Gamida Cell Reports Second Quarter and First Half 2023 Financial Results and Provides Company Update
Strong start for Omisirge® (omidubicel-onlv) launch with significant payer coverage and number of transplant centers onboarded exceeding expectations
Company continues to pursue strategic partnership to further support Omisirge launch
Cash runway extended into Q2 2024; balance sheet strengthened with
Company to host conference call today at
“Since the approval of Omisirge in April,
The
“We are very encouraged by the strong interest we have received from transplant centers to date, including centers that did not participate in our clinical studies,” said
Second Quarter Highlights and Recent Developments
Omisirge
-
Commercial progress:
-
The company is seeing strong demand from transplant centers and is ahead of its goal of onboarding 10-15 transplant centers in 2023. As of the morning of
August 14, 2023 , 12 transplant centers have been onboarded and eight additional transplant centers are in the onboarding process. - Patients are enrolled in the company’s Gamida Cell Assist program, which means that their transplanter has the intent to utilize Omisirge as the patient’s donor source.
- The company has confirmed coverage with payers who cover more than 85% of commercial lives and is in ongoing discussions with additional commercial payers.
-
CMS coverage and reimbursement has been confirmed for patients covered by Medicare. All required documentation is in place for patients who are covered under Medicaid,
Department of Defense andVeterans Affairs . - The company is ready to reliably deliver Omisirge within 30 days from the start of manufacturing.
-
The company is seeing strong demand from transplant centers and is ahead of its goal of onboarding 10-15 transplant centers in 2023. As of the morning of
- Publication: The company announced the publication of a prospective sub-study of the Phase 3 clinical trial for Omisirge titled “Immune Reconstitution Profiling Suggests Antiviral Protection After Transplantation with Omidubicel: A Phase 3 Substudy.” The publication is available online on the Transplantation and Cellular Therapy journal website.
Corporate Developments
-
Strategic review: The company continues to work with
Moelis & Company LLC to engage and advance discussions with multiple parties as part of its efforts to explore alternatives to support a fully resourced launch.
-
Terry Coelho , MBA, appointed Chief Financial Officer: InMay 2023 ,Gamida Cell announced the appointment ofTerry Coelho as Chief Financial Officer.Ms. Coelho , a seasoned finance executive with more than 35 years of experience across all areas of finance and business development at emerging growth companies and established global companies, is positioned to support Gamida Cell’s transition into a commercial-phase company and its pursuit of a strategic partnership.
-
Jeremy Blank appointed to Board of Directors: InAugust 2023 , the company’s Board of Directors appointedJeremy Blank , Chief Investment Officer ofCommunity Fund , to the Board, where he will serve on the Transactions Committee. “Having closely followedGamida Cell for over a decade, it is a privilege to join the Board of Directors,” saidMr. Blank . “I have high confidence in Gamida’s team and technology and our firm invested in both of Gamida’s most recent equity offerings. I look forward to supporting Gamida’s strategic process which is a great opportunity to create shareholder value.”Mr. Blank will provide a valuable perspective to the Board as it aids the company in executing its corporate strategy. From 2005 to 2020,Mr. Blank also served as a partner atYork Capital Management , a$15 billion global investment fund. Before that, he was a Vice President and credit analyst at Morgan Stanley.Mr. Blank currently serves as a Director on the boards ofInsightec Ltd. andAdvanced Emissions Solutions, Inc. (NASDAQ: ADES).Community Fund is a significant shareholder inGamida Cell .
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Strengthened balance sheet: The company ended the second quarter with
$54.1 million in cash as a result of the net proceeds of$29.8 million from both the April equity offering and the at-the-market offering (ATM), thereby extending cash runway into the second quarter of 2024. Additionally, the company reduced its outstanding principal balance in the quarter by$9.0 million , from$94.0 million to$85.0 million .
-
Investor Day:
Gamida Cell hosted an Investor Day onJune 29, 2023 . The event was attended by over 180 participants, both in-person and virtual, and included an update on the commercial launch of Omisirge as well as discussions with industry thought leaders.Steven Devine , M.D., Chief Medical Officer at the National Marrow Donor Program® (NMDP)/Be The Match®, discussed the unmet needs and barriers to care in stem cell transplant, and explained how Omisirge can help address some of these issues.Usama Gergis , M.D., MBA, Professor of Oncology & Director of Transplant and Cellular Therapy,Sidney Kimmel Cancer Center ,Thomas Jefferson University , discussed the implications of a health outcomes economics research model developed in partnership withGamida Cell that showed that a 20% peak market share of Omisirge may increase transplant access for eligible patients, particularly those from racially and ethnically diverse groups that are currently underserved.
GDA-201
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Phase 1 study: Gamida Cell’s GDA-201, an intrinsic natural killer (NK) cell therapy candidate being investigated for the treatment of hematologic malignancies, is being evaluated in an ongoing Phase 1 study for treatment of non-Hodgkin lymphoma. The study is continuing to enroll patients at six sites in the
U.S. Data are expected in the first quarter of 2024.
-
Data presented at
International Society for Cell and Gene Therapy (ISCT) 2023 Annual Meeting: GDA-201 data presented at ISCT onJune 2, 2023 demonstrated the robustness of cryopreserved GDA-201 and continued to support signs of strong lymphoid homing and decreased exhaustion of GDA-201 cells.
-
New data on nicotinamide (NAM) mechanism of action: Data published in Science Translational Medicine in the
July 19 edition demonstrated that culturing NK cells with NAM, which the company uses to enhance and expand cells, and IL-15 increases metabolic fitness, energy charge and glucose flux within NK cells, providing a pathway for resistance to oxidative stress and increased potency compared to NK cells cultured with IL-15 but without NAM. Through preventing degradation of the protein FOXO1, the presence of NAM was found to increase levels of CD62L, an important lymph node homing marker. This expression cascade provides evidence for the strong lymph node homing, direct killing and antibody dependent cell-mediated cytotoxicity capabilities of NK cells cultured with NAM. The publication also includes outcome data from the Phase 1 dose escalation clinical trial for Gamida Cell’s NK cell therapy candidate GDA-201 in patients with non-Hodgkin lymphoma as well as translational data from biopsy specimens.
Second Quarter 2023 Financial Results
-
Research and development expenses were
$8.7 million in the second quarter of 2023, compared to$10.6 million in the same quarter in 2022. The decrease of$1.9 million was primarily due to a$1.6 million reduction associated with the discontinuation of development of our engineered NK cell therapy pipeline, and$0.7 million in lower Omisirge Phase 3 spend, including a decrease in payments for manufacturing services, partially offset by a decrease of$0.4 million in IIA (Israeli Innovation Authority ) income.
-
Commercial expenses were
$3.9 million in the second quarter of 2023, compared to$3.2 million in the second quarter of 2022. The increase of$0.7 million was attributable to an increase in launch readiness activities.
-
General and administrative expenses were
$6.3 million in the second quarter of 2023, compared to$4.3 million in the same period in 2022. The increase of$2.0 million was associated with higher professional services expenses, in part due to theApril 2023 follow on offering and business development activities.
-
Financial expenses, net, were
$12.9 million in the second quarter of 2023, compared to$0.5 million in the same period of 2022. The increase of$12.4 million was primarily due to non-cash expenses totaling approximately$10.4 million , including the fair value impact on our warrants liability of$4.9 million , the fair value impact on the 2022 convertible note of$4.3 million , and a decrease in capitalization of finance costs to fixed assets of$0.6 million . In addition, the increase was due to higher cash expenses of$2.0 million , including$1.7 million in issuance costs from ourApril 2023 underwritten public offering and an increase of$1.0 million in interest expenses associated with the 2022 convertible notes, partially offset by increased interest income of$0.5 million .
-
Net loss was
$31.7 million in the second quarter of 2023, compared to a net loss of$18.6 million in the second quarter of 2022, driven primarily by the increase in financial expenses of$12.4 million .
-
Cash Position: As of
June 30, 2023 ,Gamida Cell had total cash and cash equivalents of$54.1 million compared to$64.7 million as ofDecember 31, 2022 . The decrease of$10.4 million is due primarily to net cash used in operating activities of$44.3 million partially offset by$34.7 million in net cash proceeds from the issuance of shares and warrants from our underwritten public offering and the issuance of shares via the ATM facility. Subsequent to the quarter close and throughAugust 9 th, the company raised an additional$14.0 million in net proceeds via the ATM facility. The company expects its current cash and cash equivalents, including the funds raised subsequent to the close of the second quarter, to support its ongoing operating activities into the second quarter of 2024, based on Gamida Cell’s current operational plans and excluding commercialization activities beyond the initial launch of Omisirge, as well as any additional financing activities that may be undertaken.
-
Debt Position: As of
June 30, 2023 , the company had reduced its principal balance on the 2022 secured convertible note by$15.0 million , from$25.0 million as ofDecember 31, 2022 , to$10.0 million at the end of the second quarter. The company also holds a 2021 convertible senior note with an aggregate principal amount of$75.0 million .
Conference Call Information
About
Omisirge® is a registered trademark of
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), expectations regarding the commercial launch of Omisirge and potential to capture market share, the company’s plans for commercial or strategic partnerships to support the launch of Omisirge and the company’s anticipated financial runway. 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
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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2023 |
|
2022 |
||||
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(Unaudited) |
|
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||||
ASSETS |
|
|
|
||||
CURRENT ASSETS: |
|
|
|
||||
Cash and cash equivalents |
$ |
54,075 |
|
|
$ |
64,657 |
|
Restricted Cash |
|
138 |
|
|
|
- |
|
Inventory |
|
2,390 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
2,262 |
|
|
|
1,889 |
|
Total current assets |
|
58,865 |
|
|
|
66,546 |
|
|
|
|
|
||||
NON-CURRENT ASSETS: |
|
|
|
||||
Restricted deposits |
|
3,150 |
|
|
|
3,668 |
|
Property, plant and equipment, net |
|
43,639 |
|
|
|
44,319 |
|
Operating lease right-of-use assets |
|
4,336 |
|
|
|
7,024 |
|
Severance pay fund |
|
1,291 |
|
|
|
1,703 |
|
Other long-term assets |
|
1,227 |
|
|
|
1,513 |
|
Total non-current assets |
|
53,643 |
|
|
|
58,227 |
|
Total assets |
$ |
112,508 |
|
|
$ |
124,773 |
|
|
|
|
|
||||
LIABILITIES AND SHAREHOLDERS' DEFICIT |
|
|
|||||
CURRENT LIABILITIES: |
|
|
|
||||
Trade payables |
$ |
2,440 |
|
|
$ |
6,384 |
|
Employees and payroll accruals |
|
5,545 |
|
|
|
5,300 |
|
Operating lease liabilities |
|
2,176 |
|
|
|
2,648 |
|
Accrued interest of convertible senior notes |
|
1,842 |
|
|
|
1,652 |
|
Accrued expenses and other current liabilities |
|
8,735 |
|
|
|
8,891 |
|
Total current liabilities |
|
20,738 |
|
|
|
24,875 |
|
|
|
|
|
||||
NON-CURRENT LIABILITIES: |
|
|
|
||||
Convertible senior notes, net |
|
86,117 |
|
|
|
96,450 |
|
Warrants liability |
|
25,629 |
|
|
|
- |
|
Accrued severance pay |
|
1,403 |
|
|
|
1,914 |
|
Long-term operating lease liabilities |
|
2,461 |
|
|
|
4,867 |
|
Other long-term liabilities |
|
1,873 |
|
|
|
4,690 |
|
Total non-current liabilities |
|
117,483 |
|
|
|
107,921 |
|
|
|
|
|
||||
CONTINGENT LIABILITIES AND COMMITMENTS |
|
|
|||||
|
|
|
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SHAREHOLDERS’ DEFICIT: |
|
|
|
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Ordinary shares of |
|
305 |
|
|
|
211 |
|
|
* |
|
* |
||||
Additional paid-in capital |
|
443,450 |
|
|
|
408,598 |
|
Accumulated deficit |
|
(469,468 |
) |
|
|
(416,832 |
) |
Total shareholders’ deficit |
|
(25,713 |
) |
|
|
(8,023 |
) |
|
|
|
|
||||
Total liabilities and shareholders’ deficit |
$ |
112,508 |
|
|
$ |
124,773 |
|
|
|
|
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* Represents an amount lower than |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(Unaudited) |
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Three months ended |
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Six months ended |
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
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Research and development expenses, net |
$ |
8,687 |
|
$ |
10,563 |
|
$ |
17,527 |
|
$ |
21,868 |
|
Commercial expenses |
|
3,862 |
|
|
3,193 |
|
|
9,438 |
|
|
7,072 |
|
General and administrative expenses |
6,253 |
|
|
4,290 |
|
|
11,417 |
|
|
8,429 |
||
Total operating loss |
|
18,802 |
|
|
18,046 |
|
|
38,382 |
|
|
37,369 |
|
|
|
|
|
|
|
|
|
|||||
Financial expenses, net |
|
12,874 |
|
|
508 |
|
|
14,254 |
|
|
1,408 |
|
|
|
|
|
|
|
|
|
|||||
Loss |
$ |
31,676 |
|
$ |
18,554 |
|
$ |
52,636 |
|
$ |
38,777 |
|
|
|
|
|
|
|
|
|
|||||
Net loss per share attributable to ordinary shareholders, basic and diluted |
0.31 |
|
|
0.31 |
|
|
0.59 |
|
|
0.65 |
|
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
|||||||
|
|||||||
(Unaudited) |
|||||||
|
Six months ended |
||||||
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
Net Income (Loss) |
$ |
(52,636 |
) |
$ |
(38,777 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to reconcile loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Depreciation of property, plant and equipment |
|
214 |
|
|
224 |
|
|
Financing expense (income), net |
|
1,363 |
|
|
(273 |
) |
|
Share-based compensation |
|
2,921 |
|
|
2,530 |
|
|
Change in Fair Value of Warrants liability |
|
4,876 |
|
|
- |
|
|
Change in Fair Value of convertible senior note |
|
4,254 |
|
|
- |
|
|
Warrants Issuance Costs |
|
1,733 |
|
|
- |
|
|
Amortization of loan issuance costs |
|
455 |
|
|
385 |
|
|
|
|
|
|
|
|
|
|
Change in assets and liabilities: |
|
|
|
|
|
|
|
Inventory |
|
(295 |
) |
|
- |
|
|
Operating lease right-of-use assets |
|
1,363 |
|
|
1,226 |
|
|
Operating lease liabilities |
|
(1,553 |
) |
|
(1,649 |
) |
|
Accrued severance pay, net |
|
(99 |
) |
|
14 |
|
|
Increase in prepaid expenses and other assets |
|
(211 |
) |
|
(19 |
) |
|
Decrease in trade payables |
|
(3,944 |
) |
|
(5,535 |
) |
|
Increase (decrease) in accrued expenses and other liabilities |
|
(2,728 |
) |
|
2,285 |
|
|
Net cash used in operating activities |
|
(44,287 |
) |
|
(39,589 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
Purchase of property, plant and equipment |
|
(821 |
) |
|
(1,540 |
) |
|
Purchase of marketable securities |
|
- |
|
|
(3,708 |
) |
|
Proceeds from maturity of marketable securities |
|
- |
|
|
26,175 |
|
|
Proceeds from restricted deposits |
|
- |
|
|
500 |
|
|
Net cash provided by (used in) investing activities |
$ |
(821 |
) |
$ |
21,427 |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
Proceeds from exercise of options |
$ |
- |
|
$ |
76 |
|
|
Proceeds from exercise of warrants liability |
|
45 |
|
|
- |
|
|
Proceeds from share issuance and warrants liability, net |
|
34,785 |
|
|
84 |
|
|
Payment of warrants issuance cost |
|
(166 |
) |
|
- |
|
|
Net cash provided by financing activities |
|
34,664 |
|
|
160 |
|
|
|
|
|
|
|
|
|
|
Decrease in cash and cash equivalents and restricted cash |
|
(10,444 |
) |
|
(18,002 |
) |
|
Cash and cash equivalents at beginning of period |
|
64,657 |
|
|
55,892 |
|
|
Cash, cash equivalents and restricted cash at end of period |
$ |
54,213 |
|
$ |
37,890 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230811182915/en/
Investor Contacts:
Chuck@lifesciadvisors.com
1-646-627-8390
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Orangefiery
media@orangefiery.com
1-818-209-1692
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