Cellect Biotechnology Ltd Provides Corporate Update and Reports Third Quarter 2017 Financial Results

TEL AVIV, Israel, Nov. 22, 2017 /PRNewswire/ -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, today provided a corporate update and announced financial results for the third quarter ended September 30, 2017.

"We are very pleased with our accomplishments in the third quarter of 2017" said Dr. Shai Yarkoni, Chief Executive Officer; "As planned, the third quarter continues to show progress in Cellect's path to global leadership in the regenerative medicine arena. We were granted an important FDA Orphan Drug Designation Status for Cellect's ApoGraft™ for the prevention of acute and chronic GvHD which we believe will allow us to efficiently speed up the commercialization process of ApoGraft™ and with the view to the future, we have successfully completed a voluntary de-listing from the Tel-Aviv stock exchange and migrated to trade exclusively on the NASDAQ to maximize shareholders' value from our future endeavors. In this respect we have also successfully raised $4.3M gross during the third quarter of 2017, to finance our strategic business development activities. We remain confident of our progress and leadership position in the stem cell market."

Recent Corporate Highlights:

  • We reported positive results from a 20 patients trial at Tel-Aviv Ichilov Medical Center in which ApoGraft™ significantly improved stem cells derived from fat tissues. The significance of the findings opens ApoGraft™ up to be used by a much wider array of companies and medical centers worldwide developing stem cell based products and treatments. Of special importance are the aesthetic and orthopedic indications where fat-derived stem cells are the main raw material;
  • We nominated Dr. Ronit Bakimer-Kleiner as Chief Development Officer replacing Dr. Yaron Pereg;
  • Company's CEO, Dr. Shai Yarkoni, was chosen to present Cellect technology and recent advancements at the Bio-Europe 2017 conference in Berlin (https://ebdgroup.knect365.com/bioeurope/about-bio-europe) alongside other selected industry leaders including Andrew Yost, VP, Corporate Development, REGENXBIO Inc., Gabriele Proetzel, Director, Regenerative Medicine, Takeda and Sharon Brownlow, Head of Collaborations - Manufacturing Centre, The Cell and Gene Therapy Catapult. The panel was moderated by the Founder of Alliance of Regenerative Medicine (ARM);
  • Company's CEO, Dr. Shai Yarkoni, was selected to provide the keynote (Plenary) presentation at the 11th world congress of Regenerative Medicine and Stem Cell technologies in Singapore (http://www.bitcongress.com/rmsc2017/default.asp).

Third Quarter 2017 Financial Results:

  • Research and development (R&D) expenses for the third quarter of 2017 were $0.81 million, compared to $0.69 million in the second quarter of 2017 and $0.58 million in the third quarter of 2016. The increase in the third quarter of 2017 as compared to the second quarter of 2017 mainly derived due to a grant received from the BIRD foundation in the amount of $0.12 million in the second quarter of 2017 which was not received in the third quarter of 2017.
  • General and administrative (G&A) expenses for the third quarter of 2017 were $0.99 million, compared to $1.0 million in the second quarter of 2017 and $0.77 million in the third quarter of 2016. The change in the third quarter of 2017 as compared to the second quarter of 2017 mainly derived from an increase in expenses related to business development and professional fees in the third quarter of 2017, offset by a decrease in costs of delisting from the second quarter of 2017.
  • Finance expenses for the third quarter of 2017 were $0.41 million, compared to finance income of $0.37 million in the second quarter of 2017. The change was primarily due to changes related to fair value of the tradable and non-tradable warrants issued in prior financings.
  • Net loss for the third quarter of 2017 was $2.2 million, or $0.02 per share and $0.4 per ADS, compared to $1.3 million, or $0.012 per share and $0.24 per ADS, in the second quarter of 2017 and $1.5 million, or $0.016 per share and $0.3 per ADS, in the third quarter of 2016.

Balance Sheet Highlights:

  • Cash and cash equivalents, marketable securities and short-term deposits totaled $9.2 million as of September 30, 2017, compared to $6.3 million on June 30, 2017, and $8.8 million on December 31, 2016. The increase from June 30, 2017, was primarily due to proceeds of $4.2 million (after deducting placement agents' fees) raised through a registered direct offering and concurrent private placement completed in September 2017, offset by cash used in operations during the period.
  • Tradable and non-tradable warrants exercisable into ADSs totaled $3.1 million as of September 30, 2017, and represented, according to the international financial reporting standards (IFRS), the fair value of tradable and non-tradable warrants issued in prior financings.
  • Shareholders' equity totaled $5.9 million as of September 30, 2017, compared to $4.3 million on June 30, 2017, and $8.1 million on December 31, 2016.

* For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2017 (U.S. $1 = NIS 3.529).

The Company's unaudited consolidated financial results for the three and nine months ended September 30, 2017 are presented in accordance with International Financial Reporting Standards.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: "APOP", "APOPW") has developed a breakthrough technology for the selection of stem cells from any given tissue that aims to improve a variety of stem cell applications.

The Company's technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells in quantity and quality that will allow stem cell related treatments and procedures. Cellect's technology is applicable to a wide variety of stem cell related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of bone marrow transplantations.

Forward Looking Statements                     

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss our anticipated performance in 2017 and the potential of our technology and its proposed uses. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov and in the Company's periodic filings with the SEC and the Tel-Aviv Stock Exchange.

Cellect Biotechnology Ltd.

Consolidated Statement of Operation

                     
   

Convenience

               
   

translation

               
   

Nine months

       
   

ended

 

Nine months ended

 

Three months ended

   

September 30,

 

September 30,

 

September 30,

   

2017

 

2017

 

2016

 

2017

 

2016

   

Unaudited

 

Unaudited

   

U.S. dollars

 

NIS

   

(In thousands, except share and per

share data)

                     

Research and development expenses

 

2,295

 

8,099

 

5,738

 

2,872

 

2,059

                     

General and administrative expenses

 

2,699

 

9,524

 

6,247

 

3,478

 

2,700

                     

Other income

 

-

 

-

 

(280)

 

-

 

-

                     

Operating loss

 

4,994

 

17,623

 

11,705

 

6,350

 

4,759

                     

Financial expenses due to warrants
   exercisable into ADS

 

1,933

 

6,821

 

532

 

1,509

 

532

                     

Other financial expenses (income), net

 

116

 

411

 

198

 

(57)

 

175

                     

Total comprehensive loss

 

7,043

 

24,855

 

12,435

 

7,802

 

5,466

                     

Loss per share and ADS:

                   
                     

Basic and diluted loss per share

 

0.065

 

0.228

 

0.145

 

0.070

 

0.055

                     

Basic and diluted loss per ADS

 

1.292

 

4.56

 

2.90

 

1.40

 

1.10

                     

Weighted average number of shares
   outstanding used to compute basic and
   diluted loss per share

 

109,188,626

 

109,188,626

 

85,583,252

 

111,476,292

 

98,494,725

Cellect Biotechnology Ltd.

Consolidated Balance Sheet Data

ASSETS

 
 

Convenience

         
 

translation

         
 

September 30,

 

September 30,

 

December 31,

 
 

2017

 

2017

 

2016

 
 

Unaudited

 

Unaudited

 

Audited

 
 

U.S. dollars

 

NIS

 
 

(In thousands, except share and per

share data)

 

CURRENT ASSETS:

           

Cash and cash equivalents

6,396

 

22,572

 

6,279

 

Short term deposits, net

-

 

-

 

19,660

 

Marketable securities

2,833

 

9,996

 

4,997

 

Other accounts receivable

284

 

1,004

 

1,461

 
             
 

9,513

 

33,572

 

32,397

 

NON-CURRENT ASSETS:

           

Restricted cash

87

 

307

 

140

 

Other long-term assets

27

 

95

 

-

 

Property, plant and equipment, net

360

 

1,270

 

1,373

 
             
 

474

 

1,672

 

1,513

 
             
 

9,987

 

35,244

 

33,910

 


LIABILITIES AND

SHAREHOLDERS' EQUITY

 

CURRENT LIABILITIES:

           

Trade payables

575

 

2,027

 

1,401

 

Other accounts payable

368

 

1,297

 

2,084

 

Non Traded Warrants to ADS

693

 

2,447

 

-

 
 

1,636

 

5,771

 

3,485

 

NON-CURRENT LIABILITIES:

           

Traded Warrants to ADS

2,443

 

8,622

 

1,938

 

EQUITY:

           

Ordinary shares of no par value:
  
Authorized: 500,000,000 shares at December 31, 2016
   and September 30 2017; Issued and outstanding:
   107,583,485*) at December 31, 2016;      
   119,843,679*) at September 30, 2017.

-

 

-

 

-

 

Share premium

22,773

 

80,367

 

67,414

 

  Capital funds

2,971

 

10,483

 

6,217

 

Treasury shares

(2,671)

 

(9,425)

 

(9,425)

 

Accumulated deficit

(17,165)

 

(60,574)

 

(35,719)

 
             
 

5,908

 

20,851

 

28,487

 
             
 

9,987

 

35,244

 

33,910

 

*) Net of 2,686,693 treasury shares of the Company held by the Company.

 

Cellect Biotechnology Ltd.

Consolidated Cash Flow Data

 
   

Convenience

       
   

translation

       
   

Nine months

ended

Nine months ended

 

Three months ended

 
   

September 30,

September 30,

 

September 30,

 
   

2017

2017

 

2016

 

2017

 

2016

 
   

Unaudited

Unaudited

 
   

U.S. dollars

NIS

 
   

(In thousands)

 

Cash flows from operating activities:

                   

Total comprehensive loss

 

(7,043)

(24,855)

 

(12,435)

 

(7,802)

 

(5,466)

 
                     

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

                   

Net financing expenses

 

143

504

 

146

 

(29)

 

137

 

Loss (gain) from revaluation of financial
   assets presented at fair value through
   profit and loss

 

40

140

 

21

 

(149)

 

22

 

Depreciation

 

79

278

 

218

 

94

 

38

 

Capital loss from sell of property, plant and
   equipment

 

-

-

 

9

 

-

 

-

 

Changes in fair value of traded and not
   traded warrants to ADS

 

1,884

6,650

 

(77)

 

1,337

 

(77)

 

Share-based payment

 

1,138

4,016

 

2,086

 

1,572

 

576

 

Decrease (increase) in other receivables

 

103

362

 

(743)

 

126

 

17

 

Increase (decrease) in other payables

 

(179)

(633)

 

595

 

(4)

 

1,090

 

Net cash used in operating activities

 

(3,835)

(13,538)

 

(10,180)

 

(4,855)

 

(3,663)

 
                     

Cash flows from investing activities:

                   

Proceeds received from the sale of fixed
   assets

 

-

-

 

95

 

-

 

-

 

Short term deposits, net

 

5,534

19,530

 

(19,635)

 

18,020

 

(19,515)

 

Purchase of marketable securities measured
   at fair value through profit and loss

 

(2,834)

(10,000)

 

-

 

(10,000)

 

-

 

Restricted cash, net

 

(47)

(167)

 

-

 

(2)

 

-

 

Sales of marketable securities measured at
   fair value through profit and loss

 

1,414

4,991

 

1,801

 

-

 

-

 

Purchase of property, plant and equipment

 

(50)

(175)

 

(1,183)

 

(59)

 

(59)

 

Net cash provided by (used in) investing activities

 

4,017

14,179

 

(18,922)

 

7,959

 

(19,574)

 
                     

Cash flows from financing activities:

                   

Exercise of stock options

 

358

1,263

 

7

 

197

 

-

 

Issue of share capital and warrants, net of
issue costs

 

4,220

14,893

 

35,084

 

14,893

 

27,620

 

Net cash provided by financing activities

 

4,578

16,156

 

35,091

 

15,090

 

27,620

 

Exchange differences on balances of cash
   and cash equivalents

 

(143)

(504)

 

(146)

 

29

 

(137)

 

Increase in cash and cash equivalents

 

4,617

16,293

 

5,843

 

18,223

 

4,246

 

Balance of cash and cash equivalents at the
   beginning of the period

 

1,779

6,279

 

3,913

 

4,349

 

5,510

 

Balance of cash and cash equivalents at
   the end of the period

 

6,396

22,572

 

9,756

 

22,572

 

9,756

 

Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
www.cellect.co 
+972-9-974-1444

SOURCE Cellect Biotechnology Ltd.

Related Links

http://www.cellect.co/