Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, today provided a business update for first quarter ended March 31, 2022.

Recent highlights:

  • Expanded POCare with Johns Hopkins University through creation of the Maryland Center for Cell Therapy Manufacturing
  • Reached milestone in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid
  • Awarded €4M European Innovation Council Pathfinder Grant

Vered Caplan, CEO of Orgenesis, said, “We are completing the first phase of the rollout of our POCare Platform, as we have now built a robust network of POCare centers across Europe, Asia and the Middle East, and are focusing on implementation of our POCare supply strategy in the US. Each of our POCare centers serve as hubs for their respective territories. We have cost effectively executed this model through partnerships with leading hospitals and centers of excellence in the field of cell and gene therapies, which provide us an immediate revenue stream related to process development, technology transfer, setup, and validation of both our POCare systems and Orgenesis Mobile Processing Units and Labs (OMPULs). In turn, we have built out significant capacity to support our anticipated growth.”

“We are now entering the second phase of our rollout. Specifically, we are conducting work related to validation, process development, and supply for clinical trials of advanced therapies utilizing our POCare platform and OMPULs. As these activities ramp up, we expect to benefit from recurring revenue streams, based on long term contracts for the next two to three years. Moreover, if any one of these therapies is granted regulatory approval, we believe that the revenue potential is significant since our POCare strategy positions us as a long term industrial partner. We are currently working to expand our capacity to supply products for over 10 distinct clinical programs. We believe our approach is highly scalable and provides us diversification across multiple revenue generating contracts. As our customers’ needs grow, our goal is to be well prepared to add new capacity utilizing our OMPUL-based approach, within 3-6 months versus the 18-24 months typical for building out additional cleanroom-based manufacturing capacity.”

“Overall, we are witnessing dramatic capacity constraints across the industry. We believe our model is uniquely positioned to address the challenges of current centralized production through a highly innovative decentralized model, which lowers costs, streamlines logistics, and expands capacity. We are overcoming the growing pains and challenges arising from our rapid transformation and believe that our model is essential and sustainable. This is best evidenced by our existing contract pipeline—which has total potential revenue in excess of $75 million for the next two years, as well as our capacity to continually expand our revenue generating relationships with additional biotech companies, therapy developers and other providers such as hospitals and academic centers.”

The complete financial results for the first quarter of 2022 are available on the Company’s website in its Form 10-Q, which has been filed with the Securities and Exchange Commission.

About OrgenesisOrgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCare Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. www.orgenesis.com.

Notice Regarding Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform and OMPUL business, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the COVID-19 pandemic, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products, risks relating to legal proceedings against us and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

IR contact for Orgenesis:Crescendo Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com

Communications contact for OrgenesisImage Box CommunicationsNeil Hunter / Michelle BoxallTel +44 (0)20 8943 4685neil@ibcomms.agency / michelle@ibcomms.agency

ORGENESIS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. Dollars, in thousands, except share and per share amounts)(Unaudited)

   

As of

   

March 31,2022

   

December 31,2021

Assets

             
               

CURRENT ASSETS:

             

Cash and cash equivalents

$

1,123

 

$

5,473

Restricted cash

 

490

   

501

Accounts receivable, net

 

17,075

   

15,245

Prepaid expenses and other receivables

 

1,438

   

1,188

Convertible Loan receivables-related parties

 

2,969

   

3,064

Loans receivable

 

802

   

-

Grants receivable

 

-

   

169

Inventory

 

113

   

118

Total current assets

 

24,010

   

25,758

               

NON-CURRENT ASSETS:

             

Deposits

$

358

 

$

363

Investments in and loans to associated entities

 

1,574

   

584

Loans receivable

 

-

   

821

Property, plant and equipment, net

 

11,104

   

10,271

Intangible assets, net

 

11,539

   

11,821

Operating lease right-of-use assets

 

886

   

1,015

Goodwill

 

8,329

   

8,403

Other assets

 

738

   

805

Total non-current assets

 

34,528

   

34,083

TOTAL ASSETS

$

58,538

 

$

59,841

ORGENESIS INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d)(U.S. Dollars, in thousands, except share and per share amounts)(Unaudited)

   

As of

   

March 31,2022

   

December 31,2021

Liabilities and Equity

         
           

CURRENT LIABILITIES:

         

Accounts payable

$

6,933

   

$

5,238

 

Accrued expenses and other payables

 

1,076

     

485

 

Income tax payable

 

91

     

54

 

Employees and related payables

 

2,041

     

1,907

 

Advance payments on account of grant

 

1,216

     

1,238

 

Contract liabilities

 

70

     

59

 

Current maturities of finance leases

 

18

     

18

 

Current maturities of operating leases

 

451

     

481

 

Current maturities of convertible loans

 

3,357

     

5,885

 

Total current liabilities

 

15,253

     

15,365

 
           

LONG-TERM LIABILITIES:

         

Non-current operating leases

$

461

   

$

561

 

Convertible loans

 

7,544

     

4,854

 

Retirement benefits obligation

 

105

     

101

 

Non-current finance leases

 

36

     

41

 

Other long-term liabilities

 

282

     

288

 

Total long-term liabilities

 

8,428

     

5,845

 

TOTAL LIABILITIES

 

23,681

     

21,210

 
           
           

EQUITY:Common stock of $0.0001 par value: Authorized at March 31, 2022 and December 31, 2021: 145,833,334 shares; Issued at March 31, 2022 and December 31, 2021: 25,107,323 and 24,567,366 shares, respectively; Outstanding at March 31, 2022 and December 31, 2021: 24,820,756 and 24,280,799 shares, respectively.

 

3

     

3

 

Additional paid-in capital

 

146,290

     

145,916

 

Accumulated other comprehensive income

 

56

     

207

 

Treasury stock, 286,567 shares as of March 31, 2022 and December 31, 2021

 

(1,266

)

   

(1,266

)

Accumulated deficit

 

(110,381

)

   

(106,372

)

Equity attributable to Orgenesis Inc.

 

34,702

     

38,488

 

Non-controlling interest

 

155

     

143

 

Total equity

 

34,857

     

38,631

 

TOTAL LIABILITIES AND EQUITY

$

58,538

   

$

59,841

 

ORGENESIS INC.CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS(U.S. Dollars in Thousands, Except Share and Loss Per Share Amounts)(Unaudited)

 

Three Months Ended

   

March 31,

     

March 31,

2022

 

2021

 

POC development services

$

5,689

   

$

7,987

 

POC development services from related party

 

635

     

1,157

 

Cell process development services and hospital services

 

888

     

245

 

Total revenues

 

7,212

     

9,389

 

Cost of revenues cell process development services and hospital services

 

714

     

770

 

Cost of development services and research and development expenses

 

6,651

     

5,357

 

Amortization of intangible assets

 

232

     

238

 

Selling, general and administrative expenses

 

2,851

     

2,968

 

Operating loss (income)

 

3,236

     

(56

)

Other income, net

 

-

     

(25

)

Financial expenses, net

 

213

     

233

 

Share in net loss of associated companies

 

547

     

15

 

Loss before income taxes

 

3,996

     

167

 

Tax (income) expense

 

1

     

(2

)

Net loss

 

3,997

     

165

 

Net loss attributable to non-controlling interests

 

12

     

54

 

Net loss attributable to Orgenesis Inc.

 

4,009

     

219

 
             

Loss per share:

           

Basic and diluted

$

0.16

   

$

0.01

 
             

Weighted average number of shares used in computation of Basic and Diluted loss per share:

           

Basic and diluted

 

24,600,954

     

24,192,951

 
             

Comprehensive loss:

           

Net loss

$

3,997

   

$

165

 

Other Comprehensive loss – Translation adjustment

 

151

     

277

 

Comprehensive loss

 

4,148

     

442

 

Comprehensive loss attributed to non-controlling interests

 

12

     

54

 

Comprehensive loss attributed to Orgenesis Inc.

$

4,160

   

$

496

 

 

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