This week's Lab Notes has a major acquisition by a local medical device manufacturer, an update from a South Jersey biotechnology firm that delayed filing its quarterly financial report, the progress a Berwyn biopharmaceutical company is making with its potential Parkinson's disease therapy and more.
Here's the roundup:
Teleflex (NYSE: TFX)
The Wayne medical technology company entered into an agreement to acquire Standard Bariatrics of Ohio in a deal valued at up to $300 million.
Under the agreement, Teleflex will make an upfront payment of $170 million to Standard Bariatrics, which has developed powered stapling technology for use in bariatric weight loss surgery. Standard Bariatrics could received up to an additional $130 million if certain commercial milestones are met.
The deal, subject to regulatory approvals, is expected to be completed early in the fourth quarter of 2022.
Standard Bariatrics' lead product is the Titan SGS — a single-patient use, laparoscopic, linear stapler used for cutting and stapling gastric tissue during sleeve gastrectomy. A Sleeve gastrectomy is a surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size by surgical removal of a large portion of the stomach along the greater curvature. The remaining portion of the stomach is about the size and shape of a banana.
Teleflex CEO Liam Kelly said the acquisition will provide Teleflex with a "differentiated product serving the large and growing sleeve gastrectomy market," which is estimated at about 120,000 procedures annually in the U.S.
Teleflex plans to finance the acquisition through borrowings under its existing revolving credit agreements.
Vyant Bio (NASDAQ: VYNT)
The Cherry Hill biotechnology company working on new therapies for complex neurological disorders filed its second quarter financial results this week, about a week after stating the filing would be delayed because of accounting issues connected to the potential sale of its contract research organization subsidiary.
The company provided further clarification on the matter saying earlier this month, in connection with efforts to sell its vivoPharm subsidiary, Vyant determined that certain historical vivoPharm tax returns either had not been filed or were incorrectly filed with the IRS. As a result, the company delayed the timing of its second quarter report to ensure it had properly accounted for the matter.
Vyant said it is continuing the process of divesting the vivoPharm business, which it expects to complete this year. The vivoPharm business is being classified as a “held-for-sale” asset, and its financial information as “discontinuing operations."
During the three and six-month periods ended June 30, Vyant recorded non-cash impairment charges of $1.5 million and $5.8 million, respectively, related to the vivoPharm business based on its estimated fair value.
Overall for the second quarter, Vyant's loss from continuing operations was $4.3 million, up from the $4 million loss recorded in the same period in 2021. The company has cash and cash equivalents of $11.7 million as of June 30. Vyant expects that amount along with its equity line credit with Lincoln Park Equity, a $14.5 million "at-the-market" stock offering deal in place with Canaccord Genuity and the proceeds of the sale of vivoPharm will fund its operations for the next 18 months.
Going forward, Vyant CEO Jay Roberts said the company is "highly focused on validating the power of our drug discovery platform" and plans to initiate a human proof-of-concept clinical trial beginning in early 2023.
The company's drug-development programs target Rett syndrome, CDKL5 deficiency disorders, and Parkinson’s disease.
Annovis Bio (NYSE: ANVS)
The Berwyn biopharmaceutical company said it has dosed the first patient in a late-stage clinical trial testing its lead new drug candidate, buntanetap, in patients with Parkinson's disease.
Annovis plans to enroll a total of 450 early Parkinson's patients in the phase 3 trial. Phase 3 drug studies are typically the last hurdle a company must successfully clear before seeking approval for an experimental therapy. Patients in the study will receive either 10 or 20 milligrams of buntanetap or a placebo along with their existing standard of care for six months.
Maria Maccecchini, CEO of Annovis Bio, said buntanetap has shown promising preliminary safety data in all clinical work to date, Just as encouraging, she said, is the significant improvement in speed of movement, motor function and cognitive function observed in early-to-moderate Parkinson's disease patients treated with buntanetap in the company's phase 2 trial.
"Now as we officially advance buntanetap into a phase 3 trial, we are one step closer to delivering a solution that can transform the lives of patients with Parkinson's Disease," Maccecchini said.
Annovis is also studying buntanetap as a potential treatment for Alzheimer's disease.
Quick Hits
Iovance Biotherapeutics (NASDAQ: IOVA), a California biotechnology company that operated a cell therapy manufacturing plant at the Philadelphia Navy Yard in South Philadelphia, said it has initiated a rolling biologics license application submission to the FDA lifileucel, the company's T cell-based cancer immunotherapy targeting advanced melanoma. The "rolling" submission will allow Iovance to submit portions of the application to the FDA on an ongoing basis, enabling the federal agency to begin its review early. Iovance expects to complete the submission in the fourth quarter of 2022.… Philadelphia-based Century Therapeutics (NASDAQ: IPSC) said it was notified by the FDA that the company may proceed with its clinical study assessing its lead cell therapy candidate CNTY-101 in cancer patients with certain B-cell malignancies. The study is expected to begin later this year.
