The Daily Biotech Pulse: Adcom Rules In Favor Of Mesoblast, CureVac IPO, Novavax Clinches UK COVID-19 Vaccine Deal

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 13)

• Aerpio Pharmaceuticals Inc ARPO
• Fulgent Genetics Inc FLGT
• GENMAB A/S/S ADR GMAB
• Halozyme Therapeutics, Inc. HALO
• Inozyme Pharma Inc INZY
• iTeos Therapeutics Inc ITOS
• Mirati Therapeutics Inc MRTX
• Natera Inc NTRA
• Nurix Therapeutics Inc NRIX
• Orthopediatrics Corp KIDS
• Penumbra Inc PEN
• Rocket Pharmaceuticals Inc RCKT
• Silk Road Medical Inc SILK
• TFF Pharmaceuticals Inc TFFP
• Vaxcyte Inc PCVX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 13)

• Entera Bio Ltd ENTX
• Forma Therapeutics Holdings Inc FMTX(reacted to its second-quarter results)
• Lantern Pharma Inc. LTRN
• NanoVibronix Inc NAOV
• Recro Pharma Inc REPH

Stocks In Focus

Novavax Agrees to Supply 60M Doses of Coronavirus Vaccine to U.K.

Novavax, Inc. NVAX said it has signed a term sheet with the U.K. for supplying 60 million doses of NVX-CoV2373, its COVID-19 vaccine candidate. The company has also agreed with the government regarding a Phase 3 clinical trial to assess the efficacy of the vaccine in the U.K. population.

Novavax said it will also expand its collaboration with FUJIFILM Diosynth Biotechnologies, which will manufacture the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in the U.K., in addition to its sites in North Carolina and Texas in the U.S.

The company has been stitching up partnerships for manufacturing as well as the supply of the vaccine, as it looks to scale manufacturing ahead of a potential emergency use authorization or approval.

In pre-market trading, the stock rose 6.53% to $141.98.

Imara Begins Dosing Patients In a Phase 2a Study of Sickle Cell Disease

Imara Inc IMRA said it has dosed the first patient in its Ardent Phase 2b clinical trial of IMR-687 for adult patients with sickle cell disease.

"Dosing of the first patient in the Ardent clinical trial represents a critical step forward as we advance IMR-687 into Phase 2b testing, a clinical trial that will test higher doses and longer durations of IMR-687," said Rahul Ballal, CEO of Imara.

The stock rose 3.91% to $21 in after-hours trading.

Kamada Up Big Despite No Catalyst

Shares of Israeli plasma-derived biopharma Kamada Ltd. KMDA were advancing solidly. Monday, the company announced the commencement of a Phase 1/2 study of its anti-SARS-CoV-2 plasma-derived immunoglobulin product as a potential treatment for COVID-19 in Israel. Wednesday, the company reported its second-quarter results, showing below consensus bottom-line results and a decline in revenues, which led to some selling in the stock in the session.

The stock jumped 43% to $12.87 in after-hours trading.

Mesoblast Stem Cell Therapy For Pediatric Acute Graft-versus-host Disease Endorsed by FDA Panel

Mesoblast limited MESO shares, which were halted for trading Thursday, pending announcement on an Adcom verdict, are likely to move higher after it said FDA's Oncologic Drugs Advisory Committee voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L in pediatric patients with steroid-refractory acute graft versus host disease.

The investigational therapy, which goes by the trade name Ryoncil, has a PDUFA action date of Sept.30, and the company said it expects the launch the therapy in the U.S. in 2020.

TFF Pharma Executes Licensing Agreement For TFF Technology For Up to $210M

TFF Pharmaceuticals said it has entered into a worldwide exclusive licensing agreement with Union therapeutics, which provides for the latter acquiring an option to obtain a worldwide exclusive license of former's TFF technology to be used in the field of niclosamide, including oral and inhalation versions of niclosamide, potentially for COVID-19, as well as other niclosamide-based therapies.

Subject to Union's exercise of its option, it has agreed to pay TFF potential development, regulatory and sales-related milestone payments of up to $210 million. Union will also pay TFF tiered single-digit royalties on product sales.

The companies have also agreed to collaborate on securing government support for funding the development of niclosamide-based products for the treatment of COVID-19.

The stock rallied 23.83% to $12.73 in after-hours trading.

Earnings

Navidea Biopharmaceuticals Inc NAVB reported second-quarter revenues of $271,000 compared to $260,000 a year ago. The net loss per share narrowed from 27 cents to 11 cents compared to the 12-cent per share consensus loss estimate.

The stock climbed 18.30% to $3.75 in after-hours trading.

Molecular diagnostics company Myriad Genetics, Inc. MYGN reported a 57% year-over-year decline in fiscal year fourth-quarter revenues to $93.2 million. The company reversed to a loss of 31 cents per share on a non-GAAP basis from a profit of 41 cents per share.

The company also announced the appointment of Paul Diaz as president and CEO, effective August 13, 2020. He will also serve on the board, it added.

Caladrius Biosciences Inc CLBS reversed from a loss of 49 cents in the second quarter of 2019 to a profit of 50 cents per share in 2020, thanks to a benefit from income taxes.

In after-hours trading, the stock added 6.05% to $2.28.

Co-Diagnostics Inc CODX reported second-quarter revenues of $24.04 million, up from $61,574 reported for the year-ago period. The company reversed from a loss of 8 cents per share to a profit of 43 cents per share, which however, trailed the 59-cent per share consensus estimate.

In after-hours trading, the stock slumped 16.24% to $17.59.

Offerings

Equillium Inc EQ said it has priced its underwritten public offering of 5 million shares of common stock at $7 per share. Equillium said it expects to use the gross proceeds from the offering to be about $35 million. The offering is expected to close on or about August 18.

The stock slipped 15.53% to $7.45 in after-hours trading.

OptiNose Inc OPTN announced the commencement of a proposed underwritten public offering of shares of its common stock. All of the shares of common stock are to be offered by the company.

Optinose said it intends to use the net proceeds of the offering for working capital and general corporate purposes, including the commercialization of Xhance, the clinical development of Xhance for a follow on indication for the treatment of chronic sinusitis and the clinical development of OPN-019 for the treatment of COVID-19.

In after-hours trading, the stock fell 13.04% to $5.90.

On The Radar

Earnings

PLx Pharma Inc PLXP (before the market open)
Ocugen Inc OCGN (before the market open)
Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP
Bio-Path Holdings Inc BPTH (before the market open)
BioXcel Therapeutics Inc BTAI (before the market open)
Soligenix, Inc. Common Stock SNGX (before the market open)
Imara (before the market open)
Thermogenesis Holdings Inc THMO (after the close)

IPO

German biotech firm CureVac, which is developing a mRNA vaccine for the novel coronavirus, priced its initial public offering of 13.33 million shares at $16 apiece, raising gross proceeds of about $213.3 million. The company previously estimated a price range of $16. The shares will begin trading on the Nasdaq under the ticker symbol CVAC. Recently, GlaxoSmithKline plc GSK took a 10% stake in the company.