The Daily Biotech Pulse: Valneva Inks COVID-19 Vaccine Supply Contract In Europe, I-Mab Spikes On China Deal, DermTech Sinks On Guidance

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

MorphoSys COO To Leave To Pursue Other Opportunities

MorphoSys AG MOR announced that Roland Wandeler has decided to step down from his position as chief operating officer and member of the board, effective Dec. 31, to pursue other opportunities. Following Wandeler's departure, the commercial organization led by Joe Horvat, U.S. General Manager, will report directly to the chief executive officer, Jean-Paul Kress.

The stock was down 2.35% at $11.20 in premarket trading.

GeoVax In-licenses Phase 2 COVID-19 Vaccine Candidate

GeoVax Labs Inc. GOVX announced it has entered into an exclusive license agreement with cancer research and treatment organization City of Hope.

The agreement grants GeoVax exclusive rights to further develop and commercialize a multi-antigenic SARS-CoV-2 investigational vaccine, developed at City of Hope for immunocompromised patients, which is currently being studied in an ongoing Phase 2 clinical trial and shows a strong potential to be used in the general population as a primary and/or general booster vaccine against COVID-19 worldwide.

The stock was advancing 3.82% to $4.35 in premarket trading.

Click here to access Benzinga's FDA Calendar

CodexDNA to Buy Synthetic Biology Product Company Eton Bioscience

Codex DNA, Inc. DNAY announced it has agreed to acquire Eton Bioscience, a privately held provider of synthetic biology products and services. Under the terms of the deal, Codex DNA will pay approximately $13 million in cash for the acquisition.

"Together with the Eton team, we will be able to accelerate our BioXp system growth strategy within the synthetic biology market," said Todd Nelson, CEO of Codex DNA.

Separately, the company reported below-consensus results for the third quarter.

In premarket trading, Codex DNA was up 7.21% to $9.96.

I-Mab Announces Distribution Agreement For Pediatric Growth Hormone Deficiency Hormone Drug Candidate In China

I-Mab IMAB announced it has entered into a strategic collaboration agreement with Jumpcan Pharmaceutical Group, a Chinese pharmaceutical company, for the development, manufacturing and commercialization of I-Mab's highly differentiated long-acting recombinant human growth hormone, eftansomatropin alfa in mainland China.

According to the terms of the collaboration agreement, Jumpcan will make an upfront payment of 224 million yuan ($35.05 million) to I-Mab and, upon achievement of development, registration and sales milestones, certain milestone payments of up to 1.792 billion yuan, making the non-royalty payments a total of up to 2.016 billion yuan. In addition, I-Mab and Jumpcan will share profits generated from commercialization of the product in mainland China on a 50/50 basis, pursuant to which I-Mab will be entitled to receive tiered low double-digit royalties on net sales.

The stock was gaining 8.08% to $62.10 in after-hours trading.

Nanobiotix Announces Positive Pre-clinical Data For Radiotherapy-activated NBTXR3

Nanobiotix NBTX said preclinical data to be presented at the Society For Immunotherapy of Cancer meeting show that radiotherapy-activated NBTXR3 increases CD8+ T cell infiltration and modulates the T cell receptor repertoire, as well as marked modulation of immunopeptidome in treated tumor cells in a mouse model.

KalVista To Begin Phase 3 Study Of Angioedema Treatment Candidate Following Positive End-Of-Phase Meeting

KalVista Pharmaceuticals, Inc. KALV said it had a productive end-of-Phase 2 meeting with the Food and Drug Administration regarding KVD900 in development for oral on-demand treatment of hereditary angioedema. It recently received meeting minutes which confirmed that its Phase 3 trial design is expected to be appropriate to support an NDA submission.

The company noted that its development team is finalizing the Phase 3 trial protocol and preparing for study initiation, and it anticipates patients will be dosed during the first quarter of 2022.

"KalVista is well-capitalized, with funding until at least early 2024, which we expect takes us beyond data from both this Phase 3 trial and the ongoing Phase 2 trial of KVD824," the company said.

Valneva Clinches COVID-19 Vaccine Supply Contract With European Commission

Valneva SE VALN announced that the European Commission has approved an agreement pursuant to which Valneva would supply up to 60 million doses of VLA2001, its inactivated COVID-19 vaccine candidate, over two years including approximately 27 million doses in 2022.

Under the current terms of the agreement, the EC has the option to increase its initial purchase, in 2022, of VLA2001 up to a total of 60 million doses by the end of 2023.

The stock was surging up 19.61% to $48.36 in premarket trading.

Earnings

Inari Medical, Inc. NARI reported third-quarter revenues of $72.99 million, up 88% year-over-year. The company reversed to a net loss of 6 cents per share from a profit of 13 cents per share. The results exceeded estimates. The company raised its full-year revenue guidance.

The stock was rallying 13.09% to $98.25 in premarket trading.

TransMedics Group, Inc.'s TMDX third-quarter revenues fell 24% to $5.4 million. The net loss per share widened from 19 cents to 47 cents. The company's full-year revenue guidance trailed the consensus estimate.

The stock was slipping 9.94% to $28 in premarket trading.

DermTech, Inc. DMTK reported a wider loss for the third quarter that was also wider than the consensus estimate. Revenues increased from $1.36 million to $3.03 million. Citing unforeseen impacts from the Delta variant and hurricane Ida, the company lowered its full year 2021 assay revenue guidance.

The stock was plunging 16.74% to $22.98 in premarket trading.

Offerings

AnPac Bio-Medical Science Co., Ltd. ANPC priced its underwritten public offering of 1.301 million of its ADSs at a public offering price of $2.22 per share, for gross proceeds of approximately $2.9 million.

In premarket trading, the stock was slipping 13.01% to $2.14.

Avenue Therapeutics, Inc. ATXI priced its underwritten public offering with gross proceeds to the company. The offering equates to 1.947 million shares at a price to the public of $1.34 per share.

The stock was retreating 12.66% to $1.38 in premarket trading.

Mirati Therapeutics, Inc. MRTX announced that it intends to offer and sell in an underwritten public offering $500 million of shares of its common stock.

The stock was seen moving lower by 2.31% to $163.97.

On The Radar

Clinical Readouts/Presentations

Connective Tissue Oncology Society, or CTOS, 2021 Annual Meeting

Inhibrx, Inc. INBX: update from the Phase 2 1 expansion cohort for INBRX-109 in patients with conventional chondrosarcoma

14th Clinical Trial On Alzheimer's Disease Meeting Presentations

AC Immune SA ACIU: topline results from Phase 2 study of Semorinemab in Alzheimer's disease

SITC Meeting Presentations

Corvus Pharmaceuticals, Inc. CRVS: data from its Phase 1/1b trial of mupadolimab in solid tumors, as well as from the Phase 2 study of mupadolimab in human papilloma virus positive head and neck squamous cell cancers

Nektar Therapeutics NKTR: Phase 1b data for NKTR-255 plus cetuximab in patients with solid tumors

Immutep Limited IMMP: results from a Phase 2 study of eftilagimod alpha (and Merck & Co., Inc.'s MRK Keytruda in patients with PD-L1 unselected metastatic 2nd line head and neck squamous cell carcinoma, and data from Phase 2 study of eftilagimod alpha and Keytruda in patients unselected for PD-L1 expression in first line metastatic head and neck squamous cell carcinoma

Genmab A/S GMAB & BioNTech SE BNTX: results of the Phase 1/2 trial evaluating investigational bispecific antibody, GEN1042 in patients with advanced solid tumors as well as Phase ½ data for GEN1046 in solid tumors

Earnings

Fennec Pharmaceuticals Inc. FENC(before the market open)
LumiraDx Limited LMDX(before the market open)
HOOKIPA Pharma Inc. HOOK(before the market open)
Nuvalent, Inc. NUVL(before the market open)
Verve Therapeutics, Inc. VERV(before the market open)
Cerevel Therapeutics Holdings, Inc. CERE(before the market open)
Affimed N.V. AFMD(before the market open)
BioXcel Therapeutics, Inc. BTAI (before the market open)
Bioceres Crop Solutions Corp. BIOX (before the market open)
Zentalis Pharmaceuticals, Inc. ZNTL (before the market open)
TScan Therapeutics, Inc. TCRX (before the market open)
PDS Biotechnology Corporation PDSB (before the market open)
Immunocore Holdings plc IMCR (before the market open)
Ikena Oncology, Inc. IKNA (before the market open)
Galera Therapeutics, Inc. GRTX (before the market open)
Astria Therapeutics, Inc. ATXS before the market open)
Sotera Health Company SHC (before the market open)
23andMe Holding Co. ME (after the close)
Maravai LifeSciences Holdings, Inc. MRVI (after the close)
Ampio Pharmaceuticals, Inc. AMPE (after the close)
aTyr Pharma, Inc. LIFE (after the close)
ADMA Biologics, Inc. ADMA (after the close)
Clearside Biomedical, Inc. CLSD (after the close)
Daré Bioscience, Inc. DARE (after the close)
Navidea Biopharmaceuticals, Inc. NAVB (after the close)
BIOLASE, Inc. BIOL (after the close)
BioCardia, Inc. BCDA (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates