Company continues to advance launch, reports initial revenue from Omisirge® (omidubicel-onlv)
Company to host conference call today at 8:30 a.m. ET
BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) — Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.
“The third quarter marked the first patients receiving Omisirge following FDA approval and the point at which Gamida Cell truly transitioned to a commercial-stage company with our first revenue reported,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. “Our lean launch prioritized two key performance indicators – transplant center onboarding and market access – both of which have surpassed our expectations, ahead of schedule. We anticipate continuing to onboard additional transplant centers, leading to a ramp-up of patients and Omisirge deliveries in the coming months.”
To date, a total of 17 transplant centers have been onboarded, exceeding the company’s 2023 target range of 10 to 15. Transplant center onboarding is a critical step in the process of making Omisirge available to patients, as it is required in order for transplant center teams to select Omisirge as a donor source. The company reported revenue for the delivery of two units of Omisirge in the third quarter of 2023 and projects revenue from a total of four to six units for full year 2023.
The company also provided an update on its market access efforts, reporting confirmed coverage with U.S. payers covering more than 90% of commercial lives, exceeding the full year goal of 70%. This includes confirmed coverage with all 20 of the top U.S. commercial payers. Omisirge also has confirmed coverage and reimbursement with Medicare from the Centers for Medicare and Medicaid Services (CMS).
Looking to 2024, the company will continue to maintain a lean launch effort due to resource constraints. Contingent on additional funding to extend its cash runway, the company anticipates onboarding more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the U.S.
Michele Korfin, Chief Operating and Chief Commercial Officer of Gamida Cell, said, “The strong interest for transplant centers to be onboarded and excellent feedback from transplanters as they are evaluating patients for Omisirge are encouraging indicators of its potential. We are excited about the opportunity for Omisirge to capture up to 20% market share at peak, provided we are able to secure the necessary funding to support fully resourced commercialization. We are proud of what our team has accomplished to date with limited resources to deliver Omisirge to patients in need of a donor source for allogenic stem cell transplant.”
Additionally, Jenkins provided an update on the company’s operations in Israel, noting that Gamida Cell’s manufacturing facility in Kiryat Gat has remained operational amid the ongoing Israel-Hamas war. “The dedication, courage and resilience demonstrated by our employees in Israel is an inspiration to us all. Despite the horror of terrorist attacks, they have continued to put patients first and have shown incredible strength and commitment to ensuring we can reliably deliver Omisirge to patients in need.”
Gamida Cell will hold a fireside chat with Gary Schiller, M.D., Professor, Department of Medicine, Hematology/Oncology and Director, Hematological Malignancies/Stem Cell Transplantation Unit at Ronald Reagan UCLA Medical Center, a part of UCLA Health. UCLA Health was a clinical trial site for the Phase 3 study of omidubicel in patients with hematologic malignancies and is one of the 17 transplant centers where patients can currently access Omisirge. Dr. Schiller will discuss his experience working with patients in need of allogeneic stem cell transplant, including the patient journey from diagnosis to transplant, decision making around donor source selection and his experience with Omisirge since approval. The virtual event will take place on Monday, December 4 from 4:30-5:15pm ET.
Third Quarter Highlights and Recent Developments
Corporate Developments
Scientific Publications and Medical Meetings
GDA-201
Third Quarter 2023 Financial Results
Conference Call Information
Gamida Cell will host a conference call today, November 14, at 8:30 a.m. ET to discuss these financial results and company updates. To access the conference call by phone, please register here or dial 1-877-425-9470 for domestic callers or 1-201-389-0878 for international callers and enter the conference ID 13741024. A live conference call webcast can be accessed here. A webcast replay will be available approximately two hours after the event for approximately 30 days.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic natural killer (NK) cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
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 the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), the Company’s cell therapy candidate, GDA-201, expectations regarding the commercial launch of Omisirge and potential to capture market share or generate revenue, Gamida Cell’s plans for commercial or strategic partnerships to support the launch of Omisirge, Gamida Cell’s financial runway, Gamida Cell’s ability to keep its Israel facilities open, the state of its workforce, and future developments that may adversely impact Gamida Cell’s Israel operations. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. 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 Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
OMISIRGE® is a registered trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved.
GAMIDA CELL LTD. AND ITS SUBSIDIARY | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
U.S. dollars in thousands (except share and per share data) | |||||||
September 30, | December 31, | ||||||
2023 | 2022 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 60,431 | $ | 64,657 | |||
Short-term restricted deposit | 2,723 | – | |||||
Inventory | 2,324 | – | |||||
Accounts Receivable | 676 | – | |||||
Prepaid expenses and other current assets | 2,355 | 1,889 | |||||
Total current assets | 68,509 | 66,546 | |||||
NON-CURRENT ASSETS: | |||||||
Restricted deposits | 377 | 3,668 | |||||
Property, plant and equipment, net | 42,667 | 44,319 | |||||
Operating lease right-of-use assets | 3,706 | 7,024 | |||||
Severance pay fund | 1,288 | 1,703 | |||||
Other long-term assets | 1,201 | 1,513 | |||||
Total non-current assets | 49,239 | 58,227 | |||||
Total assets | $ | 117,748 | $ | 124,773 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT) | |||||||
CURRENT LIABILITIES: | |||||||
Trade payables | $ | 1,664 | $ | 6,384 | |||
Employees and payroll accruals | 6,058 | 5,300 | |||||
Operating lease liabilities | 1,497 | 2,648 | |||||
Accrued interest of convertible senior notes | 710 | 1,652 | |||||
Accrued expenses and other current liabilities | 10,725 | 8,891 | |||||
Total current liabilities | 20,654 | 24,875 | |||||
NON-CURRENT LIABILITIES: | |||||||
Convertible senior notes, net | 81,419 | 96,450 | |||||
Warrants liability | 11,610 | – | |||||
Accrued severance pay | 1,381 | 1,914 | |||||
Long-term operating lease liabilities | 2,302 | 4,867 | |||||
Other long-term liabilities | – | 4,690 | |||||
Total non-current liabilities | 96,712 | 107,921 | |||||
CONTINGENT LIABILITIES AND COMMITMENTS | |||||||
SHAREHOLDERS’ EQUITY (DEFICIT): | |||||||
Ordinary shares of NIS 0.01 par value | 357 | 211 | |||||
Treasury ordinary shares of NIS 0.01 par value | * | * | |||||
Additional paid-in capital | 471,012 | 408,598 | |||||
Accumulated deficit | (470,987 | ) | (416,832 | ) | |||
Total shareholders’ equity (deficit) | 382 | (8,023 | ) | ||||
Total liabilities and shareholders’ equity (deficit) | $ | 117,748 | $ | 124,773 | |||
* Represents an amount lower than $1 |
GAMIDA CELL LTD. AND ITS SUBSIDIARY | ||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||
U.S. dollars in thousands (except share and per share data) | ||||||||||||||
(Unaudited) | ||||||||||||||
Three months ended September 30, |
Nine months ended September 30, |
|||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Net Revenue | $ | 673 | – | $ | 673 | – | ||||||||
Cost of Sales | 626 | – | 626 | – | ||||||||||
Research and development expenses, net | $ | 4,248 | $ | 9,864 | $ | 21,776 | $ | 31,732 | ||||||
Selling, general and administrative | 13,837 | 7,197 | 34,691 | 22,698 | ||||||||||
Total operating expenses | 18,085 | 17,061 | 56,467 | 54,430 | ||||||||||
Total operating loss | 18,038 | 17,061 | 56,420 | 54,430 | ||||||||||
Financial (income) expenses, net | (16,519 | ) | 741 | (2,265 | ) | 2,149 | ||||||||
Net Loss | $ | 1,519 | $ | 17,802 | $ | 54,155 | $ | 56,579 | ||||||
Net loss per share attributable to ordinary shareholders, basic and diluted | 0.01 | 0.29 | 0.53 | 0.95 |
GAMIDA CELL LTD. AND ITS SUBSIDIARY | |||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||
U.S. dollars in thousands (except share and per share data) | |||||||||||
(Unaudited) | |||||||||||
Nine months ended September 30, | |||||||||||
2023 | 2022 | ||||||||||
Cash flows from operating activities: | |||||||||||
Net Income (Loss) | $ | (54,155 | ) | $ | (56,579 | ) | |||||
Adjustments to reconcile loss to net cash used in operating activities: | |||||||||||
Depreciation of property, plant and equipment | 1,024 | 391 | |||||||||
Financing expense (income), net | 61 | (2,461 | ) | ||||||||
Share-based compensation | 4,297 | 3,829 | |||||||||
Change in Fair Value of Warrants liability | (9,143 | ) | – | ||||||||
Change in Fair Value of convertible senior note | 1,039 | – | |||||||||
Warrants Issuance Costs | 1,733 | – | |||||||||
Amortization of loan issuance costs | 625 | 582 | |||||||||
Change in assets and liabilities: | |||||||||||
Inventory | (92 | ) | – | ||||||||
Operating lease right-of-use assets | 2,020 | 1,922 | |||||||||
Operating lease liabilities | (2,417 | ) | (2,395 | ) | |||||||
Increase in Accounts Receivable | (676 | ) | – | ||||||||
Increase (decrease) in accrued severance pay, net | (118 | ) | 23 | ||||||||
Increase (decrease) in prepaid expenses and other assets | (239 | ) | 1,719 | ||||||||
Decrease in trade payables | (4,720 | ) | (6,355 | ) | |||||||
Increase (decrease) in accrued expenses and other liabilities | (2,096 | ) | 5,079 | ||||||||
Net cash used in operating activities | (62,857 | ) | (54,245 | ) | |||||||
Cash flows from investing activities: | |||||||||||
Purchase of property, plant and equipment | (833 | ) | (2,865 | ) | |||||||
Purchase of marketable securities | – | (4,557 | ) | ||||||||
Proceeds from maturity of marketable securities | – | 37,972 | |||||||||
Proceeds from restricted deposits | 294 | 500 | |||||||||
Net cash provided by (used in) investing activities | $ | (539 | ) | $ | 31,050 | ||||||
Cash flows from financing activities: | |||||||||||
Proceeds from exercise of warrants liability | $ | 45 | – | ||||||||
Proceeds from exercise of options | – | 76 | |||||||||
Principal payments of convertible senior note | (1,142 | ) | – | ||||||||
Proceeds from share issuance and warrants liability, net | 60,267 | 22,298 | |||||||||
Net cash provided by financing activities | 59,170 | 22,374 | |||||||||
Decrease in cash and cash equivalents | (4,226 | ) | (821 | ) | |||||||
Cash and cash equivalents at beginning of period | 64,657 | 55,892 | |||||||||
Cash and cash equivalents at end of period | $ | 60,431 | $ | 55,071 |
FORT WORTH, Texas, Dec. 24, 2024 (GLOBE NEWSWIRE) -- CorVel Corporation (NASDAQ: CRVL) today announced…
- Proprietary data and samples from TRACERx and Achilles’ Material Acquisition Platform (MAP) will be…
If you are male and in your 40's and 50's and feel your testosterone levels…
Transforming Anxiety into Positive Energy: A New Approach by The Anxiety ClinicBondi Junction, New South…
Embracing Mental Well-Being During the Festive SeasonCarlton North, Australia--(Newsfile Corp. - December 24, 2024) -…
If you are researching the strongest over the counter weight loss supplements in 2025 -…