UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

Washington, DC 20549

 

FORM 10-Q

 

(Mark One) 

☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 20212022

 

OR

 

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________

 

Commission File Number 001-36747

 

Second SightVivani Medical, Products, Inc.

(Exact name of Registrant as specified in its charter)

 

California 02-0692322

(State or other jurisdiction of

incorporation or organization)

 (I.R.S. Employer Identification No.)

13170 Telfair Avenue5858 Horton Street, SylmarSuite 280Emeryville, CA 9134294608 

(Address of principal executive offices, including zip code)

 

((818)818) 833-5000 

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class 

Trading

Symbol(s)

 Name of each exchange on which
registered
Common Stock EYESVANI NASDAQ
Warrants EYESWVANIW NASDAQ

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒   No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes   ☒   No  ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer☐ Accelerated filer☐
Non-accelerated filer☒ Smaller reporting company☒
Emerging growth company☐   

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes ☐   No ☒

 

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐   No ☐

As of November 10, 2021,11, 2022, the registrant had 39,409,17650,735,770 shares of common stock, no par value per share and 7,680,938 warrants, outstanding.

 

 

 

 

SECOND SIGHT

VIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARY

 

FORM 10-Q 

TABLE OF CONTENTS

 

PART IFINANCIAL INFORMATION 
   
Item 1.Financial Statements (unaudited) 
   
 Condensed Consolidated Balance Sheets as of September 30, 2021 (unaudited)2022 and December 31, 202020213
 Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 20212022 and 2020 (unaudited)20214
 Condensed Consolidated Statements of Comprehensive LossIncome for the three and nine months ended September 30, 20212022 and 2020 (unaudited)20215
 Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for each of the three-month periods ended during the nine months ended September 30, 20212022 and 2020 (unaudited)20216
 Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 20212022 and 2020 (unaudited)20217
 Notes to Condensed Consolidated Financial Statements8
 
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1718
   
Item 3.Quantitative and Qualitative Disclosures About Market Risk23
Item 4.Controls and Procedures23
   
Item 4.Controls and Procedures23
PART IIOTHER INFORMATION 
   
Item 1.Legal Proceedings2524
   
Item 1A.Risk Factors2524
   
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds24
Item 3.Defaults Upon Senior Securities24
Item 4.Mine Safety Disclosures24
Item 5.Other Information24
Item 6.Exhibits25
   
Item 3.SIGNATURESDefaults Upon Senior Securities25
Item 4.Mine Safety Disclosures25
Item 5.Other Information25
Item 6.Exhibits26
SIGNATURES27


PPart I. Financial Statements

 

Item 1. Financial Statements

 

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARY

 

Condensed Consolidated Balance Sheets (unaudited) 

(in thousands)

       
  September 30,
2021		  December 31,
2020		 
  (unaudited)     
ASSETS        
Current assets:        
Cash and cash equivalents $72,028  $3,177 
Prepaid expenses and other current assets  1,193   1,092 
Total current assets  73,221   4,269 
Property and equipment, net  117   174 
Right-of-use assets, net  270   — 
Deposits and other assets  22   17 
Total assets $73,630  $4,460 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)        
Current liabilities:        
Accounts payable $758  $486 
Accrued expenses  1,073   875 
Accrued compensation expense  575   173 
Accrued clinical trial expenses  999   1,063 
Current operating lease liabilities  179   — 
Current debt  —   2,200 
Contract liabilities  335   335 
Total current liabilities  3,919   5,132 
Long term operating lease liabilities  102   — 
Total liabilities  4,021   5,132 
Commitments and contingencies        
Stockholders’ equity (deficit):        
Preferred stock, 0 par value, 10,000 shares authorized; NaN outstanding  —   — 
Common stock, 0 par value; 300,000 shares authorized; shares issued and outstanding: 39,409 and 23,214 as of September 30, 2021 and December 31, 2020, respectively  347,940   270,126 
Additional paid-in capital  49,371   49,314 
Accumulated other comprehensive loss  (400)  (448)
Accumulated deficit  (327,302)  (319,664)
Total stockholders’ equity (deficit)  69,609   (672)
Total liabilities and stockholders’ equity $73,630  $4,460 

  September 30,  December 31, 
  2022  2021 
       
ASSETS        
Current assets:        
Cash and cash equivalents $51,684  $2,178 
Prepaid expenses and other current assets  2,779   291 
Total current assets  54,463   2,469 
Property and equipment, net  1,250   1,173 
Right-of-use assets  1,050   1,611 
Deposits and other assets  259   200 
Total assets $57,022  $5,453 
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $1,969  $281 
Accrued expenses  1,853   895 
Accrued compensation expense  555   — 
Current operating lease liabilities  1,243   910 
Total current liabilities  5,620   2,086 
Long term operating lease liabilities  42   902 
Total liabilities  5,662   2,988 
Commitments and contingencies        
Stockholders’ equity:        
Preferred stock, no par value, 10,000 shares authorized; none outstanding  —   — 
Common stock, no par value; 300,000 shares authorized; shares issued and outstanding: 50,736 as of September 30, 2022 and 36,803 as of December 31, 2021  109,050   54,649 
Additional paid-in capital  7,838   6,713 
Accumulated other comprehensive loss  (26)  — 
Accumulated deficit  (65,502)  (58,897)
Total stockholders’ equity  51,360   2,465 
Total liabilities and stockholders’ equity $57,022  $5,453 

See accompanying notes to the condensed consolidated financial statements.notes.

 

3

 

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC. 

AND SUBSIDIARY

 

Condensed Consolidated Statements of Operations (unaudited) 

(in thousands, except per share data)

         
          Three Months Ended Nine Months Ended 
 Three Months Ended
September 30,		  Nine Months Ended
September 30,		  September 30,  September 30, 
 2021  2020  2021  2020  2022  2021  2022  2021 
Net sales $—  $—  $—  $—  $—  $—  $—  $— 
Cost of sales  —   —   —   —   —   —   —   — 
Gross profit  —   —   —   —   —   —   —   — 
                                
Operating expenses:                                
Research and development, net of grants $697  $279  $1,726  $4,489  $3,855  $2,868  $9,738  $8,027 
Clinical and regulatory, net of grants  276   261   576   1,604   4   —   4   — 
Selling and marketing  —   —   —   701 
General and administrative  1,530   1,062   5,340   4,599   1,585   617   3,709   1,748 
Restructuring charges  —   —   —   2,229 
Total operating expenses  2,503   1,602   7,642   13,622   5,444   3,485   13,451   9,775 
                                
Loss from operations  (2,503)  (1,602)  (7,642)  (13,622)  (5,444)  (3,485)  (13,451)  (9,775)
Other income (expense), net  2   (1)  4   33   6,867   (6)  6,846   622 
                                
Net loss $(2,501) $(1,603) $(7,638) $(13,589)
Net income/(loss) $1,423  $(3,491) $(6,605) $(9,153)
                                
Net loss per common share – basic and diluted $(0.06) $(0.07) $(0.25) $(0.69)
Net income/(loss) per common share – basic $0.04  $(0.10) $(0.18) $(0.28)
Net income/(loss) per common share – diluted $0.04  $(0.10) $(0.18) $(0.28)
                                
Weighted average common shares outstanding – basic and diluted  39,409   23,118   30,596   19,714 
Weighted average common shares outstanding – basic  37,965   33,799   37,712   32,771 
Weighted average common shares outstanding – diluted  38,477   33,799   37,712   32,771 

 

See accompanying notes to the condensed consolidated financial statements.

4

 

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC. 

AND SUBSIDIARY

 

Condensed Consolidated Statements of Comprehensive LossIncome (unaudited) 

(in thousands)

                  
 Three Months Ended
September 30,		  Nine Months Ended
September 30,		  Three Months Ended Nine Months Ended 
 2021  2020  2021  2020  September 30,  September 30, 
Net loss $(2,501) $(1,603) $ (7,638) $(13,589)
 2022  2021  2022  2021 
Net income(loss) $1,423  $(3,491) $(6,605) $(9,153)
                                
Other comprehensive income (loss):                                
Foreign currency translation adjustments  (13)  35   48   64   (26)  —   (26)  — 
Comprehensive loss $(2,514) $(1,568) $(7,590) $(13,525)
Comprehensive income/(loss) $1,397  $(3,491) $(6,631) $(9,153)

See accompanying notes to the condensed consolidated financial statements.

 


5VIVANI MEDICAL, INC.

AND SUBSIDIARY

 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Stockholders’ Equity (Deficit) (unaudited)

(in thousands)

                   
  Common Stock  Additional
Paid-in		  Accumulated
Other
Comprehensive		  Accumulated  Total
Stockholders’		 
  Shares  Amount  Capital  Loss  Deficit  Equity(Deficit) 
Balance, December 31, 2019 15,643  $264,008  $48,613  $(562) $(304,784) $7,725 
Repurchase of fractional shares in connection with reverse stock split  (2)  (11)  —   —   —   (11)
Issuance of shares of common stock  1   6   —   —   —   6 
Release of restricted stock units  15   —   —   —   —   — 
Stock-based compensation expense  —   —   279   —   —   279 
Net loss  —   —   —   —   (8,886)  (8,886)
Foreign currency translation adjustment  —   —   —   19   —   19 
Balance, March 31, 2020  15,657  $264,003  $48,892  $(543) $(313,670) $(1,318)
Issuance of shares of common stock and warrants in connection with share offering, net of issuance costs  7,500   6,393   280   —   —   6,673 
Repurchase of ESSP shares as part of rescission offer  (39)  (270)  —   —   —   (270)
Stock-based compensation expense  —   —   88   —   —   88 
Net loss  —   —   —   —   (3,100)  (3,100)
Foreign currency translation adjustment  —   —   —   10   —   10 
Balance, June 30, 2020  23,118  $270,126  $49,260  $(533) $(316,770) $2,083 
Stock-based compensation expense  —   —   27   —   —   27 
Net loss  —   —   —   —   (1,603)  (1,603)
Foreign currency translation adjustment  —   —   —   35   —   35 
Balance, September 30, 2020  23,118  $270,126  $49,287  $(498) $(318,373) $542 

 

       Accumulated     
     Additional Other   Total 
 Common Stock Additional
Paid-in		 Accumulated
Other
Comprehensive		 Accumulated Total
Stockholders’		  Common Stock Paid-in Comprehensive Accumulated Stockholders’ 
 Shares Amount Capital Loss Deficit Equity(Deficit)  Shares Amount Capital Loss Deficit Equity 
Balance, December 31, 2020 23,214  $270,126  $49,314  $(448) $(319,664) $(672)  32,197  $43,029  $5,045  $—  $(46,123) $1,951 
Issuance of shares of common stock in connection with private placement  4,650   24,451   —   —   —   24,451 
Warrants exercised  44   15   —   —   —   15 
Issuance of shares of common stock and warrants, net of issuance costs  688   2,166   —   —   —   2,166 
Options exercised  36   24   —   —   —   24 
Stock-based compensation expense  —   —   19   —   —   19   —   —   450   —   —   450 
Net loss  —   —   —   —   (2,843)  (2,843)  —   —   —   —   (2,988)  (2,988)
Foreign currency translation adjustment  —   —   —   36   —   36 
Balance, March 31, 2021  27,908  $294,592  $49,333  $(412) $(322,507) $21,006   32,921  $45,219  $5,495  $—  $(49,111) $1,603 
Issuance of shares of common stock in underwritten public offering  11,500   53,338   —   —   —   53,338 
Warrants exercised  1   10   —   —   —   10 
Issuance of shares of common stock and warrants, net of issuance costs  662   2,076   —   —   —   2,076 
Stock-based compensation expense  —   —   19   —   —   19   —   —   394   —   —   394 
Net loss  —   —   —   —   (2,294)  (2,294)  —   —   —   —   (2,675)  (2,675)
Foreign currency translation adjustment  —   —   —   25   —   25 
                        
Balance, June 30, 2021  39,409  $347,940  $49,352  $(387) $(324,801) $72,104   33,583  $47,295  $5,889  $—  $(51,786) $1,398 
                        
Issuance of shares of common stock and warrants, net of issuance costs  990   3,105   —   —   —   3,105 
Warrants exercised  627   32   —   —   —   32 
Repurchase of common stock  (60)  —   —   —   —   — 
Stock-based compensation expense  —   —   19   —   —   19   —   —   389   —   —   389 
Net loss  —   —   —   —   (2,501)  (2,501)  —   —   —   —   (3,491)  (3,491)
Foreign currency translation adjustment  —   —   —   (13)  —   (13)
                        
Balance, September 30, 2021  39,409  $347,940  $49,371  $(400) $(327,302) $69,609   35,140  $50,432  $6,278  $—  $(55,277) $1,433 

 

See accompanying notes to the condensed consolidated financial statements.

           Accumulated       
        Additional  Other     Total 
  Common Stock  Paid-in  Comprehensive  Accumulated  Stockholders’ 
  Shares  Amount  Capital  Loss  Deficit  Equity(Deficit) 
Balance, December 31, 2021  36,803  $54,649  $6,713  $—  $(58,897) $2,465 
Repurchase of common stock  4   —   —   —   —   — 
Options exercised  24   1   —   —   —   1 
Stock-based compensation expense  —   —   340   —   —   340 
Net loss  —   —   —   —   (3,924)  (3,924)
                         
Balance, March 31, 2022  36,831  $54,650  $7,053  $—  $(62,821) $(1,118)
Options exercised  6   12   —   —   —   12 
Stock-based compensation expense  —   —   394   —   —   394 
Net loss  —   —   —   —   (4,104)  (4,104)
                         
Balance, June 30, 2022  36,837  $54,662  $7,447  $—  $(66,925) $(4,816)
Options and warrants exercised, net of partial shares adjustment  763   3               3 
Shares issued for SSMP net assets  13,136   54,385               54,385 
Stock-based compensation expense  —   —   391   —   —   391 
Net income  —   —   —   —   1,423   1,423 
Foreign currency translation adjustment  —   —   —   (26)  —   (26)
Balance, September 30, 2022  50,736  $109,050  $7,838  $(26) $(65,502) $51,360 

6


 

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC. 

AND SUBSIDIARY

Condensed Consolidated Statements of Cash Flows 

(in thousands)

          
 Nine Months Ended
September 30,		  Nine Months Ended September 30, 
 2021  2020  2022  2021 
 (unaudited)  (unaudited) 
Cash flows from operating activities:                
Net loss $(7,638) $(13,589) $(6,605) $(9,153)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation  57   148 
Depreciation and amortization  271   262 
Stock-based compensation  57   394   1,125   1,233 
Non-cash lease expense  11   3   23   (16)
Restructuring charges-inventory and fixed asset impairment  —   1,116 
Gain from bargain purchase  (6,877)    
PPP loan forgiveness  —   (637)
Changes in operating assets and liabilities:                
Accounts receivable  —   461 
Inventories  —   218 
Prepaid expenses and other assets  (106)  (568)  (792)  34 
Accounts payable  253   (1,256)  (1,163)  (1)
Accrued compensation expenses  102   — 
Accrued expenses  266   64   332   286 
Accrued compensation expenses  401   (2,360)
Accrued clinical trial expenses  (64)  — 
Net cash used in operating activities  (6,763)  (15,369)  (13,584)  (7,992)
Cash flows from investing activities:                
Sale of assets held for sale  —   398 
Purchase of intangibles  (48)  — 
Purchases of property and equipment  —   (331)  (249)  (316)
Net cash used in investing activities  —   67   (297)  (316)
Cash flows from financing activities:                
Net proceeds from sale of common stock and/or warrants  77,814   6,679 
Repayment of debt  (2,200)  — 
Repurchase of ESPP shares and fractional shares in connection with reverse stock split  —   (281)
Cash acquired in merger for stock consideration  55,374   — 
Proceeds from SAFE note  8,000   — 
Net proceeds from sale of common stock and exercise of warrants  16   7,403 
Net cash provided by financing activities  75,614   6,398   63,390   7,403 
Effect of exchange rate changes on cash and cash equivalents  —   14   (3)  — 
Cash and cash equivalents:                
Net increase (decrease)  68,851   (8,890)  49,506   (905)
Balance at beginning of period  3,177   11,327   2,178   2,081 
Balance at end of period $72,028  $2,437  $51,684  $1,176 
                
Supplemental disclosures of cash flow information:        
Cash paid during the period ended for:        
Interest $135   — 
Non-cash investing and financing activities:        
Cancellation of SAFE indebtedness in merger $8,000   — 
Net liabilities acquired in merger for stock consideration $(2,112)  — 

 

See accompanying notes to the condensed consolidated financial statements.


SECOND SIGHT

VIVANI MEDICAL, PRODUCTS, INC. 

AND SUBSIDIARY

Notes to Condensed Consolidated Financial Statements 

(unaudited)

1.Organization and Business Operations

(unaudited)

1. Organization and Business Operations

Second SightVivani Medical, Products, Inc. (“Second Sight,Vivani,” the “Company,” “we,” “us,” “our” or similar terms) has developed, manufactured and marketed implantable visual prosthetics that are intended to deliver useful artificial vision to blind individuals. We areis a recognized global leader in neuromodulation devices for blindness, and are committed toclinical-stage, biopharmaceutical company developing new technologiestherapeutic implants to treat conditions with high unmet medical need. Vivani’s Biopharm Division, which is the broadest populationmain focus of sight-impaired individuals.

Our principal officesthe company, develops miniaturized, subdermal drug implants utilizing its proprietary NanoPortal™ technology to enable long-term, near constant-rate delivery of a broad range of medicines to treat chronic diseases. An alarmingly significant 50% of patients are locatednon-adherent to their medicines, contributing to more than $500 billion in Los Angeles, California.

In 2007, Second Sight formed Second Sight Medical Products (Switzerland) Sàrl, initiallyavoidable healthcare costs and approximately 125,000 potentially preventable deaths per year in the US alone. Vivani’s portfolio of tiny, sub-dermal drug implants seeks to manage clinical trials and sales and marketing in Europe, the Middle East and Asia-Pacific, and more recentlyaddress medication non-adherence by providing steady levels of medication over a target duration of six months or longer. Vivani’s lead product, NPM-119, is a 6-month implant candidate under investigation for the researchtreatment of future technologies. As the laws of Switzerland require at least two corporate stockholders, Second Sight Medical Products (Switzerland) SàrlType 2 diabetes. Medication non-adherence is 99.5% owned directly by us and 0.5% owned by an executive of Second Sight as of September 30, 2021. Accordingly, Second Sight Medical Products (Switzerland) Sàrla primary reason why Type 2 diabetes treatments face significant challenges in achieving positive real-world effectiveness. Vivani’s Neuromodulation Division is considered 100% owned for financial statement purposes and is consolidated with Second Sight for all periods presented. We have closed our foreign operations and expect final dissolution of this entity sometime in 2022.

Leveraging our 20 years of experience in neuromodulation for vision, we are developing the Orion® Visual Cortical Prosthesis System (“Orion”), an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease and eye injury. Orion is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light. We are conducting a six-subjectan Early Feasibility Study of the Orion device at the Ronald Reagan UCLA Medical Center in Los Angeles (“UCLA”) and Baylor College of Medicine in Houston (“Baylor”). Regularly scheduled visits at both sites

The Biopharm Division and Neuromodulation Division represent business segments as determined by our chief operating decision maker, the chief executive officer (“CEO”), who reviews financial information for the purposes of making operating decisions, assessing financial performance and allocating resources. Operating expenses were paused in mid-March 2020 dueallocated $12.8 million to the coronavirus outbreak, however visitsBiopharm Division and $0.6 million to the Neuromodulation Division. Property and equipment, net and operating lease right-of-use assets were allocated $2.3 million to the Biopharm Division and $0.2 million to the Neuromodulation Division.


Agreement and Plan of Merger with Nano Precision Medical, Inc.

On February 4, 2022, Second Sight Medical Products, Inc. (“Second Sight”) entered into an agreement and plan of merger (the “Merger Agreement”) with Nano Precision Medical, Inc. (“NPM”). The Merger was approved by the shareholders of Second Sight on July 27, 2022 and closed on August 30, 2022. Upon consummation of the Merger, NPM became a wholly-owned subsidiary of Second Sight. Concurrent with to the Merger, Second Sight changed its name to Vivani Medical, Inc. and changed its trading symbol from EYES to VANI, and trades under the ticker VANI on the NASDAQ market. Certain investors and members of the NPM board of directors are also investors and members of the board of directors of Second Sight.

Under the terms and conditions of the Merger Agreement, the securities of NPM converted into the right to receive shares of Second Sight’s common stock representing 77.32% of the total issued and outstanding shares of common stock of Second Sight on a fully converted basis, including, without limitation, giving effect to the conversion of all options, warrants, and any and all other convertible securities assuming net settlement. Second Sight filed a Registration Statement on Form S-4 on May 13, 2022 in connection with the Merger to register the merger shares effective June 24, 2022.

On February 4, 2022, in connection with the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight provided to NPM an investment advance of $8 million. The Merger Agreement provided that the SAFE would terminate if the Merger were to be successfully completed. Under the terms of the SAFE, upon successfully completion of the Merger on August 30, 2022, the investment advance was eliminated. Under the accounting for a business combination, the $8 million adjusted the purchase consideration.

The Merger involved a change of control and was accounted for as a reverse merger in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Under this method of accounting, Second Sight was treated as the “acquired” company for financial reporting purposes with NPM as the acquirer. The assets acquired and liabilities assumed by NPM were recorded at UCLA resumed mid-September 2020fair value under Accounting Codification Standard (“ASC 805”), Business Combinations. Accordingly, on August 30, 2022 (the “Acquisition Date”), NPM (a calendar year-end entity) was deemed to have acquired 100% of the outstanding common shares and Baylor resumedvoting interest of Second Sight, Medical, Inc. The results of Second Sight’s operations have been included in December 2020. Our 36 monththe consolidated financial statements since that date.

The acquisition-date fair value of consideration transferred totaled $54.4 million, which consisted of the fair value of the 13,136 common shares deemed issued to Second Sight shareholders, was determined based on the per share closing price of the Company’s common shares on the acquisition date of $4.14.

The following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date (in thousands):

At August 30, 2022   
   
Cash $55,374 
Property and equipment  99 
Prepaid expenses  1,657 
Right of use assets  140 
Other assets  56 
Total identifiable assets acquired  57,326 
Current liabilities  (3,913)
Right of use liabilities  (151)
Total liabilities assumed  4,064 
Net identifiable assets acquired $53,262 

The SAFE loan of $8.0 million was cancelled in the Merger which adjusted the fair value of net assets acquired.

The following table summarizes the calculation of the gain on bargain purchase (in thousands): 

     
Total consideration $54,385 
SAFE loan forgiven  (8,000)
Less net identifiable assets acquired  (53,262)
Gain on bargain purchase $6,877 

Because NPM purchased 100% of Second Sight and the fair value of identifiable assets acquired and liabilities assumed exceeded the fair value of the consideration, we reassessed the recognition and measurement of identifiable assets acquired and liabilities assumed and concluded that all acquired assets and assumed liabilities were properly recognized and that the valuation procedures and resulting measures were appropriate. As a result, we recognized a gain of $6.9 million. The gain is included in the line item “Other income (expense)” in the consolidated income statement.

We recognized $0.7 million of acquisition related costs that were expensed in the nine months ended September 30, 2022. These costs are included in the consolidated income statement in the line item entitled “General and administrative costs.”

Operating expenses of Second Sight included in the consolidated income statement from the acquisition date August 30, 2022 to the period ending September 30, 2022 were $0.5 million. Pro forma consolidated net loss as if Second Sight had been included in the consolidated results which were measured after the study resumed, indicate to us that:was $21.7

●We have a good safety profile. Five subjects experienced a total of thirteen adverse events (AEs) related to the device or to the surgery, through July 2021. One was considered a serious adverse event (SAE), and all of the adverse events were in the expected category. The one SAE occurred at about three months post-implant, was resolved quickly, and did not require a hospital stay. There have been no serious adverse events due to the device or surgery since June 2018.

●The efficacy data is encouraging. We measure efficacy by looking at three measures of visual function: The first is square localization, where Orion subjects sit in front of a touch screen and are asked to touch within the boundaries of a square when it appears. The second is direction of motion, where subjects are asked to identify the direction and motion of lines on a screen. The third is grating visual acuity, a measure of visual acuity that is adapted for very low vision. Four subjects have completed these tests at 36-months, one subject at 24-months, and one subject at 12-months. Considering the most recent results for each subject, on square localization, six of six subjects tested in our feasibility study performed significantly better with the system on than off. On direction of motion, six of six performed better with the system on than off. On grating visual acuity, two of six tested had measurable visual acuity on the scale of this test (versus none who can do it with the device off). Another efficacy measurement of day-to-day functionality and benefit is FLORA, an acronym for Functional Low-Vision Observer Rated Assessment. FLORA is an assessment performed by an independent, third-party low vision orientation and mobility specialist who spends time with each of the subjects in their homes. The specialist asks each of the subjects a series of questions and also observes them performing 15 or more daily living tasks, such as finding light sources, following a sidewalk, or sorting laundry. The specialist then determines if the system is providing a benefit, if it is neutral, or if it is actually hurting the abilities of subjects to perform these tasks. Due to the Covid-19 pandemic, 4 out of 6 FLORA assessments were not performed at the 24 month timeframe. A protocol update was made to add FLORA assessments at the 36 month timeframe. FLORA results to date (the latest for each subject) show that 6 out of 6 had positive or mild positive results, indicating the Orion system is providing benefit. We reached agreement with the FDA in the fourth quarter of 2019 to utilize a revised version of FLORA as our primary efficacy endpoint in our pivotal trial for Orion, pending successful validation of the instrument.

No peer-reviewed data is available yetmillion for the Orion system. We are currently negotiatingyear ended December 31, 2021, and $20.6 million for the clinical and regulatory pathway to commercializationnine months ended September 30, 2022.

SAFE

On February 4, 2022, in connection with the FDA as partMerger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight provided to NPM an investment advance of $8 million. The agreement provided that the SAFE would terminate if the Merger were to be successfully completed.

Under the terms of the Breakthrough Devices Program. One subject inSAFE, upon successfully completion of the Early Feasibility study had the Orion device explantedMerger on August 9, 2021. The explant30, 2022, the investment advance was due toeliminated. Under the needaccounting for an MRI to diagnose a condition unrelated tobusiness combination, the Orion device. 

$8.0 million adjusted the purchase consideration.

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Liquidity

Product and Clinical Development Plans

By further developing our visual cortical prosthesis, Orion, we believe we may be able to significantly expand our market to include nearly all profoundly blind individuals. The principal notable exceptions for potential use of the Orion are those who are blind due to otherwise currently treatable diseases, individuals who are born blind, or blindness due to direct damage of the visual cortex, which is rare. Of the estimated 36 million blind people worldwide, there are approximately 5.8 million people who are legally blind due to causes that are not otherwise treatable. We continue to develop and refine our estimates of the potential addressable market size as we evaluate the commercial prospects for Orion using a combination of published sources, third party market research, and physician feedback. We currently estimate over 500,000 individuals in the US are legally blind due to retinitis pigmentosa, glaucoma, diabetic retinopathy, optic nerve disease and eye injury. Of this population, we estimate the potential US addressable market is between 50,000 and 100,000 individuals with bi-lateral blindness at the light-perception level or worse. Our marketing approvals by the FDA and other regulatory agencies will ultimately determine the subset of these patients who are eligible for the Orion based on our clinical trials and the associated results.

Our objective in designing and developing the Orion visual prosthesis system is to bypass the optic nerve and directly stimulate the part of the brain responsible for human vision. A six-subject Early Feasibility Study of the Orion device is currently underway at UCLA and Baylor. Our 36 month results indicate a good safety profile with encouraging efficacy data and benefits in helping subjects perform their daily living tasks. We believe these data results are encouraging and support advancement of Orion into a larger pivotal clinical study. Early promising results are not necessarily indicative of results that may be obtained in our larger Orion clinical trials.

In November 2017, the FDA granted Breakthrough Devices Program designation for the Orion. This designation is given to a few select medical devices in order to provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review.

On February 26, 2021, the U.S. Food and Drug Administration (FDA) approved the Argus 2s Retinal Prosthesis System, a redesigned set of external hardware (glasses and video processing unit) initially for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP). The Company expects that the Argus 2s will be adapted to be the external system for the next generation Orion Visual Cortical Prosthesis System currently under development. In addition to ergonomic improvements, the Argus 2s system offers significantly more processing power, potentially allowing for improved video processing.

Liquidity and Capital Resources

From inception, our operations have been funded primarily through the sales of our common stock and warrants, as well as from the issuance of debt, convertible debt, research and clinical grants, and limited product revenue generated from the salewarrants. The completion of our Argus II product. Funding of our business since 2019 has been primarilyreverse merger with Second Sight Medical Products, Inc. provided by:$53.3 million in net assets including approximately $55.4 million in cash.

●On June 25, 2021, we closed an underwritten public offering of 11,500,000 shares of common stock at a price of $5.00 per share for aggregate net proceeds of $53.3 million

●On March 23, 2021, we closed our private placement to seven institutional investors of 4,650,000 shares of common stock at a price of $6.00 per share for aggregate net proceeds of approximately $24.5 million

●On December 8, 2020, we borrowed $1 million from Gregg Williams, Chairman of the Board of Directors of the Company and $1.2 million from two unaffiliated shareholders. These loans and accrued interest were repaid in the second quarter of 2021

●On May 5, 2020, we closed our underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate net proceeds of approximately $6.7 million

We were awarded a $1.6 million grant (with the intent to fund $6.4 million over five years subject to annual review and approval) from the National Institutes of Health (NIH) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018. Our second year grant of $1.4 million was approved on April 6, 2021 and our third year grant of $1.4 million was approved on May 12, 2021. As of September 30, 2021 we recorded $0.3 of deferred grant costs receivable, included in prepaid expenses and other current assets. For the three and nine months ended September 30, 2021 $0.3 million and $1.1 million of costs were offset by grants as compared to $0.4 million and $1.0 million for the comparable periods in 2020.

Our financial statements have been preparedpresented on the basis that our business is a going concern, basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We are subject to the risks and uncertainties associated with a business with no revenue that is developing novel medical devices, including limitations on our operating capital resources. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the foreseeable future. We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations for at least eighteenthe next twenty-four months. Our ability to continue as a going concern is dependent on our ability to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there can be no assurances that we will be able to do so.

We were notified by the Nasdaq stock market on July 23, 2020 regarding our non-compliance with one of the continued listing requirements of the Nasdaq Capital Market. We have subsequently satisfied the Nasdaq compliance listing requirement.

9

 


2. Basis of Presentation, Significant Accounting Policies and Recent Accounting Pronouncements

Basis of Presentation

These unaudited interim financial statements have been prepared in accordance with accounting principlesUnited States generally accepted in the United Statesaccounting principles (“GAAP”) and following the requirements of the United States Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In our opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of our financial position and our results of operations and cash flows for periods presented. The balance sheet as of December 31, 2020 has been derived from our audited balance sheet included in our annual report on Form 10-K for the year ended December 31, 2020 as filed with the SEC on March 16, 2021. These statements do not include all disclosures required by GAAP and should be read in conjunction with our financial statements and accompanying notes for the fiscal year ended December 31, 2020, contained in our Annual Report on Form 10-K.2021. The results of the interim periods are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period.

Reverse Stock SplitIncome taxes - interim periods

On December 31, 2019In calculating the provision for interim income taxes, in accordance with ASC 740, Income Taxes, an estimated annual effective tax rate is applied to year-to-date ordinary income. At the end of each interim period, we effectedestimate the effective tax rate expected to be applicable for the full fiscal year. This differs from the method utilized at the end of an annual period.

Use of estimates

The preparation of financial statements requires management to make a reverse stock splitnumber of estimates and assumptions related to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the outstanding shares of our no par value common stock and outstanding warrants to purchase our common stock by a ratio of 1-for-8 (1:8). The common stock and warrants began trading on the Nasdaq Capital Market on a split-adjusted basis on January 6, 2020.

The accompanying consolidated financial statements, and notes thereto give retrospective effectthe reported amounts of expenses during the period. Estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Some of the more significant estimates include the purchase price of net assets acquired in the Merger, useful lives of long-lived assets, the fair value of equity-based compensation and evaluation of going concern. Actual results could differ materially from those estimates. 

Net income/loss per share

Basic net income/loss per share is computed using net income/loss from operations divided by the weighted-average number of shares of common stock outstanding during the period.

Diluted net income/loss per share represents net income/loss from operations divided by the weighted- average number of common shares outstanding during the period, including all potentially dilutive common stock equivalents. Common stock equivalents consist of shares subject to warrants and share-based awards with exercise prices less than the average market price of common stock for the period, to the reverse stock split for all periods presented. All issued and outstandingextent their inclusion would be dilutive.

The computation of the weighted-average shares of common stock optionsoutstanding for diluted EPS excludes the following potential common shares as of September 30, 2022 and warrants exercisable for common stock, restricted stock units, and per share amounts contained2021 (in thousands):

   September 30,   September 30,
  2022  2021
Shares underlying warrants outstanding  10,311   7,731
Shares underlying stock options outstanding  4,515   6,387

The shares underlying the SAFE obligation were issuable only if the Merger were to be terminated. These contingently issuable shares were excluded from the dilutive computation because conversion was not “probable” as defined in our consolidated financial statementsthe accounting literature. However, if the evaluation met the probability threshold, the shares would be excluded from diluted EPS since their inclusion would have been retrospectively adjusted.an anti-dilutive effect.

Significant Accounting Policies

Segment Reporting. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. Our chief operating decision-maker reviews financial information presented on a consolidated basis. Accordingly, we consider ourselves to be in a single reporting segment, specifically the discovery, development and commercialization of visual prosthetics for profoundly blind individuals. We historically managed our Argus II and Orion programs on a consolidated basis within this single operating segment and do not assess the performance of our product lines or geographic regions on other measures of income or expense, such as program expense, operating income or net income. Our underlying technology consists of hardware components (implanted and wearable) and software. A vast majority of this underlying technology was shared between the Argus II and Orion branded systems. While we have ceased production and marketing the Argus II product we are developing Orion as a next generation product with potential to treat a broader market of blind individuals.

On March 31, 2020, due to the COVID-19 pandemic and related inability to secure additional funding, we laid off the majority of our employees and reduced our operating expenses significantly to allow for our continuing business operations. In the nine months ended September 30, 2020, due to our focus on Orion and wind down of selling and marketing activities related to Argus II, we recorded impairment charges to our inventory of $0.5 million and $0.7 million to our fixed assets used primarily for Argus activities. We also incurred $0.2 million in severance payments. We continue to advance the development of our Orion technology and are exploring various strategic options to accelerate development of Orion.

Our significant accounting policies are set forth in Note 2 of theour financial statements in our Annual Report on Form 10-K for the year ended December 31, 2020.2021 as filed in the prospectus.

Recently Issued Accounting Pronouncements

We do not believe that any recently issued, but not yet effective, accounting standards, if adopted, will have a material effect on the financial statements.

 

3. Concentration of Risk

Credit Risk

Financial instruments that subject us to concentrations of credit risk consist primarily of cash and money market funds. We maintain cash and money market funds with financial institutions that we deem reputable.

10

 

Foreign Operations

The accompanying condensed consolidated financial statements as of September 30, 2021 and December 31, 20202022 include gross assets amounting to $32,0000.1 million and $18,000, respectively, relating to operations of our subsidiary based in Switzerland.


4. Fair Value Measurements

The authoritative guidance with respect to fair value establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required.

Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that we have the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives.

Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange basednon-exchange-based derivatives, mutual funds, and fair-value hedges.

Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based derivatives and commingled investment funds, and are measured using present value pricing models.

Cash equivalents, which includes money market funds, are the only financial instrument measured and recorded at fair value on our consolidated balance sheet, and they are valued using Level 1 inputs.

Assets measured at fair value on a recurring basis are as follows (in thousands):

 Total Level 1 Level 2 Level 3  Total  Level 1  Level 2  Level 3 
September 30, 2021 (unaudited):         
September 30, 2022 (unaudited):                
Money market funds $71,970 $71,970 $— $—  $50,427  $50,427  $—  $— 
December 31, 2020:         
December 31, 2021:                
Money market funds $3,122 $3,122 $— $—  $—  $—  $—  $— 

 

 

5. Selected Balance Sheet Detail

 

Property and equipment net

Property and equipment consisted of the following (in thousands):

         
  September 30,  December 31, 
  2021  2020 
Laboratory equipment $584  $584 
Computer hardware and software  69   69 
   653   653 
Accumulated depreciation and amortization  (536)  (479)
Property and equipment, net $117  $174 

  September 30,  December 31, 
  2022  2021 
Equipment $3,481  $3,174 
Furniture and fixtures  10   10 
Software  49   8 
Leasehold improvements  12   12 
   3,552   3,204 
Accumulated depreciation and amortization  (2,302)  (2,031)
Property and equipment, net $1,250  $1,173 

11


As a result of our decision to cease marketing of Argus II we recorded an impairment of $0.7 million during the nine month period ended September 30, 2020 related to our fixed assets.

Debt

On December 8, 2020, we borrowed $1 million from Gregg Williams, Chairman of the Board of Directors of the Company and $1.2 million from two unaffiliated shareholders. Each promissory note was unsecured and accrued interest at a rate of twelve percent (12%) per annum beginning on receipt of the loan amounts. We repaid the principal and accrued interest of $135,000 during the quarter ended June 30, 2021.

Contract Liabilities

Contract liabilities consisted of the following (in thousands):

Beginning balance as of December 31, 2020 $335 
Consideration received in advance of revenue recognition  — 
Revenue recognized  — 
Ending balance as of September 30, 2021 $335 

 

Product Warranties

A summary of activity of our warranty liabilities, which are included in accrued expenses, for the period ended September 30, 2021 is presented below:

Beginning balance as of December 31, 2020 $200 
Additions  — 
Settlements  — 
Adjustments and other  (7)
Ending balance as of September 30, 2021 $193 

Right-of-use assets and operating lease liabilities

We lease certain office space and equipment for our use. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease costs are recognized in the income statement over the lease term on a straight-line basis. Depreciation is computed using the straight-line method over the estimated useful life of the respective assets. The depreciable life of assets and leasehold improvements are limited by the expected lease term. Our lease agreements do not contain any material residual value guarantees or restrictive covenants. As most of our leases do not provide an implicit rate, we used our estimated incremental borrowing rate of 10% based on the information available at commencement date in determining the present value of lease payments.

On May 18, 2020 we entered into a Letter Agreement with Sylmar Biomedical Park, LLC (the “Landlord”), pursuant to which the parties agreed to accelerate the expiration datesWe are presently negotiating for new lease sites for both of our existing leases (the “Leases”),current offices and expect to a date no later than June 18, 2020 (“Accelerated Termination Date”). We agreed to pay the Landlord (i) $210,730 to bring the Leases current (the “Owed Rent”) and to remit (ii) a one- time early termination feeenter into new agreements in the amountlast quarter of $2022.

150,000 (the “Early Termination Amount”). Prior to the early termination agreed in this letter we were obligated to pay aggregate base rentSchedule of approximately $0.9 million and common area maintenance expenses for the term remaining under the Leases through the respective expiration dates in February 2022 and April 2023. The Landlord acknowledged that asright of the date of the Letter Agreement the Owed Rent and the Early Termination Amount constituted all amounts owing to the Landlord under the Leases. As a result of the letter agreement, we wrote down the right-of-useuse assets and extinguished relatedoperating lease liabilities in the amounts of $2.3liabilties million and $2.4 million, respectively. We accrued an early termination fee of $150,000 which is included in the restructuring charges as of and for the nine months ended September 30, 2020.

On January 22, 2021, we entered into a lease agreement, effective February 1, 2021, to sub-lease office space to replace our existing headquarters. We pay $17,000 per month, increasing to $17,500 per month on February 1, 2022, plus operating expenses, to lease 17,290 square feet of office space at 13170 Telfair Avenue, Sylmar, CA 91342. Additionally, we received full rent abatement for March 2021, and will receive half rent abatement during March 2022. The sub-lease is for two years and two months. We are not affiliates of, are not related to, or otherwise have any other relationship with, the other parties, other than the lease.

12

The Company evaluated the lease amendment under the provisions of ASC 842. Information related to the Company’s right-of-use assets and related lease liabilities are as follows (in thousands, except for remaining lease term and discount rate):

Year ending December 31:    
2021 (3 months remaining) $51 
2022  201 
2023  52 
Total lease payments  304 
Less imputed interest  (23)
Total lease liabilities $281 
     
Other supplemental information:    
Current operating lease liabilities $179 
Long term operating lease liabilities  102 
Total lease liabilities $281 
Discount rate  10%

              
  For the three
months ended
 September 30,
2021		 

For the three
months ended
September 30,

2020

 For the nine
months ended
 September 30,
2021		 For the nine
months ended
 September 30,
2020		 
Cash paid for operating lease liabilities $51 $48  119  275 
Assets Classification 

September 30,

2022 (in thousands)

  December 31,
2021 (in thousands)		 
      Non-current assets Right-of-use assets $1,050  $1,611 
Liabilities          
  Current Current operating lease liabilities $1,243  $910 
      Long term Long term operating lease liabilities $42  $902 

 

Schedule of lease liabilities

  For the three  For the three  For the nine  For the nine 
  months ended  months ended  months ended  months ended 
  September 30,  September 30,  September 30,  September 30, 
  2022  2021  2022  2021 
Cash paid for operating lease liabilities in thousands: $241  $207   766   616 

Rent expense, including common area maintenance charges, was $146,0000.2 million and $277,0000.2 million and $0.7 million and $0.6 million during the three and nine-month periods ended September 30, 2022 and 2021, and 2020, respectively.

13


 

6. Equity Securities

Potentially Dilutive Common Stock Equivalents

As of September 30, 2021 and 2020, we excluded the potentially dilutive securities summarized below, which entitle the holders thereofWe are authorized to potentially acquireissue 300,000,000 shares of common stock from our calculationswith 50,735,770 issued as of net loss perSeptember 30, 2022. In addition, we are authorized to issue 10,000,000 shares of preferred stock with none issued. On August 19, 2022 the Company initiated a reverse stock split of one share and weighted average common shares outstanding, as their effect wouldfor every three shares. All share numbers have been anti-dilutiveretroactively adjusted for the split. On August 30, 2022, 13,136,362 (in thousands).

  September 30, 
  2021 2020 
Common stock warrants issued to underwriter in connection with May 2020 offering  10  375 
Common stock warrants issued in connection with March 2017 rights offering  1,706  1,706 
Common stock warrants issued in connection with February 2019 rights offering  5,975  5,976 
Common stock options  182  265 
   7,873  8,322 

shares were deemed issued for the merger acquisition.

 

7. Warrants

On February 22, 2019, we completed a registered rights offering

NPM, prior to existing stockholders in which we sold approximately 5,976,000 units at $5.792 per unit, which was the adjusted closing price of our common stock on that date. Each Unit consisted of a share of ourMerger, issued common stock and a warrantwarrants (collectively, the “unit” or “units”) in 2019, 2020 and 2021 for $3.147 per unit. Outstanding warrants to purchase an additional share of our stock for $11.76. The warrants have a five-year life and trade on Nasdaq under the symbol EYESW.

On March 6, 2017, we completed a registered rights offering to existing stockholders in which we sold approximately 1,706,000 units at $11.76 per unit, which was the adjusted closing price of our common stock on that date. Each unit consistedare shown in the table below and generally expire 5 years from the date of aissuance at $3.147 per share, are transferable into one share of our common stock and may be exercised on a warrant to purchase an additional share of our stock for $11.76.cashless basis. The warrants have a five-year lifequalified for an exception to derivative accounting and, have been approvedaccordingly, their value was not bifurcated from the total purchase price.

The other adjustment for trading on Nasdaq under2,563,688 warrants in the symbol EYESW.

We extended the term of 1.7 milliontable below were outstanding Second Sight warrants issued in our March 2017 rights offering by approximately two years effective as of February 15, 2019exchanged as part of our February 2019 rights offering. We determined the Merger for VIVANI warrants on a like-for-like basis. The warrants are tradeable on the open market. Under accounting standards in a business combination, these warrants were measured at fair value as of the March 2017 Warrants immediately before and after the modification. The fair value of the March 2017 Warrants after the modification was increased by approximately$1.6 million, resulting in an accounting adjustment to additional paid-in capital and accumulated deficit in the consolidated statements of shareholders’ equity. The assumptions used in the determination of fair value ofMerger date; however, the warrants beforewere substantially out-of-the-money and after the extension included a risk free interest rate of 2.50% and 2.49%, expected volatility of 81% and 82%, and expected lives of 3.08 years and 5.08 years, respectively and 0% dividend yields for both.

Upon close of our May 2020 registered offering we issued 375,000 warrants to our underwriter. These warrants are exercisable at $1.25 per share and expire on May 5, 2025. At September 30, 2021, 10,125 of the warrants remain outstanding.

were assigned no value.

14


 

A summary of warrantswarrant activity for the nine months ended September 30, 20212022 is presented below (in thousands, except per share and contractual life data).

 Number of
Shares		  Weighted
Average
Exercise
Price
Per Share		  Weighted
Average
Remaining
Contractual
Life (in Years)		  

Number of 

Shares 

 

Weighted 

Average 

Exercise 

Price 

Per Share 

 

Weighted 

Average 

Remaining 

Contractual 

Life (in Years) 

 
Warrants outstanding as of December 31, 2020  7,759  $11.66   3.21 
Warrants outstanding as of December 31, 2021  9,074  $3.147   2.93 
Issued  —           —   —   — 
Exercised  (68)  1.45       (1,327)  $3,147     
Forfeited or expired  —           —         
Warrants outstanding as of September 30, 2021  7,691  $11.75   2.46 
Warrants exercisable as of September 30, 2021  7,691  $11.75   2.46 
Other adjustment  2,564  $11.75   1.46 
Warrants outstanding as of September 30, 2022  10,311  $5.29   2.56 
Warrants exercisable as of September 30, 2022  10,311  $5.29   2.56 

 

The warrants outstanding as of September 30, 20212022 had $20,000 inno intrinsic value.

8. Stock-Based Compensation

A summary of stock option activity under our 2011 Equity Incentive Plan (“2011 Plan”) for the nine months ended September 30, 20212022 is presented below (in thousands, except per share and contractual life data).

 Number of
Shares		  Weighted
Average
Exercise
Price
Per Share		  Weighted
Average
Remaining
Contractual
Life (in Years)		  

Number of 

Shares 

 

Weighted 

Average 

Exercise 

Price 

Per Share 

 

Weighted 

Average 

Remaining 

Contractual 

Life (in Years) 

 
Options outstanding as of December 31, 2020  196  $15.48   7.65 
Options outstanding as of December 31, 2021  4,542  $2.89   6.49 
Granted  —  $—       454  $2.80     
Exercised  —  $—       (73) $1.66     
Forfeited or expired  (14) $12.95       (168) $5.19     
Options outstanding and expected to vest as of September 30, 2021  182  $15.68   6.84 
Options exercisable as of September 30, 2021  143  $18.82   6.45 
Other adjustment  272  $12.84     
Options outstanding, vested and expected to vest as of September 30, 2022  5,027  $3.21   6.99 
Options exercisable as of September 30, 2022  3,816  $3.27   6.51 

 

The estimated aggregate intrinsic value of stock options exercisable as of September 30, 20212022 was $15,0000.9 million. As of September 30, 2021,2022, there was $105,0001.9 million of total unrecognized compensation cost related to outstanding stock options that will be recognized over a weighted average period of 2.291.16 years. In connection with the Merger, 272 options presented in the table above were outstanding Second Sight options exchanged as part of the Merger for VIVANI options on a like-for-like basis. Under accounting standards in a business combination, these options have been measured at fair value as of the Merger date; however, the options were substantially out-of-the-money and were assigned no value.

We adopted an employee stock purchase plan in June 2015 for all eligible employees. AtDuring the quarter ended September 30, 20212022, we granted stock options to purchase 453,576 shares of common stock to certain employees and board members. The options are exercisable for a period of ten years from the available numberdate of shares that maygrant at a price of $2.80 per share, which was the fair value of our common stock on the respective grant date. The options generally vest over a period of four years. The fair value of these options, calculated using the Black-Scholes option-pricing model, was determined to be issued under$1.0 million ($2.01 to $2.20 per share) using the plan isfollowing assumptions: expected term of 77,0314.25 to 5.58 years, volatility of 100%, risk-free interest rate of 3.42% to 3.60%, and expected dividend rate of 0.0%.


Stock-based compensation expense recognized for stock-based awards in the condensed consolidated statements of operations for the three and nine months ended September 30, 20212022 and 20202021 was as follows (in thousands):

 Three Months Ended Nine Months Ended 
 Three Months Ended
September 30,		  Nine Months Ended
September 30,		  September 30,  September 30, 
 2021  2020  2021  2020   2022  2021  2022  2021 
Research and development $5  $11  $ 15 $ 120  $274  $341  $788  $989 
Clinical and regulatory  9   12   27  39 
Selling and marketing  —   —  —  41 
General and administrative  5   4     15     194   118   49   338   244 
Total $19  $27  $  57 $  394  $392  $390  $1,125  $1,233 


 

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9. Risk and Uncertainties

COVID-19 has directly and indirectly adversely affected Second Sight and will likelyWe continue to do so for an uncertain periodmonitor the ongoing COVID-19 global pandemic which has resulted in travel and other restrictions to reduce the spread of time. In Marchthe disease. We presently are not experiencing any significant disruptions from the ongoing COVID-19 pandemic. All clinical and April 2020 we laid off a substantial majority of our employees as a result of COVID-19chemistry, manufacturing and an inability to obtain financing. Wecontrol activities are currently employ 15 employees to oversee current operations. The cumulative effects of COVID-19 on the Company cannot be predicted at this time, but could include, without limitation:active.

●reputational damages of the Company and its products;
●inability to raise additional funds to finance and continue our operations;
●inability to maintain adequate facilities;
●inability to retain and hire experienced personnel;
●inability to finalize our plan for and enroll patients into our proposed pivotal clinical trial;
●material delays or inability to complete development and commercialization of Orion;
●inability to satisfy Nasdaq’s continued listing requirements and exposure to delisting if not remedied; and
●other uncertain events that may have negative impact effect on our operations.

 

The safety, health and well-being of all patients, medical staff and internal and external teams is the paramount and primary focus. As the pandemic and its resulting restrictions evolve in jurisdictions across the country, the potential exists for further disruptions to projected timelines. We are in close communication with clinical teams and key vendors and are prepared to take action should the pandemic worsen and impact the business in the future.

10. Litigation, Claims and Assessments

FourThree oppositions filed by Pixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity of a European patent owned by us. The outcomes of the challenges are not certain, however, if successful, they may affect our ability to block competitors from utilizing our patented technology. We do not believe a successful challenge will not have a material effect on our ability to manufacture and sell our products, or otherwise have a material effect on our operations.

As described in the Company’s 10-K for the year ended December 31, 2020, the Company hadSecond Sight entered into a Memorandum of Understanding (“MOU”) for a proposed business combination with Pixium Vision SA (“Pixium”).Pixium. In response to a press release by Pixium dated March 24, 2021, and subsequent communications between usSecond Sight and Pixium, ourSecond Sight’s Board of Directors determined that the business combination with Pixium was not in the best interest of ourtheir shareholders. On April 1, 2021, weSecond Sight gave notice to Pixium that wethey were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. WeSecond Sight accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021 and remitted that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, claimingand currently claims damages of €5,217,659.60,approximately €5.1 million or about $6,162,7605.1. million at current exchange rates. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000.$1,000,000 and thus the Company does not believe any further loss accrual is necessary.

In November 2020, weSecond Sight and Pixium retained Oppenheimer & Co. Inc. as placement agent for a proposed private placement of securities in connection with the Pixium Business Combination. On April 1, 2021, weSecond Sight received an invoice from Oppenheimer for more than $1.86 million. This amount includes a requested commission of 6.5% on $27.9 million raised in the private placement that we completed in March 2021.placement. We believe that claims for payment presented by this invoice are without merit.

On or about July 19, 2021 Martin Sumichrast filed a complaint with the Superior Court of the State of California, County of Los Angeles—Central District, claiming that he is entitled to compensation for services, as well as exemplary and other damages in an amount to be determined at trial but not less than $2 million, which arise from his allegedly arranging and securing financing that the Company obtained in May 2020 via a registered underwritten public offering of common stock. The action is in early stages and the Company is considering its responses, however the Company believes that the claims for compensation are without merit and intends to defend vigorously.

We are party to litigation arising in the ordinary course of business. It is our opinion that the outcome of such matters will not have a material effect on our results of operations, however, the results of litigation and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations

  

The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q as well as our audited 2020 financial statements and related notes included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission (“SEC”) on March 16, 2021 and as thereafter amended on April 14, 2021 and April 27, 2021.10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect toourproducts,plansand strategy for our business and related financing, contains forward-looking statements that involve risks and uncertainties, including statements regarding our expected financial results in future periods. The words “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “projects,” “will,” “would,” “strategy” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding expectations for revenues, liquidity, cash flows and financial performance, the anticipated results of our development efforts and the timing for receipt of required regulatory approvals, insurance reimbursements and product launches, our financing plans and future capital requirements, and statements regarding the anticipated or projected impact of our merger on our business, results of operations, financial condition or prospects, the materially adverse impact of the recent COVID-19 coronavirus pandemic and related public health measures on our business. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. We assume no obligations to update these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report or to reflect actual outcomes.

  

Second SightVivani Medical, Products, Inc. (NASDAQ: EYES) develops implantable visual prosthetics that are intended to deliver useful artificial vision to blind individuals. We are(“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a recognized global leader in neuromodulation devices for blindness, and are committed toclinical-stage company developing new technologiestherapeutic implants to treat conditions with high unmet medical need. Vivani’s biopharm division, which is the broadest populationsmain focus of sight-impaired individuals.

Leveraging our 20 yearsthe company, develops miniaturized, subdermal drug implants utilizing its proprietary NanoPortal™ technology to enable long-term, near constant-rate delivery of experiencea broad range of medicines to treat chronic diseases. An alarmingly significant 50% of patients are non-adherent to their medicines, contributing to more than $500 billion in neuromodulationavoidable healthcare costs and approximately 125,000 potentially preventable deaths per year in the US alone. Vivani’s portfolio of tiny, sub-dermal drug implants seeks to address medication non-adherence by providing steady levels of medication over a target duration of six months or longer. Vivani’s lead product, NPM-119, is a 6-month implant candidate under investigation for vision,the treatment of Type 2 diabetes. Medication non-adherence is a primary reason why Type 2 diabetes treatments face significant challenges in achieving positive real-world effectiveness. Based on feedback from the U.S. FDA, we expect to utilize the 505(b)(2) pathway under the Food, Drug and Cosmetics Act for the development of NPM-119.  In addition to NPM-119, we are also exploring compounds in the feasibility stage for feline pre-diabetes and diabetes, non-alcoholic steatohepatitis and human obesity.  If regulatory approval is obtained, we expect our product candidates in our biopharm division to compete in markets with large potential.  Vivani’s neuromodulation division is developing the Orion® Visual Cortical Prosthesis System (“Orion”), an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including RP, glaucoma, diabetic retinopathy, optic nerve injury or disease and eye injury. Orion is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light. We are conducting a six- subjectan Early Feasibility Study of the Orion device at the Ronald Reagan UCLA Medical Center in Los Angeles (“UCLA”) and Baylor College of Medicine in Houston (“Baylor”).   Our 36 month results, which were measured after the study resumed, indicate to us that:

●We have a good safety profile. Five subjects experienced a total of thirteen adverse events (AEs) related to the device or to the surgery, through July 2021. One early AF was considered a serious adverse event (SAE), and all of the adverse events were in the expected category. The one SAE occurred at about three months post-implant, was resolved quickly, and did not require a hospital stay. There have been no serious adverse events due to the device or surgery since June 2018.

●The efficacy data is encouraging. We measure efficacy by looking at three measures of visual function: The first is square localization, where Orion subjects sit in front of a touch screen and are asked to touch within the boundaries of a square when it appears. The second is direction of motion, where subjects are asked to identify the direction and motion of lines on a screen. The third is grating visual acuity, a measure of visual acuity that is adapted for very low vision. Four subjects have completed these tests at 36-months, one subject at 24-months, and one subject at 12-months. Considering the most recent results for each subject, on square localization, six of six subjects tested in our feasibility study performed significantly better with the system on than off. On direction of motion, six of six performed better with the system on than off. On grating visual acuity, two of six tested had measurable visual acuity on the scale of this test (versus none who can do it with the device off). Another efficacy measurement of day-to-day functionality and benefit is FLORA, an acronym for Functional Low-Vision Observer Rated Assessment. FLORA is an assessment performed by an independent, third-party low vision orientation and mobility specialist who spends time with each of the subjects in their homes. The specialist asks each of the subjects a series of questions and also observes them performing 15 or more daily living tasks, such as finding light sources, following a sidewalk, or sorting laundry. The specialist then determines if the system is providing a benefit, if it is neutral, or if it is actually hurting the abilities of subjects to perform these tasks. Due to the Covid-19 pandemic, 4 out of 6 FLORA assessments were not performed at the 24 month timeframe.  A protocol update was made to add FLORA assessments at the 36 month timeframe.  FLORA results to date (the latest for each subject) show that six out of six completing the FLORA at 36 months had positive or mild positive results, indicating the Orion system is providing benefit. We reached agreement with the FDA in the fourth quarter of 2019 to utilize a revised version of FLORA as our primary efficacy endpoint in our pivotal trial for Orion, pending successful validation of the instrument.

No peer-reviewed data is available yet for the Orion system. We are currently negotiating the clinical and regulatory pathway to commercialization with the FDA as part of the Breakthrough Devices Program. One subject in the Early Feasibility study had the Orion device explanted on August 9, 2021. The explant was due to the need for an MRI to diagnose a condition unrelated to the Orion device.

Our principal offices are located in Los Angeles, California.

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Our first commercially approved product was the Argus® II Retinal Prosthesis System (“Argus II”). The Argus II was the only retinal prosthesis approved in the United States by the Food and Drug Administration (“FDA”), and was the first approved retinal prosthesis in the world. The Argus II system provided an artificial form of vision that differs from the vision of people with normal sight. It did not restore normal vision and there is no evidence that it slowed or reversed the progression of any disease. The majority of patients received a significant benefit from the Argus II, however results did vary and some patients reported receiving little or no benefit. By creating an artificial form of useful vision in patients who otherwise had total sight loss, the Argus II provided benefits that included:

●restoring independence through a renewed ability to navigate independently in unfamiliar environments;

●improving patients’ orientation and mobility, such as locating doors and windows, avoiding obstacles, and following the lines of a crosswalk;

●allowing patients to feel more connected with people in their surroundings, such as seeing when someone is approaching or moving away;

●providing patients with enjoyment from being “visual” again, such as locating the moon, tracking groups of players as they move around a field, and watching moving streams of lights from fireworks;

●enabling some patients to re-enter the workforce through multiple vocations that become possible because of Argus II; and

●improving patients’ well-being and ability to perform activities of daily living

We began selling the Argus II System in Europe at the end of 2011, Saudi Arabia in 2012, the United States and Canada in 2014, Turkey in 2015, Iran, Taiwan, South Korea and Russia in 2017, and Singapore in 2018. Given the limited addressable market of Argus II, we no longer market the Argus II and have focused all of our resources on the development of Orion.

We also researched multiple technologies that we believe to be complimentary to artificial vision and could potentially provide significant enhancements to the Orion user experience. In most cases, we collaborate with 3rd party firms to advance and integrate these innovative technologies with our artificial vision systems. Examples of technologies that we believe will be complimentary to our products include: eye tracking, object recognition and localization, thermal imaging and depth-based decluttering.

Product and Clinical Development Plans

By further developing our visual cortical prosthesis, Orion, we believe we may be able to significantly expand our market to include nearly all profoundly blind individuals. The only notable exceptions for potential use of the Orion are those who are blind due to otherwise currently treatable diseases, individuals who are born blind, or blindness due to direct damage of the visual cortex, which is rare. However, of the estimated 36 million blind people worldwide, there are approximately 5.8 million people who are legally blind due to causes that are not otherwise treatable. We continue to develop and refine our estimates of the potential addressable market size as we evaluate the commercial prospects for Orion using a combination of published sources, third party market research, and physician feedback. We currently estimate over 500,000 individuals in the US are legally blind due to retinitis pigmentosa, glaucoma, diabetic retinopathy, optic nerve disease and eye injury. Of this population, we estimate the potential US addressable market is between 50,000 and 100,000 individuals with bi-lateral blindness at the light-perception level or worse. Our marketing approvals by the FDA and other regulatory agencies will ultimately determine the subset of these patients who are eligible for the Orion based on our clinical trials and the associated results.

Our objective in designing and developing the Orion visual prosthesis system is to bypass the optic nerve and directly stimulate the part of the brain responsible for human vision. A six-subject Early Feasibility Study of the Orion device is currently underway at UCLA and Baylor. Regularly scheduled visits at both sites were paused in mid-March due to Covid-19, however visits at UCLA resumed mid- September 2020 and Baylor resumed in December 2020. Our 24 month results for the six subjects indicate a good safety profile with encouraging efficacy data and benefits in helping subjects perform their daily living tasks. We believe these data are encouraging and support advancement of Orion into a larger pivotal clinical study. Early promising results are not necessarily indicative of results that may be obtained in large clinical trials. No assurance can be given that we will achieve similar results in our larger Orion clinical trials. No peer-reviewed data is available yet for the Orion system.

 

In November 2017,February 2022, we announced the FDA granted Breakthrough Devices Program designation forsigning of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Second Sight Medical Products, Inc. (“Second Sight”), pursuant to which NPM would become a wholly-owned subsidiary of Second Sight. On August 30, 2022, the Orion. This designation is giventwo companies completed the merger, concurrent with which Second Sight changed its name to a few select medical devices in orderVivani Medical, Inc. and now conducts the present business of the Company. In September 2022, we announced the formation of the Company’s Biopharm Division to provide more effective treatmentadvance the assets of life-threatening or irreversibly debilitating diseases or conditions. This program is intendedthe former NPM and the Neuromodulation Division to help patients have more timely access to these medical devices by expediting their development, assessment, and review. The U.S. Food and Drug Administration (FDA) approvedadvance the Argus 2s Retinal Prosthesis System, a redesigned setassets of external hardware (glasses and video processing unit) initially for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP). The Company expects that the Argus 2s will be adapted to be the external system for the next generation Orion Visual Cortical Prosthesis System currently under development. In addition to ergonomic improvements, the Argus 2s system offers significantly more processing power, potentially allowing for improved video processing.former Second Sight.  

 

Below is a summary of other key business highlights and upcoming milestones:

Biopharm Division  

NPM-119 (GLP-1 receptor agonist implant) 

●Recent extensive studies have confirmed the excellent biocompatibility of NPM-119’s device constituent.
●Successfully completed an IND-enabling non-clinical toxicology study. 
●Initiated GMP manufacturing of clinical trial supplies for planned Phase 2 study designated as LIBERATE-1. 
●On track for IND filing and LIBERATE-1 study initiation in early 2023.  LIBERATE-1 is designed as a 12-week, randomized, multiple-dose, first-in-human clinical trial of NPM-119.Its primary objectives are to assess safety and tolerability and full pharmacokinetic characterization, with a secondary objective to evaluate change from baseline in glycemic control.
●Top-line results from LIBERATE-1 anticipated in late 2023. 
●Achieved 6-month NPM-119 preclinical proof-of-concept.

Pipeline 

●Demonstrated feasibility of companion feline program OKV-119 which is now advancing into preclinical development with partner Okava Pharma.

Neuromodulation Division 
Orion (cortical implant)

●Exploring strategic options to support advancement of this innovative technology. 
●Developing improved customer support proposals for legacy product customers.

18

 

Liquidity and Capital Resources

 

From inception, our operations have been funded primarily through the sales of our common stock and warrants, as well as from the issuance of debt, convertible debt, research and clinical grants, and limited product revenue which was generated from the salewarrants. The completion of our Argus II product. Funding of our business since 2019 has been primarilyreverse merger with Second Sight Medical Products, Inc. provided by:$53.3 million in net assets including approximately $55.4 million in cash.

 

●On June 25, 2021, we closed an underwritten public offering of 11,500,000 shares of common stock at a price of $5.00 per share for aggregate net proceeds of $53.3 million.

●On March 23, 2021, we closed our private placement to seven institutional investors of 4,650,000 shares of common stock at an offering price of $6.00 per share for aggregate net proceeds of approximately $24.5 million

●On December 8, 2020, we borrowed $1 million from Gregg Williams, Chairman of the Board of Directors of the Company and $1.2 million from two unaffiliated shareholders. These loans and accrued interest were repaid in the second quarter of 2021.

●On May 5, 2020, we closed our underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate net proceeds of approximately $6.7 million

We wereSecond Sight was awarded a $1.6 million grant (with the intent to fund $6.4 million over five years subject to annual review and approval) from the National Institutes of Health (NIH) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018. Our second year. The fourth-year grant of $1.4$1.1 million was approved on April 6, 2021 and our third year grant of $1.4 million was approved on May 12, 2021. As of September 30, 2021 we recorded $0.3 million of deferred grant costs, included in prepaid expenses and other current assets. For the three and nine months ended September 30, 2021 $0.3 million and $1.1 million of costs were offset by grants as compared to $0.4 million and $1.0 million for the comparable periods in 2020.July 18, 2022.

 

We were notified by the Nasdaq stock market on July 23, 2020 regarding our non-compliance with one of the continued listing requirements of the Nasdaq capital market. We have subsequently satisfied the Nasdaq compliance listing.

19

We are subject to the risks and uncertainties associated with a business with no revenue that is developing a novel pharmaceutical product candidates and medical device.devices candidates. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the foreseeable future. Our financial statements have been presented on the basis that our business is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. To finance our operations we will need to raise additional capital, which cannot be assured. Our operating plan may change as a result of many factors currently unknown to us, and we will need to seek additional funds through public or private equity offerings or debt financings, grants, collaborations, strategic partnerships or other sources. Separate from a discontinued proposed combination with Pixium, we have engaged in discussions relating to possible strategic transactions, with others, however, no assurances can be given that these discussions will continue, or if continued, that they will result in agreement or a completed transaction. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs, or we may be unable to expand or maintain our operations, maintain our current organization and employee base or otherwise capitalize on our business opportunities, as desired, which could materially and adversely affect our business, financial condition and results of operations.We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations for at least the next twenty-four months.

Merger Agreement 

As discussed in the Notes to Condensed Consolidated Financial Statements of the Company, on February 4, 2022, the Company entered the Merger Agreement. On May 13, 2022, the Company filed a Registration Statement on Form S-4 (the “Registration Statement”) with the SEC in connection with the contemplated Merger, which is currently effective. Shareholders of the Company approved the Merger on July 27, 2022 and the merger was completed in August 2022. We encourage you to review the final proxy statement/prospectus filed with the SEC on June 24, 2022 for more information about the Merger.

Safe Agreement

On February 4, 2022, in connection with the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight provided to NPM an investment advance of $8 million. If the Merger were to be terminated without completion, NPM would issue to Second Sight that number of shares of NPM common stock equal to not less than 2.133% of the issued and outstanding shares of NPM common stock assuming exercise or conversion of all outstanding vested and unvested options, warrants, and convertible securities. The agreement provided that the SAFE would terminate if the Merger were to be successfully completed.

Under the terms of the SAFE, upon successfully completion of the Merger on August 30, 2022, the investment advance was eliminated. Under the accounting for a business combination, the $8 million adjusted the purchase consideration.

 19

 

Critical Accounting Policies and Estimates

 

The preparation of our condensed consolidated financial statements in conformity with generally accepted accounting principles in the United States (“GAAP”) and the requirements of the United States Securities and Exchange Commission require management to make estimates, assumptions and judgments that affect the amounts, liabilities, revenue and expenses reported in the financial statements and the notes to the financial statements. On an ongoing basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2020.

 

There have been no material changes to our critical accounting policies during the nine months ended September 30, 2021 from those disclosed in the Annual Report on 10-K for the year ended December 31, 2020.2022.

 

20

Results of Operations

 

Net sales. Our net sales consisted of revenue primarily from the sale of our Argus II product which is no longer marketed. We have discontinued sales of this product to focus on development of Orion.

Cost of sales. Cost of sales includes the salaries, benefits, material, overhead, third party costs, warranty, charges for excess and obsolete inventory, and other costs required to make the Argus II system at our Los Angeles, California facility. Our product involves technologically complex materials and processes. We record cost of sales when products are implanted, which may differ from the period we are able to record revenue. Such timing differences may cause our reported results of operations to be difficult to compare from period to period.

Operating Expenses. We generally recognize our operating expenses as incurred in fourthree general operational categories: research and development, clinical and regulatory sales and marketing, and general and administrative. Our operating expenses also include a non-cash component related to the amortization of stock-based compensation for research and development, clinical and regulatory sales and marketing, and general and administrative personnel. We have received grants from institutions or agencies, such as the National Institutes of Health, to help fund the some of the cost of our development efforts. We have recorded the amount of funding received from these grants as reductions to operating expenses.

 

 ●Research and development expenses consist primarily of employee compensation and consulting costs related to the design, development, and enhancements of our current and potential future products, offset by grant revenue received in support of specific research projects. We expense our research and development costs as they are incurred. Due to the recent downsizing of our business, we are currently evaluating the path forward for our research and development activities for Orion, including the potential for collaboration with 3rd parties and/or outsourcing the engineering work for Orion.

 

 ●Clinical and regulatory expenses consist primarily of salaries, travel and related expenses for personnel engaged in clinical and regulatory functions, as well as internal and external costs associated with conducting clinical trials and maintaining relationships with regulatory agencies offset by grant revenue received in support of specific clinical research products. We expect clinical and regulatory expenses to be lower in the short-run as we have closed our clinical study activities related to Argus II and Orion clinical site visits were temporarily paused due to COVID-19. In the long-run, we expect clinical and regulatory expenses to increase if and when we conduct a pivotal clinical study of Orion.

●Sales and marketing expenses consist primarily of salaries, commissions, travel and related expenses for personnel engaged in sales, marketing, market access and business development functions, as well as costs associated with promotional and other marketing activities including the cost of units consumed as demos or samples. We expect sales and marketing expenses to be significantly lower in 2021 than in 2020 as we no longer employ sales and marketing personnel and no longer market the Argus II product.

 

 ●General and administrative expenses consist primarily of salaries and related expenses for executive, legal, finance, human resources, information technology and administrative personnel, as well as recruiting and professional fees, patent filing and annuity costs, insurance costs and other general corporate expenses, including rent. We expect general and administrative expenses to be significantly lower in 2021 as we have significantly reduced staff.

 

Comparison of the Three Months Ended September 30, 20212022 and 20202021

 

Research and development expense. Research and development expense increased by $0.4$1.0 million, or 150%34%, to $0.7$3.9 million in the third quarter of 20212022 from $0.3$2.9 million in the samethird quarter of 2020.2021. The costs increased as we restarted our curtailed activity due to COVID-19.the inclusion of our acquired company Second Sight costs being included from the merger acquisition date of August 30, 2022. This inclusion increased these costs for the quarter by $0.3 million. The remainder of the increase was due to subdermal drug implants development costs.

 

Clinical and regulatory expense.Clinical and regulatory expense was flat at $0.3 million in both quarters. This is attributable to continuingas the current quarter costs associated with the Orion feasibility study and similar offsets of grant funds. We expect clinical and regulatory costs to continuewere almost offset by grants in the future at a reduced level as we resume activities for our Early Feasibility Study.quarter.

 

General and administrative expense. General and administrative expense increased $0.4$1.0 million, or 44%156%, to $1.5$1.6 million in the third quarter of 20212022 from $1.1$0.6 million in the same quarterperiod of 2020. General and administrative expenses2021. This increase is primarily attributable to increased as a result of increased outside consultant services.costs associated with the current merger transaction.

 

Other income. Other income was impacted by the bargain purchase gain which occurred from the purchase accounting of the merger acquisition. The gain was the result of the acquired assets being valued in excess of the total equity value deemed issued to consummate the merger. This gain of $6.9 million was derived from the 13.1 million shares deemed issued at the merger date valued at the market price as of that date, as adjusted by the cancellation of the SAFE agreement, as compared to the net assets acquired which consisted primarily of cash.

21 20

 

Comparison of the Nine Months Ended September 30, 20212022 and 20202021

 

Research and development expense.Research and development expense decreasedincreased by $2.8$1.7 million, or 62%21%, to $1.7$9.7 million in the first nine months 2021of 2022 from $4.5$8.0 million in the same period of 2020.2021. The costs decreasedprimarily increased due to increased cost associated with our staffing reductions. We expect our research and development expenses to increase as we restart our curtailed activity based upon our revised development plans.of the subdermal drug implants.

 

Clinical and regulatory expense.Clinical and regulatory expense decreased $1.0 million, or 64%, to $0.6 million incost only include the first nine months of 2021 from $1.6 million in the same period of 2020. This decrease is attributable to decreasedone month costs associated with our acquisition of Second Sight since the Orion feasibility study and increased offsets of grant funds. We expect clinical and regulatorymerger date. These costs to continuewere flat as the costs were almost offset by grants in the future at a reduced level.this period.

 

Selling and marketing expense. Selling and marketing expense was zero in the first nine months of 2021 as compared to $0.7 million in the same period of 2020. We expect selling and marketing expense to cease until we begin marketing our Orion product.

General and administrative expense. General and administrative expense increased $0.7$2.0 million, or 16%112%, to $5.3$3.7 million in the first nine months of 20212022 from $4.6$1.7 million in the same period of 2020.2021. This increase is primarily attributable to increased legalthe costs and termination fee associated with our termination of the MOU of $1.0 million. These increases in general and administrative expenses were offset by staffing reductions.current merger agreement.

 

Restructuring charges.Other income. We recorded non-cash restructuring chargesOther income was impacted by the bargain purchase gain which occurred from the purchase accounting of $1.2the merger acquisition. The gain was the result of the acquired assets being valued in excess of the total equity value deemed issued to consummate the merger. This gain of $6.9 million inwas derived from the first nine months13.1 million shares deemed issued at the merger date valued at the market price as of 2020 comprisedthat date, as adjusted by the cancellation of $0.5 millionthe SAFE agreement, as compared to fully reserve our inventory in connection with our decision to no longer market Argus II and $0.7 million to write-down our fixed assets that are not directly involved in the developmentnet asset acquired which consisted primarily of Orion and $0.2 million in material and overhead costs associated with Argus II and $0.8 million charge for severance compensation and other associated costs all of which was substantially settled by September 30, 2020.cash.

 

Liquidity and Capital Resources

 

Our financial statements have been preparedpresented on the basis that our business is a going concern, basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our abilityWe are subject to the risks and uncertainties associated with a business with no revenue that is developing a novel pharmaceutical product candidates and medical device candidates, including limitations on our operating capital resources and uncertain demand for our products. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue as a going concern is dependent on our ability to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there can be no assurances that we will be able to do so.incur operating losses and negative operating cash flows for the foreseeable future. 

 21

 

On June 25, 2021, we closed an underwritten public offering of 11,500,000 shares of common stock at a price of $5.00 per share for aggregate net proceeds of $53.3 million.

On March 23, 2021, we closed our private placement to seven institutional investors of 4,650,000 shares of stock at an offering price of $6.00 per share for aggregate net proceeds of approximately $24.5 million.

On December 8, 2020, we borrowed $1 million from Gregg Williams, Chairman of the Board of Directors of the Company and $1.2 million from two unaffiliated shareholders. These loans and accrued interest were repaid during May and June 2021.

On May 5, 2020, we closed our underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate net proceeds of approximately $6.6 million.

Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward- looking statement that involves risks and uncertainties, and actual results could vary materially. Conducting clinical trials is a time- consuming,time-consuming, expensive and uncertain process that takes many years to complete and we may never generate the necessary data or results required to obtain marketing approval. We do not expect revenues until we are successful in completing the development and obtaining marketing approval for Orion.our products. We expect expenses to increase in connection with our ongoing activities, particularly as we continueinitiate clinical trials, of Orion, initiate new research and development projects and seek marketing approval for any product candidates that we successfully develop. In particular, we expect to incur increased expenses as we initiate our planned Phase 2 clinical trial of NPM-119, for which we plan to file an Investigational New Drug application, or IND, in the first quarter of 2023 with the FDA. In addition, if we obtain marketing approval for Orion, we expect to incur significant additional expenses related to sales, marketing, distribution and other commercial infrastructure to commercialize such product. In addition, our product candidates, if approved, may not achieve commercial success. We incur significant costs associated with operating as a public company in a regulated industry.

 

Until such time, if ever, we can generate substantial product revenues, we anticipate that we will seek to fund our operations through public or private equity or debt financings, grants, collaborations, strategic partnerships or other sources. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity, convertible debt or other equity-linked securities, the ownership interests of some or all of our common stockholders will be diluted, the holders of new equity securities may have priority rights over our existing stockholders and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If adequate funds are not available, we may be required to further curtail operations significantly or to obtain funds by entering into agreements on unattractive terms. If, for example, we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us. Our inability to raise capital could have a material adverse effect on our business, financial condition and results of operations.

 

22

Cash and cash equivalents increased by $68.9$49.5 million from $3.2$2.2 million as of December 31, 20202021 to $72.0$51.7 million as of September 30, 2021.2022. Working capital was $69.3$48.8 million as of September 30, 2021, as2022 compared to a deficit of $0.9$0.4 million as of December 31, 2020,2021, an increase of $70.2 million.$48.4 million primarily as a result merger with Second Sight. We use our cash and cash equivalents and working capital to fund our operating activities.

 

Cash Flows from Operating Activities

 

During the first nine months of 2021,2022, we used $6.8$13.6 million of cash in operating activities, consisting primarily of a net loss of $7.6$6.6 million increased by non-cash charges which used cash of $5.4 million for depreciation and amortization of property and equipment, stock-based compensation and change in right of use assets and the gain from the bargain purchase and a net change in operating assets and liabilities of $1.6 million. During the first nine months of 2021, we used $8.0 million of cash in operating activities, consisting primarily of a net loss of $9.1 million, offset by non-cash charges which provided cash of $0.1$0.8 million for depreciation and amortization of property and equipment, stock-based compensation, change in right of use assets and PPP loan forgiveness and by a net change in operating assets and liabilities of $0.7 million. During the first nine months of 2020, we used $15.4 million of cash in operating activities, consisting primarily of a net loss of $13.6 million, offset by non-cash charges which provided cash of $1.7 million for depreciation and amortization of property and equipment, stock-based compensation, change in right of use assets, impairment charge and offset by a net change in operating assets and liabilities of $3.5$0.3 million.

 

Cash Flows from Investing Activities

 

Cash used for investing activities in the first nine months of 2022 and 2021 was zero$0.3 million. In 2022 $0.2 was used for the purchase of property and cash providedequipment and $0.1 million for investing activitiesthe purchase on intangibles. In 2021, $0.3 million was $67,000 in the first nine months of 2020 consisting of $398,000 generated from sale of assets held for sale, partially offset by $331,000used for the purchase of property and equipment.

 

Cash Flows from Financing Activities

 

Financing activities provided $75.6$63.4 million in the first nine months of 2022. Of this amount $55.4 million was the cash acquired in the merger for stock consideration and $8.0 million for the SAFE borrowing. Financing activities provided $7.4 million of cash in the first nine months of 2021 consisting of $77.8 million of net proceeds from the sale of common stock and $25,000 from the proceeds from warrant exercises offset by the repaymentexercise of debt of $2.2 million. Financing activities provided $6.4 million of cash in the first nine months of 2020 consisting of $6.7 million of net proceeds from the sale of common stock offset by the use of $281,000 for the repurchase of partial shares in connection with our reverse stock split and the repurchase of ESPP shares.warrants.

 

Off-Balance Sheet Arrangements

 

AtAs of September 30, 2021,2022, we did not have any transactions, obligations or relationships that constitute off-balance sheet arrangements.

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Item 3.Quantitative and Qualitative Disclosures about Market Risk

Interest Rate Sensitivity

 

The primary objective of our investment activities is to maintain the safety of principal and preserve liquidity without incurring significant risk. We invest cash in excess of our current needs in money market funds. As of September 30, 2021,2022, our investments consisted solely of money market funds.

 

Exchange Rate Sensitivity

 

The majority of our operating expenses were denominated in U.S. dollars. We have not entered into foreign currency forward contracts to hedge our operating expense exposure to foreign currencies, but we may do so in the future.

 

Item 4.Controls and Procedures

Evaluation of Disclosure Controls and Procedures

 

Our management, including our Acting Chief Executive Officer (“CEO”) and our Acting Chief AccountingFinancial Officer (“CAO”CFO”), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2021.the end of the period covered by this report. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. As of September 30, 2021,2022, based on the evaluation of these disclosure controls and procedures, our CEO and CAOCFO have concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

There has been no change in our internal control over financial reporting during the nine monthsquarter ended September 30, 20212022, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We are updating our internal control environment to address changes in our risks in financial reporting to accommodate our reductions in operating activities, reductions in staffing levels, and segregation of duties. Such changes may result in new or reduced controls.

 

23

Inherent Limitations on Effectiveness of Controls

 

Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

24 23

 

PART II-OTHER INFORMATION

 

Item 1.Legal Proceedings

FourThree oppositions filed by Pixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity of a European patent owned by us.Second Sight. The outcomes of the challenges are not certain, however, if successful, they may affect our ability to block competitors from utilizing our patented technology. We believe a successful challenge will not have a material effect on our ability to manufacture and sell our products, or otherwise have a material effect on our operations.

 

As described in the Company’s 10-K for the year ended December 31, 2020, the CompanySecond Sight had entered into a Memorandum of Understanding (“MOU”) for a proposed business combination with Pixium Vision SA (“Pixium”).Pixium. In response to a press release by Pixium dated March 24, 2021, and subsequent communications between usSecond Sight and Pixium, ourSecond Sight’s Board of Directors determined that the business combination with Pixium was not in the best interest of ourtheir shareholders. On April 1, 2021, weSecond Sight gave notice to Pixium that wethey were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. WeSecond Sight accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021 and remitted that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the Company’sSecond Sight’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, claimingand currently claim damages of €5,217,659.60,approximately €5.1 million or about $6,162,760.$5.1 million at current exchange rates. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000.$1,000,000 and thus the Company does not believe any further loss accrual is necessary.

 

In November 2020, weSecond Sight and Pixium retained Oppenheimer & Co. Inc. as placement agent for a proposed private placement of securities in connection with the Pixium Business Combination. On April 1, 2021, weSecond Sight received an invoice from Oppenheimer for more than $1.86 million. This amount includes a requested commission of 6.5% on $27.9 million raised in the private placement that we completed in March 2021.placement. We believe that claims for payment presented by this invoice are without merit.

On or about July 19, 2021 Martin Sumichrast filed a complaint with the Superior Court of the State of California, County of Los Angeles—Central District, claiming that he is entitled to compensation for services, as well as exemplary and other damages in an amount to be determined at trial but not less than $2 million, which arise from his allegedly arranging and securing financing that the Company obtained in May 2020 via a registered underwritten public offering of common stock. The action is in early stages and the Company is considering its responses, however the Company believes that the claims for compensation are without merit and intends to defend vigorously.

 

From time to time, we may be involved in a variety of legal proceedings and claims relating to securities laws, product liability, patent infringement, contract disputes, employment matters and other matters relating to various claims that arise in the normal course of our business in addition to governmental and other regulatory investigations and proceedings. It is our opinion that the outcome of such matters will not have a material adverse effect on our results of operations, however, the results of litigation, proceedings, disputes and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

 

Item 1A.Item 1A.     Risk Factors

Our business is subject to numerous material and other risks. You should carefully consider the risks and uncertainties described below together with all of the other information contained in this Form 10-Q, including our consolidated financial statements and the related notes, and in our other filings with the SEC. If any of the stated risks actually occur, our business, prospects, operating results, and financial condition could suffer materially. In such event, the trading price of our common stock could decline and you might lose all or part of your investment. The material risks associated with our business were most recently discussed in our definitive proxy statement/prospectus that we filed on June 24, 2022 in relation to our reverse merger transaction. There have been no material changes in information regarding ourfrom the risk factors as described: Item 1A of our Annual Report on Form 10-K as filed with the SEC on March 16, 2021 and any subsequent filings.previously disclosed in such filing. 

 

Item 2.Unregistered Sales of Equity Securities and Use of ProceedsOther Global Developments 

 

NoneIn 2022, various central banks around the world (including the Federal Reserve in the United States) raised interest rates. While these rate increases have not had a significant adverse impact on the Company to date, the impact of such rate increases on the overall financial markets and the economy may adversely impact the Company in the future. In addition, the global economy has experienced and is continuing to experience high levels of inflation and global supply chain disruptions. The Company continues to monitor these supply chain, inflation and interest rate factors, as well as the uncertainty resulting from the overall economic environment. 

 

Item 3.In addition, although the Company has no operations in or direct exposure to Russia, Belarus and Ukraine, the Company has experienced limited constraints in availability and increasing costs required to obtain some materials and supplies due, in part, to the negative impact of the Russia-Ukraine military conflict on the global economy. To date, the Company’s business has not been materially impacted by the conflict, however, as the conflict continues or worsens, it may impact the Company’s business, financial condition or results of operations.Defaults upon Senior Securities

 

Item 2.Unregistered Sales of Equity Securities and Use of Proceeds

None.

 

Item 3.Defaults upon Senior Securities

Item 4.Mine Safety DisclosuresNone.

 

Item 4.Mine Safety Disclosures

Not applicable.

 

Item 5.Other Information

 Item 5.Other Information

None.

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Item 6.Exhibits

Item 6.Exhibits

EXHIBIT INDEX

 

Exhibit No. 

No.

 Exhibit Description
   
31.12.1Merger Agreement dated February 4, 2022 (incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on February 8, 2022).
 
2.2Waiver of Available Cash Requirement to the Merger Agreement dated June 15, 2022 (incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on June 21, 2022).
3.1

Restated Articles of Incorporation of the Registrant as amended (incorporated by reference to Exhibit 3.1 in the Company’s Registration Statement on Form S-1 filed with the SEC on September August 12, 2014)

3.2

Amendment to Restated Articles of Incorporation of the Registrant (incorporated by reference to Exhibit 3.2 in the Company’s Registration Statement on Form S-4 filed with the SEC on September May 13, 2022)

3.3

Second Amendment to Restated Articles of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 in the Company’s Current Report on Form 8-K filed with the SEC on January 3, 2020)

3.4

Certificate of Amendment, filed August 25, 2022, and effective August 30, 2022 changing the name of the Company to “Vivani Medical, Inc.” (incorporated by reference Exhibit 3.1 in the Company’s Current Report on Form 8-K filed with the SEC on September 2, 2022)

3.5

Amended and Restated Bylaws of the Registrant, as currently in effect (incorporated by reference to Exhibit 3.1 in the Company’s Registration Statement on Form S-1 filed with the SEC on September August 12, 2014)

10.1

Form of Lock-Up Agreement (incorporated by reference to the registrant’s proxy statement/prospectus on Form S-4, file no. 333-264959, originally filed with the Securities and Exchange Commission on May 13, 2022)

10.2

Non-Employee Director Compensation Policy*

21.1

List of Subsidiaries*

31.1Certification of Principal Executive Officer of Second Sight Medical Products, Inc. pursuant to Section 302 of Sarbanes-Oxley Act of 2002.*
   
31.2 Certification of Principal Financial and Accounting Officer of Second Sight Medical Products, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
   
32.1 Certifications of Principal Executive Officer and Principal Financial and Accounting Officer of Second Sight Medical Products, Inc.  pursuant to Rule 13a-14(b) under the Exchange Act and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
   
101.INS XBRL Instant Document.*
   
101.SCH XBRL Taxonomy Extension Schema Document.*
   
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document.*
   
101.DEF XBRL Taxonomy Extension Definition Linkbase Document.*
   
101.LAB XBRL Taxonomy Extension Label Linkbase Document.*
   
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document.*
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)*

 

*Included herein.

26 25

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report has beenreport to be signed belowon its behalf by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.undersigned thereunto duly authorized.

 

Name Title Date
     
/s/ Scott DunbarAdam Mendelsohn Acting Chief Executive Officer November  12, 202114, 2022
Scott Dunbar Adam Mendelsohn (Principal Executive Officer)  
     
/s/  Edward SedoBrigid Makes Acting Chief AccountingFinancial Officer November  12, 202114, 2022
Edward SedoBrigid Makes (Principal Financial and Accounting Officer)  

27