Cambridge, Mass.-based Editas Medicine, Inc. (Nasdaq:EDIT) reported its second quarter 2023 financial results, sharing progress on its clinical-stage gene-editing efforts as well as updates on other business matters. The clinical-stage genome editing company has been at the forefront of technological breakthroughs in gene editing, pushing the boundaries of innovation and scientific discovery.
Editas Medicine made great strides in the second quarter towards their strategic plan that centers around the advancement of the EDIT-301 program towards a BLA filing. With the June announcement of the promising EDIT-301 data, the Editas team is thrilled about the potential that a one-time, durable medicine could have to bring life changing clinical benefits to patients with sickle cell disease and beta thalassemia.
To drive forward towards this goal, Editas welcomed the new Chief Financial Officer, Erick Lucera, and the new Chief Scientific Officer, Linda Burkly, to their leadership team. Together, the team hopes to build an in vivo pipeline and become a commercial-stage organization that is capable of transforming the lives of those living with serious diseases.
Recent Achievements and Outlook
Ex Vivo Hemoglobinopathies
EDIT-301 for Sickle Cell Disease (SCD)
- Editas Medicine is on track to reach a major milestone this year – dosing a total of 20 patients with sickle cell disease in their RUBY clinical trial. This is a huge step forward in the fight against this debilitating condition and is a testament to the commitment and hard work of everyone involved.
- We are thrilled to announce that we are still on track to provide a crucial Ruby clinical update by the end of this year, bringing us one step closer to achieving our long-term goals.
- In June, Editas Medicine made headlines after presenting initial clinical safety and efficacy data from the RUBY trial at the European Hematology Association (EHA) Hybrid Congress in Frankfurt, Germany and hosting a Company-sponsored webinar. Remarkably, the data revealed positive results in the trial, representing an important step forward in the area of medical research.
EDIT-301 for Transfusion-dependent Beta Thalassemia (TDT)
- Editas Medicine has taken a major step forward in its EDITHAL clinical trial for Transthyretin-Mediated Amyloidosis (TDT) with the initiation of parallel dosing. This exciting development is an important milestone in the company’s mission to develop treatments for people with serious diseases who need them.
- The Company is rapidly progressing towards its goal of delivering an enticing EDITHAL clinical update by the end of the year.
- Editas Medicine made headlines in June when it released initial clinical safety and efficacy data from the EDITHAL trial, revealing promising results from the first patient treated. In a Company-sponsored webinar, the data presented showcased a major milestone in the potential progression of medical treatments.
Other Corporate Highlights
Leadership
Erick Lucera joined Editas as Chief Financial Officer
Editas Medicine is thrilled to welcome Joe Lucera to their team—a veteran of more than three decades of financial, operational, and investment experience in the life sciences field. At AVEO Pharmaceuticals, Mr. Lucera masterfully scaled the company from a clinical-stage to an FDA approved and commercially launched entity, all before its acquisition by LG Chem. We are excited to see the strategic partnerships that he identifies and successfuly closes at Editas Medicine.
Linda C. Burkly joined Editas as Chief Scientific Officer
Drawing upon her unparalleled experience in biotechnology, with more than 35 years of drug discovery and development experience, Dr. Linda Burkly joins Editas Medicine to tackle some of the most complex immunological, neurological, and rare genetic disorder therapeutic areas. Her accomplishments range from inventing therapeutic compositions and discovering novel pathway biology and uses of therapeutic compositions, to co-authoring INDs and leading project teams across the drug discovery and development value chain.
Most recently, Dr. Burkly worked for 37 years at Biogen, where she held the position of Vice President and Senior Distinguished Investigator leading neuroscience-focused research teams from 2014 to 2022 and was part of the teams responsible for successful medicines such as Trogarzo®, Tysabri®, and the upcoming Phase 3 Dapirolizumab.
Manufacturing
Editas Medicine is pushing forward with the advancement of their internal production and quality control protocols. By adding clean room capacity and relocating activities to a new Azzur facility in Devens, MA – expected to be completed in 2024 – the company is taking strides to secure the success of the EDIT-301 program. This includes producing sufficient supply for the RUBY and EDITHAL trials, and helps to ensure the readiness for a commercial launch.
Second Quarter 2023 Financial Results
At the end of June 2023, the Company was able to increase its cash, cash equivalents, and marketable securities to a total of $480 million, compared to $401.8 million at the start of the quarter in March. Thanks to its increased fiscal reserves, the Company is in a strong position to finance its operational expenses and capital expenditures until at least the third quarter of 2025.
- For the three month-period ending June 30, 2023, our net loss attributable to common stockholders experienced a significant decrease when compared to the same time frame in 2022. We saw a drop in net loss from $53.5 million, or $0.78 per share, to only $40.3 million, or $0.56 per share.
- Collaboration and other research and development revenues experienced a drop for the three months ended June 30, 2023 – from $6.4 million to $2.9 million in comparison to the same period in 2022. This decrease is due to Bristol Myers Squibb not participating in a program opt-in that had occurred in the previous year.
- For the three months ended June 30, 2023, the Company’s research and development expenses decreased to a total of $29.8 million, a decrease of $13.9 million when compared to the same period in 2022. This decrease is a result of strategic reprioritization, focusing on EDIT-301 and reduced employee-related costs. This demonstrates the Company’s commitment to making strategic investments that prioritize longevity and growth.
- For the three months ended June 30, 2023, general and administrative expenses saw a slight increase of $0.3 million, amounting to $17.2 million compared to $16.9 million during the same period in the previous year.
About Editas Medicine
Editas Medicine is on a mission to revolutionize the treatment of serious diseases around the world, harnessing the power of CRISPR/Cas12a and Cas9 genome editing systems to develop a comprehensive pipeline of life-changing genomic medicines. As the exclusive licensee of Broad Institute’s Cas12a patent estate and Broad Institute and Harvard University’s Cas9 patent estates for human medicines, Editas Medicine is leading the way in pioneering a new era of precision molecular care.
Forward-Looking Statements
Our company is excited to announce its advances in preclinical and clinical studies, along with research and development plans. Before the year’s end, we hope to dose 20 total patients in a ground-breaking trial called RUBY. We look forward to both receiving and presenting data from not only this trial, but from our other preclinical studies and clinical trials.
By the end of the year, patients can expect to gain further insight into the potential of our product candidates through additional clinical updates pertaining to RUBY and a related trial, EDITHAL. Our team is determined to maintain commercial readiness and maximize our cash runway. Though the future may bring some uncertainty, we remain optimistic that our plans, intentions, and expectations will be successfiully realized.