The Daily Biotech Pulse: Co-Diagnostics Earnings, NantKwest Plans Pancreatic Cancer Study, ADC Therapeutics IPO

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs May 14)

• Allogene Therapeutics Inc ALLO(reacted to ASCO abstract)
• Altimmune Inc ALT(announced first-quarter results and update to its COVID-19 vaccine program)
• BioXcel Therapeutics Inc BTAI( announced full enrollment of Phase 3 trials evaluating BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder and said it expects results from the two studies in July)
• Co-Diagnostics Inc CODX
• Myokardia Inc MYOK
• Repligen Corporation RGEN
• Translate Bio Inc TBIO
• VBI Vaccines Inc VBIV

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 14)

• Genfit SA GNFT
• Lyra Therapeutics Inc LYRA (IPOed May 1)
• RA Medical Systems Inc RMED(reacted to first-quarter results)
• Recro Pharma Inc REPH
• Sensus Healthcare Inc SRTS
• Sonnet Biotherapeutics Holdings Inc (NASDAQ: SONN

Stocks In Focus

NantKwest To Start Mid-Stage Study Of Pancreatic Cancer Drug Combo In June

Nantkwest Inc NK announced plans for a Phase 2, randomized, open-label study to evaluate the efficacy and safety of a combination immunotherapy: NantKwest's PD-L1 t-haNK, ImmunityBio's N-803, and aldoxorubicin HCI plus standard of care, versus standard-of-care chemotherapy for first- and second-line treatment of locally advanced or metastatic pancreatic cancer.

The company noted that out of the four patients treated with PD-L1 t-haNK and N-803 under single patient INDs, two were on treatment for the evaluable period. Of these two patients, one reported ongoing, durable, complete response six months after treatment, and one observed response of stable disease. It expects to begin the Phase 2 study in June.

"Our results from expanded access use of PD-L1 t-haNK in combination with N-803 offer proof-of-concept that, together with these agents, the immune system may play a role to activate robust and durable responses in metastatic cancer patients who have failed all standard-of-care therapies, said Patrick Soon-Shiong, CEO of NantKwest and ImmunityBio.

NantKwest stock fell 8.54% to $4.71 in after-hours trading.

Phio Presents Encouraging Data For Gene Silencing Platform

Phio Pharmaceuticals Corp PHIO announced data analyzing the applicability of the INTASYL platform as a gene silencing technology that offers an alternative or complementary approach to gene editing technologies, such as CRISPR/Cas9, in the treatment of solid tumors.

The data presented as a poster at the American Society of Gene and Cell Therapy 23rd Virtual Annual Meeting showed that INTASYL compared favorably to other technologies for improving cells used in adoptive cell therapy for the treatment of solid tumors, especially in cases where permanent gene modification is not required or is undesirable.

The stock rose 5.14% to $2.25 in after-hours trading.

Earnings

Sellas Life Sciences Group Inc SLS reported a first-quarter net loss of 66 cents per share compared to a loss of $11.12 per share last year. Analysts estimated a wider loss of 74 cents per share. Cash and cash equivalents totaled about $6.7 million at the end of March 31, 2020, compared to $2.6 million as of March 31, 2019

The stock rallied 13.24% to $3.25 in after-hours trading.

Applied DNA Sciences Inc's APDN fiscal year second-quarter revenues fell 29% year-over-year to $552,000. The net loss narrowed from $1.12 per share to 79 cents per share. Analysts, on average, estimated a loss of 77 cents per share on revenues of $950,000.

In after-hours trading, the stock was down 11.77% to $13.42.

TFF Pharmaceuticals Inc TFFP reported a first-quarter loss of 20 cents per share compared to a loss of 55 cents per share a year ago. Analysts estimated a loss of 24 cents per share.
The stock jumped 17.02% to $5.50 in after-hours trading.

Co-Diagnostics reported a strong increase in its first-quarter revenues to $1.55 million from $3,400 a year ago. The loss per share narrowed from 9 cents to 5 cents, in line with estimate.

Offering a mid-quarter update for the second quarter, the company said it has manufactured more than 6 million COVID-19 tests to date and has ordered for components for more than 20 million additional tests. The company also said its test kit showed 100% specificity and 100% sensitivity in several independent evaluations.

The stock retreated 15.95% to $18.60 in after-hours trading.

Offerings

TG Therapeutics Inc common stock TGTX priced its upsized underwritten public offering of 8.5 million shares at $18 per share for raising gross proceeds of $153 million. All the shares are being offered by the company. The company expects the offering to close May 19.

The stock slipped 2.26% to $19.48 in after-hours trading.

Boston Scientific Corporation BSX priced its public offering of $1.7 billion aggregate principal amount of its senior notes.The public offering consists of $500 million in aggregate principal amount of 1.90% notes due 2025 and $1.2 billion in aggregate principal amount of 2.65% notes due 2030. The company intends to use the net proceeds to repay its debt.

Oyster Point Pharma Inc OYST priced its underwritten public offering of 3.75 million shares at $28 per share. All of the shares are being offered by the company. The offering, which is expected to close May 19, is likely to generate gross proceeds of $105 million for the company.

The stock was slipping 6.31% to $30.01 in premarket trading Friday.

On The Radar

PDUFA Dates

Clovis Oncology Inc CLVS awaits FDA nod for an expanded indication for its cancer therapy Rubraca. The sNDA seeks approval of Rubraca as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer.

Clinical Readouts

Pfizer Inc. PFE will present at the ASGCT meeting, Phase 1b data for PF-06939926 in Duchenne muscular dystrophy at 10 am ET.

Earnings

Digirad Corporation DRAD (before the market open)

• Zyla Life Sciences ZCOR (before the market open)
• PLx Pharma Inc PLXP (before the market open)
• Titan Pharmaceuticals, Inc. common stock TTNP (before the market open)
• Bio-Path Holdings Inc BPTH (before the market open)

IPO

Late clinical-stage oncology-focused Swiss biotech ADC THERAPEUTICS priced its upsized initial public offering of 12,245,631 shares of its common shares at $19.00 per share, above the estimated price range of $16-18. The company expects the offering to generate gross proceeds of $232.7 million. The shares are to be listed on the NYSE under the ticker symbol "ADCT."