The following companies belonging to the healthcare sector reported quarterly results and provided business update yesterday.
1. Affimed N.V. (AFMD) expects to report topline data from its REDIRECT study in the fourth quarter of 2022.
REDIRECT is a phase II, registration-directed study of its lead drug candidate AFM13 as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma.
AFM13 has also been studied in a proof-of-concept phase II trials in CD30-positive T cell lymphoma and Hodgkin’s lymphoma.
Next in the pipeline is AFM24, which is being tested as monotherapy in a phase 1/2a clinical trial patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EFGR mutant), and colorectal cancer.
The other ongoing studies with AFM24 are:
— A phase I/IIa combination study of AFM24 with Tecentriq to treat patients with non-small cell lung cancer, gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer.
— A phase I/IIa combination study of AFM24 with the SNK01 (ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech) cells to treat patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck, and colorectal cancer.
The company, which had cash and cash equivalents of €169.9 million as of March 31, 2022, raised gross proceeds of $103.5 million in a public offering in April of this year.
AFMD closed Wednesday’s trading at $3.13, up 0.97%.
2. Mesoblast Limited (MESO) is working towards resubmission of its Biologics License Application for Remestemcel-L in the treatment of children with steroid-refractory graft versus host disease to the FDA.
The FDA had declined to approve Remestemcel-L in October 2020 – citing potency assay and chemistry, manufacturing and controls (CMC) issues and had asked the company to conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of Remestemcel-L for steroid-refractory graft versus host disease.
Last week, Mesoblast completed a successful mock pre-approval inspection of its GMP manufacturing facility and process comprising both on-site and virtual inspections by external auditors.
The company plans to submit the new data to FDA and address all outstanding chemical, manufacturing, and controls (CMC) issues in time for the anticipated BLA resubmission in the coming quarter.
MESO closed Wednesday’s trading at $3.46, down 1.42%.
3. Veeva Systems Inc. (VEEV), which reported promising financial results for its first quarter ended April 30, 2022, has boosted its earnings and revenue outlook for fiscal year ending January 31, 2023.
The company is a provider of industry cloud solutions for the global life sciences industry.
For the first quarter of 2022, net income declined to $100.1 million or $0.62 per share from $115.6 million or $0.71 per share in the year-ago period. On a non-GAAP basis, net income for the first quarter of 2022 climbed to $159.8 million or $0.99 per share from $146.9 million or $0.91 per share in the year-ago quarter.
Total revenues for the first quarter of 2022 were $505.1 million, up from $433.6 million one year ago, an increase of 16% year over year.
Looking ahead to fiscal second quarter ending July 31, 2022, the company expects non-GAAP net income per share to range between $1.00 and $1.01 on revenue in the range of $529 million and $531 million.
Non-GAAP net income per share for the second quarter ended July 31, 2021 was $0.94 on revenue of $455.6 million.
For fiscal year ending January 31, 2023, the company expects non-GAAP net income per share of approximately $4.16, on revenues in the range of $2,165 million to $2,175 million. Earlier, the company had forecast non-GAAP net income per share of approximately $4.02 and revenue between $2,160 million and $2,170 million for the year.
The non-GAAP net income per share was $3.73 and revenue was $1,850.8 million for the fiscal year ended January 31, 2022.
VEEV closed Wednesday’s trading at $167.84, down 1.42%.
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