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Gamida Cell Reports Second Quarter 2021 Financial Results and Provides Company Update

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Gamida Cell Ltd. (Nasdaq: GMDA) reported a net loss of $21.3 million for Q2 2021, up from $15.1 million in Q2 2020. The company has $150.2 million in cash as of June 30, 2021, which is expected to fund operations into H2 2022. Key advancements include plans for a Biologic License Application (BLA) submission for omidubicel by year-end and the initiation of a Phase 1/2 trial for GDA-201 in non-Hodgkin lymphoma. Gamida is also expanding its NK cell pipeline targeting various cancers. Overall, the company is advancing its commercial readiness and development efforts.

Positive
  • Cash and cash equivalents of $150.2 million supporting operations into H2 2022.
  • Planned BLA submission for omidubicel anticipated in Q4 2021.
  • Initiation of Phase 1/2 trial for GDA-201 expected by year-end 2021.
  • Expansion of NAM-enabled NK cell pipeline targeting both solid tumors and hematological cancers.
Negative
  • Net loss increased to $21.3 million from $15.1 million year-over-year.
  • Research and development expenses rose to $13.5 million, primarily due to omidubicel manufacturing readiness.

Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today reported financial results for the quarter ended June 30, 2021. Net loss for the second quarter of 2021 was $21.3 million, compared to a net loss of $15.1 million for the same period in 2020. As of June 30, 2021, Gamida Cell had total cash and cash equivalents of $150.2 million.

During the quarter, the company continued to execute on plans to submit a Biologic License Application (BLA) for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. This submission is expected to occur by the end of the year, subject to a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) planned for the fourth quarter. In addition, Gamida prepared to begin a Phase 1/2 trial of GDA-201 in non-Hodgkin lymphoma (NHL), expected to occur by the end of 2021. Also, the company expanded its NAM-enabled natural killer (NK) cell pipeline targeting solid-tumor and hematological cancers, including genetically modified variants of proprietary NK therapies using both CRISPR/Cas9 and CAR methodologies.

“Our progress this quarter represents a major step forward for Gamida Cell and our mission to bring cancer patients potentially curative cell therapies,” said Julian Adams, Ph.D., chief executive officer of Gamida Cell. “We are delivering against key process development, quality and manufacturing milestones in preparation for a BLA submission for omidubicel while also advancing our go-to-market strategy for our planned commercial launch. In parallel, we bolstered our NAM-enabled NK pipeline both by readying to advance GDA-201 into the clinic based on its encouraging clinical data in patients with hematological cancers and by expanding our NK cell pipeline to address solid and liquid tumors.”

Q2 and Recent Developments

Omidubicel: Advanced Cell Therapy

  • Continued advancement toward planned BLA submission for omidubicel to the FDA in the fourth quarter of this year. The company’s activities included CMC qualification requirements at both the Gamida–owned facility in Israel and at Lonza, a contract manufacturing organization that will be supplying commercial material upon FDA approval. Advancements were made in analytical methods validation, analytical comparability and clinical manufacturing for Expanded Access Program patients, which are also planned to be used for clinical comparability.
  • Advanced launch planning activities by expanding Gamida’s commercial, operational and medical affairs teams. Conducted further market research and health economic and outcomes research (HEOR) to support planned market entry and market access activities. Readied Gamida Cell Assist, supply chain and logistics programs to facilitate positive patient and transplant center experiences at time of launch.
  • Announced that results of the international, multi-center, randomized Phase 3 clinical study of omidubicel were published in Blood, the official journal of the American Society of Hematology. This pivotal trial compared the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant. The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery, and results in fewer bacterial, viral and fungal infections and less time in the hospital, compared to a standard umbilical cord blood graft.

GDA-201: NAM-Enabled NK Immunotherapy

  • Prepared for filing of an Investigational New Drug (IND) application with the FDA.
  • Finalized clinical study protocol and statistical plan for a planned Phase 1/2 clinical trial of allogeneic, cryopreserved GDA-201 in patients with follicular and diffuse large B-cell lymphoma.
  • Conducted study start-up activities, including contract research organization (CRO) and clinical site selections.

NAM-Enabled NK Cell Pipeline Expansion

  • Advanced four new development programs that involve modifications intended to direct NK cells against specific tumor markers to improve their cancer killing capabilities against both hematological and solid tumors. Newly designated product candidates include:
    • GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra. Designed to improve tumor killing by promoting activation and inhibiting negative feedback signals. Potential applications exist across a range of solid tumors and lymphoma.
    • GDA-401: Undisclosed target genetically engineered to enhance NK cell survival in the solid tumor microenvironment for potential application across a broad range of solid tumors.
    • GDA-501: CAR-engineered NK cells to target HER2+ solid tumors with the potential to enhance homing and activation against cancers with HER2 overexpression, including breast, ovarian, lung, bladder, gastric and others.
    • GDA-601: Knockout of CD38 on NK cells to avoid fratricide by CD38 targeted antibodies in combination treatment of multiple myeloma, combined with a CD38 CAR designed to enhance killing of cancerous cells.
  • Advanced additional NAM-enabled research programs targeting immunosuppressive pathways using both CRISPR/Cas9 and CAR, with potential to treat solid tumor and blood cancers.

Corporate

  • Hired Vladimir Melnikov as Senior Vice President, Global Operations and Manufacturing. Vladimir has over 25 years of experience in the biopharmaceutical industry. He previously served as general manager at Omrix Biopharmaceuticals and biologic technical operations lead at Ethicon Biosurgery, both part of a Johnson & Johnson Company. In those roles he supervised three Israeli biotech manufacturing sites and technology transfer to external partners. Vladimir will have responsibility for the company’s Israeli manufacturing site and manufacturing partnership with Lonza.
  • Hired Josh Patterson as General Counsel, effective August 30, 2021. Josh has over 20 years of experience as in-house legal counsel for biopharmaceutical companies. Josh will be joining Gamida Cell from Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals, where he is currently General Counsel. Josh will be responsible for building, leading and managing the legal function for Gamida Cell.

Second Quarter 2021 Financial Results

  • Research and development expenses in the second quarter of 2021 were $13.5 million, compared to $9.3 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities, and the advancement of the GDA-201 program, including broadening scientific capabilities and talent.
  • Commercial expenses in the second quarter of 2021 were $5.2 million, compared to $1.0 million for the second quarter of 2020. The increase was mainly attributed to progress with omidubicel commercial readiness activities.
  • General and administrative expenses were $3.8 million for the second quarter of 2021, compared to $2.5 million for the same period in 2020. The increase was mainly due to the hiring of key management positions to support business growth.
  • Finance income, net, was $1.2 million for the second quarter of 2021, compared to $2.2 million for the second quarter of 2020. The increase was primarily due to non-cash income, resulting from revaluation of warrants offset by interest expenses that resulted from the $75 million convertible note financing in February 2021.

Net loss for the second quarter of 2021 was $21.3 million, compared to a net loss of $15.1 million for the same period in 2020.

2021 Financial Guidance

Gamida Cell reiterates its prior financial guidance and expects cash used for ongoing operating activities in 2021 to range from $110 million to $120 million. The company believes that its current cash and cash equivalents will support the ongoing operating activities into the second half of 2022. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.

Expected 2021 Developments and Milestones

Gamida Cell plans to achieve the following key milestones during the second half of 2021:

Omidubicel

  • Pre-BLA meeting with FDA in the fourth quarter of 2021
  • BLA submission to the FDA in the fourth quarter of 2021
  • Commercial readiness activities ongoing for potential launch following approval

GDA-201

  • IND submission to FDA in third quarter 2021
  • Initiation of a company-sponsored Phase 1/2 clinical study in NHL before year-end 2021

NK cell pipeline expansion

  • Advance pipeline of NAM-enabled, genetically-modified NK cells in solid tumor and blood cancers

Conference Call Information

Gamida Cell will host a conference call today, August 11, 2021, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the “Investors & Media” section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 5258448. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potentially life-saving1 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.2,3 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.gamida-cell.com.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-based cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 has been in development through an investigator-sponsored study in patients with refractory NHL and multiple myeloma. For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About Gamida Cell

Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources — including umbilical cord blood-derived cells and NK cells — to create therapies with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook, Instagram, or YouTube 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 Cell’s product candidates, anticipated regulatory filings (including the submission of the BLA for omidubicel to the FDA), commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of omidubicel, and Gamida Cell’s expectations regarding its projected cash to be used for operating activities and cash 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 the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost thereof; 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, and in the endeavor of building a business around such product candidates. 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 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, as amended, 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 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.

___________________
1 Gragert et al. HLA Match Likelihoods for Hematopoietic Stem-Cell Grafts in the U.S. Registry. N Engl J Med 2014;371:339-48. Bejanyan et al. Myeloablative Conditioning for Allogeneic Transplantation Results in Superior Disease-Free Survival for Acute Myelogenous Leukemia and Myelodysplastic Syndromes with Low/Intermediate but not High Disease Risk Index: A Center for International Blood and Marrow Transplant Research Study. Biol Blood Marrow Transplant 00 (2020) 1-9.
2 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374.
3 Horwitz M.E., et al. Blood. 2021 Jun 22;blood.2021011719. doi: 10.1182/blood.2021011719. Online ahead of print.
4 Bachanova et al. ASH 2020 abstract

INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

U.S. dollars in thousands

 

 

 

June 30,

 

December 31,

 

 

2021

 

2020

 

2020

 

 

Unaudited

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

100,490

 

 

$

88,638

 

 

$

127,170

 

Marketable securities

 

 

49,702

 

 

 

-

 

 

 

-

 

Prepaid expenses and other current assets

 

 

3,730

 

 

 

2,241

 

 

 

2,815

 

 

 

 

 

 

 

 

Total current assets

 

 

153,922

 

 

 

90,879

 

 

 

129,985

 

 

 

 

 

 

 

 

NON-CURRENT ASSETS:

 

 

 

 

 

 

Property, plant and equipment, net

 

 

25,607

 

 

 

14,204

 

 

 

18,238

 

Right-of-use assets

 

 

5,404

 

 

 

7,490

 

 

 

6,474

 

Other assets

 

 

1,787

 

 

 

642

 

 

 

786

 

 

 

 

 

 

 

 

Total non-current assets

 

 

32,798

 

 

 

22,336

 

 

 

25,498

 

 

 

 

 

 

 

 

Total assets

 

$

186,720

 

 

$

113,215

 

 

$

155,483

 

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Trade payables

 

$

5,435

 

 

$

2,738

 

 

$

6,329

 

Employees and payroll accruals

 

 

4,796

 

 

 

3,187

 

 

 

4,705

 

Current maturities of lease liabilities

 

 

1,937

 

 

 

2,145

 

 

 

2,532

 

Accrued interest

 

 

1,618

 

 

 

-

 

 

 

-

 

Accrued expenses and other payables

 

 

8,839

 

 

 

5,509

 

 

 

7,988

 

 

 

 

 

 

 

 

Total current liabilities

 

 

22,625

 

 

 

13,579

 

 

 

21,554

 

 

 

 

 

 

 

 

NON-CURRENT LIABILITIES:

 

 

 

 

 

 

Liabilities presented at fair value

 

 

6,233

 

 

 

4,551

 

 

 

12,043

 

Employee benefit liabilities, net

 

 

768

 

 

 

773

 

 

 

768

 

Other long-term liabilities

 

 

4,839

 

 

 

5,946

 

 

 

5,378

 

Liability to Israel Innovation Authority

 

 

19,146

 

 

 

13,816

 

 

 

17,003

 

Convertible senior notes, net

 

 

69,025

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

Total non-current liabilities

 

 

100,011

 

 

 

25,086

 

 

 

35,192

 

 

 

 

 

 

 

 

SHAREHOLDERS' EQUITY:

 

 

 

 

 

 

Share capital

 

 

167

 

 

 

137

 

 

 

166

 

Share premium

 

 

379,981

 

 

 

304,175

 

 

 

375,280

 

Capital reserve

 

 

(441

)

 

 

(541

)

 

 

(441

)

Reserve from financial assets measured at FVOCI

 

 

(25

)

 

 

-

 

 

 

-

 

Accumulated deficit

 

 

(315,598

)

 

 

(229,221

)

 

 

(276,268

)

 

 

 

 

 

 

 

Total shareholders' equity

 

 

64,084

 

 

 

74,550

 

 

 

98,737

 

 

 

 

 

 

 

 

Total liabilities and shareholders' equity

 

$

186,720

 

 

$

113,215

 

 

$

155,483

 

INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S. dollars in thousands (except share and per share data)

 

 

 

Six months ended

June 30,

 

Three months ended

June 30,

 

Year ended

December 31,

 

 

2021

 

2020

 

2021

 

2020

 

2020

 

 

Unaudited

 

Unaudited

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

Research and development, net

 

$

24,817

 

 

$

17,198

 

 

$

13,451

 

 

$

9,319

 

 

$

41,385

 

Commercial activities

 

 

9,660

 

 

 

2,497

 

 

 

5,230

 

 

 

1,029

 

 

 

8,748

 

General and administrative

 

 

7,230

 

 

 

5,490

 

 

 

3,817

 

 

 

2,496

 

 

 

12,167

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

41,707

 

 

 

25,185

 

 

 

22,498

 

 

 

12,844

 

 

 

62,300

 

 

 

 

 

 

 

 

 

 

 

 

Finance expense

 

 

4,150

 

 

 

1,366

 

 

 

2,594

 

 

 

2,320

 

 

 

10,640

 

Finance income

 

 

(6,080

)

 

 

(894

)

 

 

(3,801

)

 

 

(109

)

 

 

(236

)

 

 

 

 

 

 

 

 

 

 

 

Loss before tax benefit

 

 

39,777

 

 

 

25,657

 

 

 

21,291

 

 

 

15,055

 

 

 

72,704

 

Tax benefit

 

 

(447

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

39,330

 

 

 

25,657

 

 

 

21,291

 

 

 

15,055

 

 

 

72,704

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

 

Basic loss per share

 

$

0.66

 

 

$

0.69

 

 

$

0.36

 

 

$

0.37

 

 

$

1.66

 

 

 

 

 

 

 

 

 

 

 

 

Diluted loss per share

 

$

0.76

 

 

$

0.69

 

 

$

0.42

 

 

$

0.37

 

 

$

1.66

 

 

Weighted average share count

 

59,725,076

 

 

37,141,582

 

 

59,336,633

 

 

49,589,719

 

 

43,725,584

 

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 

 

Six months ended

June 30,

Three months ended

June 30,

Year ended

December 31,

 

2021

2020

2021

2020

2020

 

Unaudited

Unaudited

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

$

(39,330

)

$

(25,657

)

$

(21,291

)

$

(15,055

)

$

(72,704

)

 

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Adjustments to the profit or loss items:

 

 

 

 

 

 

Depreciation of property, plant and equipment and right-of-use assets

 

1,277

 

 

1,106

 

 

642

 

 

556

 

 

2,397

 

Financial (income) expense, net

 

1,007

 

 

(260

)

 

522

 

 

(128

)

 

483

 

Share-based compensation

 

2,463

 

 

1,221

 

 

1,449

 

 

322

 

 

2,864

 

Change in employee benefit liabilities, net

 

-

 

 

-

 

 

 

-

 

 

94

 

Amortization of premium on available-for-sale financial assets

 

-

 

 

4

 

 

 

-

 

 

4

 

Revaluation of liabilities presented at fair value derivatives

 

(5,810

)

 

(670

)

 

(3,525

)

 

1,778

 

 

6,822

 

Revaluation of liability to IIA

 

1,858

 

 

1,315

 

 

832

 

 

593

 

 

4,302

 

Deferred income taxes

 

(447

)

 

-

 

 

 

-

 

 

-

 

 

 

 

 

 

 

 

 

348

 

 

2,716

 

 

(80

)

 

3,121

 

 

16,966

 

 

Changes in asset and liability items:

 

 

 

 

 

 

Decrease (increase) in prepaid expenses, other current assets, and other assets

 

68

 

 

(1,065

)

 

591

 

 

(607

)

 

(1,626

)

Increase (decrease) in trade payables

 

(893

)

 

1,574

 

 

(1,768

)

 

(360

)

 

5,083

 

Increase (decrease) in accrued expenses and other payables

 

(201

)

 

(624

)

 

2,523

 

 

2,472

 

 

3,454

 

 

 

 

 

 

 

 

 

(1,026

)

 

(115

)

 

1,346

 

 

1,505

 

 

6,911

 

 

 

 

 

 

 

Cash received during the period for:

 

 

 

 

 

 

Interest received

 

268

 

 

357

 

 

268

 

 

9

 

 

361

 

Interest paid

 

(85

)

 

(80

)

 

(34

)

 

(33

)

 

(161

)

 

 

 

 

 

 

Net cash used in operating activities

 

(39,825

)

 

(22,779

)

 

(19,791

)

 

(10,453

)

 

(48,627

)

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

Purchase of property, plant and equipment

 

(5,390

)

 

(7,109

)

 

(2,584

)

 

(4,990

)

 

(11,804

)

Investment in long term deposit

 

(1,000

)

 

-

 

 

(1,000

)

 

-

 

 

-

 

Purchase of marketable securities

 

(68,151

)

 

-

 

 

(68,151

)

 

-

 

 

-

 

Proceeds from maturity of marketable securities

 

17,824

 

 

-

 

 

17,824

 

 

-

 

 

(158

)

Proceeds from sale of marketable securities

 

-

 

 

13,551

 

 

-

 

 

-

 

 

13,551

 

 

 

 

 

 

 

Net cash provided by (used in) investing activities

$

(56,717

)

$

6,442

 

$

(53,911

)

$

(4,990

)

$

1,589

 

 

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 

 

 

Six months ended

June 30

 

Three months ended

June 30

 

Year ended

December 31,

 

 

2021

 

2020

 

2021

 

2020

 

2020

 

 

Unaudited

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from secondary offering, net

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

133,316

 

Receipt of grants from the IIA

 

 

52

 

 

 

200

 

 

 

-

 

 

 

147

 

 

 

399

 

Proceeds from secondary offering, net

 

 

-

 

 

 

63,860

 

 

 

-

 

 

 

63,860

 

 

 

-

 

Proceeds from issuance of convertible senior notes, net of issuance costs

 

 

70,777

 

 

 

-

 

 

 

(235

)

 

 

 

 

-

 

Payment of lease liabilities

 

 

(1,129

)

 

 

(1,122

)

 

 

(465

)

 

 

(335

)

 

 

(1,985

)

Exercise of options

 

 

556

 

 

 

147

 

 

 

54

 

 

 

141

 

 

 

650

 

Payment of issuance costs related to public offering

 

 

(468

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

Net cash (used in) provided by financing activities

 

 

69,788

 

 

 

63,085

 

 

 

(646

)

 

 

63,813

 

 

 

132,380

 

 

 

 

 

 

 

 

 

 

 

 

Exchange differences on balances of cash and cash equivalents

 

 

74

 

 

 

52

 

 

 

40

 

 

 

(24

)

 

 

(10

)

 

 

 

 

 

 

 

 

 

 

 

Increase (decrease) in cash and cash equivalents

 

 

(26,680

)

 

 

46,800

 

 

 

(74,308

)

 

 

48,346

 

 

 

85,332

 

Cash and cash equivalents at beginning of period

 

 

127,170

 

 

 

41,838

 

 

 

174,798

 

 

 

40,292

 

 

 

41,838

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

 

$

100,490

 

 

$

88,638

 

 

$

100,490

 

 

$

88,638

 

 

$

127,170

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Significant non-cash transactions:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Lease liabilities arising from new right-of-use asset

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

3,409

 

 

 

 

 

 

 

 

 

 

 

 

IIA liability for grants to be received

 

$

656

 

 

$

-

 

 

$

607

 

 

$

-

 

 

$

103

 

 

 

 

 

 

 

 

 

 

 

 

Issuance expenses on credit

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

468

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property, plant and equipment on credit

 

$

1,563

 

 

$

960

 

 

$

1,563

 

 

$

960

 

 

$

415

 

 

 

 

 

 

 

 

 

 

 

 

Borrowing costs capitalization

 

$

574

 

 

$

-

 

 

$

574

 

 

$

-

 

 

$

-

 

 

FAQ

What are Gamida Cell's financial results for Q2 2021?

Gamida Cell reported a net loss of $21.3 million for Q2 2021, compared to a net loss of $15.1 million in Q2 2020.

What is the status of Gamida Cell's omidubicel BLA submission?

Gamida Cell plans to submit a Biologic License Application (BLA) for omidubicel by the end of 2021.

When is Gamida Cell's Phase 1/2 trial for GDA-201 expected to begin?

The Phase 1/2 trial for GDA-201 in non-Hodgkin lymphoma is expected to begin by the end of 2021.

What is Gamida Cell's cash runway for 2021?

Gamida Cell expects its current cash and cash equivalents to support operations through the second half of 2022.

What are the main challenges reported by Gamida Cell in Q2 2021?

Gamida Cell reported an increase in net loss and rising research and development expenses due to manufacturing readiness activities.

Gamida Cell Ltd.

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