BPC June 08 update

Biotech stock price movers and pipeline updates for Tuesday

Price and Volume Movers

Lyra Therapeutics, Inc. (NASDAQ: LYRA) shares are trading up 13% to $8.90 after hours following an update that the FDA has agreed on the design of its Phase 3 trial of LYR-210, its pipeline candidate for the treatment of chronic rhinosinusitis (CRS). The single primary endpoint will evaluate improvement at week 24 using a composite score of three cardinal symptoms (3CS) of CRS: nasal blockage, nasal discharge, and facial pain. Initiation of the trial is due towards the end of 2021.

CytRx Corporation (CYTR) shares closed up 26% to $1.99 with traders looking ahead to the upcoming decision by the FDA for the New Drug Application of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC) filed by Orphazyme A/S (NASDAQ:ORPH). CytRx is eligible for milestone payments should the NDA be approved. The PDUFA date is scheduled for June 17, 2021.

CEL-SCI Corporation (NYSE:CVM) announced it will be raising at least $22.6m following news of an agreement with Kingswood Capital Markets to purchase on a firm commitment basis a minimum of 1m shares at a price of $22.62 per share. Shares are trading down 4% to $22.95 after hours.

PDS Biotechnology Corporation (NASDAQ:PDSB) shares rebounded to close up 19% to $11.16, paring back most of its losses from Monday when shares fell 26% following the presentation of data from its Phase 2 combination trial of PDS010 in patients with refractory HPV16-associated cancers.

Aclaris Therapeutics, Inc. (NASDAQ:ACRS) announced after hours it intends to offer $75 million in shares of its common stock in an underwritten public offering. Shares, which fell 16% during normal trading hours, are trading down 2% after hours to $18.43.

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Other major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Cyclerion Therapeutics, Inc. (CYCN): $4.10; +30%.

Agenus Inc. (AGEN): $4.99; +17%.

VBI Vaccines Inc. (VBIV): $3.96; +14%.

Graybug Vision, Inc. (GRAY): $4.82; +11%.

Vera Therapeutics, Inc. (VERA): $14.97; +11%.

DECLINERS:

HOOKIPA Pharma Inc. (HOOK): $10.70; -19%.

Aclaris Therapeutics, Inc. (ACRS): $18.76; -16%.

CureVac N.V. (CVAC): $109.29; -13%.

AC Immune SA (ACIU): $7.18; -10%.

Alector, Inc. (ALEC): $18.97; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ACRS – Aclaris Therapeutics Inc.
ATI-1777-AD-201
Atopic dermatitis

$17.98
+0.07  +0%
Phase 2a Phase 2a data met primary endpoint - June 8, 2021.
$1.1 billion

ARNA – Arena Pharmaceuticals Inc.
Temanogrel
Coronary Microvascular Obstruction (cMVO)

$66.88
-1.26  -2%
Phase 2 Phase 2 trial first patient has been randomized - June 8, 2021. Data due 2H 2022.
$4.1 billion

AVXL – Anavex Life Sciences Corp.
ANAVEX2-73-AD-004
Mild to moderate Alzheimer’s disease

$23.83
-1.34  -5%
Phase 2/3 Phase 2b/3 data due mid-2022.
$1.7 billion

CRDF – Cardiff Oncology Inc.
Onvansertib (PCM-075) and Irinotecan and 5-FU
Pancreatic ductal adenocarcinoma (PDAC)

$7.66
-0.16  -2%
Phase 2 Phase 2 initiation of dosing announced June 8, 2021.
$287.6 million

CTXR – Citius Pharmaceuticals Inc.
Mino-Lok
Catheter related blood stream infection

$3.82
-0.41  -10%
Phase 3 Phase 3 interim analysis to be conducted June 29, 2021. Outcome to be provided to company by DMC within 5 days following.
$517.5 million

IFRX – InflaRx N.V.
Vilobelimab (IFX-1)
Cutaneous squamous cell carcinoma (cSCC)

$3.00
-0.14  -4%
Phase 2 Phase 2 initiation of dosing announced June 8, 2021.
$132.6 million

INCY – Incyte Corporation
JAKAFI (Ruxolitinib)
Steroid-refractory chronic GVHD (Graft versus host disease)

$85.09
+0.16  +0%
PDUFA priority review PDUFA date under priority review extended by three months to September 22, 2021.
$18.7 billion

KNSA – Kiniksa Pharmaceuticals Ltd.
Mavrilimumab
COVID-19-related acute respiratory distress syndrome (ARDS

$14.29
+0.07  +0%
Phase 2/3 Phase 3 data due 1Q 2022.
$976.5 million

LYRA – Lyra Therapeutics Inc.
LYR-210
Chronic rhinosinusitis

$8.08
-0.24  -3%
Phase 3 Phase 3 trial to be initiated at the end of 2021.
$105 million

ORMP – Oramed Pharmaceuticals Inc.
ORMD-0801 (ORA-D-013-1)
Type 2 Diabetes

$13.86
+0.38  +3%
Phase 3 Phase 3 top-line data due 2022.
$430.1 million

OTLK – Outlook Therapeutics Inc.
NORSE 2 (ONS-5010-002)
Wet age-related macular degeneration (wet AMD)

$2.34
-0.11  -4%
Phase 3 Phase 3 data due 3Q 2021.
$406.2 million

VCNX – Vaccinex Inc.
Pepinemab
Alzheimer’s Disease (AD)

$2.68
+0.02  +1%
Phase 1/2 Phase 1/2 trial first clinical sites have been activated - June 8, 2021.
$76.2 million