Gamida Cell Reports First Quarter 2023 Financial Results and Provides Company Update
Company reports positive feedback and continued progress on transplant center onboarding and payer coverage around launch of Omisirge® (omidubicel-onlv), a new cell therapy for allogeneic stem cell transplant approved
Company successfully completed public offering, raising gross proceeds of
Company reports positive momentum on two-pronged corporate strategy: executing commercial plan and pursuing strategic partnerships to support Omisirge launch
Company to host conference call today at
“With the recent approval of Omisirge and the funds raised via our public offering,
First Quarter and Recent Developments
Omisirge® (omidubicel-onlv)
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FDA approval of Omisirge: On
April 17 , the company announced that the FDA approved Gamida Cell’s allogeneic cell therapy, Omisirge, as a new donor source for allogeneic stem cell transplant. Omisirge had previously received orphan drug, breakthrough therapy and priority review designations. Omisirge is the first enhanced and expanded cell therapy approved for stem cell transplant.
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Commercial progress: The company continues to advance efforts throughout the organization to execute the launch of Omisirge. As of
May 15, 2023 :- The company is on target to complete the goal of onboarding 10-15 of the top 70 transplant centers in 2023.
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The company has confirmed coverage with commercial payers that cover 65% of targeted lives and has discussions ongoing with other commercial payers and the
Centers for Medicare & Medicaid Services .
Corporate developments
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Public offering of securities: The company announced a
$22.8 million public offering of its securities. The underwritten public offering consisted of 17,500,000 ordinary shares and accompanying warrants to purchase 17,500,000 ordinary shares at a public offering price of$1.30 per ordinary share and accompanying warrant, for gross proceeds of$22.8 million , before deducting underwriting discounts and commissions and estimated offering expenses. The warrants have an exercise price of$1.35 per share, are exercisable immediately upon issuance, and will expire five years following the date of issuance. The net proceeds from the offering will be used to support the launch of Omisirge, the continued development of GDA-201 and for general corporate purposes.
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Debt reduction: The company announced that between January and
May 2023 ,Highbridge Capital Management, LLC , which issuedGamida Cell a$25 million senior secured convertible term loan inDecember 2022 , voluntarily exchanged an aggregate of$11.5 million in principal of that loan for ordinary shares inGamida Cell . The share redemptions were priced at$1.91 per share. In addition, the company repaid an additional$1 million of principal through an ordinary share issuance. As a result, the outstanding principal balance of this loan has been reduced from$25 million to$12.5 million .
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Special shareholders meeting: The company will hold a special shareholders meeting
May 19 to vote on an amendment to the company’s articles of incorporation that increases the number of ordinary shares authorized for issuance from 150,000,000 to 225,000,000. The purposes of this increase — which include providing the company with the flexibility to issue ordinary shares in connection with a commercial or strategic partnership, to pay down debt or to fund operations — are outlined in the company’s proxy statement. Following the increase, if approved, all ordinary shares issuable from the company’s authorized share capital would have the same voting rights and rights to any dividends or other distributions by the company as the ordinary shares currently issuable from its share capital.
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Strategic partnerships: The company continues to explore partnerships or broader strategic alternatives that would provide additional resource to support the launch of Omisirge and associated commercial activities in
the United States and the rest of the world. The company recently announced it has hiredMoelis & Company LLC to support these efforts.
First Quarter 2023 Financial Results
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Research and development expenses were
$8.8 million in the first quarter of 2023, compared to$11.3 million in the same quarter in 2022. The decrease was attributable mainly to a$2.4 million decrease in payments to Lonza for manufacturing services, a$1.3 million decrease in clinical activities relating to the conclusion of our Phase 3 clinical trial, offset by an increase of$1.2 million in the GDA-201 clinical program.
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Commercial expenses were
$5.6 million in the first quarter of 2023, compared to$3.9 million in the first quarter of 2022. The increase was attributable mainly to an increase in launch readiness activities. We anticipate that our commercial expenses will increase over time due to the recent FDA approval of Omisirge.
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General and administrative expenses were
$5.2 million in the first quarter of 2023, compared to$4.1 million in the same period in 2022. The increase was primarily due to professional services expenses.
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Finance expenses, net, were
$1.4 million in the first quarter of 2023, compared to$0.9 million in the same period in 2022. The increase was attributable to interest due on the convertible notes issued in 2022, offset by interest income from cash management.
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Net loss was
$21.0 million in the first quarter of 2023, compared to a net loss of$20.2 million in the first quarter of 2022.
2023 Financial Guidance
As of
Conference Call Information
About
Omisirge® is a registered trademark of
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), the company’s plans for commercial or strategic partnerships to support the launch of Omisirge and the company’s anticipated financial runway. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Annual Report on Form 10-K, filed with the
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2023 |
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2022 |
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(unaudited) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
46,763 |
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$ |
64,657 |
Prepaid expenses and other current assets |
|
|
1,404 |
|
|
1,889 |
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|
|
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Total current assets |
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48,167 |
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66,546 |
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NON-CURRENT ASSETS: |
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|
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Restricted deposits |
|
|
3,680 |
|
|
3,668 |
Property, plant and equipment, net |
|
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45,644 |
|
|
44,319 |
Operating lease right-of-use assets |
|
|
4,726 |
|
|
7,024 |
Severance pay fund |
|
|
1,649 |
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|
1,703 |
Other long-term assets |
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1,266 |
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1,513 |
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Total non-current assets |
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56,965 |
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58,227 |
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Total assets |
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$ |
105,132 |
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$ |
124,773 |
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2023 |
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2022 |
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(unaudited) |
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LIABILITIES AND SHAREHOLDERS' DEFICIT |
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CURRENT LIABILITIES: |
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Trade payables |
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$ |
4,398 |
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$ |
6,384 |
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Employees and payroll accruals |
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4,333 |
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|
|
5,300 |
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Operating lease liabilities |
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|
2,082 |
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|
|
2,648 |
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Accrued interest of convertible senior notes |
|
|
986 |
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|
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1,652 |
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Accrued expenses and other current liabilities |
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10,474 |
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|
8,891 |
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Total current liabilities |
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22,273 |
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24,875 |
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NON-CURRENT LIABILITIES: |
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Convertible senior notes, net |
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90,646 |
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96,450 |
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Accrued severance pay |
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1,862 |
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|
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1,914 |
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Long-term operating lease liabilities |
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2,976 |
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4,867 |
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Other long-term liabilities |
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2,742 |
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4,690 |
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Total non-current liabilities |
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98,226 |
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107,921 |
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CONTINGENT LIABILITIES AND COMMITMENTS |
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SHAREHOLDERS' EQUITY (DEFICIT): |
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Share capital - Ordinary shares of |
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222 |
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211 |
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* |
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* |
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Additional paid-in capital |
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422,203 |
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408,598 |
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Accumulated deficit |
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(437,792 |
) |
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(416,832 |
) |
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Total shareholders' deficit |
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(15,367 |
) |
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(8,023 |
) |
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Total liabilities and shareholders' equity |
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$ |
105,132 |
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$ |
124,773 |
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Three months ended
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2023 |
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2022 |
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|
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(unaudited) |
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(unaudited) |
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Research and development expenses, net |
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$ |
8,840 |
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$ |
11,305 |
Commercial expenses |
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5,576 |
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3,879 |
General and administrative expenses |
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5,164 |
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4,139 |
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Total operating loss |
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19,580 |
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19,323 |
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Financial expenses, net |
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1,380 |
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|
900 |
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Net Loss |
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$ |
20,960 |
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$ |
20,223 |
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Net loss per share attributable to ordinary shareholders, basic and diluted |
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0.27 |
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0.34 |
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Three months ended
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2023 |
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2022 |
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(unaudited) |
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(unaudited) |
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Cash flows from operating activities: |
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Net Loss |
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$ |
(20,960 |
) |
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$ |
(20,223 |
) |
Adjustments to reconcile loss to net cash used in operating activities: |
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Depreciation of property, plant and equipment |
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106 |
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112 |
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Financing expense (income), net |
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(464 |
) |
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(1,172 |
) |
Share-based compensation |
|
|
1,499 |
|
|
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1,194 |
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Amortization of debt discount and issuance costs |
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196 |
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|
191 |
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Changes in operating assets and liabilities: |
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Operating lease right-of-use assets |
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527 |
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|
562 |
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Operating lease liabilities |
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(686 |
) |
|
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(613 |
) |
Accrued severance pay, net |
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2 |
|
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|
33 |
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Decrease (increase) in prepaid expenses and other assets |
|
|
607 |
|
|
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(889 |
) |
Decrease in trade payables |
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(1,986 |
) |
|
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(3,927 |
) |
Decrease in accrued expenses and current liabilities |
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(1,125 |
) |
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(996 |
) |
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Net cash used in operating activities |
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(22,284 |
) |
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(25,728 |
) |
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Cash flows from investing activities: |
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Purchase of property, plant and equipment |
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(830 |
) |
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(723 |
) |
Purchase of marketable securities |
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- |
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(2,086 |
) |
Proceeds from maturity of marketable securities |
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- |
|
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14,126 |
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Proceeds from restricted deposits |
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- |
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500 |
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Net cash provided by (used in) investing activities |
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$ |
(830 |
) |
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$ |
11,817 |
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Cash flows from financing activities: |
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Proceeds from exercise of options |
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$ |
- |
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$ |
76 |
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Proceeds from share issuance, net |
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5,217 |
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- |
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Net cash provided by financing activities |
|
|
5,217 |
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|
|
76 |
|
|
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Decrease in cash and cash equivalents |
|
|
(17,894 |
) |
|
|
(13,835 |
) |
Cash and cash equivalents at beginning of period |
|
|
64,657 |
|
|
|
55,892 |
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Cash and cash equivalents at end of period |
|
$ |
46,763 |
|
|
$ |
42,057 |
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