BPC July 27 update

Moderna and Pfizer / BioNTech initiate Phase 3 COVID vaccine trials; Lumos LUMO sells Priority Review Voucher +25% AH

Price and Volume Movers

TCR2 Therapeutics Inc. (NASDAQ:TCRR) shares closed up 25% to $16.39 on news that 2/5 (40%) of patients showed unconfirmed partial responses in its Phase 1 trial of TC-210 in patients with mesothelin-expressing solid tumors. Two other patients exhibited stable disease through six months. The company took advantage of the price action when it announced after hours that it has commenced an underwritten public offering of 6m shares of its common stock, which has seen shares retreat 2% to $16.02 after hours.

Lumos Pharma, Inc. (NASDAQ:LUMO) shares are trading up 25% to $18.50 after hours following its announcement that it will sell its Priority Review Voucher (PRV) to Merck. Under the terms of the original license agreement Lumos Pharma is entitled to retain 60% of the value of the PRV. Based upon an agreed valuation of $100m Merck will pay Lumos $60m.

Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) announced that it met the pre-specified primary endpoint in the ZENITH20 Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2). The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8%. Data from Cohort 3 are due later this year. Shares are currently trading up 72% to $5.58 after hours.

MediciNova (NASDAQ: MNOV) shares closed up 95% to $11.00 following its announcement of an agreement with BioComo and Mie University, Japan, to develop a vaccine against SARS-CoV-2.

Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL) announced after hours the commencement of a proposed underwritten public offering of 3.75m shares of its common stock.

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) announced that it has commenced an underwritten public offering of $200m of shares of its common stock. Shares are trading down 2% after hours to $60.50.

CorMedix Inc. (NYSE:CRMD) also announced it plans to offer shares of its common stock in an underwritten public offering. Shares are trading down 15% after hours to $5.10.

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Major price movers (stocks priced > $1.00, volume > 50k):

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

ADVANCERS:

vTv Therapeutics Inc. (VTVT): $2.98; +28%.

Capricor Therapeutics, Inc. (CAPR): $9.81; +27%.

Genocea Biosciences, Inc. (GNCA): $5.53; +23%.

Ampio Pharmaceuticals, Inc. (AMPE): $1.17; +22%.

Arcturus Therapeutics Holdings Inc. (ARCT): $63.19; +18%.

DECLINERS:

iBio, Inc. (IBIO): $4.66; -15%.

Diffusion Pharmaceuticals Inc. (DFFN): $1.14; -14%.

Altimmune, Inc. (ALT): $22.43; -12%.

Immuron Limited (IMRN): $11.45; -11%.

Entera Bio Ltd. (ENTX): $1.80; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AYLA – Ayala Pharmaceuticals Inc.
AL101 (ACCURACY)
Adenoid cystic carcinoma

Phase 2 Phase 2 updated data due at ESMO September 18, 2020, 03:55 CEST.
$150.3 million

CRSP – CRISPR Therapeutics AG
CTX110
CD19+ malignancies

Phase 1/2 Phase 1/2 top-line data due at the end of 2020.
$6.4 billion

CYDY – CytoDyn Inc
Leronlimab
COVID-19 (critically ill)

Phase 2/3 Phase 3 trial to continue as planned following DSMB safety review. Interim analysis likely due 2H 2020.
$2.3 billion

DARE – Dare Bioscience Inc.
DARE-HRT1
Hormone replacement therapy

Phase 1 Phase 1 initiation announced July 27, 2020. Data due 2021.
$30.9 million

DFFN – Diffusion Pharmaceuticals Inc.
Trans sodium crocetinate (TSC)
COVID-19

Phase 1b Phase 1a/b dosing to commence August 2020 with first data due early-4Q 2020.
$69.1 million

ETON – Eton Pharmaceuticals Inc.
DS-100
Methanol poisoning

NDA Filing NDA filing announced July 27, 2020.
$132.5 million

FBIO – Fortress Biotech Inc.
Cosibelimab (CK-301)
Cutaneous squamous cell carcinoma (CSCC)

Phase 1 Phase 1 additional data due at ESMO September 19-21, 2020 with full top-line data due 2021.
$246.2 million

IMUX – Immunic Inc.
IMU-838 and Oseltamivir (Tamiflu) - (IONIC)
COVID-19

Phase 2b Phase 2 commencement of enrolment announced July 27, 2020.
$395.3 million

MRNA – Moderna Inc.
mRNA-1273
COVID-19 vaccine

Phase 2/3 Phase 2 interim efficacy data due 3Q 2020. Phase 3 enrollment to be completed September 2020.
$27.6 billion

NGM – NGM Biopharmaceuticals Inc.
NGM621
Geographic atrophy

Phase 1 Phase 1 safety & tolerability data 2H 2020. Phase 2 initiation announced July 27, 2020.
$1.3 billion

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

Phase 2/3 Phase 2/3 trial initiation announced July 27, 2020. Data due October 2020. On track to seek regulatory review in October 2020.
$214.1 billion

SCPH – scPharmaceuticals Inc.
Furoscix
Heart failure

PDUFA PDUFA date December 30, 2020.
$219.7 million

SPPI – Spectrum Pharmaceuticals Inc.
Poziotinib - Zenith20
Non-small cell lung cancer (NSCLC) with exon 20 insertion mutation in EGFR or HER2

Phase 2 Phase 2 primary endpoint from Cohort 1 was not met - December 26, 2019. Cohort 2 primary endpoint met - July 27, 2020. Cohort 3 data due by year-end 2020.
$515.8 million

VERU – Veru Inc.
VERU-111 (bisindole)
Castration Resistant Prostate Cancer

Phase 1/2 Phase 1b/2 data to be presented at ESMO September 19-21, 2020.
$213.4 million