BPC July 26 update

​Iterum ITRM issued Complete Response Letter -44%; Atreca BCEL data due Thursday

Price and Volume Movers

Iterum Therapeutics plc (Nasdaq: ITRM) announced that the FDA issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for sulopenem. The FDA recommended that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug. Shares dropped 44% to $0.63.

Denali Therapeutics Inc. (NASDAQ:DNLI) shares closed down 15% to $54.31 following the release of updated data from its Phase 1/2 trial of DNL310 for the potential treatment of Hunter syndrome (MPS II), a rare neurodegenerative disease that affects children. Reductions in normalization of levels of heparan sulfate in cerebrospinal fluid (CSF) were noted. However, the downward move appears to be in reaction to increased levels of neurofilament light (Nf-L), a biomarker of neuronal structure, following six months of treatment. A Phase 2/3 trial is due to commence during 1H 2022.

Atreca, Inc. (NASDAQ:BCEL) announced it will host a webinar to present initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types on Thursday, July 29, 2021, at 8:00 a.m. ET.

Intec Pharma Ltd. (NASDAQ:NTEC) shares fell 25% to $2.57 following news it will raise $30 million in a private placement. Prior to the private placement a 1-for-4 reverse split will come into effect at the beginning of trading on July 27.

Tyme Technologies, Inc. (NASDAQ: TYME) shares closed up 28% to $1.38 following news that it has received additional patent claims related to its metabolomic technology platform for various tumors. The technology is currently in the preclinical phase of development.

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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:

IMV Inc. (IMV): $2.05; +26%.

Xenetic Biosciences, Inc. (XBIO): $3.03; +20%.

Translate Bio, Inc. (TBIO): $34.42; +15%.

Oramed Pharmaceuticals Inc. (ORMP): $15.98; +11%.

Intersect ENT, Inc. (XENT): $21.86; +9%.

DECLINERS:

INmune Bio, Inc. (INMB): $16.22; -23%.

XTL Biopharmaceuticals Ltd. (XTLB): $3.60; -19%.

Synaptogenix, Inc. (SNPX): $9.79; -19%.

PainReform Ltd. (PRFX): $3.33; -17%.

Adagene Inc. (ADAG): $16.86; -16%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

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

$2.54
+0.22  +9%
Phase 1b Phase 1b top-line data released July 26, 2021 with full data due 2H 2021.
$243.9 million

BCEL – Atreca Inc.
ATRC-101
Solid tumors

$6.29
+0.18  +3%
Phase 1b Phase 1b initial data released July 29, 2021. 20/50 (40%) of patients exhibited stable disease.
$232.1 million

BGNE – BeiGene Ltd.
DKN-01 and Tislelizumab ( DisTinGuish)
Gastric / Gastroesophageal Junction Cancer

$403.14
+17.90  +5%
Phase 2a Phase 2a data showed of the 25 patients, 15 patients had experienced a partial response (PR), 6 patients had stable disease (SD), 1 patient was non-evaluable for response (NE), and 3 patients were unable to complete a full cycle of DKN-01 therapy. The ORR was 68.2%, with 90% ORR in DKK1-high patients and 56% in DKK1-low patients noted September 16, 2021.
$37.5 billion

CADL – Candel Therapeutics Inc.
CAN-2409 combined with Valacyclovir
Prostate cancer

$7.84
-0.49  -6%
Phase 3 Phase 3 enrollment completed September 7, 2021 with data due 2024.
$224.9 million

CADL – Candel Therapeutics Inc.
CAN-3110
Glioma

$7.84
-0.49  -6%
Phase 1 Phase 1 biomarker data to be presented at the European Association of Neuro-Oncology meeting September 25-26, 2021.
$224.9 million

CADL – Candel Therapeutics Inc.
CAN-2409
Pancreatic Cancer

$7.84
-0.49  -6%
Phase 2 Phase 2 interim data due 2023.
$224.9 million

DARE – Dare Bioscience Inc.
DARE-BV1
Bacterial Vaginosis

$1.77
+0.08  +5%
PDUFA priority review PDUFA date under priority review December 7, 2021.
$124.8 million

DNLI – Denali Therapeutics Inc.
DNL310
Hunter syndrome MPS II

$52.83
-0.20  -0%
Phase 1/2 Phase 1/2 24-week data presented July 25, 2021. 12-month data likely due early-2022. Phase 2/3 trial to be initiated 1H 2022.
$6.4 billion

FSTX – F-star Therapeutics Inc.
SB 11285
Solid tumors

$7.59
+0.62  +9%
Phase 1 Phase 1a/1b update due 2022. Update June 26, 2021 noted treatment was well tolerated.
$156.5 million

IONS – Ionis Pharmaceuticals Inc.
IONIS-MAPTRx (ISIS 814907; BIIB080)
Alzheimer's disease

$37.21
+0.78  +2%
Phase 1/2 Phase 1/2 trial met its primary objective of safety and tolerability. Further data due later in 2021.
$5.3 billion

ISEE – IVERIC bio Inc.
Zimura - GATHER2
Geographic atrophy

$16.62
+0.26  +2%
Phase 3 Phase 3 second trial top-line data due 2H 2022.
$1.7 billion

ITRM – Iterum Therapeutics plc
Sulopenem
Uncomplicated urinary tract infections (uUTI)

$0.63
+0.02  +4%
CRL CRL announced July 26, 2021.
$114.3 million

MDWD – MediWound Ltd.
MW005
Basal Cell Carcinoma

$3.56
+0.06  +2%
Phase 1/2 Phase 1/2 trial initiation announced July 26, 2021 with data due by end of 2021.
$97 million

VIRI – Virios Therapeutics Inc.
IMC-1 (FORTRESS)
Fibromyalgia

$5.13
-0.48  -9%
Phase 2b Phase 2b data due mid-2022.
$42.7 million