumococcal Vaccine in children

$92.42
+1.25  +1%
Approved Approved June 22, 2022.
$233.7 billion

NRSN – NeuroSense Therapeutics Ltd.
Prime C - (PARADIGM)
Amyotrophic Lateral Sclerosis

$3.30
-0.08  -2%
Phase 2 Phase 2a preliminary results showed levels of disease-related biomarkers remain unchanged in people living with ALS who are treated with standard of care, in contrast to the statistically significant decline in these biomarkers in patients treated, noted June 27, 2022. Phase 2b topline data due in 2Q 2023 and Phase 3 initiation expected to initiate 2H 2023.
$38.5 million

VACC – Vaccitech plc
VTP-300 (HBV002)
Hepatitis B (HBV)

$4.61
+0.16  +4%
Phase 1/2 Phase 1b/2a 3-month study interim data from 27 patients demonstrated noted changes in surface antigen (HBsAg) levels, especially in the group receiving low-dose nivolumab with the heterologous boost, noted December 7, 2021. Phase 1b/2a interim efficacy review presented at the International Liver Congress reported that the monotherapy group had reductions of HBsAg in all three patients with baseline HBsAg under 50 IU/mL, and combination data reported that the mean reduction in HBsAg was over 1 log10 at six months, noted June 22, 2022. Phase 1b/2 efficacy data due in 2H 2022.
$171.5 million

VTGN – VistaGen Therapeutics Inc.
PH94B - (PALISADE)
Social Anxiety Disorder (SAD)

$0.87
-0.01  -1%
Phase 3 Phase 3 regulatory update confirmed that there is no signal of abuse potential, noted May 5, 2022. Phase 3 study dosing completed, noted June 22, 2022. Phase 3 top-line data due mid-2022. NDA due in mid-2023.
$180.2 million

VTGN – VistaGen Therapeutics Inc.
PH94B - (PALISADE-2)
Social Anxiety Disorder (SAD)

$0.87
-0.01  -1%
Phase 3 Phase 3 trial initiated September 13, 2021. Top-line data due late 2022.
$180.2 million

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

$1.17
+0.03  +3%
Phase 2 Phase 2 top-line data reported that trial met efficacy endpoints and treatment was well-tolerated, noted June 22, 2022. Meeting with FDA planned.
$51 million