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Gamida Cell Reports Third Quarter 2019 Financial Results and Provides Company Update

November 13, 2019 GMT

BOSTON--(BUSINESS WIRE)--Nov 13, 2019--

Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, today reported financial results for the quarter ended September 30, 2019. The company also highlighted continued progress in advancing its clinical development candidates: omidubicel, an advanced cell therapy in Phase 3 clinical development as a potential life-saving treatment option for patients in need of bone marrow transplant, and GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma and multiple myeloma.

“During the quarter, we made important progress toward our goal of developing next-generation cell therapies with the potential to redefine standards of care for patients with blood cancers and rare, serious hematologic diseases,” stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. “We are nearing completion of patient enrollment in our multi-center, randomized Phase 3 study of omidubicel and are on track to report topline data from the study in the first half of 2020. Positive data from the study would enable us to file our first biologics license application next year.”

“Our second cell therapy program, GDA-201, is also advancing, and next month we will report additional data from the ongoing Phase 1 study at the Annual Meeting of the American Society of Hematology,” Dr. Adams continued. “During the meeting, we will also show new gene expression data that reinforce our understanding of the mechanism of action underlying our NAM technology platform which enabled the generation of both of our development candidates.”

Program Highlights

Third Quarter 2019 Financial Results

2019 Financial Guidance

Gamida Cell continues to expect cash used for ongoing operating activities in 2019 to range from $35 million to $40 million, reflecting anticipated expenditures to advance the company’s clinical programs.

Gamida Cell expects that its current cash, cash equivalents and available-for-sale securities will support the company’s ongoing operating activities into the fourth quarter of 2020. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

Conference Call Information

Gamida Cell will host a conference call today, November 13, 2019, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the “Investors” 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 8653335. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel (formerly known as NiCord ® ), the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and durable time to engraftment and was generally well-tolerated. 1 A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia. 2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia. 3 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.clinicaltrials.gov.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201 (formerly known as NAM-NK), an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. 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 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma. 4

Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com.

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 patient enrollment in and timing of initiation and progress of and data reported from the clinical trials of Gamida Cell’s product candidates, and Gamida Cell’s expectations regarding its projected operating expenses and cash runway, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Gamida Cell’s clinical trials and variability, and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of Gamida Cell’s public filing on Form 20-F, filed with the SEC on February 25, 2019, 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. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

U.S. dollars in thousands

 

 

September 30,

 

Dec 31,

 

 

2019

 

2018

 

2018

 

 

Unaudited

 

Audited

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

39,573

 

$

14,109

 

$

40,272

Available-for-sale financial assets

 

 

28,544

 

 

9,570

 

 

20,417

Prepaid expenses and other current assets

 

 

1,134

 

 

1,018

 

 

1,502

 

 

 

 

 

 

 

Total current assets

 

 

69,251

 

 

24,697

 

 

62,191

 

 

 

 

 

 

 

NON-CURRENT ASSETS:

 

 

 

 

 

 

Property and equipment, net

 

 

4,209

 

 

1,743

 

 

2,311

Right-of-use assets

 

 

5,568

 

 

-

 

 

-

Other assets

 

 

651

 

 

354

 

 

662

Deferred issuance cost

 

 

-

 

 

1,718

 

 

-

 

 

 

 

 

 

 

Total non-current assets

 

 

10,428

 

 

3,815

 

 

2,973

 

 

 

 

 

 

 

Total assets

 

$

79,679

 

$

28,512

 

$

65,164

LIABILITIES AND EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Trade payables

 

$

2,105

 

$

3,060

 

 

$

1,985

Employees and payroll accruals

 

 

3,096

 

 

2,128

 

 

 

2,888

Current maturities of lease liabilities

 

 

1,926

 

 

-

 

 

 

-

Accrued expenses and other payables

 

 

1,979

 

 

2,111

 

 

 

1,832

 

 

 

 

 

 

 

Total current liabilities

 

 

9,106

 

 

7,299

 

 

 

6,705

 

 

 

 

 

 

 

NON-CURRENT LIABILITIES:

 

 

 

 

 

 

Liabilities presented at fair value

 

 

5,434

 

 

15,400

 

 

 

24,049

Employee benefit liabilities, net

 

 

280

 

 

194

 

 

 

183

Lease liability

 

 

4,342

 

 

-

 

 

 

-

Liability to Israel Innovation Authority (IIA)

 

 

11,594

 

 

10,474

 

 

 

9,540

 

 

 

 

 

 

 

Total non-current liabilities

 

 

21,650

 

 

26,068

 

 

 

33,772

 

 

 

 

 

 

 

SHAREHOLDERS' EQUITY:

 

 

 

 

 

 

Total shareholders' equity

 

 

48,923

 

 

(4,855

)

 

 

24,687

 

 

 

 

 

 

 

Total liabilities and shareholders' equity

 

$

79,679

 

$

28,512

 

 

$

65,164

INTERIMCONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

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

 

 

Nine months ended
September 30,

 

Three months ended
September 30,

 

Year ended
December 31,

 

 

2019

 

2018

 

2019

 

2018

 

2018

 

 

Unaudited

 

Audited

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

Research and development, net

 

$

21,682

 

 

$

17,169

 

 

$

7,363

 

 

$

5,132

 

 

$

22,045

 

General and administrative

 

 

12,195

 

 

 

7,008

 

 

 

4,621

 

 

 

2,438

 

 

 

11,599

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

33,877

 

 

 

24,177

 

 

 

11,984

 

 

 

7,570

 

 

 

33,644

 

 

 

 

 

 

 

 

 

 

 

 

Finance expenses

 

 

2,499

 

 

 

6,560

 

 

 

895

 

 

 

2,356

 

 

 

20,259

 

Finance income

 

 

(16,665

)

 

 

(434

)

 

 

(2,613

)

 

 

(104

)

 

 

(1,042

)

 

 

 

 

 

 

 

 

 

 

 

Loss (income) before taxes on income

 

 

19,711

 

 

 

30,303

 

 

 

10,266

 

 

 

9,822

 

 

 

52,861

 

Taxes on income (benefit)

 

 

(70

)

 

 

-

 

 

 

(170

)

 

 

-

 

 

 

70

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

19,641

 

 

 

30,303

 

 

 

10,096

 

 

 

9,822

 

 

 

52,931

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss (income) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net loss per share

 

$

0.70

 

 

$

43.92

 

 

$

0.30

 

 

$

14.23

 

 

$

10.53

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net loss per share

 

$

1.24

 

 

$

43.92

 

 

$

0.30

 

 

$

14.23

 

 

$

10.53

 

 

INTERIMCONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 

 

Nine months ended
September 30,

 

Three months ended
September 30,

 

Year ended
December 31,

 

 

2019

 

2018

 

2019

 

2018

 

2018

 

 

Unaudited

 

Audited

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(19,641

)

 

$

(30,303

)

 

$

(10,096

)

 

$

(9,822

)

 

$

(52,931

)

 

 

 

 

 

 

 

 

 

 

 

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

 

 

1,792

 

 

 

146

 

 

 

547

 

 

 

49

 

 

 

269

 

Financial (income) expenses, net

 

 

(768

)

 

 

(161

)

 

 

(199

)

 

 

214

 

 

 

(858

)

Cost of share-based compensation

 

 

3,731

 

 

 

2,503

 

 

 

1,321

 

 

 

880

 

 

 

3,575

 

Change in employee benefit liabilities, net

 

 

14

 

 

 

(6

)

 

 

6

 

 

 

(23

)

 

 

(15

)

Amortization of premium on available-for-sale financial assets

 

 

150

 

 

 

191

 

 

 

49

 

 

 

200

 

 

 

272

 

Revaluation of financial derivatives

 

 

(15,691

)

 

 

5,100

 

 

 

(2,220

)

 

 

1,700

 

 

 

17,600

 

Revaluation of liability to IIA

 

 

1,852

 

 

 

3,167

 

 

 

653

 

 

 

567

 

 

 

2,037

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,920

)

 

 

10,940

 

 

 

157

 

 

 

3,587

 

 

 

22,880

 

Changes in asset and liability items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

113

 

 

 

(1,266

)

 

 

(4

)

 

 

(1,637

)

 

 

942

 

Increase (decrease) in trade payables

 

 

120

 

 

 

670

 

 

 

(124

)

 

 

1,902

 

 

 

(405

)

Increase (decrease) in accrued expenses and other payables and employee and payroll accrual

 

 

680

 

 

 

1,071

 

 

 

518

 

 

 

(8

)

 

 

2,296

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

913

 

 

 

475

 

 

 

390

 

 

 

257

 

 

 

2,833

 

 

 

 

 

 

 

 

 

 

 

 

Cash received during the period for:

 

 

 

 

 

 

 

 

 

 

Interest received

 

 

1,132

 

 

 

570

 

 

 

302

 

 

 

179

 

 

 

792

 

Interest paid

 

 

(92

)

 

 

-

 

 

 

(41

)

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,040

 

 

 

570

 

 

 

261

 

 

 

179

 

 

 

792

 

 

 

 

 

 

 

 

 

 

 

 

Net cash used in operating activities

 

 

(26,608

)

 

 

(18,318

)

 

 

(9,288

)

 

 

(5,799

)

 

 

(26,426

)

 

 

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(2,139

)

 

 

(949

)

 

 

(1,261

)

 

 

(246

)

 

 

(1,645

)

Purchase of available-for-sale financial assets

 

 

(32,021

)

 

 

-

 

 

 

(32,021

)

 

 

-

 

 

 

(10,905

)

Proceed from sale of available-for-sale financial assets

 

 

-

 

 

 

4,984

 

 

 

-

 

 

 

-

 

 

 

4,949

 

Proceed from maturity of available-for-sale financial assets

 

 

23,789

 

 

 

-

 

 

 

8,049

 

 

 

-

 

 

 

-

 

Proceeds from bank deposits

 

 

-

 

 

 

5,000

 

 

 

-

 

 

 

-

 

 

 

5,000

 

Investment in restricted bank deposits

 

 

-

 

 

 

(150

)

 

 

-

 

 

 

(150

)

 

 

(150

)

 

 

 

 

 

 

 

 

 

 

 

Net cash provided by (used in) investing activities

 

 

(10,371

)

 

 

8,885

 

 

 

(25,233

)

 

 

(396

)

 

 

(2,751

)

INTERIMCONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 

 

Nine months ended

September 30,

 

Three months ended

September 30,

 

Year ended

December 31,

 

 

2019

 

2018

 

2019

 

2018

 

2018

 

 

Unaudited

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from secondary offering, net

 

 

37,235

 

 

 

-

 

 

 

37,343

 

 

 

-

 

 

 

-

Receipt of grants from the IIA

 

 

202

 

 

 

2,953

 

 

 

35

 

 

 

1,300

 

 

 

612

Proceeds from issuance of shares, initial public offering (payment of issuance expenses), net

 

 

(238

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

47,479

Payment of lease liabilities

 

 

(1,144

)

 

 

-

 

 

 

(380

)

 

 

-

 

 

 

-

Exercise of options

 

 

120

 

 

 

-

 

 

 

3

 

 

 

-

 

 

 

2

Increase in deferred issuance cost

 

 

-

 

 

 

(736

)

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net cash provided by financing activities

 

 

36,175

 

 

 

2,217

 

 

 

37,001

 

 

 

1,300

 

 

 

48,093

 

 

 

 

 

 

 

 

 

 

 

Exchange differences on balances of cash and cash equivalents

 

 

105

 

 

 

-

 

 

 

15

 

 

 

-

 

 

 

31

 

 

 

 

 

 

 

 

 

 

 

Increase (decrease) in cash and cash equivalents

 

 

(699

)

 

 

(7,216

)

 

 

2,495

 

 

 

(4,895

)

 

 

18,947

Cash and cash equivalents at beginning of period

 

 

40,272

 

 

 

21,325

 

 

 

37,078

 

 

 

19,004

 

 

 

21,325

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

 

$

39,573

 

 

$

14,109

 

 

$

39,573

 

 

$

14,109

 

 

$

40,272

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1 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.
2 ClinicalTrials.gov identifier NCT02730299.
3 ClinicalTrials.gov identifier NCT03173937.
4 ClinicalTrials.gov identifier NCT03019666.

View source version on businesswire.com:https://www.businesswire.com/news/home/20191113005671/en/

CONTACT: Jaren Irene Madden

jaren@gamida-cell.com

1-617-286-6264Krystle Gibbs (media)

krystle@tenbridgecommunications.com

508-479-6358

KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY

SOURCE: Gamida Cell Ltd.

Copyright Business Wire 2019.

PUB: 11/13/2019 04:01 PM/DISC: 11/13/2019 04:01 PM

http://www.businesswire.com/news/home/20191113005671/en