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NETSOL Technologies Reports Fiscal First Quarter 2021 Financial Results

  • Net Income of $718,000, $0.06 EPS and $4.7 Million Cash from Operations
  • Gross Subscription (SaaS) and Annual Recurring And Contracted Support Revenues Exceeded $5 Million for the First Time
  • Major Go-Live Event, Double-Digit Recurring Revenue Growth, and Continued Cost Management Efforts Yield Fourth Straight Quarter of Profitability
  • OTOZ Partnering to Launch a Digital Automotive Retail Platform for a U.S. Based Subsidiary of a Renowned German Auto Manufacturer for One of its Key Brands with an Initial Launch in California in Early Calendar 2021
  • Moderate Return to Business Conditions, Coupled with High-Value, Near-Term Pipeline of Opportunities Underscore Cautiously Optimistic Growth Outlook for Fiscal 2021

CALABASAS, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — NETSOL Technologies, Inc. (Nasdaq: NTWK), a global business services and enterprise application solutions provider, reported results for the fiscal first quarter ended September 30, 2020.

Fiscal First Quarter 2021 and Recent Operational Highlights

  • Successfully implemented the NFS Ascent® Retail Platform, including the Company’s proprietary Loan Origination System (LOS) and Contract Management System (CMS) for a tier-one German auto captive finance company in China in the second phase of a previously announced $30 million contract.
  • Regarding previously announced 12-country, $110 million contract with German auto manufacturing giant, the Company made continued progress with respect to additional NFS Ascent® implementations. The Company has successful Go Live events in Singapore and Thailand in September and October, respectively. The implementation process has also now begun in New Zealand and Australia.
  • Announced the successful implementation of the Company’s first North American cloud-based NFS Ascent Contract Management System (CMS) for SCI Lease Corp, a Canadian-based national automotive leasing company.
  • Appointed Peter Minshall as Executive Vice President (EVP) of NTA. The EVP role will report directly to the Company CEO and is responsible for the entire NTA portion of NETSOL’s business operations.
  • Generated $315,000 in additional SaaS subscription and support revenues, which are recurring in nature and anticipated to gradually increase as the Company implements NFS legacy products and NFS Ascent®.
  • NETSOL effectively generated approximately $1.3 million by successfully implementing change requests from various customers across multiple regions.
  • NETSOL’s new mobility startup subsidiary, Otoz, is partnering to launch its digital automotive retail platform for a U.S. based subsidiary of a renowned German auto manufacturer for one of its key brands.

Fiscal First Quarter 2021 Financial Results

Total net revenues for the first quarter of fiscal 2021 were $12.6 million, compared with $13.6 million in the prior year period. The decrease in total net revenues was primarily due to a decrease in total license fees of $2.5 million, which was offset by an increase in subscription and support revenues of $565,000 and an increase in total service revenues of $970,000.

  • Total license fees were $3,500, compared with $2.5 million in the prior year period.
  • Total subscription (SaaS and Cloud) and support revenues were $5.2 million, compared with $4.6 million in the prior year period.
  • Total services revenues were $7.5 million, compared with $6.5 million in the prior year period.

Gross profit for the first quarter of fiscal 2021 was $6.4 million (or 50.5% of net revenues), compared to $6.1 million (or 45.0% of net revenues) in the first quarter of fiscal 2020. The increases in gross profit and gross profit as a percentage of revenue were primarily due to decreases in cost of revenues, which were predominantly driven by a decrease in travel expenses resulting from the COVID-19 pandemic.

Operating expenses for the first quarter of fiscal 2021 decreased 18.2% to $5.3 million (or 42.3% of net revenues) from $6.5 million (or 48.2% of net revenues) for the first quarter of fiscal 2020. The decrease in operating expenses was primarily due to decreases in selling and marketing, professional services, research and development and general and administrative expenses, which were offset by a minor increase in depreciation and amortization.

GAAP net income attributable to NETSOL for the first quarter of fiscal 2021 totaled $718,000 or $0.06 per diluted share, compared with GAAP net loss of $(1.8) million or $(0.16) per diluted share in the first quarter of fiscal 2020. GAAP net income attributable to NETSOL included a $296,000 gain on foreign currency exchange transactions in the first quarter of fiscal 2020, which was a significant increase compared with a loss of $1.8 million in the prior year period.

Non-GAAP adjusted EBITDA for the first quarter of fiscal 2021 totaled $1.6 million or $0.14 per diluted share, compared with non-GAAP adjusted EBITDA loss of $(1.1) million or $(0.09) per diluted share in the first quarter of fiscal 2020 (see note regarding “Use of Non-GAAP Financial Measures,” below for further discussion of this non-GAAP measure).

At September 30, 2020, cash and cash equivalents were $24.9 million, an increase from $20.2 million at June 30, 2020.

Management Commentary
“The beginning of the fiscal year was an extension of the same business conditions we’ve witnessed since the pandemic took hold, but we are continuing to operate efficiently, control costs and execute on our long-term strategic growth plan,” said NETSOL Co-Founder, Chairman and Chief Executive Officer Najeeb Ghauri. “Financially, we generated roughly $1.3 million from change requests and reduced expenses by nearly 20% leading to sustained profitability on a trailing-twelve-month basis. We also grew our recurring revenue base by double digits to $5.2 million. As we layer on maintenance fees through larger, traditional, enterprise contracts and increase our SaaS-based footprint, we expect to build this base over time, which provides for more predictable revenues with a more attractive margin profile.

“During fiscal Q1, we were very active on the implementation front and had multiple successful ‘Go Live’ events within our APAC region for a pair of major international auto manufacturers. We are also gaining traction with mid-size auto captives in our North American and European markets with the latter comprising a greater portion of overall revenues compared to last year. Our Otoz Innovation Lab remains a bright spot, making great progress on current partnerships, including work with a renowned German OEM on a digital automotive retail platform for one of its key brands. With several catalysts on the horizon, we are optimistic about our prospects for the new fiscal year.”

Sales Outlook

Ghauri added: “Sales discussions with a number of potential customers remain active, and we are confident that the market is beginning to pick up in all global regions. We have a number of high-value, near-term opportunities in our pipeline and are cautiously optimistic about our growth outlook.”

Otoz Update
“We recently began a partnership to launch a fully-digital mobile app for a major German auto captive in the U.S. that will enable a touchless customer journey, all built on the Otoz platform,” said Naeem Ghauri, CEO of Otoz. “The end product will be rolled out to hundreds of auto dealers across the U.S. and is expected to generate significant SaaS revenues for our business. Separately, we are in the final contract negotiation stages with a number of other major players in the automotive space and look forward to announcing those agreements in the near future.”

Conference Call

NETSOL Technologies management will hold a conference call today (November 16, 2020) at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) to discuss these financial results. A question and answer session will follow management’s presentation.

U.S. dial-in: 1-877-407-0789
International dial-in: 1-201-689-8562

Please call the conference telephone number 5-10 minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Gateway Investor Relations at 1-949-574-3860.

The conference call will be broadcasted live and available for replay here and via the Investor Relations section of NETSOL’s website.

A replay of the conference call will be available after 12:00 p.m. Eastern time on the same day through November 30, 2020.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 13712135

About NETSOL Technologies
NETSOL Technologies, Inc. (Nasdaq: NTWK) is a worldwide provider of IT and enterprise software solutions primarily serving the global leasing and finance industry. The Company’s suite of applications is backed by 40 years of domain expertise and supported by a committed team of more than 1300 professionals placed in eight strategically located support and delivery centers throughout the world. NFS, LeasePak, LeaseSoft or NFS Ascent® – help companies transform their Finance and Leasing operations, providing a fully automated asset-based finance solution covering the complete finance and leasing lifecycle.

About Otoz

Otoz provides business-to-business, white-label technology solutions for new mobility. Our suite of agile and customizable mobility solutions ranges from car sharing and subscription products to AI-enabled chatbots, allowing businesses to engage consumers and facilitate the complete transaction lifecycle intelligently and digitally. Otoz technologies empower automotive companies and start-ups to launch new mobility models quickly and efficiently. The technology Otoz has developed is cloud-native and supported by artificial intelligence (AI), machine learning (ML), internet of things (IoT) and blockchain. Our technology drives utilization, while supporting robust and efficient operations.


Forward-Looking Statements


This press release may contain forward-looking statements relating to the development of the Company’s products and services and future operating results, including statements regarding the Company that are subject to certain risks and uncertainties such as the effect of stay at home orders and social distancing imposed by COVID-19 and its resultant impact on our financials and the world economy that could cause actual results to differ materially from those projected. The words “expects,” “anticipates,” variations of such words, and similar expressions, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Factors that could affect the Company’s actual results include the progress and costs of the development of products and services and the timing of the market acceptance, as well as the delay in recovery or a prolonged economic downturn that effects our Company, our customers and the world economy. The subject Companies expressly disclaim any obligation or undertaking to update or revise any forward looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based.

Use of Non-GAAP Financial Measures

The reconciliation of Adjusted EBITDA to net income, the most comparable financial measure based upon GAAP, as well as a further explanation of adjusted EBITDA, is included in the financial tables in Schedule 4 of this press release. 

Investor Relations Contact:

Matt Glover and Tom Colton

Gateway Investor Relations
1-949-574-3860
[email protected]

NETSOL Technologies, Inc. and Subsidiaries

Schedule 1: Consolidated Balance Sheets

       As of     As of 
  ASSETS September 30, 2020   June 30, 2020
Current assets:      
  Cash and cash equivalents $                24,885,365     $        20,166,830  
  Accounts receivable, net of allowance of $279,903 and $435,611                       6,732,575                10,131,752  
  Accounts receivable – related party, net of allowance of $1,373,099 and $90,594                                      –                  1,282,505  
  Revenues in excess of billings, net of allowance of $91,250 and $188,914                     18,430,766                17,198,281  
  Revenues in excess of billings – related party, net of allowance of $8,163 and $0                                      –                         8,163  
  Other current assets, net of allowance of $1,243,633 and $0                       2,616,769                  3,108,180  
    Total current assets                    52,665,475                51,895,711  
Revenues in excess of billings, net – long term                                     –                  1,300,289  
Convertible note receivable – related party, net of allowance of $4,250,000  and $0                                      –                  4,250,000  
Property and equipment, net                    11,256,306                11,329,631  
Right of use of assets – operating leases                      2,133,902                  2,360,129  
Long term investment                      2,417,291                  2,387,692  
Other assets                           41,175                       41,992  
Intangible assets, net                      5,032,630                  5,391,077  
Goodwill                      9,516,568                  9,516,568  
    Total assets $                83,063,347     $        88,473,089  
           
  LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
  Accounts payable and accrued expenses $                  6,005,999     $          5,680,837  
  Current portion of loans and obligations under finance leases                      9,677,277                  9,139,561  
  Current portion of operating lease obligations                      1,165,957                  1,111,912  
  Unearned revenues                      2,775,600                  4,095,472  
  Common stock to be issued                           88,324                       88,324  
    Total current liabilities                    19,713,157                20,116,106  
Loans and obligations under finance leases; less current maturities                      1,705,699                  1,539,975  
Operating lease obligations; less current maturities                      1,110,832                  1,339,965  
    Total liabilities                    22,529,688                22,996,046  
Commitments and contingencies      
Stockholders’ equity:      
  Preferred stock, $.01 par value; 500,000 shares authorized;                                       –                                 –  
  Common stock, $.01 par value; 14,500,000 shares authorized;      
    12,137,045  shares issued and 11,742,490  outstanding as of September 30, 2020  and     
    12,122,149  shares issued and 11,874,646  outstanding as of June 30, 2020                         121,371                     121,222  
  Additional paid-in-capital                  128,764,618              128,677,754  
  Treasury stock (at cost, 394,555 shares and 247,503 shares      
   as of September 30, 2020 and June 30, 2020, respectively)                     (1,920,645 )               (1,455,969 )
  Accumulated deficit                   (39,861,985 )             (34,269,817 )
  Other comprehensive loss                   (33,210,231 )             (34,085,047 )
    Total NetSol stockholders’ equity                    53,893,128                58,988,143  
  Non-controlling interest                      6,640,531                  6,488,900  
    Total stockholders’ equity                    60,533,659                65,477,043  
    Total liabilities and stockholders’ equity $                83,063,347     $        88,473,089  
           

 

NETSOL Technologies, Inc. and Subsidiaries

Schedule 2: Consolidated Statement of Operations

      For the Three Months
      Ended September 30,
        2020       2019  
Net Revenues:      
  License fees $ 3,475     $ 2,464,216  
  Subscription and support   5,171,863       4,606,376  
  Services   7,472,040       6,418,891  
  Services – related party   –       82,933  
    Total net revenues   12,647,378       13,572,416  
           
Cost of revenues:      
  Salaries and consultants   4,526,649       4,454,964  
  Travel   103,752       1,342,635  
  Depreciation and amortization   707,249       719,665  
  Other   928,153       944,524  
    Total cost of revenues   6,265,803       7,461,788  
           
Gross profit   6,381,575       6,110,628  
           
Operating expenses:      
  Selling and marketing   1,609,604       1,743,868  
  Depreciation and amortization   221,790       202,387  
  General and administrative   3,427,636       3,918,613  
  Research and development cost   85,989       672,970  
    Total operating expenses   5,345,019       6,537,838  
           
Income (loss) from operations   1,036,556       (427,210 )
           
Other income and (expenses)      
  Loss on sale of assets   (21,742 )     (289 )
  Interest expense   (103,327 )     (63,663 )
  Interest income   200,821       399,229  
  Gain (loss) on foreign currency exchange transactions   296,041       (1,760,190 )
  Share of net loss from equity investment   (107,850 )     (189,224 )
  Other income   87,272       18,326  
    Total other income (expenses)   351,215       (1,595,811 )
           
Net income (loss) before
 
income taxes 		  1,387,771       (2,023,021 )
Income tax provision   (264,294 )     (238,238 )
Net income (loss)   1,123,477       (2,261,259 )
  Non-controlling interest   (405,923 )     433,312  
Net income (loss) attributable to NetSol $ 717,554     $ (1,827,947 )
           
           
Net income per share:      
  Net income per common share      
    Basic $ 0.06     $ (0.16 )
    Diluted $ 0.06     $ (0.16 )
           
Weighted average number of shares outstanding      
  Basic   11,787,233       11,664,239  
  Diluted   11,787,233       11,664,239  
           

 

NETSOL Technologies, Inc. and Subsidiaries

Schedule 3: Consolidated Statement of Cash Flows

               
         For the Three Months   
         Ended September 30,   
          2020       2019    
 
Cash flows from operating activities:
  		       
   Net income (loss)  $        1,123,477     $        (2,261,259 )  
   Adjustments to reconcile net income (loss)         
     to net cash provided by operating activities:         
   Depreciation and amortization                929,039                     922,052    
   Provision for bad debts              (258,160 )                   (38,621 )  
   Share of net loss from investment under equity method                107,850                     189,224    
   Loss on sale of assets                  21,742                            289    
   Stock based compensation                  90,995                     164,293    
   
Changes in operating assets and liabilities:
  		       
     Accounts receivable             3,823,299                  4,836,183    
     Accounts receivable – related party                            –                       46,016    
     Revenues in excess of billing                394,995                (1,870,517 )  
     Revenues in excess of billing – related party                            –                       66,330    
     Other current assets              (393,253 )                 (278,677 )  
     Accounts payable and accrued expenses                255,239                     122,012    
     Unearned revenue           (1,383,619 )              (1,631,245 )  
   
Net cash provided by operating activities
  		           4,711,604                     266,080    
               
 
Cash flows from investing activities:
  		       
   Purchases of property and equipment              (489,289 )                 (321,125 )  
   Sales of property and equipment                  32,673                            958    
   Convertible note receivable – related party                            –                   (435,000 )  
   Investment in associates                (60,500 )                               –    
   
Net cash used in investing activities
  		            (517,116 )                 (755,167 )  
               
 
Cash flows from financing activities:
  		       
   Proceeds from exercise of subsidiary options                              –                       11,621    
   Purchase of treasury stock              (464,676 )                               –    
   Proceeds from bank loans                697,295                                 –    
   Payments on finance lease obligations and loans – net              (143,506 )                 (147,376 )  
   
Net cash provided by (used in) financing activities
  		                89,113                   (135,755 )  
 
Effect of exchange rate changes
  		              434,934                     879,857    
 
Net increase in cash and cash equivalents
  		           4,718,535                     255,015    
 Cash and cash equivalents at beginning of the period           20,166,830                17,366,364    
 
Cash and cash equivalents at end of period
  		$      24,885,365     $        17,621,379    
               

NETSOL Technologies, Inc. and Subsidiaries

Schedule 4: Reconciliation to GAAP

  For the Three Months Ended   For the Three Months Ended  
  September 30, 2020   September 30, 2019  
         
Net Income (loss) attributable to NetSol $ 717,554     $ (1,827,947 )  
Non-controlling interest   405,923       (433,312 )  
Income taxes   264,294       238,238    
Depreciation and amortization   929,039       922,052    
Interest expense   103,327       63,663    
Interest (income)   (200,821 )     (399,229 )  
EBITDA $ 2,219,316     $ (1,436,535 )  
Add back:        
Non-cash stock-based compensation   90,995       164,293    
Adjusted EBITDA, gross $ 2,310,311     $ (1,272,242 )  
Less non-controlling interest (a)   (698,844 )     191,235    
Adjusted EBITDA, net $ 1,611,467     $ (1,081,007 )  
         
         
Weighted Average number of shares outstanding        
Basic   11,787,233       11,664,239    
Diluted   11,787,233       11,664,239    
         
Basic adjusted EBITDA $ 0.14     $ (0.09 )  
Diluted adjusted EBITDA $ 0.14     $ (0.09 )  
         
         
(a)The reconciliation of adjusted EBITDA of non-controlling interest        
to net income attributable to non-controlling interest is as follows        
         
Net Income (loss) attributable to non-controlling interest $ 405,923     $ (433,312 )  
Income Taxes   48,649       53,335    
Depreciation and amortization   264,565       259,635    
Interest expense   31,520       19,041    
Interest (income)   (65,957 )     (105,501 )  
EBITDA $ 684,700     $ (206,802 )  
Add back:        
Non-cash stock-based compensation   14,144       15,567    
Adjusted EBITDA of non-controlling interest $ 698,844     $ (191,235 )  
         



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CytRx Comments on Quarterly Results and Recent Strategic Progress

CytRx Comments on Quarterly Results and Recent Strategic Progress

LOS ANGELES–(BUSINESS WIRE)–
CytRx Corporation (OTCQB: CYTR) (“CytRx” or the “Company”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today commented on its results for the third quarter ended September 30, 2020. In addition, CytRx highlighted recent steps to support Centurion Biopharma’s progress as well as external developments pertaining to its agreements with ImmunityBio, Inc. (“ImmunityBio”) and Orphazyme A/S (“Orphazyme”). The Company’s 10-Q was filed on November 13, 2020.

Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, stated:

“We continue to maintain a stable capital position and prioritize rigorous cost containment despite having to incur certain large, one-time expenditures due to this summer’s proxy contest. During the past quarter, we made prudent research and development investments to support our efforts to find the right partner for Centurion Biopharma’s LADR™ platform and companion diagnostic. We also monitored the promising news pertaining to ImmunityBio’s use of our licensed drug – aldoxorubicin – in the successful treatment of former Senate Majority Leader Harry Reid’s stage IV pancreatic cancer and positive developments related to Orpahzyme’s efforts to secure potential regulatory approvals in the U.S. and Europe for arimoclomol in the treatment of Niemann-Pick disease Type C. We remain hopeful that our investments in Centurion Biopharma and our third-party agreements will result in tangible progress and results in the near-term.”

Recent Highlights

  • As previously noted, CytRx’s agreement with Orphazyme can deliver up to $120 million in potential milestone payments and future royalties paid on sales of arimoclomol.

    • CytRx is positioned to receive up to $10 million in potential milestone payments in 2021 based on possible U.S. and European approvals for arimoclomol to treat Niemann-Pick disease Type C (“NPC”).
  • As previously noted, CytRx’s agreement with ImmunityBio can deliver up to $343 million in potential milestones and future royalties paid on sales of aldoxorubicin’s use for multiple tumor types.
  • Orphazyme announced in September that the U.S. Food and Drug Administration (“FDA”) has accepted, with Priority Review, its New Drug Application (“NDA”) for arimoclomol for the treatment of NPC.
  • Orphazyme subsequently announced new plans to accelerate commercial and other pre-launch activities during the fourth quarter of 2020 in preparation for potential approval of arimoclomol in NPC, which is currently under Priority Review by the FDA with a target action date of March 17, 2021.
  • Orphazyme most recently announced that it submitted a Marketing Authorisation Application (“MAA”) to the European Medicines Agency (“EMA”) for approval of arimoclomol in the treatment of NPC.
  • The Chief Executive Officer of ImmunityBio spoke this summer about the successful experimental treatment delivered to former Senator Reid for his stage IV pancreatic cancer. Former Senator Reid has described himself as being in “complete remission” after receiving experimental combination immunotherapy that included aldoxorubicin.
  • ImmunityBio and NantKwest, Inc. recently announced the addition of a third cohort to their ongoing Phase 2 study of a novel combination immunotherapy, which includes aldoxorubicin, for locally advanced or metastatic pancreatic cancer (QUILT-88). The third cohort will enable pancreatic cancer patients who have failed all approved standards of care to participate in the study.
  • With respect to Centurion, Mr. Kriegsman and Lead Director Louis Ignarro, PhD have been pursuing third-party financing and strategic partnership opportunities to advance clinical testing for Centurion BioPharma’s high-potential assets. Discussions with prospective partners are ongoing. There are no formal partnership updates to report at this time.
  • As of December 31, 2019, CytRx had federal and state net operating loss carryforwards – not subject to limitation under Section 382 of the Internal Revenue Code – of $249.1 million and $235.6 million, respectively, available to offset against future taxable income.

Third Quarter 2020 Financial Results

  • CytRx ended the quarter with cash on hand of approximately $12.6 million, which management believes is sufficient to fund ongoing operations for the foreseeable future.
  • The Company recorded a net loss of approximately $2.8 million and $5.3 million for the respective three-month and nine-month periods ended September 30, 2020, compared to net losses of approximately $1.5 million and $4.2 million for the three-month and nine-month periods ended September 30, 2019.

    • General and administrative expenses were $2.2 million for the quarter, compared with $1.5 million for the same period in 2019. This increase was primarily due to an increase in professional fees and related costs associated with this summer’s proxy contest.
    • Research and development expenses were approximately $0.6 million for the quarter, compared with minimal expenses for the same period in 2019. This was due to increased consulting expenditures related to establishment of a regulatory plan for Centurion Biopharma’s assets.
  • Based on a current projection of expenditures for the next 12 months, the Company’s monthly cash burn rate is estimated to be approximately $423,000 per month.

About CytRx Corporation

CytRx Corporation (OTCQB: CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics principally to treat patients with cancer and neurodegenerative diseases. CytRx’s most recent advanced drug conjugate, aldoxorubicin, is an improved version of the widely used anti-cancer drug doxorubicin and has been out-licensed to ImmunityBio, Inc. In addition, CytRx’s drug candidate, arimoclomol, was sold to Orphazyme A/S in exchange for milestone payments and royalties. Orphazyme is developing arimoclomol in four indications including amyotrophic lateral sclerosis (ALS), Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx Corporation’s website is www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks and uncertainties relating to the ability of Orphazyme to obtain regulatory approval for, manufacture and commercialize its products and therapies that use arimoclomol; the results of future clinical trials involving arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme; the ability of ImmunityBio, to obtain regulatory approval for its products that use aldoxorubicin; the ability of ImmunityBio, to manufacture and commercialize products or therapies that use aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from ImmunityBio; and other risks and uncertainties described in the most recent annual and quarterly reports filed by the Company with the Securities and Exchange Commission (the “SEC”) and current reports filed since the date of the Company’s most recent annual report. All forward-looking statements are based upon information available to the Company on the date the statements are first published. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

###

For Investors:

Greg Marose / Charlotte Kiaie

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Oncology Health FDA Genetics Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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Jounce Therapeutics Receives Study May Proceed Letter from US FDA to Initiate Phase 1 Clinical Trial of JTX-8064 Targeting the LILRB2/ILT4 Mechanism

-Phase 1 INNATE trial will evaluate JTX-8064 as a monotherapy and in combination with Jounce’s PD-1 inhibitor,
JTX-4014
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–
O
n track
to begin
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2020
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CAMBRIDGE, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today announced the company has received a Study May Proceed Letter from the United States Food and Drug Administration (FDA) to begin a Phase 1 trial, named INNATE, for JTX-8064. JTX-8064 is an anti-Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) antibody and is the first tumor-associated macrophage candidate from Jounce’s Translational Science Platform. Through the Study May Proceed Letter, the FDA has cleared the original Investigational New Drug (IND) application for JTX-8064. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s Annual Meeting and the 2019 American Association for Cancer Research Annual Meeting support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity.

The Phase 1 INNATE trial will consist of 4 parts:

  • JTX-8064 monotherapy dose escalation in solid tumors
  • JTX-8064 dose escalation in combination with Jounce’s PD-1 inhibitor, JTX-4014, or with pembrolizumab in solid tumors
  • JTX-8064 monotherapy in indication-specific expansion cohorts
  • JTX-8064 + JTX-4014 or pembrolizumab in indication-specific expansion cohorts

“Our INNATE trial represents the first time we are combining two wholly owned Jounce immunotherapies targeting two different immune cells in the tumor microenvironment,” said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. “We believe that targeting multiple immune cell types including immunosuppressive macrophages in the tumor microenvironment may offer new promise for patients, particularly those with PD-(L)1 inhibitor resistant tumors, where IO therapies have yet to make a substantial impact. Expansion cohorts in INNATE will include PD-(L)1 resistant and sensitive tumor types, and PD-(L)1 naïve and experienced patients. INNATE is designed to advance rapidly to initiation of indication-specific JTX-8064 monotherapy and PD-1 inhibitor combination expansion cohorts, with a goal to establish proof-of-concept as quickly as possible, and we are on track to begin enrollment in INNATE by the end of the year.”

A
bout JTX-8064

JTX-8064 is a humanized anti-LILRB2 (ILT4) antibody and is the first tumor-associated macrophage candidate to emerge from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s Annual Meeting and the 2019 American Association for Cancer Research Annual Meeting support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial, named INNATE, for JTX-8064 as a monotherapy and in combination with a PD-1 inhibitor is planned to begin enrollment by year-end 2020.

About JTX-4014

JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. JTX-4014 demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, JTX-4014 was shown to have an acceptable safety profile. JTX-4014 is currently being assessed in the SELECT Phase 2 clinical trial in combination with vopratelimab, a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. The SELECT trial compares vopratelimab plus JTX-4014 to JTX-4014 alone in immunotherapy naïve NSCLC patients who have been pre-selected with the TISvopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor.

About Jounce Therapeutics

Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. JTX-4014 is a PD-1 inhibitor intended for combination use in the SELECT trial and with Jounce’s broader pipeline. Jounce’s next development stage product candidate, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state. A Phase 1 trial evaluating JTX-8064 is planned to begin enrollment in the fourth quarter of 2020. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit www.jouncetx.com.

Cautionary Note Regarding
Forward-Looking Statements
Various statements in this release concerning Jounce’s future expectations and plans, including without limitation, Jounce’s expectations regarding the timing and initiation of clinical trials of JTX-8064 and JTX-4014, may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as “expect,” “plan” or similar terms, variations of such terms or the negative of those terms. Although Jounce believes that the expectations reflected in the forward-looking statements are reasonable, Jounce cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, risks that the COVID-19 pandemic may disrupt Jounce’s business and/or the global healthcare system more severely than anticipated, which may have the effect of delaying enrollment and completion of Jounce’s clinical trials, or delaying timelines or data disclosures and regulatory submissions for its product candidates; Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates; Jounce’s ability to successfully manage its clinical trials; the development plans of its product candidates and any companion or complementary diagnostics; management of Jounce’s supply chain for the delivery of drug product and materials for use in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Jounce’s product candidates; and those risks more fully discussed in the section entitled “Risk Factors” in Jounce’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and Jounce undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor and Media Contacts:

Mark Yore
+1-857-200-1255
[email protected] 

Malin Deon
+1-857-259-3843
[email protected] 



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BrainChip Demonstrates How Its Akida Technology Is Delivering the Next-Generation of AI at the Edge at First-Ever AI Field Day

BrainChip Demonstrates How Its Akida Technology Is Delivering the Next-Generation of AI at the Edge at First-Ever AI Field Day

ALISO VIEJO, Calif.–(BUSINESS WIRE)–BrainChip Holdings Ltd. (ASX: BRN), a leading provider of ultra-low power high performance AI technology, today announced its participation at the AI Field Day 1 virtual event November 18-20.

AI Field Day is the first-ever entry into the long-running series of Tech Field Day events presented by Gestalt IT. BrainChip will present the Akida™Neuromorphic System-on-Chip (NSoC),the company’s next-generation, ultra-low power event domain neural processor. The Akida NSoC is capable of inference and incremental learning and supports many of today’s standard neural networks. The AI Field Day will be a live-streamed meeting of invite-only influencers November 19 at 9 a.m. PST. The session will later be available for viewing on the program’s social media channels.

The Akida NSoC is a revolutionary advanced neural networking processor that brings artificial intelligence to the edge in a way that existing technologies are not capable. The solution is high-performance, small, ultra-low power and enables a wide array of edge capabilities. The Akida NSoC represents a new breed of neural processing devices for Edge AI applications. Comparisons to leading DNN accelerator devices show significantly better images/second/watt in video applications running industry standard benchmarks with MobileNet, MobileNet-SSD and Key Word Spotting, while maintaining excellent accuracy.

The Akida NSoC is designed for use as an embedded accelerator or as a co-processor. It includes high-speed data interfaces such as PCI-Express, USB, I2S and I3C. An on-chip MPU is used to control the configuration of the Akida neuron fabric as well as off-chip communication of metadata. The Akida NSoC is a scalable solution utilizing a built-in serial chip-to-chip connectivity to allow up to 64 devices to be arrayed as a single solution.

“We are excited to be among the first companies invited to present at AI Field Day and look forward to sharing with attendees the advancements that we have made in artificial intelligence through the development of our Akida technology,” said Louis DiNardo, BrainChip CEO. “As AI continues to move out of the data center and cloud to the Edge where data is being created, we are enabling inference and incremental learning for a wide variety of use cases. We believe that our presentation at AI Field Day will be among the most enlightening and showcase the fundamental shift that is occurring in the industry and how Akida is leading that change.”

Tech Field Day is a series of invite-only technical meetings between delegates invited from around the world and sponsoring enterprise IT companies that share their products and ideas through presentations, demos, roundtables, and more. Over 2-3 days, a panel of a dozen delegates interact with 6-10 companies on-site in areas like Silicon Valley. These sessions are live-streamed, and recordings are shared across their social media channels like YouTube and Twitter. These events focus on enterprise IT topics from the datacenter to the cloud, mobility and networking to security and storage.

About BrainChip Holdings Ltd (ASX: BRN)

BrainChip is a global technology company that is producing a groundbreaking neuromorphic processor that brings artificial intelligence to the edge in a way that is beyond the capabilities of other products. The chip is high performance, small, ultra-low power and enables a wide array of edge capabilities that include on-chip training, learning and inference. The event-based neural network processor is inspired by the spiking nature of the human brain and is implemented in an industry standard digital process. By mimicking brain processing BrainChip has pioneered a processing architecture, called Akida™, which is both scalable and flexible to address the requirements in edge devices. At the edge, sensor inputs are analyzed at the point of acquisition rather than through transmission via the cloud to a data center. Akida is designed to provide a complete ultra-low power and fast AI Edge Network for vision, audio, olfactory and smart transducer applications. The reduction in system latency provides faster response and a more power efficient system that can reduce the large carbon footprint of data centers.

Additional information is available at https://www.brainchipinc.com

Follow BrainChip on Twitter: https://www.twitter.com/BrainChip_inc

Follow BrainChip on LinkedIn: https://www.linkedin.com/company/7792006

JPR Communications

Mark Smith, [email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Semiconductor Data Management Technology Other Technology Audio/Video Networks

MEDIA:

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Evolving Gold announces passing of R. Bruce Duncan, CEO

VANCOUVER, British Columbia, Nov. 16, 2020 (GLOBE NEWSWIRE) — Evolving Gold Corp. (CSE: EVG) (FSE: EV7) (OTCB: EVOGF) (the “Company” or “EVG”) sadly confirms that we have been advised that R. Bruce Duncan, our Chief Executive Officer, passed away suddenly last week.

Mr. Duncan was not only our CEO, but he was also a valued friend and will be sorely missed by the board, management and the Company. Our thoughts and condolences are with his family at this time.

Management and the board of directors of the company will meet shortly and will provide further updates when appropriate.

On Behalf of the Board of Directors

EVOLVING GOLD CORP.

“Charles E. Jenkins”

Chief Financial Officer

FOR MORE INFORMATION, PLEASE CONTACT:


[email protected]

Neither Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

 



Date Total repurchased shares Weighted average price Total repurchased value
9-Nov-20 31,695 349.23 11,068,938.35
10-Nov-20 47,092 343.84 16,192,270.57
11-Nov-20 18,178 341.35 6,204,988.86
12-Nov-20 54,000 353.56 19,092,012.66
13-Nov-20 32,348 355.54 11,501,149.93

ASML’s current share buyback program was announced on 22 January 2020, and details are available on our website at https://www.asml.com/en/news/share-buyback

This regular update of the transactions conducted under the buyback program is to be made public under the Market Abuse Regulation (Nr. 596/2014).

Media Relations Contacts Investor Relations Contacts
Monique Mols, phone +31 6 528 444 18 Skip Miller, phone +1 480 235 0934
  Marcel Kemp, phone +31 40 268 6494

 



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RingCentral’s CEO, CFO, and Investor Relations Named to Institutional Investor’s 2021 All-America Executive Team

RingCentral’s CEO, CFO, and Investor Relations Named to Institutional Investor’s 2021 All-America Executive Team

BELMONT, Calif.–(BUSINESS WIRE)–RingCentral, Inc. (NYSE: RNG), a leading provider of global enterprise cloud communications, collaboration, and contact center solutions, today announced its executive and investor relations leadership were named to Institutional Investor’s prestigious 2021 All-America Executive Team. For the second consecutive year, the team achieved the ‘Most Honored’ company distinction and ranked in the top three positions across all categories in the software sector.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005439/en/

Provided by RingCentral

Provided by RingCentral

Overall ranking in software sector:

  • “Best CEO” category: Ranked 2nd – Vlad Shmunis, RingCentral Founder, Chairman & CEO
  • “Best CFO” category: Ranked 2nd – Mitesh Dhruv, RingCentral CFO
  • “Best Investor Relations Professional” category: Ranked 1st – Ryan Goodman, RingCentral Investor Relations

RingCentral also ranked second place in Best Investor Relations, IR Team, Financially Material ESG Disclosures, and Communication of Strategy and Risk Management Amid COVID-19.

Institutional Investor is the leading publication for institutional investors, including money managers and pension fund managers. Each year, the publication releases its All-America Executive Team ranking, which reflects extensive polling of investment professionals to name the best CEOs, CFOs, and investor relation teams.

“It’s an honor to once again be ranked in Institutional Investor’s annual executive study alongside companies like Microsoft and Salesforce,” said RingCentral’s Mitesh Dhruv. “Thank you to our investors and the sell-side community for the recognition.”

Additional information can be found here.

About RingCentral

RingCentral, Inc. (NYSE: RNG) is a leading provider of cloud Message Video Phone™ (MVP™), customer engagement and contact center solutions for businesses worldwide. More flexible and cost-effective than legacy on-premise PBX and video conferencing systems that it replaces, RingCentral empowers modern mobile and distributed workforces to communicate, collaborate, and connect via any mode, any device, and any location. RingCentral’s open platform integrates with leading third-party business applications and enables customers to easily customize business workflows. RingCentral is headquartered in Belmont, California, and has offices around the world.

© 2020 RingCentral, Inc. All rights reserved. RingCentral, Message Video Phone, and the RingCentral logo are trademarks of RingCentral, Inc.

Mariana Leventis

650-562-6545

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Audio/Video VoIP Technology Telecommunications Software

MEDIA:

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Philips continues its top ranking in the Dow Jones Sustainability Indices

November 16, 2020

Amsterdam, the Netherlands –

Royal Philips
 (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has once again been named as a leading company for sustainability performance in the global 2020 Dow Jones Sustainability Indices (DJSI) list. Philips scored 81 out of 100 points in the DJSI Health Care Equipment & Services industry group, continuing its #2 ranking.

Evaluated across the Governance & Economic, Environmental and Social dimensions of DJSI’s sustainability review, Philips received the maximum scores (100/100) in several categories, including the health outcome contribution, environmental reporting, climate strategy, and social reporting categories.

“Our purpose is to improve the health and well-being of 2 billion people a year by 2025, as we aim to grow Philips responsibly and sustainably,” said Frans van Houten, CEO of Royal Philips. “We continuously challenge ourselves with ambitious environmental, social and governance targets. It is very rewarding that the efforts of our 81,000 employees and partners have once again been recognized by the prestigious Down Jones Sustainable Index. I am proud that we were able to further enhance our performance in many key dimensions, and we have a strong base for further improvement.”

Philips is set to achieve all of the targets of its ‘Healthy people, Sustainable planet’ 2016 – 2020 program. This includes becoming CO2-neutral in its operations and generating 70% of its sales from green products and services with 15% from circular economy solutions. Building on these achievements, Philips recently launched a new framework comprising a comprehensive set of key targets and commitments across all the Environmental, Social and Corporate Governance (ESG) dimensions. These include a commitment to improving the health and well-being of 2 billion people a year by 2025 through its innovations. Philips also commits to 100% EcoDesign, expanded renewable energy sourcing, and ensuring transparency regarding its tax contribution for all countries it operates in.

Philips holds a top position in the Sustainalytics rankings, and recently took second place in the Wall Street Journal’s 100 Most Sustainably Managed Companies in the World. Earlier this year, Philips was awarded the IEEE Spectrum ‘Technology in the Service of Society’ award for its app-based Lumify point-of-care ultrasound solution as the technology having the greatest potential to provide the most overall benefit to humankind.

For further information, please contact:

Ben Zwirs
Philips Global Press Office
Tel.: +31 6 15213446
E-mail: [email protected]

Derya Guzel
Philips Investor Relations
Tel.: +31 20 59 77055
E-mail: [email protected]

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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Southside Bancshares, Inc. Resumes Stock Repurchase Plan

TYLER, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) — Southside Bancshares, Inc., (NASDAQ:SBSI) (the “Company”), will resume purchases of our common stock subject to its current Stock Repurchase Plan (the “Plan”), under which 1.1 million authorized shares remain.

“Due to our financial performance and the continued volatility in the market, we believe the opportunity remains to purchase shares of our stock at attractive price levels,” stated Lee R. Gibson, President and Chief Executive Officer. “On April 1, 2020, we temporarily paused purchases under the Plan due to uncertainties resulting from the pandemic.”

On March 13, 2020, the Company announced the Board of Directors increased its authorization under the Plan, previously authorized in September 2019, by an additional 1.0 million shares, for a total authorization to repurchase up to 2.0 million shares. Under the Plan, approximately 900,000 shares have been repurchased at an average price of $29.82 per share. There have been no repurchases since March 31, 2020.

Repurchases may be carried out in open market purchases, privately negotiated transactions and pursuant to any trading plan that might be adopted in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended. The Company has no obligation to repurchase any shares under the Plan and may modify, suspend or discontinue the Plan at any time.


About Southside Bancshares, Inc.

Southside Bancshares, Inc. is a bank holding company headquartered in Tyler, Texas, with approximately $7.19 billion in assets as of September 30, 2020. Through its wholly-owned subsidiary, Southside Bank, Southside currently operates 57 branches and a network of 80 ATMs/ITMs throughout East Texas, Southeast Texas, Dallas/Fort Worth and Austin. Serving customers since 1960, Southside Bank is a community-focused financial institution that offers a full range of financial products and services to individuals and businesses. These products and services include consumer and commercial loans, mortgages, deposit accounts, safe deposit boxes, treasury management, wealth management, trust services, brokerage services and an array of online and mobile services.

To learn more about Southside Bancshares, Inc., please visit our investor relations website at https://investors.southside.com. Our investor relations site provides a detailed overview of our activities, financial information and historical stock price data. To receive e-mail notification of company news, events and stock activity, please register on the E-mail Notification portion of the website. Questions or comments may be directed to Lindsey Bailes at (903) 630-7965, or [email protected].


Forward-Looking Statements

Certain statements of other than historical fact that are contained in this press release and in other written material, documents and oral statements issued by or on behalf of the Company may be considered to be “forward-looking statements” within the meaning of and subject to the safe harbor protections of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are not guarantees of future performance, nor should they be relied upon as representing management’s views as of any subsequent date.  These statements may include words such as “expect,” “estimate,” “project,” “anticipate,” “appear,” “believe,” “could,” “should,” “may,” “likely,” “intend,” “probability,” “risk,” “target,” “objective,” “plans,” “potential,” and similar expressions.  Forward-looking statements are statements with respect to the Company’s beliefs, plans, expectations, objectives, goals, anticipations, assumptions and estimates about the Company’s future performance and are subject to significant known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from the results discussed in the forward-looking statements.  For example, discussions about trends in asset quality, capital, liquidity, the pace of loan and revenue growth, the Company’s ability to sell nonperforming assets, expense reductions, planned operational efficiencies, earnings, successful integration of completed acquisitions and certain market risk disclosures, including the impact of interest rates, tax reform and other economic factors, are based upon information presently available to management and are dependent on choices about key model characteristics and assumptions and are subject to various limitations.  By their nature, certain of the market risk disclosures are only estimates and could be materially different from what actually occurs in the future.  The most recent factor that could cause future results to differ materially from those anticipated by our forward-looking statements include the negative impact of the COVID-19 pandemic on our business, financial position, operations and prospects, including our ability to continue our business activities in certain communities we serve, the duration of the pandemic and its continued effects on financial markets, a reduction in financial transactions and business activities resulting in decreased deposits and reduced loan originations, increases in unemployment rates impacting our borrowers’ ability to repay their loans, our ability to manage liquidity in a rapidly changing and unpredictable market, additional interest rate changes by the Federal Reserve and other government actions in response to the pandemic, including additional quarantines, regulations or laws enacted to counter the effects of the COVID-19 pandemic on the economy.

Additional information concerning the Company and its business, including additional factors that could materially affect the Company’s financial results, is included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, under “Part I – Item 1. Forward Looking Information” and “Part I – Item 1A. Risk Factors,” the Company’s Quarterly Report on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, under “Part II – Item 1A. Risk Factors” and in the Company’s other filings with the Securities and Exchange Commission.  The Company disclaims any obligation to update any factors or to announce publicly the result of revisions to any of the forward-looking statements included herein to reflect future events or developments.

For further information:
Lindsey Bailes
(903) 630-7965



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Lineage Cell Therapeutics Presents New OpRegen® Data for Dry AMD With GA at 2020 American Academy of Ophthalmology Annual Meeting

Lineage Cell Therapeutics Presents New OpRegen® Data for Dry AMD With GA at 2020 American Academy of Ophthalmology Annual Meeting

  • Improved Visual Acuity Continues to be Observed in Cohort 4 Patients
  • First Known Clinical Report of Retinal Tissue Regeneration Persisted to 23 Months with Further Improvement in Visual Acuity
  • Patient Enrollment Recently Completed
  • Therapeutic Expert Call with Principal Investigator Christopher D. Riemann, M.D. Scheduled for November 17, 2020 at 4:00 pm Eastern Time

CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing three novel cell therapies for serious medical conditions, today announced positive interim results from the ongoing 24-patient Phase 1/2a clinical study of Lineage’s lead product candidate, OpRegen®. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). At AAO, new data were presented on 20 patients, including 8 patients treated in Cohort 4, which feature better baseline vision and smaller areas of GA. All 8 of these patients were treated with a new “thaw-and-inject” formulation of OpRegen and 4 were treated using the Gyroscope Orbit Subretinal Delivery System (Gyroscope SDS). Data presented at AAO showed improvements in visual acuity in Cohort 4 patients, with treated versus fellow eye comparisons reaching statistical significance at 9 and 12 months following OpRegen administration. These improvements were maintained for up to 24 months in some patients. A trend towards slower GA growth was observed in the first 6 Cohort 4 patients, a trend maintained for as long as 24 months in patients with 24-month data available. Previously reported structural improvements in the retina and decreases in drusen density have continued with evidence of durable engraftment of OpRegen cells in treated patients, some more than 4 years following administration, with no immunosuppression utilized beyond the perioperative period. Overall, OpRegen appears to be well-tolerated in all patients treated to date. The final four patients in the study were treated during November and will provide additional visual acuity data in the coming months.

“These new data increasingly suggest to us that treatment with OpRegen can provide clinically meaningful outcomes in dry AMD patients with GA, particularly for those with earlier-stage disease,” stated Brian M. Culley, Lineage CEO. “According to a recent survey published in Investigative Ophthalmology & Visual Science, only 27% percent of retinal specialists believed patients with visual acuity of 20/200 or worse could benefit from treatment with an agent which slows the growth of GA, while 93-99% of them believed patients with visual acuity of 20/200 or better could benefit from this approach. This is consistent with our belief that recent data from our Cohort 4 patients, which have less advanced disease and better baseline vision, are more exciting and provide a better surrogate for the potential clinical and commercial opportunity for OpRegen.”

Mr. Culley added, “In addition to reporting the first known finding of anatomical restoration of retinal tissue, which has persisted below baseline for 23 months and counting, treatment with OpRegen continues to demonstrate other benefits in some patients, including increases in visual acuity, reductions in the growth rate of GA and increases in reading speed. These are additive to the improvements we previously reported in retinal architecture and drusen reduction. Further, the multi-year durability of transplants without rejection is notable for our allogeneic cell therapy approach, especially as patients did not require long-term immunosuppression. With enrollment recently completed, our focus turns next toward collecting safety and efficacy data on the most recently treated patients, advancing partnership and investor discussions we’ve been having, exploring our options for later-stage clinical development, and speaking with the FDA about next steps. Our objective is to position the OpRegen program as a front-runner in the race to address an unmet need in what is widely expected to be a multi-billion-dollar dry AMD therapeutic market and to drive Lineage forward as the pre-eminent allogeneic cell therapy company.”

OpRegen Data Update & Highlights from the AAO Presentation (data presented on 20 patients, dosed through October 5, 2020):

  • Continued progressive functional improvement.
    • In Cohort 4, 6 out of 7 (86%) of patients’ treated eyes measured above their baseline vision (Best Corrected Visual Acuity, or BCVA) at 12 months, a clinically relevant timeframe, or as of the longest available timepoint less than 12 months (data collection continues for more recently-treated patients).
    • Data to date demonstrate a localized slowing of GA progression in the treated areas with a trend towards slower GA growth in treated versus fellow eyes in pooled analyses.
  • Long-term engraftment is supported with imaging observations up to more than 4 years, even with a short immunosuppression regimen.
    • In all Cohort 4 patients receiving OpRegen TAI formulation, per protocol, immunosuppressants have been discontinued as scheduled, typically within 90 days post-operatively, and no cases of acute or delayed rejection or inflammation have been reported.
    • One Cohort 4 patient was treated only with mycophenolate mofetil and received no tacrolimus for immunosuppression.
  • Anatomical restoration of retinal tissue.
    • A Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, which was first reported at 9 months, continues at month 23 to have an area of GA smaller than at baseline.
    • This patient also experienced additional improvement in BCVA from 9 to 23 months post-treatment, while the untreated eye has experienced further reduction in visual acuity.
    • Long-term monitoring on this patient is expected to continue.
  • Treatment overview.
    • As of October 5, 2020, 16 patients were treated via pars planar vitrectomy (PPV), while 4 were treated with the Gyroscope SDS.
    • As of November 10, 2020, 17 patients were treated via PPV, while 7 were treated with the Gyroscope SDS.
    • Enrollment in the phase 1/2a study is complete; follow-up continues for safety and efficacy.
  • Safety and tolerability.
    • The primary objective of the study is to evaluate the safety and tolerability of OpRegen at 12 months, and in patients which have reached this time point OpRegen appears well tolerated.
    • There have been no unexpected adverse events (AEs) or treatment-related systemic serious AEs reported in enrolled patients.
    • The most common and expected ocular AEs were the formation or exacerbation of mild to moderate epiretinal membranes (ERMs) and a single report of a retinal detachment, with cause unknown (all occurring in patients receiving OpRegen via the PPV route of administration).
    • The Gyroscope SDS is an alternative to the PPV route and is designed to avoid ERM formation.

      • Through October 2020, 16 patients were treated via PPV while 4 were treated with the Gyroscope SDS. ERMs were observed in 13 PPV patients.
      • One patient treated with the Gyroscope SDS developed a mild choroidal neovascularization (CNV) at the site of needle penetration 6 months post-treatment which was successfully treated with a single dose of an approved anti-VEGF agent. The cause was unknown.
      • One patient treated via PPV developed a mild CNV at > 24 months post-treatment.
    • Other changes observed following OpRegen treatment persisted through the last time point examined (> 4 years in some patients), including subretinal pigmentation and hyper-reflective areas seen on optical coherence tomography (OCT).

The results were presented at the 2020 American Academy of Ophthalmology Annual Meeting (AAO 2020). The presentation, “Phase 1/2a Study of Subretinally Transplanted hESC-Derived RPE Cells in Advanced Dry-Form AMD Patients” was featured as part of the Original Paper Session, OP02V Retina, Vitreous Original Papers on November 15, 2020 and was presented by Christopher Riemann, M.D.

KOL Call and Webcast

Lineage will host a therapeutic area expert call with Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute and University of Cincinnati School of Medicine, to discuss the interim results on November 17, 2020 at 4:00 pm Eastern Time / 1:00 p.m. Pacific Time. Interested parties can access the event on the Events and Presentations section of Lineage’s website.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (vision from 20/65 to 20/250 with smaller areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. In total, 17 patients were treated via PPV, while 7 were treated with the Gyroscope SDS. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing the Gyroscope SDS, objectives will include the evaluation of the safety of delivery of OpRegen using the Gyroscope SDS.

OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.

About Dry AMD

Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the development plans for OpRegen and post-enrollment timing expectations. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR

Ioana C. Hone

([email protected])

(442) 287-8963

Solebury Trout IR

Gitanjali Jain Ogawa

([email protected])

(646) 378-2949

Russo Partners – Media Relations

Nic Johnson or David Schull

[email protected]

[email protected]

(212) 845-4242

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Health Genetics Pharmaceutical Clinical Trials

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