News
Gamida Cell to Present Full Data from Phase 3 Study of Omidubicel at TCT, the Combined Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the full results of the Phase 3 clinical trial of omidubicel will be presented for the first time at the TCT Meetings, the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR), which is being held virtually from February 8“12, 2021.
The international, multi-center, randomized Phase 3 study for omidubicel evaluated the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.
This will be the first presentation of the full efficacy and safety results of this study. Gamida Cell previously reported in 2020 top-line data for omidubicel, an advanced cell therapy under development as a potentially life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies. Last May, Gamida Cell reported that the study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patients recovery from a bone marrow transplant. Last October, the company reported that the omidubicel phase 3 study achieved its secondary endpoints of platelet engraftment, infections, and hospitalizations.
Details about the presentation are as follows: Title: Improved Clinical Outcomes with Omidubicel Versus Standard Myeloablative Umbilical Cord Blood Transplantation: Results of a Phase III Randomized, Multicenter Study Lead Author: Mitchell E. Horwitz, M.D. Time: Tuesday, February 9, 2021, 4:45-5:00 p.m. EST
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated. The company expects to submit a full biologics licensing application to the U.S. FDA in the second half of 2021.Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the U.S. Food and Drug Administration or any other health authority.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of and data reported from the clinical trials of Gamida Cells product candidates, anticipated regulatory filings, launch readiness and FDA approval, commercialization efforts and Gamida Cells expectations regarding its projected ongoing operating activities, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on February 26, 2020 and its Report on Form 6-K furnished to the SEC on August 12, 2020, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.
For investors:
Stephanie Ascher
Stern Investor Relations, Inc.
[email protected]
1-212-362-1200
For media:
Matthew Corcoran
Ten Bridge Communications
[email protected]
1-617-866-7350
News
Transom Consulting Group Announces the Promotion of Paul Yoo to Partner
LOS ANGELES, Jan. 18, 2021 /PRNewswire/ — Transom Consulting Group, a leading strategy and operational excellence consultancy and investment bank, announced today the promotion of Paul Yoo to Partner.
“We are delighted to announce the promotion of Paul to Partner. Paul has made significant contributions to the breadth and depth of our capabilities and has been a key reason for our growth in the consumer goods and retail sector. His promotion is a recognition of the value he has brought to our clients and our firm. Paul has not only achieved tremendous results for corporate clients, but also for investors in the space,” says David Ascher, founder and Managing Partner of Transom Consulting.
Paul joined Transom in 2019 and leads the firm's Consumer Goods and Retail practice. Prior to joining, Paul served as the CEO of This Saves Lives and as Head of Business Development at The Honest Company. Previously, Paul was a Senior Manager at McKinsey & Company, where he advised Fortune 100 clients on corporate strategy, operations, and M&A strategy.
Paul has an undergraduate degree from Stanford University and a J.D. from Harvard Law School.
About Transom Consulting Group:
Transom Consulting Group provides consulting services focused on strategy and organizational excellence as well as investment banking services in the financial services, consumer goods/retail, and business services sectors. Transom's clients range from high-growth companies to established Fortune 100s and top investment firms. Transom helps clients tackle their most challenging problems by working closely with top executives to develop pragmatic and data-driven recommendations with immediate financial impact. For more information about Transom Consulting Group, visit http://www.transomconsulting.com or contact [email protected].
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SOURCE Transom Consulting Group
News
Hawaiian Electric Industries To Announce Fourth Quarter And Full Year 2020 Results And 2021 Earnings Guidance Feb. 16; American Savings Bank To Announce 2020 Results Jan. 29
HONOLULU, Jan. 18, 2021 /PRNewswire/ — Hawaiian Electric Industries, Inc. (HEI) (NYSE: HE) will announce its fourth quarter and full year 2020 financial results Tuesday, February 16. In addition, American Savings Bank, F.S.B. (American), a wholly owned indirect subsidiary of HEI, will announce its fourth quarter and full year 2020 financial results Friday, January 29.
HEI will conduct a webcast and conference call to discuss fourth quarter and full year 2020 earnings, 2021 earnings guidance and regulatory and other matters on Tuesday, February 16 at 11:15 am Hawaii time (4:15 pm Eastern time).
Parties in the U.S. may listen to the conference call by dialing (844) 834-0652. International parties may listen to the conference call by dialing (412) 317-5198. Parties may also access presentation materials and/or listen to the conference call by visiting the conference call link on HEI's website at www.hei.com under “Investor Relations,” sub-heading “News and Events – Events and Presentations.”
A replay will be available online and via phone. The online replay will be available on HEI's website about two hours after the event. An audio replay will also be available about two hours after the event through March 2, 2021. To access the audio replay, dial (877) 344-7529 (U.S.) or (412) 317-0088 (international) and enter passcode 10151332.
HEI and Hawaiian Electric Company, Inc. (Hawaiian Electric) intend to continue to use HEI's website, www.hei.com, as a means of disclosing additional information; such disclosures will be included in the Investor Relations section of the website. Accordingly, investors should routinely monitor the Investor Relations section of HEI's website, in addition to following HEI's, Hawaiian Electric's and American's press releases, HEI's and Hawaiian Electric's SEC filings and HEI's public conference calls and webcasts. Investors may sign up to receive e-mail alerts via the “Investor Relations” section of the website. The information on HEI's website is not incorporated by reference into this document or into HEI's and Hawaiian Electric's SEC filings unless, and except to the extent, specifically incorporated by reference.
Investors may also wish to refer to the Public Utilities Commission of the State of Hawaii (PUC) website at dms.puc.hawaii.gov/dms to review documents filed with, and issued by, the PUC. No information on the PUC website is incorporated by reference into this document or into HEI's and Hawaiian Electric's SEC filings.
HEI supplies power to approximately 95% of Hawaii's population through its electric utility, Hawaiian Electric; provides a wide array of banking and other financial services to consumers and businesses through American, one of Hawaii's largest financial institutions; and helps advance Hawaii's clean energy and sustainability goals through investments by its non-regulated subsidiary, Pacific Current.
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Contact: Julie Smolinski |
Phone: (808) 543-7300 |
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Vice President, Investor Relations & Corporate Sustainability |
E-mail: [email protected] |
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SOURCE Hawaiian Electric Industries, Inc.
News
Planswell Fills C-Suite with Eye Towards Global Expansion
Early US success ignites drive to Latin America, Asia
TORONTO, Jan. 18, 2021 /PRNewswire/ – Planswell, the Toronto-based startup delivering free financial plans in about three minutes at Planswell.com, is preparing for expansion to Latin America and Asia by filling key executive positions. C-suite hires join Chief Executive Officer Eric Arnold and Chief Operating Officer Scott Wetton to navigate rapid growth for the company.
Planswell entered the US market in October of 2020 with US revenue quickly surpassing business in Canada, the company's home base. To date, over 1000 advisors in North America have partnered with Planswell from virtually every major financial institution— in addition to solo, independent firms—to help consumers action their financial plans. Planswell has delivered over 300,000 free financial plans to households located in every US state and Canadian province.
In preparation for further expansion, Planswell adds Trevor Oseen of Calgary as Chief Financial Officer. Oseen has extensive experience building companies around the world after landing in his first CFO position of a public, internationally traded energy company at 29. He's since worked in eighty countries while finding time to complete 23 marathons and seven Ironman triathlons.
Jennifer Mastrud joins as Chief Marketing Officer after over twenty years of notable marketing leadership experience in diverse sectors ranging from globally syndicated TV to SaaS. She has an impressive track record of turning young startups into industry leaders, building scalable marketing systems, and managing remote teams. Most recently, Mastrud led two-sided national marketing efforts aimed at financial advisors and financial planning clients. Based in the US, Mastrud is a forty-year survivor of Minnesota winters.
Dean Khialani, a Florida-based technology visionary with a Ph.D. in Information Systems, joins as Chief Technology Officer. Specializing in big data, blockchain, machine learning, and artificial intelligence, Khialani has over 20 years of experience turning code into profitable products in C-level roles at startups and large, established corporations alike.
Scott P. Gill, a leading expert on the US financial regulatory environment, joins as Chief Compliance Officer heading the development of Planswell's US planning engine. Gill brings guru-level knowledge of RIA compliance after advising hundreds of firms throughout fifteen years in the business. Based in North Carolina, Gill is currently completing a doctorate and operates a charitable organization he founded to serve the homeless.
The executive team leads remote staff dispersed across Canada, the United States, the Philippines, Serbia, Turkey, and Nigeria.
“I am so humbled,” said Eric Arnold, Planswell Chief Executive Officer, “This leadership team is much more experienced than me. I'm confident we'll succeed in Latin America and Asia by the end of this year.”
For information about open positions at Planswell, please visit partners.planswell.com/careers.
About Planswell
Planswell is on a mission to provide the most actionable financial planning experience to everyone, for free. To learn more, visit planswell.com.
Available For Interviews
Eric Arnold, CEO
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SOURCE Planswell
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