BPC January 06 update

Aligos ALGS -57% Halted ALG-010133; Alterity ATHE +34% Patent

Price and Volume Movers

Aligos Therapeutics, Inc. (NASDAQ: ALGS) announced it halted development for ALG-010133 due to no meaningful HBsAg reduction, and higher doses levels are unlikely to reach the 1 log10 IU/mL HBsAg reduction level that had been previously defined as necessary to advance the program. Shares closed down 57% at $4.59.

Alterity Therapeutics (NASDAQ: ATHE) announced that the United States Patent and Trademark Office (USPTO) granted it a new patent covering more than 80 novel compounds designed to redistribute excess iron implicated in many neurodegenerative diseases, including Parkinson's disease and Alzheimer's disease. Shares closed up 34% at $1.11.

Avalo Therapeutics, Inc. (NASDAQ: AVTX) reported data from its Phase 1b trial of AVTX-002 to treat Crohn's Disease and noted that they would be discontinuing development for AVTX-007 to treat multiple myeloma. Shares closed down 32% at $1.21.

Sutro Biopharma, Inc. (NASDAQ: STRO) released data from its Phase 1 study of STRO-002 to treat ovarian cancer. The overall response rate was 33%, however one grade five event of febrile neutropenia occurred causing the redesign of the trial protocol. Shares closed down 28% at $10.51.

Curis, Inc. (NASDAQ: CRIS) released data from its Phase 1/2 study of CA-4948 to treat relapsed or refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). Curis also released initial data from its Phase 1 dose-escalation study of CI-8993to treat R/R solid tumors. Shares closed down 28% at $3.49.

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

AFMD – Affimed N.V.
AFM13 + NK cells (AFM13-104)
CD30-positive lymphomas

$4.02
-0.12  -3%
Phase 1/2 Updated Phase 1/2 results reported a response rate after one cycle of treatment remains at 100% with a 38.5% complete response (CR) rate; one additional patient completed cycle 1 at the RP2D and was assessed with a partial response (PR), noted December 9, 2021. FDA approved protocol to increase enrollment at highest dose level and treatment with more than two cycles, noted January 6, 2021.
$481.6 million

AFMD – Affimed N.V.
AFM13 (REDIRECT)
CD30-positive peripheral T cell lymphoma (PTCL)

$4.02
-0.12  -3%
Phase 2 Phase 2 enrollment completed, noted January 6, 2022. Top-line data expected 2H 2022.
$481.6 million

ALGS – Aligos Therapeutics Inc.
ALG-010133
Hepatitis B

$3.03
-0.02  -1%
Phase 1 Development halted due to no meaningful HBsAg reduction and higher doses levels are very unlikely to reach the 1 log10 IU/mL HBsAg reduction level that had been previously defined as necessary to advance the program, noted January 6, 2022.
$129.1 million

AVTX – Avalo Therapeutics Inc.
AVTX-002
Crohn’s disease

$0.88
+0.06  +7%
Phase 1b Phase 1b top-line data reported clinically meaningful mucosal healing in fifty percent (4/8) of subjects with one subject achieving remission, noted January 6, 2022.
$98.7 million

BOLT – Bolt Biotherapeutics Inc.
BDC-1001 with Opdivo
HER2-Expressing Solid Tumors

$3.63
-0.13  -3%
Phase 1/2 Phase 1/2 interim data reported data from 57 subjects demonstrated a favorable safety and tolerability profile at all evaluated doses and schedules, noted December 6, 2021. Phase 1/2 combination arm first patient dosed, noted January 6, 2022.
$135.3 million

CRIS – Curis Inc.
CI-8993
Solid tumors

$3.07
-0.08  -3%
Phase 1 Phase 1 safety data reported promising safety profile to date, with no dose-limiting toxicities observed, noted January 6, 2022.
$281.2 million

CRIS – Curis Inc.
CA-4948
Acute Myeloid Leukemia / Myelodysplastic Syndromes

$3.07
-0.08  -3%
Phase 1/2 Phase 1 presentation at EHA meeting June 11, 2021. 5/17 objective responses. Phase 1/2 monotherapy data reported a CR/CRh rate of 40%, an objective response rate of 57%, and complete response (CR) rate of 33%, noted January 6, 2022. Additional data due to be presented in 2022.
$281.2 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-938 (RSVP)
Respiratory Syncytial Virus (community-acquired)

$56.49
-0.60  -1%
Phase 2b Phase 2 study enrolment completed, noted January 6, 2022. Phase 2 topline data expected 2Q 2022.
$1.1 billion

FWBI – First Wave BioPharma Inc.
Oral niclosamide - (RESERVOIR)
COVID-19-related gastrointestinal (GI) infections

$1.25
-0.07  -5%
Phase 2 Phase 2 top-line data due 1H 2022. An Independent data monitoring committee (DMC) has recommended that enrollment continue in Part 2 of trial November 30, 2021. Phase 2 enrollment complete noted January 6, 2022.
$18.5 million

INAB – IN8bio Inc.
INB-200
Glioblastoma

$3.21
-0.12  -4%
Phase 1 Phase 1 preliminary data presented at ASCO June 4, 2021. INB-200 was generally well tolerated with no observed infusion reactions. Phase 1 data reported that all four patients exceeded their expected progression-free survival (PFS) interval. Enrollment in cohort 2 to be complete in 2022, noted January 6, 2022.
$60.2 million

LIFE – aTyr Pharma Inc.
Efzofitimod (ATYR1923)
Pulmonary sarcoidosis

$5.99
-0.31  -5%
Phase 1/2 Phase 1b/2a trial met primary endpoint September 13, 2021. Registrational trial to initiate in 2022. Orphan Drug Designation issued by FDA, noted January 6, 2022.
$166.5 million

LPCN – Lipocine Inc.
LPCN 1144 - (LiFT)
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)

$0.89
-0.05  -5%
Phase 2 Phase 2 top-line change in liver fat data met primary endpoint January 12, 2021. Phase 2 36-week data met with primary endpoint of NASH resolution with no worsening of fibrosis based on NASH CRN scoring. Both treatment arms showed improvement of the observed NASH activity in steatosis, inflammation and ballooning, August 25, 2021. Phase 2 data reported statistically significant reductions of ALT and AST; up to a mean of 24.5 U/L decrease in ALT, and 12.3 U/L decrease in AST, noted November 16, 2021.
$78.7 million

OBSV – ObsEva SA
Linzagolix (OBE2109) - EDELWEISS 3
Endometriosis

$1.69
-0.10  -6%
Phase 3 Phase 3 trial met the co-primary endpoint at the 200 mg level tested once-daily dose in combination with add-back therapy (ABT) and a statistical significance at the 75 mg dose of linzagolix without ABT, noted January 6, 2022. Additional data from the post-treatment follow-up expected in 2Q 2022 and from the post-treatment follow-up of the extension study in 4Q 2022.
$131.8 million

RFL – Rafael Holdings Inc. Class B
CPI-613 (devimistat) + hydroxychloroquine - (APOLLO 613)
Clear cell sarcoma

$3.99
-0.19  -5%
Phase 1/2 Phase 1/2 first patient enrolled noted November 11, 2021. Phase 1/2 dose escalation completed, noted January 6, 2022.
$82.6 million