|Over a week ago|
What You Missed On Wall Street This Morning » 12:0809/2309/23/22
FDX, COST, FRPT, SCHL, BA, FUBO, ALLY, SPRO, GSK, EVR, MC, APO, HNHPF, MRNA, AMZN, META, AAPL, PEP, DSKE, IBEX, APEI, FLUX, AIR, CANO, HUMA, CS, APA, TELL, MDGS
Get caught up quickly on…
Humacyte announces presentations by Ukrainian surgeons on use of HAV » 08:0609/2309/23/22
Humacyte announced the…
Humacyte announced the presentation of a clinical update on the Human Acellular Vessel, HAV, for the treatment of vascular trauma. The update was presented by Ukrainian surgeon collaborators, Oleksandr Sokolov, M.D., Ph.D. and Vasyl Shaprynskyi, M.D., Ph.D., at the 36th European Society for Vascular Surgery, ESVS, Annual Meeting in Rome, Italy taking place from September 20-23, 2022. Humacyte's investigational HAV is designed to offer off-the-shelf availability and resistance to infection and to address long-standing limitations in vascular tissue repair and replacement. Dr. Shaprynskyi attended the conference in-person and presented a live talk entitled, "The First Experience of Using the Human Acellular Vessels in Ukraine for the Treatment of Patients with Vascular Trauma," while Dr. Sokolov spoke virtually from Ukraine and presented, "Vascular Trauma Due to Blast Injury. Experience of Dnipro in Russian-Ukrainian War 2022." Drs. Shaprynskyi and Sokolov reported that surgeons in Ukraine have utilized the HAV to treat patients with a multitude of wartime injuries. Dr. Sokolov provided a clinical update on a patient with a blast injury to the shoulder who received a repair using the HAV. The patient is now beyond three-month follow up without complication. Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte, added, "As we progress in our humanitarian efforts with the HAV, being able to witness these firsthand patient cases from surgeons in Ukraine is a powerful experience. We set out to develop engineered replacement vessels that are durable, infection-resistant and off-the-shelf to address long-standing limitations in vessel repair, both for civilians and for military personnel. Given our existing designation as a Priority Product from the U.S. Department of Defense, it is gratifying to see that the HAV is helping patients suffering from wartime injuries in Ukraine right now."
Humacyte expands board of directors, leadership team with new appointments » 08:0309/2009/20/22
Humacyte announced the…
Humacyte announced the appointments of two healthcare professionals to the Company's Board of Directors and leadership team. Lt. General Bruce Green, M.D., USAF-ret., former Surgeon General of the U.S. Air Force, joins as a member of the Board of Directors. In addition, pharma industry veteran Yang Cao, Ph.D. joins as the Company's Chief Regulatory Officer. Current Chief Regulatory Officer, Bill Tente, will remain with Humacyte as an Executive Advisor, partnering on regulatory initiatives for the organization with Dr. Cao and team. General Green served as Assistant Surgeon General for Health Care Operations and Deputy Surgeon General, and was appointed Air Force Surgeon General in 2009. Prior to joining Humacyte, Dr. Cao served as Senior Vice President and Head of Regulatory Affairs and Quality Assurance at Ascentage Pharma.
Humacyte announces presentation on Human Acellular Vessel » 08:0409/0909/09/22
Humacyte announced the…
Humacyte announced the presentation of a clinical update on the Human Acellular Vessel for the treatment of vascular trauma. The HAV is designed to offer off-the-shelf availability and resistance to infection, as well as to address long-standing limitations in vascular tissue repair and replacement. The update was presented by Todd E. Rasmussen, M.D., FACS, at the 44th International Committee of Military Medicine World Congress in Brussels, Belgium. Speaking to an audience of NATO and other international surgeons, Dr. Rasmussen reported that over the past several decades the incidence of wartime vascular injury has increased. Dr. Rasmussen added that vascular injury, whether in a military or civilian setting, is a leading cause of death and or amputation. Dr. Rasmussen's presentation highlighted the clinical progress of the HAV, including updates on his own experiences and those of his colleagues utilizing the vessel to treat patients, as well as the potential of the investigational product to overcome limitations in care. According to Dr. Rasmussen's conclusions, injured service members and those with certain complex injuries in the civilian sector could benefit from the use of a readily available and infection resistant vascular conduit that would facilitate quick implantation and restoration of blood flow, even in the setting of contaminated wounds such as those encountered on the battlefield. Humacyte's investigational HAVs were recently provided as part of a humanitarian relief effort to several front-line Ukrainian hospitals, allowing doctors the opportunity to utilize the HAVs to treat patients with traumatic vascular injuries during the conflict. Patients successfully treated to date under the humanitarian program include those with a range of traumatic injuries, including those from gunshots, shrapnel, and industrial accidents. Humacyte is working closely alongside the Office of International Programs within the U.S. Food and Drug Administration and the Ukrainian Ministry of Health as the humanitarian efforts in Ukraine progress, and the company continues to provide this additional treatment option to those affected.
|Over a month ago|
Humacyte files $300M mixed securities shelf 16:1909/0109/01/22
Humacyte files to sell 89.72M shares of common stock for holders 16:1709/0109/01/22
Humacyte files to sell 5.18M shares of common stock 16:1709/0109/01/22
Humacyte price target lowered to $3.50 from $4.00 at Piper Sandler » 12:0208/1208/12/22
Piper Sandler analyst…
Piper Sandler analyst Matt O'Brien lowered the firm's price target on Humacyte to $3.50 from $4.00 and keeps an Underweight rating on the shares. While Humacyte did beat financial expectations for Q2, enrollment in the trauma and AV access studies were fairly modest over the past two plus months, and O'Brien would not be surprised to see the expected timing of approval slip a little, though not significantly, the analyst tells investors in a research note.
Humacyte reports Q2 EPS 35c, consensus (22c) » 07:0308/1208/12/22
Reports Q2 revenue…
Reports Q2 revenue $1.301M, consensus $200,000. "Humacyte has continued to make great progress throughout the second quarter of 2022, advancing our lead candidate, the HAV, in both our clinical and preclinical programs as well as our humanitarian effort in Ukraine," said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. "We are thrilled that the HAVs implanted in several Ukrainian patients are reported to be functioning and infection-free, providing further real-world evidence of the potential of HAV treatment for trauma. In addition, we are pleased with the progress of our small-diameter HAV program which we believe continues to show promise in preclinical CABG models, and we look forward to continued advancement as we move toward the clinic. Finally, we welcome Dr. Diane Seimetz to our Board of Directors, and we are excited to leverage her regulatory and commercial expertise as we move through our late-stage vascular clinical programs and approach potential approval and commercialization of the HAV."
Humacyte announces presentation of preclinical data on HAV » 08:0407/1907/19/22
Humacyte announced that…
Humacyte announced that six-month outcomes from a preclinical study of a small diameter Human Acellular Vessel in coronary artery bypass grafting will be presented at the Basic Cardiovascular Sciences Scientific Sessions taking place in Chicago, IL July 25-28, 2022. Title: "Tissue-engineered Human Acellular Blood Vessels for Coronary Artery Bypass Grafting."