BPC November 12 update

Altamira CYTO +53% in vitro Covid data; Oncorus ONCR -46% Phase 1 data

Price and Volume Movers

Altamira Therapeutics Ltd. (NASDAQ: CYTO) released efficacy data from testing its Bentrio nasal spray in vitro against the Delta variant of the SARS-CoV-2 virus. Treatment resulted in significantly lower virus titers, reaching -83% when the application was started prior to infection, and -69 to -85% when the application was initiated only when the infection was already ongoing. Shares closed up 53% at $2.33.

Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) received feedback from the FDA that reinforced the company's plans to submit a New Drug Application (NDA) for intravitreal pegcetacoplan to treat geographic atrophy (GA). Apellis remains on track to submit an NDA in the first half of 2022. Shares closed up 12% at $43.50.

Oncorus, Inc. (NASDAQ: ONCR) presented data from its ongoing Phase 1 trial of ONCR-177 to treat solid tumors. Data reported one partial response, one Investigator-reported clinical response and one patient with stable disease. Shares closed down 46% at $6.04.

Catalyst Biosciences, Inc. (NASDAQ: CBIO) announced a decision to halt the clinical development of MarzAA and seek a buyer for its hemophilia assets. Catalyst plans to focus its resources on its complement therapeutics and protease medicines platform. Shares closed down 42% at $1.71.

Aditxt, Inc. (NASDAQ: ADTX) announced its Phase 3 PRESECO trial evaluating oral Avigan and Reeqonus (favipiravir) to treat Covid-19 did not meet its primary endpoint. Shares closed down 23% at $1.39.

Compugen Ltd. (NASDAQ: CGEN) announced the presentation of preliminary results from its Phase 1 study of COM902 to treat solid tumors. The best treatment response was stable disease (SD) which was reported in 9 patients (50%), with 6 patients (67%) having confirmed SD and 3 patients (17%) with SD of at least 6 months. Shares closed down 18% at $5.87.

Notable earnings releases from today:

Gain Therapeutics, Inc. (NASDAQ: GANX)

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS)

Advancers

CompanyPriceChange
BFRI
Biofrontera Inc.
$7.90+2.68  +51.34%
NRXP
NRX Pharmaceuticals Inc.
$6.75+2.25  +50.00%
ADGI
Adagio Therapeutics Inc.
$25.12+6.39  +34.12%
ATNF
180 Life Sciences Corp.
$5.41+0.95  +21.30%
GOVX
GeoVax Labs Inc.
$4.69+0.81  +20.88%
MRNA
Moderna Inc.
$329.63+56.24  +20.57%
ICVX
Icosavax Inc.
$27.55+4.51  +19.57%
VALN
Valneva SE
$59.60+9.7  +19.44%
TYRA
Tyra Biosciences Inc.
$23.87+3.66  +18.11%
PTPI
Petros Pharmaceuticals Inc.
$2.09+0.26  +14.21%

Decliners

CompanyPriceChange
LGVN
Longeveron Inc.
$30.67-11.63  -27.49%
AMTI
Applied Molecular Transport Inc.
$16.33-2.66  -14.01%
NEXI
NexImmune Inc.
$7.94-1.06  -11.78%
IGMS
IGM Biosciences Inc.
$49.63-6.58  -11.71%
CRNX
Crinetics Pharmaceuticals Inc.
$24.40-3.08  -11.21%
AVRO
AVROBIO Inc.
$4.08-0.51  -11.11%
ELYM
Eliem Therapeutics Inc
$13.76-1.72  -11.11%
MRSN
Mersana Therapeutics Inc.
$6.95-0.82  -10.55%
MNOV
MediciNova Inc.
$3.22-0.35  -9.80%
TARS
Tarsus Pharmaceuticals Inc.
$25.00-2.7  -9.75%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

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

$1.12
+0.04  +4%
Phase 3 Phase 3 trial completed enrollment. Phase 3 top-line data reported that the trial did not meet its primary endpoint, noted November 12, 2021.
$30.2 million

ALEC – Alector Inc.
AL001 (INFRONT-2)
Frontotemporal Dementia

$19.92
-1.36  -6%
Phase 2 Phase 2 12-month biomarker data reported a double from baseline in progranulin levels when measured in plasma or CSF. Changes in biomarkers suggest that AL001 restores normal lysosome and complement function in FTD-GRN patients, noted November 12, 2021.
$1.6 billion

ALGS – Aligos Therapeutics Inc.
ALG-000184
Hepatitis B

$16.27
-0.03  0%
Phase 1 Phase 1 safety, pharmacokinetics, and antiviral activity data noted that ALG-000184 administration was associated with similar rapid, substantial reductions in HBV DNA and RNA through the 28-day period, with ≥75% and 100% of evaluable subjects achieving HBV DNA and RNA reductions below the lower limit of quantitation (LLOQ), respectively, noted November 12, 2021.
$693.4 million

ASMB – Assembly Biosciences Inc.
Vebicorvir (ABI-H0731)
Hepatitis B virus (HBV)

$2.35
+0.03  +1%
Phase 2 Phase 2 data noted a meaningful rate of sustained virologic response not achieved - November 5, 2020. Phase 3 trial will not proceed. Phase 2 data reported that treatment led to a deeper level of viral suppression as measured by pgRNA and HBV DNA levels, noted November 12, 2021.
$112.5 million

ASMB – Assembly Biosciences Inc.
ABI-H3733
Healthy volunteers

$2.35
+0.03  +1%
Phase 1a Phase 1a results reported a serum half-life of approximately 18-24 hours, supporting once daily, oral administration in chronic HBV patients, and plasma concentrations exceed in vitro protein-adjusted (pa)EC50 values for inhibition of HBV DNA replication and cccDNA formation, noted November 12, 2021. Phase 1b trial planned for 2022.
$112.5 million

CADL – Candel Therapeutics Inc.
CAN-3110
Glioma

$9.78
-0.54  -5%
Phase 1 Phase 1 data displayed 1 complete response, a grade 3 cerebral Hematoma, and median survival time of 11.7 months. Data showed evidence of HSV1 antigen persistence even after several months, and survival data is still preliminary, September 25, 2021. Phase 1 biomarker data noted that treatment could induce both local and systemic immune activation associated with an encouraging clinical response, noted November 12, 2021.
$280.6 million

DRNA – Dicerna Pharmaceuticals Inc.
Belcesiran
Alpha 1-Antitrypsin deficiency-associated liver disease

$37.99
-0.01  0%
Phase 1 Phase 1 initial data announced July 21, 2021. Phase 1 data reported dose-dependent reductions in serum AAT were observed up to 6 mg/kg following a single dose of belcesiran, with no severe or serious adverse events, noted November 12, 2021. Phase 2 ESTRELLA trial commencement of dosing announced June 22, 2021.
$3 billion

REPL – Replimune Group Inc.
RP2 and OPDIVO (nivolumab)
Solid tumors

$29.00
-1.99  -6%
Phase 1 Phase 1 updated data reported that 7 of the 30 patient (23.3%) cohort of RP2 in combination with Opdivo have achieved partial responses, and 2 of the initial 3 monotherapy patients have a response (1 PR, 1CR), noted November 12, 2021.
$1.4 billion

SBTX – Silverback Therapeutics Inc.
SBT6050-201
Gastroesophageal, non-small cell lung, breast, and colorectal cancers

$7.19
-0.11  -2%
Phase 1/2 Phase 1/2 clinical evaluation due in 1Q 2022.
$252.2 million

VACC – Vaccitech plc
VTP-300 (HBV001)
Hepatitis B and healthy volunteers

$12.40
-0.80  -6%
Phase 1 Phase 1 data reported total T cell responses to the HBV immunogen peaked at day 28 post dose in both HC and CHB patients, noted November 12, 2021.
$432.2 million