UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

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

 

For the quarterly period ended:March 31,June 30, 2019

 

or

 

[  ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

[  ]TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _____________ to _____________.

 

Commission File Number:000-13789

 

ADHERA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware 11-2658569

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

   

4721 Emperor Boulevard, Suite 350

Durham, NC

 

 

27703

(Address of principal executive offices) (Zip Code)

 

(919) 578-5901

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

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 [X] 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 [X] No [  ]

 

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

 

Large accelerated filer[  ]Accelerated filer[  ]
    
Non-accelerated filer[  ] (Do not check if a smaller reporting company)Smaller reporting company[X]
    
  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 7(a)(2)(B) of the Securities Act: [  ]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ] No [X].

 

As of May 10,August 12, 2019, there were 10,869,530 shares of the registrant’s common stock outstanding.

 

 

 

   
 

 

ADHERA THERAPEUTICS, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED MARCH 31,JUNE 30, 2019

 

TABLE OF CONTENTS

 

 Page
  
PART I - FINANCIAL INFORMATION 
   
ITEM 1Financial Statements (unaudited)3
   
 Condensed Consolidated Balance Sheets as of March 31,June 30, 2019 and December 31, 20183
   
 Condensed Consolidated Statements of Operations for the Three and Six Months Ended March 31,June 30, 2019 and 20184
   
 Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the ThreeSix Months Ended March 31,June 30, 2019 and 20185
   
 Condensed Consolidated StatementStatements of Cash Flows for the ThreeSix Months Ended March 31,June 30, 2019 and 20186
   
 Notes to Condensed Consolidated Financial Statements7
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2219
   
ITEM 3.Quantitative and Qualitative Disclosures about Market Risk2724
   
ITEM 4.Controls and Procedures2725
   
PART II - OTHER INFORMATION 
   
ITEM 1.Legal Proceedings2826
   
ITEM 1A.Risk Factors2927
   
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds2927
   
ITEM 6.Exhibits3027
   
SIGNATURES3128

 

 2 
 

 

PART I – FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except for share and per share amounts)

  March 31, 2019  December 31, 2018 
  (Unaudited)    
ASSETS      
         
Current assets        
Cash $1,828,476  $3,918,290 
Accounts receivable, net of allowance  39,388   48,289 
Inventory  258,007   241,458 
Prepaid expenses and other assets  491,177   469,142 
Total current assets  2,617,048   4,677,179 
         
Operating lease right of use asset  208,830   - 
Furniture and fixtures, net of depreciation  68,852   71,774 
Intangible assets, net of amortization  374,317   391,892 
Total non-current assets  651,999   463,666 
         
Total assets $3,269,047  $5,140,845 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $322,633  $270,138 
Due to related party  52,658   27,977 
Accrued expenses  850,180   851,870 
Current portion of operating lease liability  88,940   - 
Accrued dividends  1,445,825   1,064,141 
Total current liabilities  2,760,236   2,214,126 
         
Other lease liability, net of current portion  126,540   - 
Total liabilities  2,886,776   2,214,126 
         
Commitments and contingencies (Note 9)        
         
Stockholders’ equity        
Preferred stock, $0.01 par value; 100,000 shares authorized        
         
Series C convertible preferred stock, $0.01 par value; $5,100 liquidation
preference; 1,200 shares authorized; 100 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  -   - 
         
Series D convertible preferred stock, $0.01 par value; $300 liquidation
preference; 220 shares authorized; 40 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  -   - 
         
Series E convertible preferred stock, $0.01 par value; $5,000 liquidation
preference; 3,500 shares authorized; 3,488 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  35   35 
         
Series F convertible preferred stock, $0.01 par value; $5,000 liquidation
preference; 2,200 shares authorized; 381 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  3   3 
         
Common stock, $0.006 par value; 180,000,000 shares authorized;
10,761,684 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  64,570   64,570 
Additional paid-in capital  29,105,306   28,709,916 
Accumulated deficit  (28,787,643)  (25,847,805)
         
Total stockholders’ equity  382,271   2,926,719 
         
Total liabilities and stockholders’ equity $3,269,047  $5,140,845 

  June 30, 2019  December 31, 2018 
  (Unaudited)    
ASSETS        
         
Current assets        
Cash $1,644  $3,918 
Accounts receivable, net of allowance  94   48 
Inventory  232   242 
Prepaid expenses and other assets  184   469 
Total current assets  2,154   4,677 
         
Operating lease right of use asset  178   - 
Furniture and fixtures, net of depreciation  67   72 
Intangible assets, net of amortization  357   392 
   602   464 
         
Total assets $2,756  $5,141 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)        
         
Current liabilities        
Accounts payable $955  $270 
Due to related party  4   28 
Accrued expenses  1,063   852 
Current portion of operating lease liability  78   - 
Accrued dividends  1,800   1,064 
Loan payable  1,260   - 
Total current liabilities  

5,160

   2,214 
         
Other lease liability, net of current portion  107   - 
Total liabilities  

5,267

   2,214 
         
Commitments and contingencies (Note 9)        
         
Stockholders’ equity (deficit)        
Preferred stock, $0.01 par value; 100,000 shares authorized        
         
Series C convertible preferred stock, $0.01 par value; $5,100 liquidation preference; 1,200 shares authorized; 100 shares issued and outstanding as of June 30, 2019 and December 31, 2018  -   - 
         
Series D convertible preferred stock, $0.01 par value; $300 liquidation preference; 220 shares authorized; 40 shares issued and outstanding as of June 30, 2019 and December 31, 2018  -   - 
         
Series E convertible preferred stock, $0.01 par value; $5,000 liquidation preference; 3,500 shares authorized; 3,478 and 3,488 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively  -   - 
         
Series F convertible preferred stock, $0.01 par value; $5,000 liquidation preference; 2,200 shares authorized; 381 shares issued and outstanding as of June 30, 2019 and December 31, 2018  -   - 
         
Common stock, $0.006 par value; 180,000,000 shares authorized, 10,869,530 and 10,761,684 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively  65   65 
Additional paid-in capital  29,346   28,710 
Accumulated deficit  (31,922)  (25,848)
         
Total stockholders’ equity (deficit)  (2,511)  2,927 
         
Total liabilities and stockholders’ equity (deficit) $2,756  $5,141 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(in thousands, except for share and per share amounts)

  

For the Three Months Ended

March 31,

 
  2019  2018 
       
Net sales $2,881  $- 
Cost of sales  116,933   - 
Gross loss  (114,052)  - 
         
Operating expenses        
         
Sales, marketing and commercial operations 1,059,222  - 
Research and development  -   173,256 
General and administrative  1,367,303   919,908 
Amortization  17,575   123,261 
Total operating expenses  2,444,100   1,216,425 
         
Loss from operations  (2,558,152)  (1,216,425)
         
Other expense        
         
Interest expense  -   (144,744)
   -   (144,744)
         
Loss before provision for income taxes  (2,558,152)  (1,361,169)
         
Provision for income taxes  -   - 
         
Net loss  (2,558,152)  (1,361,169)
         
Preferred Stock Dividends  (381,686)  - 
         
Net Loss Applicable to Common Stockholders $(2,939,838) $(1,361,169)
         
Net loss Per Share - Common Stockholders - basic and diluted $(0.27) $(0.13)
         
Weighted average shares outstanding- basic and diluted  10,761,684   10,521,278 

  For the Three Months Ended  For the Six Months Ended 
  June 30,  June 30, 
  2019  2018  2019  2018 
             
Net sales $66  $-  $69  $- 
Cost of sales  81   -   198   - 
Gross Margin  (15)  -   (129)  - 
                 
Operating expenses                
                 
Sales, marketing and commercial operations  1,148   2,586   2,207   2,586 
Research and development  -   -   -   173 
General and administrative  1,599   1,059   2,966   1,979 
Amortization  17   123   35   247 
Total operating expenses  2,764   3,768   5,208   4,985 
                 
Loss from operations  (2,779)  (3,768)  (5,337)  (4,985)
                 
Other expense                
                 
Interest expense  (1)  (5)  (1)  (149)
Loss on settlement  -   (875)  -   (875)
   (1)  (880)  (1)  (1,024)
                 
Loss before provision for income taxes  (2,780)  (4,648)  (5,338)  (6,009)
                 
Provision for income taxes  -   -   -   - 
                 
Net loss (2,780) (4,648) (5,338) (6,009)
                 
Preferred Stock Dividends  (357) (271) (739) (271)
                 
Net Loss Applicable to Common Stockholders $

(3,137

) $(4,919) $(6,077) $(6,280)
                 
Net loss per share – Common Shareholders - basic and diluted $(0.29) $(0.45) $(0.56) $(0.59)
                 
Weighted average shares outstanding - basic and diluted  10,860,049   10,821,230   10,811,138   10,672,082 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)

(in thousands, except for share amounts)

  Series E Preferred Stock  Series F Preferred Stock  Common Stock  Additional  Additional
Paid-in
      
  Number  Par
Value
  Number  Par
Value
  Number  Par
Value
  Paid-in
Capital
  Capital
Warrants
  Accumulated
Deficit
  Total 
                               
Balance, December 31, 2017  -  $-   -  $-   10,521,278  $63  $8,414  $-  $(8,029) $448 
Share based compensation  -   -   -   -   -   -   119   -   -   119 
Net loss  -   -   -   -   -   -   -   -   (1,361)  (1,361)
Balance, March 31, 2018  -   -   -   -   10,521,278   63   8,533   -   (9,390)  (794)
Issuance of Series E Preferred Stock, net of fees  2,812   -   -   -   -   -   12,258   -   -   12,258 
Warrants issued with Series E Preferred Stock  -   -   -   -   -   -   (31,107)  31,107   -   - 
Issuance of Series E Preferred for debt and accounts payable  687   -   -   -   -   -   3,438   -   -   3,438 
Conversion of Series C Preferred stock for common stock  -   -   -   -   433,334   3   (3)  -   -   - 
Conversion of Series D Preferred stock for common stock  -   -   -   -   25,000   -   -   -   -   - 
Warrants issued for settlement of liability  -   -   -   -   -   -   -   1,494   -   1,494 
Shares issued for settlement of litigation  -   -   -   -   210,084   1   249   -   -   250 
Shares issued for License Agreement  -   -   -   -   51,988   -   75   -   -   75 
Accrued dividend  -   -   -   -   -   -   -   -   (271)  (271)
Share based compensation  -   -   -   -   -   -   374   -   -   374 
Cancellation of Series E Preferred Stock  (9)  -   -   -   -   -   (46)  -   -   (46)
Net loss  -   -   -   -   -   -   -   -   (4,648)  (4,648)
Balance, June 30, 2018  3,490  $-   -  $-   11,241,684  $67  $(6,229) $32,601  $(14,309) $12,130 

  Series E Preferred Stock  Series F Preferred Stock  Common Stock  Additional  

Additional

Paid-in

      
  Number  Par 
Value
  Number  Par
Value
  Number  Par 
Value
  Paid-in
Capital
  

Capital -

Warrants

  Accumulated
Deficit
  Total 
                               
Balance, December 31, 2018  3,488  $        -   381  $            -   10,761,684  $65  $(5,384) $34,094  $(25,848) $2,927 
Accrued dividend  -   -   -   -   -   -   -   -   (382)  (382)
Share based compensation  -   -   -   -   -   -   395   -   -   395 
Net loss  -   -   -   -   -   -   -   -   (2,558)  (2,558)
Balance, March 31, 2019  3,488   -   381   -   10,761,684   65   (4,989)  34,094   (28,788)  382 
Conversion of Series E Preferred stock for common stock  (10)  -   -   -   107,846   -   -   -   3   3 
Accrued dividend  -   -   -   -   -   -   -   -   (357)  (357)
Share based compensation  -   -   -   -   -   -   241   -   -   241 
Net loss                          -   -   (2,780)  (2,780)
Balance, June 30, 2019  3,478  $-   381  $-   10,869,530  $65  $(4,748) $34,094  $(31,922) $(2,511)

The accompanying notes are an integral part of these consolidated financial statements.

ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITYCASH FLOWS

(Unaudited)

  Series E Preferred Stock  Series F Preferred Stock  Common Stock  

Additional

  

Additional

Paid-in

      
  Number  Par
Value
  Number  Par
Value
  Number  Par
Value
  

Paid-in

Capital

  

Capital -

Warrants

  

Accumulated

Deficit

  Total 
                               
Balance, December 31, 2017        -  $      -        -  $      -   10,521,278  $63,127  $8,413,823  $          -  $(8,028,707) $448,243 
                                         
Share based compensation  -   -   -   -   -   -   118,879   -   -   118,879 
                                         
Net loss  -   -   -   -   -   -   -   -   (1,361,169)  (1,361,169)
                                         
Balance, March 31, 2018  -  $-   -  $-   10,521,278  $63,127  $8,532,702  $-  $(9,389,876) $(794,047)

(in thousands)

 

  Series E Preferred Stock  Series F Preferred Stock  Common Stock  

Additional

  

Additional

Paid-in

  

   
  Number  Par
Value
  Number  Par
Value
  Number  Par
Value
  

Paid-in

Capital

  

Capital -

Warrants

  

Accumulated

Deficit

  Total 
Balance, December 31, 2018  3,488  $    35   381  $       3   10,761,684  $64,570  $(5,383,913) $34,093,829  $(25,847,805) $2,926,719 
                                         
Accrued dividend  -   -   -   -   -   -   -   -   (381,686)  (381,686)
                                         
Share based compensation  -   -   -   -   -   -   395,390   -   -   395,390 
                                         
Net loss  -   -   -   -   -   -   -   -   (2,558,152)  (2,558,152)
                                         
Balance, March 31, 2019  3,488  $35   381  $3   10,761,684  $64,570  $(4,988,523) $34,093,829  $(28,787,643) $382,271 

  For the Six Months Ended June 30, 
  2019  2018 
       
Cash Flows Used in Operating Activities:        
         
Net loss $(5,338) $(6,009)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share based compensation  

636

   493 
Common shares issued for settlement  -   250 
Preferred shares issued for note settlement  -   375 
Common shares issued to license agreement  -   75 
Amortization of intangibles  35   247 
Bad debt expense  

41

   

-

 
Amortization of debt discount  -   113 
Depreciation  5   - 
Non-cash interest expense  1   37 
Non-cash lease expense  62   - 
Loss on settlement  -   875 
Changes in operating assets and liabilities:        
Accounts receivable  (87)  - 
Inventory  10   (80)
Prepaid expenses and other assets  285   (193)
Accounts payable  685   161 
Accrued expenses  218   (330)
Accrued fee payable  -   (320)
Deferred revenue  -   200 
Due to related party  (24)  250 
Lease liability  (62)  - 
         
Net Cash Used in Operating Activities  (3,533)  (3,856)
         
Cash Flows Used in Investing Activities:        
Purchase of furniture and fixtures  -   (10)
         
Net Cash Used in Investing Activities  -   (10)
         
Cash Flows Provided By Financing Activities:        
         
Proceeds from sale of preferred stock, net offering expenses  -   12,258 
Proceeds from loan payable  1,495   - 
Loan payable issuance costs  (236)  - 
Payments for notes payable  -   (144)
         
Net Cash Provided by Financing Activities  1,259   12,114 
         
Net (decrease) increase in cash  (2,274)  8,248 
         
Cash – Beginning of Period  3,918   106 
Cash - End of Period $1,644  $8,354 
         
Supplemental Cash Flow Information:        
Non-cash Investing and Financing Activities:       
Capitalization of operating lease right of use asset $240  $- 
Issuance of warrants for liabilities, related party  -   1,494 
Preferred share settlement of debt and accrued liabilities  -   3,438 
Issuance of warrants  -   31,107 
Accrued dividends  739   271 
Conversion of Series E accrued dividend for common stock  3   - 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5

ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  For the Three Months Ended March 31, 
  2019  2018 
       
Cash Flows Used in Operating Activities:        
         
Net loss $(2,558,152) $(1,361,169)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share based compensation  395,390   118,879 
Amortization of intangibles  17,575   123,261 
Depreciation  2,922   - 
Non-cash interest expense  -   144,744 
Non-cash lease expense  30,938   - 
Deferred revenue  -   200,000 
Changes in operating assets and liabilities:        
Accounts receivable  8,901   - 
Inventory  (16,549)  - 
Prepaid expenses and other assets  (22,035)  (80,571)
Accounts payable  52,495   428,906 
Accrued expenses  4,862   47,816 
Due to related party  24,681   319,524 
Lease liability  (30,842)  - 
         
Net Cash Used in Operating Activities  (2,089,814)  (58,610)
         
Net decrease in cash  (2,089,814)  (58,610)
         
Cash – Beginning of Period  3,918,290   106,378 
Cash - End of Period $1,828,476  $47,768 
         
Non-cash Investing and Financing Activities:        
Capitalization of operating lease right of use asset $239,768  $- 
Accrued dividends $381,686  $- 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

6

ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE THREE AND SIX MONTHS ENDED MARCH 31,JUNE 30, 2019

(Unaudited)

 

Note 1 – Nature of Operations, Basis of Presentation and Significant Accounting Policies

 

Business Overview

 

Adhera Therapeutics, Inc. (formerly known as Marina Biotech, Inc.) and its wholly-owned subsidiaries, MDRNA Research, Inc. (“MDRNA”), Cequent Pharmaceuticals, Inc. (“Cequent”), Atossa Healthcare, Inc. (“Atossa”), and IThenaPharma, Inc. (“IThena”) (collectively “Adhera,” the “Company,” “we,” “our,” or “us”) is an emerging specialty pharmaceutical company that leverages innovative distribution models and technologies to improve the quality of care for patients in the United States suffering from chronic and acute diseases. We areThe Company is focused on fixed dose combination (“FDC”) therapies in hypertension, with plans to expand the portfolio of drugs we commercialize to include other therapeutic areas.

 

OurThe Company’s mission is to provide effective and patient centric treatment for hypertension and resistant hypertension while actively seeking additional assets that can be commercialized through our proprietary Total Care System (“TCS”). At the core of our TCS system is DyrctAxess, our patented technology platform. DyrctAxess is designed to offer enhanced efficiency, control and access to the information necessary to empower patients, physicians and manufacturers to achieve optimal care.

 

We began marketingThe Company is focused on demonstrating the therapeutic and commercial value of TCS through the commercialization of Prestalia®, a single-pill FDC of perindopril arginine (“perindopril”) and amlodipine besylate (“amlodipine”) in June of 2018. By combining Prestalia, DyrctAxess and an independent pharmacy network, we have createdwhich is used as a proprietary systemfirst-line treatment for drug adherence and the effective treatment of hypertension, improving the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, as well as improving the distribution of devices for therapeutic drug monitoring (“TDM”) (e.g., blood pressure monitors), as well as patient counseling and prescription reminder services. We are focused on demonstrating the therapeutic and commercial value of TCS through the commercialization of Prestalia.hypertension. Prestalia was developed in coordination with Les Laboratories, Servier, a French pharmaceutical conglomerate, that sells the formulation outside the United States under the brand names Coveram®and/or Viacoram®. Prestalia® was approved by the U.S. Food and Drug Administration (“FDA”) in January 2015 and is distributed through ourwas licensed by the Company from Symplmed in June 2017. By combining Prestalia®, DyrctAxess platform which, we acquired in 2017.and an independent pharmacy network, the Company has created a proprietary system for drug adherence including patient counseling and prescription reminder services, as well as improving the distribution of blood pressure monitors for therapeutic drug monitoring (“TDM”).

 

We haveIn 2018, the Company discontinued all significant clinical development activities and areis evaluating disposition options for all of ourits development assets, including:including but not limited to: (i) oura next generation celecoxib program of drug candidates for the treatment of acute and chronic pain, IT-102 and IT-103;pain; (ii) CEQ508, an oral delivery of small interfering RNA against beta-catenin, combined with IT-102FDC used to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis; (iii) CEQ508 combined with IT-103an FDC to treat Colorectal Cancer; and (iv) CEQ608 and CEQ609, an oral delivery of IL-6Ra tkRNAi againstFDC for irritable bowel disease (IBD) gene targets, which could significantly reduce colon length and abolish the IL-6Rα message in proximal ileum; (v) Claudin-2 strains which (CEQ631 and CEQ632) significantly reduce Claudin-2 mRNA expression and protein levels in the colon as well as attenuation of the disease phenotype and enhance survival; (vi) MIP3a therapeutic strains CEQ631 and CEQ632 which also resulted in a significant reduction in sum pathology scores and reduction in MIP3a mRNA expression. We plan. The Company plans to license or divest these development assets since they no longer align with ourthe Company’s focus on the treatment of hypertension.

As our strategy is to be a commercial pharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, while continuing to develop our technology platform and TCS. We intend to create value through the expanded commercialization of our FDA-approved product, Prestalia, while continuing to develop and leverage our TCS to further strengthen our commercial presence.

On November 15, 2016, Adhera entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among IThenaPharma, Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Adhera (“Merger Sub”), and a representative of the stockholders of IThena (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”).

In the second quarter of 2018, we raised approximately $12.2 million, net of fees and expenses, from a private placement of our newly created Series E Convertible Preferred Stock. In July and November 2018, we raised approximately $1.7 million net of fees and expenses, from a private placement of our newly created Series F Convertible Preferred Stock. The use of funds from the raises was used for the commercialization of Prestalia, funding working capital, capital expenditure needs, payment of certain liabilities and other general corporate requirements. We plan to license or divest our other pharmaceutical assets and halt any other development programs, since they no longer align with our focus on the treatment of hypertension.

Change of Company Name and OTC Markets Symbol

On October 4, 2018, we filed a Certificate of Amendment to our Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to change our name from “Marina Biotech, Inc.” to “Adhera Therapeutics, Inc.” The change of name was effective October 9, 2018.

Following the name change from Marina Biotech, Inc. to Adhera Therapeutics, Inc., our common stock, par value $0.006 per share, began trading on the OTCQB tier of the OTC Markets under the symbol “ATRX”.

Reverse Stock Split

In August 2017, we filed a Certificate of Amendment of our Amended and Restated Certificate of Incorporation to effect a one-for-ten reverse split of our issued and outstanding shares of common stock. Our common stock commenced trading on the OTCQB tier of the OTC Markets on a split-adjusted basis on Thursday, August 3, 2017. Unless indicated otherwise, all share and per share information included in these condensed consolidated financial statements and Notes to the Condensed Consolidated Financial Statements give effect to the reverse split.Prestalia.

 

Basis of Presentation

 

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and in accordance with the instructions pursuant to the rules and regulations of the Securities and Exchange Commission. Accordingly, they do not include all of the information and note disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP”) for complete audited financial statements. This quarterly report should be read in conjunction with the consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. The information furnished in this report reflects all adjustments (consisting of normal recurring adjustments), which are, in the opinion of management, necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented. The results of operations for the three or six months ended March 31,June 30, 2019 are not necessarily indicative of the results for the year ending December 31, 2019 or for any future period.

Principles of Consolidation

 

The condensed consolidated financial statements include the accounts of Adhera Therapeutics, Inc. and the wholly-owned subsidiaries, Ithena, Cequent, MDRNA, and Atossa, and eliminate any inter-company balances and transactions.

 

Going Concern and Management’s Liquidity Plans

 

The accompanying condensed consolidated financial statements have been prepared on the basis that wethe Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At March 31,As of June 30, 2019, wethe Company had a significant accumulated deficitcash and cash equivalents of approximately $28.8$1.6 million and has negative working capital of approximately $0.1$3.0 million. For the three months ended March 31, 2019, we had a net loss from operations of approximately $2.6 million

The Company has incurred recurring losses and negative cash flows from operations since inception and has funded its operating losses through the sale of common stock, preferred stock, warrants to purchase common stock, convertible notes and promissory notes. The Company incurred a net operating loss of approximately $2.1 million. Our operating activities consume$2.8 million and $5.3 million for the majoritythree and six months ended June 30, 2019, respectively. The Company had an accumulated deficit of our cash resources. We anticipate that we willapproximately $31.9 million as of June 30, 2019.

The Company expects to continue to incur operating losses as we execute ourit executes the commercialization plans for Prestalia®, as well as other strategic and business development initiatives. In addition, we have had and will continueIf the Company is unable to haveobtain additional financing in the future, there may be a negative impact on the financial viability of the Company. The Company plans to increase working capital by managing its cash flows from operations, at least intoand expenses, divesting development assets and raising additional capital through private or public equity or debt financing. There can be no assurance that such financing or partnerships will be available or on terms which are favorable to the near future. We have previously funded, andCompany. While management of the Company believes that it has a plan to continue funding, our losses primarily through the sale of common and preferred stock, combined with or without warrants, the sale of notes, cash generated from the out-licensing or sale of our licensed assets and, to a lesser extent, equipment financing facilities and secured loans. Wefund ongoing operations, there is no assurance that its plan will needbe successfully implemented. Failure to raise additional operating capital duringthrough one or more financings, divesting development assets or reducing discretionary spending could have a material adverse effect on the second quarter of 2019 in orderCompany’s ability to maintain our operations and realize ourachieve its intended business plan. Without additional sources of cash and/or deferral, reduction, or elimination of significant planned expenditures, we may not haveobjectives. These factors raise substantial doubt about the cash resourcesCompany’s ability to continue as a going concern thereafter. However, we cannot be certainconcern. The condensed consolidated financial statements do not contain any adjustments that we will be able to obtain such funds required for our operations at terms acceptable to us or at all.

In April and May 2018, we raised approximately $12.2 million net proceeds from a private placement of shares of our Series E Convertible Preferred Stock and warrants to purchase shares of our common stock. Further, in July 2018, we raised an additional $1.4 million net proceedsmight result from the private placementresolution of our Series F Convertible Preferred Stock. On November 9, 2018, we sold 73 sharesany of our Series F Preferred Stock for total net proceeds of approximately $0.31 million. For our assessment as of March 31, 2019, we have considered the amount raised and we will continue to reassess our ability to address the going concern. We will continue to attempt to obtain future financing or engage in strategic transactions which may require us to curtail our operations. We cannot predict, with certainty, the outcome of our actions to generate liquidity, including the availability of additional equity or debt financing, or whether such actions would generate the expected liquidity as currently planned.above uncertainties.

 

Summary of Significant Accounting Policies

 

Use of Estimates

 

The preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Significant areas requiring the use of management estimates include revenue and related discounts and allowances valuation allowance for deferred income tax assets,and accruals related to our operating activity including legal contingencies and fair value of financial instruments.other consulting expenses. Actual results could differ materially from such estimates under different assumptions or circumstances.

 

Fair Value of Financial Instruments

 

We considerThe Company considers the fair value of cash, accounts payable, due to related parties, accounts receivable and accrued expenses not to be materially different from their carrying value. These financial instruments have short-term maturities. We follow authoritative guidance with respect to fair value reporting issued by the Financial Accounting Standards Board (“FASB”) for financial assets and liabilities, which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:

 

Level 1:Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2:Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
  
Level 3:Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use.

 

Our cash is subject to fair value measurement and is determined by Level 1 inputs. We measure the liability for committed stock issuances with a fixed share number using Level 1 inputs. There were no liabilities measured at fair value as of March 31,June 30, 2019 or December 31, 2018.

 

9

Accounts Receivable, net

Accounts receivable consists of amounts due from wholesale distributors and specialty pharmacy providers. The Company records an allowance for doubtful accounts at the time potential collection risk is identified. The Company estimates its allowance based on historical experience, assessment of specific risks and discussions with individual customers.  The Company believes the reserve is adequate to mitigate current collection risks. During the three and six months ended June 30, 2019 and 2018, the Company recorded an additional allowance of approximately $41,000 and $0, respectively.

 

Goodwill and Intangible Assets

 

The Company periodically reviews the carrying value of intangible assets, including goodwill, to determine whether impairment may exist. Goodwill and certain intangible assets are assessed annually, or when certain triggering events occur, for impairment using fair value measurement techniques. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. Specifically, goodwill impairment is determined using a two-step process. The first step of the goodwill impairment test is used to identify potential impairment by comparing the fair value of a reporting unit with its carrying amount, including goodwill. The Company uses level 3 inputs and a discounted cash flow methodology to estimate the fair value of a reporting unit. A discounted cash flow analysis requires one to make various judgmental assumptions including assumptions about future cash flows, growth rates, and discount rates. The assumptions about future cash flows and growth rates are based on the Company’s budget and long-term plans. Discount rate assumptions are based on an assessment of the risk inherent in the respective reporting units. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired and the second step of the impairment test is unnecessary. If the carrying amount of a reporting unit exceeds its fair value, the second step of the goodwill impairment test is performed to measure the amount of impairment loss, if any. The second step of the goodwill impairment test compares the implied fair value of the reporting unit’s goodwill with the carrying amount of that goodwill. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess. The implied fair value of goodwill is determined in the same manner as the amount of goodwill recognized in a business combination. That is, the fair value of the reporting unit is allocated to all of the assets and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business combination and the fair value of the reporting unit was the purchase price paid to acquire the reporting unit.

 

During the year ended December 31, 2018, wethe Company determined that goodwill was impaired and as a result,recognized a loss on impairment of approximately $3.5 million was recognized.million. The impairment determination was primarily a result of the decision to divest of assets that no longer alignaligned with the Company’s strategic objectives. No impairment charges were recognized for the three and six-month period ended June 30, 2019 or 2018.

 

Impairment of Long-Lived Assets

 

We review all of ourThe Company reviews long-lived assets for impairment indicators throughout the year and performperforms detailed testing whenever impairment indicators are present. In addition, we perform detailed impairment testing for indefinite-lived intangible assets, at least annually, at December 31. When necessary, we recordthe Company records charges for impairments. Specifically:

 

For finite-lived intangible assets, such as developed technology rights, and for other long-lived assets, we compare the undiscounted amount of the projected cash flows associated with the asset, or asset group, to the carrying amount. If the carrying amount is found to be greater, we record an impairment loss for the excess of book value over fair value. In addition, in all cases of an impairment review, we re-evaluate the remaining useful lives of the assets and modify them, as appropriate; and
  
For indefinite-lived intangible assets, such as acquired in-process R&D assets, each year and whenever impairment indicators are present, we determine the fair value of the asset and record an impairment loss for the excess of book value over fair value, if any.

During the year ended December 31, 2018, theThe Company determined that the intangible asset from the Merger was impaired, and, as a result, adid not recognize any loss on impairment of $1,672,885 was recorded. The impairment determination was primarily a result offor the decision to divest of assets that no longer align with the Company’s strategic objectives.three or six-month periods ended June 30, 2019 or 2018.

 

Revenue Recognition

Customers Concentration

The Company sells its prescription drug (Prestalia®) directly to specialty contracted retail pharmacies and indirectly through wholesalers. For the three months ended June 30, 2019, the Company’s three largest customers accounted for 46%, 31% and 23% of the Company’s total gross sales. For the six months ended June 30, 2019, the Company’s three largest customers accounted for 39%, 37%, and 24% of the Company’s total gross sales. The Company works with a third-party pharmacy network manager to attract, retain, and manage the Company’s pharmacy customers and distribution channels. The Company had no sales for the three or six-month periods ending June 30, 2018.

Revenue, Net

 

The Company adopted the new revenue recognition guidelines in accordance with ASC 606,Revenue from Contracts with Customers(ASC 606), effective with the quarter ended March 31, 2018.

The Company sells its medicines primarily to wholesale distributors and specialty pharmacy providers.providers under agreements with payment terms typically less than 90 days. These customers subsequently resell the Company’s medicines to health care patients. In addition, the Company enters into arrangements with health care providers and payers that provide for government-mandated or privately-negotiated discounts and allowances related to the Company’s medicines. Revenue is recognized when performance obligations under the terms of a contract with a customer are satisfied. The majority of the Company’s contracts have a single performance obligation to transfer medicines. Accordingly, revenues from medicine sales are recognized when the customer obtains control of the Company’s medicines, which occurs at a point in time, typically upon delivery to the customer. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring medicines and is generally based upon a list or fixed price less allowances for medicine returns, rebates and discounts. The Company sells its medicines to wholesale pharmaceutical distributors and pharmacies under agreements with payment terms typically less than 90 days.

During the year ended December 31, 2018, management determined certain costs related to the sales of Prestalia, specifically, costs associated with free product, should be classified as cost of goods sold and not revenue reductions. Consistent with the accounting for the year ended December 31, 2018, the Company recordedrecords an estimate of unrealized revenue reductions, and the related liability, for bottles sold to pharmacies but not yet prescribed.

Medicine Sales Discounts and Allowances

 

The nature of the Company’s contracts gives rise to variable consideration because of allowances for medicine returns, rebates and discounts. Allowances for medicine returns, rebates and discounts are recorded at the time of sale to wholesale pharmaceutical distributors and pharmacies. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, the Company will be required to make adjustments to these allowances in the future. The Company’s adjustments to gross sales are discussed further below.

Distribution Service Fees

The Company includes distribution service fees paid for inventory management services as cost of good sold. The Company calculates accrued distribution service fee estimates using the most likely amount method. The Company accrues estimated distribution fees based on contractually determined amounts. Accrued distribution service fees are included in “accrued expenses” on the condensed consolidated balance sheet.

 

Patient Access Programs

 

The Company offers discounts to patients under which the patient receives a discount on his or her prescription. In circumstances when a patient’s prescription is rejected by a third-party payer, the Company will pay for the full cost of the prescription. The Company reimburses pharmacies for this discount directly or through third-party vendors. The Company reduces gross sales by the amount of actual co-pay and other patient assistance in the period based on the invoices received. The Company also records an accrual to reduce gross sales for estimated co-pay and other patient assistance on units sold to distributors or pharmacies that have not yet been prescribed/dispensed to a patient. The Company calculates accrued co-pay and other patient assistance fee estimates using the expected value method. The estimate is based on contract prices, estimated percentages of medicine that will be prescribed to qualified patients, average assistance paid based on reporting from the third-party vendors and estimated levels of inventory in the distribution channel. Accrued co-pay and other patient assistance fees are included in “accrued expenses” on the condensed consolidated balance sheet. Patient assistance programs include both co-pay assistance and fully bought down prescriptions.

Sales Returns

 

Consistent with industry practice, the Company maintains a return policy that allows customers to return medicines within a specified period prior to and subsequent to the medicine expiration date. Generally, medicines may be returned for a period beginning six months prior to its expiration date and up to one year after its expiration date. The right of return expires on the earlier of one year after the medicine expiration date or the time that the medicine is dispensed to the patient. The majority of medicine returns result from medicine dating, which falls within the range set by the Company’s policy and are settled through the issuance of a credit to the customer. The Company calculates sales returns using the expected value method. The estimate of the provision for returns is based upon industry experience. This period is known to the Company based on the shelf life of medicines at the time of shipment. The Company records sales returns in “accrued expenses” and as a reduction of revenue.

 

11

Cost of Goods Sold

 

Distribution Service Fees

The Company includes distribution service fees paid for inventory management services as cost of goods sold. The Company calculates accrued distribution service fee estimates using the most likely amount method. The Company accrues estimated distribution fees based on contractually determined amounts. Accrued distribution service fees are included in “accrued expenses” on the condensed consolidated balance sheet.

Shipping Fees

 

The Company includes fees incurred by pharmacies for shipping medicines to patients as cost of goodgoods sold. The Company calculates accrued shipping fee estimates using the expected value method. The Company records accrued shipping fees in “accrued expenses” on the condensed consolidated balance sheet.

 

Customers ConcentrationNon-Commercial Product

The Company sells its prescription drug (Prestalia) directlyrecords the cost of non-commercial product distributed to specialty contracted retail pharmacies and indirectly through wholesalers. For the three months ended March 31, 2019, the Company’s three largest customers accounted for approximately 56%, 26%, and 18%, respectively,patients as a cost of the Company’s total gross sales. goods sold.

Royalties on Product Sales

The Company works withrecords royalty fees on the sale of commercial product as a third-party pharmacy network manager to attract, retain, and manage the Company’s pharmacy customers and distribution channels. Allcost of 2019 gross sales were made to customers associated with or related to the Company’s third-party pharmacy network manager. The Company had no significant sales for the three months ended March 31, 2018.

goods sold.

Licensing Agreements

Licensing agreements entered into by the Company, typically include payment of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services; and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenues, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services.

During the year ended December 31, 2018, Adhera entered into a Licensing Agreement, whereby Adhera granted exclusive rights to the Company’s DiLA2delivery system in exchange for an upfront payment of approximately $200,000 and further potential future consideration dependent upon event and sales-based milestones. Under the terms of the agreement, Adhera has agreed to assign ownership of the intellectual property associated with the DiLA2 delivery system to the purchaser. The Company has not completed, and will not complete, certain performance obligations under the agreement and accordingly has classified the $200,000 payment in accrued expenses as of March 31, 2019 and December 31, 2018.

Recently Issued Accounting Pronouncements

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU No. 2016-02”). Under ASU No. 2016-02, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. For leases with a term of twelve months or less, the lessee is permitted to make an accounting policy election not to recognize lease assets and lease liabilities by class of underlying assets. ASU No. 2016-02 becomesbecame effective for the Company beginning in the first quarter of 2019. The guidance can be applied using either a modified retrospective approach at the beginning of the earliest period presented, or at the beginning of the period in which it is adopted. The Company adopted this standard on January 1, 2019, using a modified retrospective approach at the adoption date through a cumulative-effect adjustment to retained earnings. The adoption did not have a material impact on its condensed consolidated statement of operations. However, the new standard required the Company to establish approximately $0.2 million of liabilities and corresponding right-of-use assets of approximately $0.2 million on its condensed consolidated balance sheet for operating leases on rented office properties that existed as of the January 1, 2019, adoption date. The Company elected to not recognize lease assets and liabilities for leases with an initial term of twelve months or less.

 

 1211 
 

 

Net Income (Loss) per Common Share

 

Basic net income (loss)loss per common share (after giving effect of the one for ten reverse stock split that became effective in August 2017) is computedcalculated by dividing the net income (loss)loss by the weighted average number of common shares outstanding during the period, excluding any unvested restricted stock awards.period. Diluted net income (loss)loss per share includesis computed by dividing the effectnet loss by the weighted average number of common shares and common stock equivalents (stock options, unvested restricted stock, and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. Net income (loss) is adjustedoutstanding for the period. Common stock equivalents are only included when their effect is dilutive. Potentially dilutive effect of the change in fair value liability for price adjustablesecurities which include outstanding warrants, if applicable. The following number of sharesstock options and preferred stock have been excluded from the computation of diluted net (loss) since such inclusionloss per share as their effect would be anti-dilutive:anti-dilutive. For all periods presented, basic and diluted net loss were the same.

 

  Three Months Ended March 31, 
  2019  2018 
       
Stock options outstanding  4,522,807   764,707 
Warrants  36,267,329   2,548,481 
Shares to be issued upon conversion of notes payable  -   323,404 
Series E Preferred Stock  34,880,000   - 
Series F Preferred Stock  3,810,000   - 
Total  79,480,136   3,636,592 

The following table presents the computation of net loss per share (in thousands, except share and per share data):

  Three Months ended June 30,  Six Months ended June 30, 
  2019  2018  2019  2018 
Numerator                
Net loss $(2,780) $(4,648) $(5,338) $(6,009)
Preferred stock dividends $(357) $(271) $(739) $(271)
Net Loss allocable to common stock holders $

(3,137

) $(4,919) $

(6,077

) $(6,280)
Denominator                
Weighted average common shares outstanding used to compute net loss per share, basic and diluted  10,860,049   10,821,230   10,811,138   10,672,082 
Net loss per share of common stock, basic and diluted                
Net loss per share $(0.29) $(0.45) $(0.56) $(0.59)

Potentially dilutive securities not included in the calculation of diluted net loss per common share because to do so would be anti-dilutive are as follows:

  Three and Six Months
Ended June 30,
 
  2019  2018 
       
Stock options outstanding  4,992,807   1,122,457 
Warrants  36,267,329   33,028,829 
Series C Preferred Stock  68,000   68,000 
Series D Preferred Stock  3,000   3,000 
Series E Preferred Stock  34,780,000   34,990,000 
Series F Preferred Stock  3,810,000   - 
Total  79,921,136   69,212,286 

 

NOTE 2 – Inventory

 

Inventory consists of raw material and finished goods stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis. The Company reviews the composition of inventory at each reporting period in order to identify obsolete, slow-moving, quantities in excess of expected demand, or otherwise non-saleable items.

 

Inventory consistedas of the following as of March 31, 2019 and December 31, 2018:

  March 31, 2019  December 31, 2018 
       
Raw Materials $84,618  $147,139 
Finished Goods  173,389   94,319 
Inventory, Net $258,007  $241,458 

NOTE 3 – PREPAID AND OTHER ASSETS

Prepaid expenses and other assets at March 31,June 30, 2019 and December 31, 2018 included prepaid insurance of $163,777 and $179,145, respectively, and deposits with third-party co-pay program managers of $143,795 and $157,584, respectively. The deposits with co-pay program managers are used to fund patient’s insurance co-pay support, for a specified period of time, with any unused amounts refunded to the Company.as follows:

  June 30, 2019  December 31, 2018 
  (in thousands) 
Raw Materials $173  $147 
Finished Goods  59   95 
Inventory, Net $232  $242 

Note 43 - Intangible Assets

Acquisition of Prestalia & DyrctAxess

In June 2017, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Symplmed Pharmaceuticals LLC (“Symplmed”) pursuant to which we purchased from Symplmed, for aggregate consideration of approximately $620,000 (consisting of $300,000 in cash plus the assumption of certain liabilities of Symplmed in the amount of approximately $320,000), Symplmed’s assets relating to a single-pill FDC of perindopril arginine and amlodipine besylate known as Prestalia® (“Prestalia”), that has been approved by the FDA for the treatment of hypertension. In addition, as part of the transactions contemplated by the Purchase Agreement: (i) Symplmed transferred to us the New Drug Applications for the approval of Prestalia as a new drug by the FDA; and (ii) Symplmed assigned to us all of its rights and obligations under that certain Amended and Restated License and Commercialization Agreement by and between Symplmed and Les Laboratoires Servier (“Servier”) dated January 2012, pursuant to which Symplmed has an exclusive license from Servier to manufacture, have manufactured, develop, promote, market, distribute and sell Prestalia in the U.S. (and its territories and possessions) in consideration of regulatory and sales-based milestone payments and royalty payments based on net sales. Management has determined that this acquisition was deemed an asset purchase under FASB ASC 805.

The purchase price of $620,000 was allocated based on a preliminary estimate of the fair value of the assets acquired and was included in intangible assets as of December 31, 2017. During the year ended December 31, 2018, the allocation of the purchase price was finalized which resulted in $160,800 of the price being allocated to raw materials received from Symplmed, and the remaining $459,200 being allocated to intangible assets.

Further, we hired a Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment became effective in June 2017. We also agreed in such offer letter to issue 60,000 restricted shares of our common stock under our 2014 Long-Term Incentive Plan to our Chief Commercial Officer, with all of such shares vesting on the six (6) month anniversary of the date of grant. These shares were fully vested on December 31, 2017. This Chief Commercial Officer resigned in January 2019.

In furtherance of the acquisition and commercialization of Prestalia, in July 2017 we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certain of the intellectual property assets related to the patented technology platform known as DyrctAxess, also known as Total Care, that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care for $75,000 in cash.

 

Intangible Asset Summary

 

The following table summarizes the balancesIntangible assets as of March 31,June 30, 2019 of the identifiable intangible assets acquired, their useful life, and annual amortization:are as follows:

 

  

Net Book Value

March 31, 2019

  

Remaining

Estimated
Useful Life
(Years)

  Annual
Amortization
Expense
 
          
Intangible asset - Prestalia $308,469   4.76  $64,941 
Intangible asset - DyrctAxess  65,848   12.34   5,357 
Total $374,317      $70,298 

During the year ended December 31, 2018, we determined that the intangible asset from the merger was impaired, and as a result, we recognized a loss on impairment of $1,672,885. The impairment determination was primarily a result of the decision to divest of assets that no longer align with the Company’s strategic objectives.

  

Net Book Value

June 30, 2019

  

Remaining

Estimated
Useful Life
(Years)

  Annual
Amortization
Expense
 
  (in thousands)       
Intangible asset - Prestalia $292   4.50  $65 
Intangible asset - DyrctAxess  65   12.09   5 
Total $357      $70 

 

Amortization expense was $17,575 and $123,261 for the three months ended March 31,June 30, 2019 and June 30, 2018 was approximately $17,000 and $123,000, respectively. Amortization expense for the six months ended June 30, 2019 and June 30, 2018 was approximately $35,000 and $247,000 respectively.

Note 4 – Term Loan

On June 28, 2019, the Company entered into term loan subscription agreements with certain accredited investors, pursuant to which the Company issued secured promissory notes (the “Notes”) in the aggregate principal amount of approximately $1.5 million. The Company paid $236,000 in debt issuance costs which was recorded as a debt discount to be amortized as interest expense over the term of the loan using the effective interest rate method.

The Notes shall accrue interest at a rate of 12.0% per annum. Interest will be payable quarterly with the first interest payment to be made on the six-month anniversary of the date of the closing and each subsequent payment every three months thereafter.

The unpaid principal balance of the Notes, plus accrued and unpaid interest thereon, will mature on the earliest to occur of: (i) June 28, 2020 (subject to extension for up to sixty (60) days based upon the mutual agreement of the Company and the holders of a majority of the unpaid principal balance of all outstanding Notes) or (ii) at any time following an Event of Default. The Notes may not be prepaid without the prior written consent of the holders of the Notes. The Notes are secured by a first lien and security interest on all the assets of the Company and certain of its wholly owned subsidiaries.

The Company recognized approximately $1,000 in interest expense related to Notes for the three and six months ended June 30, 2019.

 

Note 5 - Related Party Transactions

 

Due to Related Party

 

The Company and other related entities have had a commonality of ownership and/or management control, and as a result, the reported operating results and/or financial position of the Company could significantly differ from what would have been obtained if such entities were autonomous.

The Company had a Master Services Agreement (“MSA”) with Autotelic Inc., a related party that is partly-ownedpartly owned by one of the Company’s former Board members and executive officers, namely Vuong Trieu, Ph.D., effective November 15, 2016. The MSA stated that Autotelic Inc. will provide business functions and services to the Company and allowed Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA included personnel costs allocated based on amount of time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The MSA required a 90-day written termination notice in the event either party requires to terminate such services. We and Autotelic Inc. agreed to terminate the MSA effective October 31, 2018. Dr. Trieu resigned as a director of our company effective October 1, 2018.

During the period commencing November 15, 2016 (the “Effective Date”) and ending on the date that the Company had completed an equity offering of either common or preferred stock in which the gross proceeds therefrom is no less than $10 million (the “Equity Financing Date”), the Company paid Autotelic the following compensation: cash in an amount equal to the actual labor cost (paid on a monthly basis), plus 100% markup in warrants for shares of the Company’s common stock with a strike price equal to the fair market value of the Company’s common stock at the time said warrants were issued. The Company also paid Autotelic for the services provided by third party contractors plus 20% mark up. The warrant price per share was calculated based on the Black-Scholes model.

 

After the Equity Financing Date, the Company paid Autotelic Inc. a cash amount equal to the actual labor cost plus 100% mark up of provided services and 20% mark up of provided services by third party contractors or material used in connection with the performance of the contracts, including but not limited to clinical trial, non-clinical trial, Contract Manufacturing Organizations, FDA regulatory process, Contract Research Organizations and Chemistry and Manufacturing Controls.

 

In accordance with the MSA, Autotelic Inc. billed the Company for personnel and service expenses Autotelic Inc. incurred on behalf of the Company. For the threesix months ended March 31,June 30, 2019 and 2018, Autotelic Inc. billed a total of $0 and $256,997,approximately $616,000, respectively, including personnel costs of $0 and $133,633,$284,000, respectively. An unpaid balance of $4,392 and $4,392approximately $4,000 is included in due to related party in the accompanying balance sheets as of March 31,for both periods ending June 30, 2019 and December 31, 2018, respectively.2018.

 

In April 2018, and in connection with the closing of our private placement on that date, we entered into a Compromise and Settlement Agreement with Autotelic Inc. pursuant to which we agreed to issue to Autotelic Inc. an aggregate of 162.59 shares of Series E Preferred Stock to settle accounts payable of $812,967$813,000 and Warrants to purchase up to 1,345,040 shares of common stock to satisfy accrued and unpaid fees in the aggregate amount of approximately $739,772,$740,000, and other liabilities, owed to Autotelic Inc. as of March 31,June 30, 2018 pursuant to the MSA. The securities that were issued to Autotelic Inc., which were issued upon the closing of the offering described above, have the same terms and conditions as the securities that were issued to investors in the offering (See Note 6). The warrants have a five-year term, an initial exercise price of $0.55, and have a fair value of $1,494,469approximately $1.5 million resulting in a loss on settlement of debt of $754,697.approximately $750,000.

 

Transactions with BioMauris, LLC/Erik Emerson

 

DuringUntil February of 2019, the three months ended March 31, 2019 and 2018, we paid a totalCompany had engaged the services of $21,690 and $46,532, respectively, for services provided by BioMauris, LLC, of which Erik Emerson, our former Chief Commercial Officer and a current director of Adhera, is Executive Chairman. A total

During the six months ended June 30, 2019 and 2018, the Company recorded approximately $65,000 and $309,000, respectively, for related party expenses incurred under the agreement. As of $48,266 and $23,585 wasDecember 31, 2018, the Company recorded approximately, $24,000 as a related party liability on the accompanying balance sheet for amounts due BioMauris, LLCLLC. No related party liability was recorded as of March 31,June 30, 2019.

Beginning in the second quarter of 2019 when components of the financial transaction took place and fully effective in July 2019, Erik Emerson, a member our Board of Directors and our former Chief Commercial Officer, became the owner of an equity interest of approximately 22% in Pharma Hub Network, our third-party network manager. During the six months ended June 30, 2019 and 2018, the Company paid approximately $17,000 and $0, respectively, to Pharma Hub Network. An unpaid balance of $27,000 and $0 was included in accounts payable and accrued expenses in the accompanying balance sheets as of June 30, 2019 and December 31, 2018, respectively, and is included in due to related party on the accompanying balance sheets.respectively.

Option Grant for Former Chief Financial Officer

On January 15, 2019, our Board of Directors (the “Board”) granted to our CFO options to purchase up to an aggregate of 100,000 shares of our common stock at an exercise price of $0.32 per share, with 25,000 options being exercisable immediately and with 25,000 options vesting on each of the first, second and third anniversary of the grant date (See Note 7).

15

Resignation of Chief Commercial Officer

On January 15, 2019, the Board accepted the resignation of our Chief Commercial Officer (our “former CCO”), effective immediately. He will remain as a member of the Board. Simultaneous with his resignation as our CCO, we and our former CCO entered into a Consulting Agreement dated as of January 15, 2019 pursuant to which our former CCO agreed to provide certain consulting services regarding our FDA-approved Prestalia product for a fee of $3,000 per month. During the three months ended March 31, 2019, the Consulting Agreement was terminated.

Resignation of Chief Financial Officer

On March 11, 2019, our CFO submitted his resignation as our CFO and from any other positions that he may hold with our company or any of its subsidiaries, effective March 22, 2019.

Resignation and Appointment of Chief Executive Officer

On April 4, 2019, the Company appointed Nancy R. Phelan, to serve as CEO and Secretary of the Company, effective immediately. In connection with the appointment Ms. Phelan as our new CEO and Secretary, Robert C. Moscato, Jr. resigned from such positions, and also from his position as a member of the Board of Directors of the Company effective immediately.

In connection with our appointment of Ms. Phelan as our CEO, we granted her options to purchase an aggregate of 1,500,000 shares of our common stock, of which 400,000 are exercisable immediately, 600,000 vest on a monthly basis over a two-year period beginning on April 4, 2020, and 500,000 vest upon the achievement of certain product sales and stock price targets.

 

Note 6 - Stockholders’ Equity

Preferred Stock

Adhera has authorized 100,000 shares of preferred stock for issuance and has designated 1,000 shares as Series B Preferred Stock (“Series B Preferred”) and 90,000 shares as Series A Junior Participating Preferred Stock (“Series A Preferred”). No shares of Series B Preferred or Series A Preferred are outstanding. In March 2014, Adhera designated 1,200 shares as Series C Convertible Preferred Stock (“Series C Preferred”). In August 2015, Adhera designated 220 shares as Series D Convertible Preferred Stock (“Series D Preferred”). In April 2018, Adhera designated 3,500 shares of Series E Convertible Preferred Stock (“Series E Preferred”). In July 2018, Adhera designated 2,200 shares of Series F Convertible Preferred Stock (“Series F Preferred”).

16

Series C Preferred

As of both March 31, 2019 and December 31, 2018, 100 shares of Series C Preferred remained outstanding.

Series D Preferred

As of both March 31, 2019 and December 31, 2018, 40 shares of Series D Preferred remained outstanding.

 

Series E Convertible Preferred Stock Private Placement

 

In April and May 2018, wethe Company entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 2,812 shares of our Series E Preferred, at a purchase price of $5,000 per share of Series E Preferred. Each share of Series E Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”, and collectively with the Series E Preferred, the “Securities”) to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Series E Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. The Series E Preferred accrues 8% dividends per annum and are payable in cash or stock at the Company’s discretion. The Series E Preferred has voting rights, dividend rights, liquidation preferences, conversion rights and anti-dilution rights as described in the Certificate of Designation of Preferences, Rights and Limitations of the Preferred Stock, which we filed with the Secretary of State of Delaware in April 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations.

In April 2019, the Company issued 107,846 unregistered shares of our common stock to a holder of our Series E Convertible Preferred Stock in connection with the conversion of $53,923 of “Stated Value” of our Series E Convertible Preferred Stock.

We

As of June 30, 2019, the Company had recorded accrued dividends of approximately $1.7 million on the Series E Preferred of $344,108 for the three months ended March 31, 2019. No similar dividends were accrued in 2018.Stock.

Series F Convertible Preferred ShareStock Private Placement

In July 2018, wethe Company entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 308 shares of our Series F Preferred, at a purchase price of $5,000 per share of Series F Preferred. Each share of Series F Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”, and collectively with the Preferred Stock, the “Securities”) to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Series F Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. The Series F Preferred accrues 8% dividends per annum and are payable in cash or stock at the Company’s discretion. The Series F Preferred has voting rights, dividend rights, liquidation preferences, conversion rights and anti-dilution rights as described in the Certificate of Designation of Preferences, Rights and Limitations of the Preferred Stock, which we filed with the Secretary of State of Delaware in July 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations.

 

WeThe Company received proceeds of approximately $1.4 million from the sale of the Securities, after deducting placement agent fees and estimated expenses payable by us of approximately $180,000 associated with such closing. We used the proceeds of the offering for funding our commercial operations to the sale and promotion of our Prestalia product, working capital needs, capital expenditures, the repayment of certain liabilities and other general corporate purposes. In connection with the private placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 308,000 shares of our common stock. The Warrant has a five-year term and an initial exercise price of $0.55 per share.

On November 9, 2018, wethe Company entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 73 shares of our Series F Preferred Stock, at a purchase price of $5,000 per share of Preferred Stock. Each share of Series F Preferred is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Series F Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. We received total net proceeds of approximately $0.31 million from the issuance of the securities described above, after deducting placement agent fees and estimated expenses payable by us associated with such closing. In connection with the private placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 73,000 shares of our common stock. The Warrant has a five-year term and an initial exercise price of $0.55 per share.

 

WeAs of June 30, 2019, the Company had recorded accrued dividends of approximately $138,000 on the Series F Preferred of $37,578 for the three months ended March 31, 2019. No similar dividends were accrued in 2018.

Stock Option Grants

During the three months ended March 31, 2019, Mr. Moscato, Mr. Emerson, and Mr. Teague resigned (See Note 5 – Related Party Transactions). All vested options held by Mr. Teague are set to expire 90 days after his resignation date and all vested options held by Mr. Moscato are set to expire 12 months after his resignation date.

During the three months ended March 31, 2019, we granted an aggregate of 135,000 stock options to employees.

Common Stock

Our common stock currently trades on the OTCQB tier of the OTC Markets under the symbol “ATRX”. As of March 31, 2019, we have 10,761,684 shares of our common stock outstanding.

Stock Issuances

We issued no common stock during the three months ended March 31, 2019.

Stock.

Warrants

 

As of March 31,June 30, 2019, there were 36,267,329 warrants outstanding, with a weighted average exercise price of $0.79 per share, and annual expirations as follows:

 

Expiring in 2019  600,000 
Expiring in 2020  1,189,079 
Expiring in 2021  343,750 
Expiring in 2022  66,667 
Expiring in 2023  33,729,180 
Expiring thereafter  338,653 
Total  36,267,329 

 

The above includes price adjustable warrants totaling 34,373,030.34,737,030 shares.

 

No warrants expired during the threesix months ended March 31,June 30, 2019.

 

18

Tender Offer

On May 28, 2019, the Company filed a Tender Offer Statement on Schedule TO. The Schedule TO related to the offer (the “Offer”) by the Company to all holders of the Company’s outstanding warrants that were issued to investors in connection with the Company’s private placement of its Series E Convertible Preferred Stock and Series F Convertible Preferred Stock during 2018, which warrants are exercisable for shares of the Company’s common stock at an exercise price of $0.50 per share (subject to adjustment) with respect to the warrants that were issued in connection with the Company’s private placement of its Series E Convertible Preferred Stock and $0.55 per share with respect to the warrants that were issued in connection with the Company’s private placement of its Series F Convertible Preferred Stock, to receive two (2) shares of common stock in exchange for every warrant tendered by the holders thereof.

On June 6, 2019, the Company amended the Schedule TO to change the conversion terms on the issuance of warrant.

As of June 30, 2019, no warrants have been accepted for exchange or been exchanged pursuant to the Offer. See Note 11 – Subsequent Events.

 

Note 7 - Stock Incentive Plans

 

Stock Options

 

The following table summarizes stock option activity for the threesix months ended March 31,June 30, 2019:

 

  Options Outstanding 
  Shares  Weighted
Average
Exercise Price
 
Outstanding, December 31, 2018  5,613,057  $0.83 
Options granted  135,000   0.31 
Options expired / forfeited  (1,225,250)  1.10 
Outstanding, March 31, 2019  4,522,807   0.86 
Exercisable, March 31, 2019  1,736,414  $      0.90 

  Options Outstanding 
  Shares  Weighted
Average
Exercise Price
 
Outstanding, December 31, 2018  5,613,057  $0.83 
Options granted  1,635,000   0.37 
Options expired / forfeited  (2,255,250)  1.03 
Outstanding, June 30, 2019  4,992,807   0.77 
Exercisable, June 30, 2019  2,186,414  $0.81 

The following table summarizes additional information on Adhera’s stock options outstanding at March 31,June 30, 2019.

 

  Options Outstanding  Options Exercisable 
Range of
Exercise
Prices
 Number Outstanding  Weighted-Average
Remaining Contractual Life (Years)
  Weighted Average Exercise Price  Number Exercisable  Weighted Average Exercise Price 
$0.28 - $0.98  3,875,000   9.85  $0.69   1,567,500  $0.71 
$1.00  7,000   2.63  $1.00   7,000  $1.00 
$1.50 - $1.80  493,207   8.43  $1.79   134,314  $1.78 
$2.60 - $8.20  135,200   3.28  $2.77   15,200  $4.48 
$10.70 - $22.00  12,400   0.46  $10.70   12,400  $10.70 
                     
Totals  4,522,807   8.60  $0.86   1,736,414  $0.90 
  Options Outstanding  Options Exercisable 
Range of
Exercise
Prices
 Number Outstanding  Weighted-
Average
Remaining Contractual Life (Years)
  Weighted Average Exercise Price  Number Exercisable  Weighted Average Exercise Price 
$0.28 - $1.00  4,352,000   8.85  $0.57   2,024,500  $0.66 
$1.50 - $1.80  493,207   8.18  $1.79   134,314  $1.78 
$2.60 - $10.70  147,600   2.79  $3.43   27,600  $7.27 
                     
Totals  4,992,807   8.60  $0.77   2,186,414  $0.81 

 

Weighted-Average Exercisable Remaining Contractual Life (Years) 7.938.06

 

During the threesix months ended March 31,June 30, 2019, wethe Company granted an aggregate of 135,0001,635,000 stock options to employees at exercise prices ranging from $0.28employees.

Total expense related to $0.34 per share. 35,000 stock options vest at a rate of one-third atwas approximately $241,000 and $374,000 for the end of each annual anniversary over three years frommonths ended June 30, 2019 and 2018, respectively and approximately $636,000 and $493,000 for the grant datesix months ended June 30, 2019 and have a 10-year term. 100,000 options vest at a rate of 25,000 upon grant and 25,000 at the end of each annual anniversary over three years from the grant date and have revised 90 day term based on our former CFO’s resignation.2018, respectively.

 

As of March 31,June 30, 2019, wethe Company had $680,057approximately $474,000 of total unrecognized compensation expense related to unvested stock options. Total expense related to stock options was $395,390 and $118,879 for the three months ended March 31, 2019 and 2018, respectively.

 

As of March 31,June 30, 2019, the intrinsic value of options outstanding or exercisable was $15,100 as there were options outstanding with an exercise price less than $0.40, the per share closing market price of our common stock at that date.zero.

 

Note 8 - Intellectual Property and Collaborative Agreements

 

License of DiLA2 Assets

 

On March 16, 2018, Adherathe Company entered into a Licensing Agreement, whereby Adhera grantedan exclusive sublicensing agreement for certain intellectual property rights to the company’sits DiLA2delivery system in exchange forsystem. The agreement included an upfront payment of $200,000 and further potential future additional consideration dependentfor sales and development milestones. The upfront fee was contingent upon event and sales-based milestones. Under the terms ofCompany obtaining a third-party consent to the agreement Adhera has agreed to assign ownershipwithin ninety days of the intellectual property associated with the DiLA2 delivery system to the purchaser. The Company has not completed, and will not complete, certain performance obligations under the agreement and accordingly has classified the $200,000 payment in accrued expenses asexecution. As of March 31,June 30, 2019 and December 31, 2018.2018, the Company had not obtained consent for the sublicense and has classified the upfront payment as an accrued liability on its balance sheet.

19

 

Asset Purchase Agreement

In July 2017, Adhera entered into an Asset Purchase Agreement with Symplmed Pharmaceuticals LLC and its wholly-owned subsidiary Symplmed Technologies, LLC pursuant to which the Company purchased from the sellers, for an aggregate purchase price of $75,000 in cash, certain specified assets of the sellers relating to the sellers’ patented technology platform known as DyrctAxess that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care (see Note 4).

Note 9 - Commitments and Contingencies

Amendment to Agreement with Windlas Healthcare Private Limited

On August 17, 2017, we entered into an amendment (the “Amendment”) of that certain Pharmaceutical Development Agreement dated as of March 30, 2017 by and between Windlas Healthcare Private Limited (“Windlas”) and our company (the “Development Agreement”), relating to the development by Windlas of certain pharmaceutical products to be used for conducting clinical trials or for regulatory submissions, as more fully described therein. Pursuant to the Amendment, we and Windlas agreed to amend the Development Agreement to reflect our agreement to issue to Windlas, and Windlas’ agreement to accept from us, in lieu of cash payments with respect to forty percent (40%) of the total amount reflected on invoices sent from time to time by Windlas to us, shares of our common stock having an aggregate value equal to forty percent (40%) of such invoiced amount (with the remaining portion of the invoiced amount being paid in cash). The maximum value of common stock that may be issued to Windlas pursuant to the Development Agreement (as modified by the Amendment) is $2 million. The parties also agreed that the foregoing payment arrangement would apply to any Contract Manufacturing and Supply Agreement (or similar agreement) relating to the manufacturing of commercial batches of the products covered by the Development Agreement that may be entered into between the parties.

 

Litigation

 

Because of the nature of our activities, we arethe Company’s it is subject to claims and/or threatened legal actions, which arise out of the normal course of business. Other than the disclosure below, as of the date of this filing, we arethe Company is not aware of any pending lawsuits against us, ourthem, its officers or our directors.

Paragraph IV Challenge

 

OurThe Company’s Prestalia product was involved in a paragraph IV challenge regarding patents issued to perindopril arginine. This challenge, which was pending in the United States District Court for the District of Delaware (No. 1:17-cv-00276), was captionedApotex Inc. and Apotex Corp. v. Symplmed Pharmaceuticals, LLC and Les Laboratoires Servier. The challengers (Apotex Inc. and Apotex Corp. (“Apotex”)) filed an Abbreviated New Drug Application seeking FDA approval to market a generic version of Prestalia and included a Paragraph (IV) certification. In the litigation, Apotex sought a declaratory judgment that no valid claims of the two patents Symplmed listed in the FDA Orange Book as having claims covering Prestalia, U.S. Patent No. 6,696,481 and 7,846,961, will be infringed by the Apotex proposed generic version of Prestalia and that the claims of those patents are invalid. The challenge was designed to provide Apotex with an opportunity to enter the market with a generic version of Prestalia, ahead of the expiration of the patents with claims covering that product.

 

Apotex entered into negotiations with Symplmed Pharmaceuticals, LLC (which entity sold its assets relating to Prestalia to us in June 2017, including its License and Commercialization Agreement with Les Laboratories Servier) and Les Laboratories Servier (which entity owns or controls intellectual property rights relating to pharmaceutical products containing as an active pharmaceutical ingredient perindopril in combination with other active pharmaceutical ingredients, which rights have been licensed to Symplmed Pharmaceuticals) to resolve the challenge in the second quarter of 2017. Such parties, along with us, have reached an agreement on terms that result in a delay to the challengers’ ability to enter the market with a generic version of Prestalia, while still providing the challenger with the right to enter the market prior to the expiration of the patent covering such product. Specifically, the parties have entered into a Confidential Settlement Agreement in connection with the settlement of the matter, pursuant to which, among other things, the parties entered into a Confidential License Agreement, whereby Symplmed, Servier and our company agreed to grant to Apotex a non-transferable, non-sublicensable, perpetual, irrevocable, royalty-free, non-exclusive license to the two patents listed in the FDA Orange Book as having claims covering Prestalia to make, use and market a generic version of Prestalia, or import a generic version of Prestalia from India into the United States, on or after January 1, 2021.

As a result of the foregoing, the matter is now settled.

 

Litigation Regarding Vaya Pharma

We had been named on a complaint filed in New York State as a defendant in the matter entitledVaya Pharma, Inc. v. Symplmed Technologies, Inc., Symplmed Pharmaceuticals, Inc., Erik Emerson and Marina Biotech, Inc. While this complaint had been filed in the Supreme Court of the State of New York, we had not been legally served. The complaint alleged, in relevant part, that: (i) the sale by Symplmed Pharmaceuticals, Inc. of its assets related to its Prestalia product, and the sale by Symplmed Technologies, Inc. of its assets related to its DyrctAxess platform, should be set aside pursuant to New York law as they were consummated without fair consideration to the sellers (the “Symplmed Defendants”), and thereby had the effect of fraudulently depriving the creditors of the Symplmed Defendants, including Vaya Pharma, Inc., of funds that could have been used to pay their debts; and (ii) we were liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement we are only contractually responsible for liabilities that accrue after the parties entered into the agreement for Prestalia and any liabilities that existed prior to the agreement are contractually held by Symplmed. In April 2018, we entered into a Stipulation of Settlement pursuant to which we issued to Vaya Pharma 210,084 shares of our common stock with a fair value of $250,000.

Leases

 

We haveThe Company entered into a Standard Form Office Lease with ROC III Fairlead Imperial Center, LLC, as landlord, pursuant to which we lease our corporate headquarters located at 4721 Emperor Boulevard, Suite 350, Durham, North Carolina 27703 for a term of 37 months starting on October 1, 2018. Our base monthly rent for such space is currently $6,458, which amount will increase to $7,057 for the final month of the term. Other than the lease for our corporate headquarters, we do not own or lease any real property or facilities that are material to our current business operations. As we expand our business operations, we may seek to lease additional facilities of our own in order to support our operational and administrative needs under our current operating plan.

 

The Company adopted ASU No. 2016-02 on January 1, 2019, using a modified retrospective approach at the adoption date through a cumulative-effect adjustment to retained earnings. The adoption did not have a material impact on its condensed consolidated statement of operations. However, the new standard required the Company to establish approximately $0.2 million of liabilities and corresponding right-of-use assets of approximately $0.2 million on its condensed consolidated balance sheet for operating leases on rented office properties that existed as of the January 1, 2019, adoption date. The total right-of-use asset was approximately $0.2 million$178,000 as of March 31,June 30, 2019 and is reflected in the operating lease right of use asset on the accompanying condensed consolidated balance sheet. The total related liability was approximately $0.2 million$185,000 as of March 31,June 30, 2019, of which approximately $0.1 million$78,000 is included in current portion of operating lease liability and approximately $0.1 million$107,000 is reflected in operating lease liability, net of current portion on the accompanying condensed consolidated balance sheet. The future minimum lease payments as of March 31, 2019 are approximately $0.07 million for the remaining nine months of 2019, $0.08 million for 2020, and $0.07 million for 2021.

 

Note 1011 - Subsequent Events

 

Except for the event(s)events discussed below, there were no subsequent events that required recognition or disclosure. WeThe Company evaluated subsequent events through the date the financial statements were issued and filed with the Securities and Exchange Commission.

 

On April 4,July 2, 2019, we entered into an employment agreement with our new CEO, Nancy R. Phelan, effective immediately, whothe Company announced the termination of the exchange offer contemplated by that certain Tender Offer Statement on Schedule TO that was also appointedoriginally filed on May 28, 2019. As a result of the termination of the Offer, no Warrants were accepted for exchange or exchanged pursuant to serve as our Secretary. In connection with the appointment of our new CEO and Secretary, Robert C. Moscato, Jr. resigned from such positions, and also from his position as a member of our Board of Directors effective immediately (See Note 5 – Related Party Transactions).Offer.

 

In AprilOn July 3, 2019, weJuly 17, 2019, and August 5, 2019, the Company completed a second, third, and fourth closing of term loan subscription agreements with certain accredited investors, pursuant to which the Company issued 107,846 unregistered sharessecured promissory notes in the aggregate principal amount of our common stock to a holderapproximately $4.2 million. The terms of our Series E Convertible Preferred Stocksuch additional closings of the loan are as described in connection with the conversionNote 4 of $53,923 of “Stated Value” of our Series E Convertible Preferred Stock.this filing.

21

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

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q includes a number of forward-looking statements within the meaning ofthe Private Securities Litigation Reform Act of 1995,Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that reflect management’s current views with respect to future events and financial performance. The following discussion should be read in conjunction with the financial statements and related notes contained in our Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (“SEC”) on April 16, 2019. Forward-looking statements are projections in respect of future events or financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology.

 

Forward-looking statements are inherently subject to risks and uncertainties, many of which we cannot predict with accuracy and some of which we might not even anticipate. Although we believe that the expectations reflected in such forward-looking statements are based upon reasonable assumptions at the time made, we can give no assurance that such expectations will be achieved. Future events and actual results, financial and otherwise, may differ materially from the results discussed in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements after the date of this Quarterly Report on Form 10-Q or to conform them to actual results, new information, future events or otherwise, except as otherwise required by securities and other applicable laws.

 

The following factors, among others, could cause our or our industry’s future results to differ materially from historical results or those anticipated:

 

 our ability to obtain additional and substantial funding for our company on an immediate basis, whether pursuant to a capital raising transaction arising from the sale of our securities, a strategic transaction or otherwise;
 our ability to attract and/or maintain research, development, commercialization and manufacturing partners;
 the ability of our company and/or a partnerpartners to successfully complete product research and development, including pre-clinical and clinical studies and commercialization;execute our commercialization activities;
 the ability of our company and/or a partnerpartners to obtain required governmental approvals, including product patent approvals;
 the ability of our company and/or a partner to develop and commercialize products that can compete favorably with those of our competitors;
the timing of costs and expenses related to the research and development programs of our company and/or our partners;
the timing and recognition of revenue from milestone payments and other sources not related to product sales;
 our ability to satisfy our disclosure obligations under the Exchange Act of 1934 and to maintain the registration of our common stock thereunder;
 our ability to attract and retain qualified officers, employees and consultants as necessary; and
 costs associated with any product liability claims, patent prosecution, patent infringement lawsuits and other lawsuits.

These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled “Risk Factors” set forth in our Annual Report on Form 10-K for the year ended December 31, 2018, as filed with the SEC on April 16, 2019, any of which may cause our company’s or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks may cause our or our industry’s actual results, levels of activity or performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity or performance. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. We are under no duty to update any forward-looking statements after the date of this report to conform these statements to actual results.

 

As used in this quarterly report and unless otherwise indicated, the terms “we,” “us,” “our” or the “Company” refer to Adhera Therapeutics, Inc., a Delaware corporation, and its wholly-owned subsidiaries, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc., Atossa Healthcare, Inc., and IthenaPharma, Inc. Unless otherwise specified, all dollar amounts are expressed in United States dollars. Our common stock is currently listed on the OTC Market, OTCQB tier, under the symbol “ATRX.”

 

Corporate Overview

 

Nature of Business

 

We are an emerging specialty pharmaceutical company that leverages innovative distribution models and technologies to improve the quality of care for patients in the United States suffering from chronic and acute diseases. We are focused on fixed dose combination (“FDC”) therapies in hypertension, with plans to expand the portfolio of drugs we commercialize to include other therapeutic areas.

 

Our mission is to provide effective and patient centric treatment for hypertension and resistant hypertension while actively seeking additional assets that can be commercialized through our proprietary Total Care System (“TCS”). At the core of our TCS is DyrctAxess, our patented technology platform. DyrctAxess is designed to offer enhanced efficiency, control and access to the information necessary to empower patients, physicians and manufacturers to achieve optimal care.

 

We began marketing Prestalia®, a single-pill FDC of perindopril arginine (“perindopril”) and amlodipine besylate (“amlodipine”) in June of 2018. By combining Prestalia, DyrctAxess and an independent pharmacy network, we have created a proprietary system for drug adherence and the effective treatment of hypertension, improving the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, as well as improving the distribution of devices for therapeutic drug monitoring (“TDM”) (e.g., blood pressure monitors), as well as patient counseling and prescription reminder services. We are focused on demonstrating the therapeutic and commercial value of our TCS through the commercialization of Prestalia. Prestalia was developed in coordination with Les Laboratories Servier, a French pharmaceutical conglomerate, that sells the formulation outside the United States under the brand names Coveram® and/or Viacoram®. Prestalia was approved by the U.S. Food and Drug Administration (“FDA”) in January 2015 and is distributed through our DyrctAxess platform, which we acquired in 2017.

 

By combining Prestalia, DyrectAxess, and a specialty pharma network, we have created a proprietary platform for drug adherence and the effective treatment of hypertension, improving the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, devices for therapeutic drug monitoring (e.g., blood pressure and other cardiac monitors), as well as patient counseling and prescription reminder services.

 

As our strategy is to be a commercial pharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, while continiuingcontinuing to develop our technology platform and TCS. We intend to create value through the expanded commercialization of our FDA-approved product, Prestalia®, while continuing to develop and leverage our TCS to further strengthen our commercial presence.

 

 2320 
 

 

Recent Developments During the Three Months Ended March 31, 2019

Co-Promotion Agreement

On March 4, 2019, we entered into a co-promotion agreement with Alyvant, Inc. The agreement affords us with the opportunity to increase the frequency of communication to healthcare providers and educate physicians beyond the reach of our sales team.

Resignation and Appointment of Officer and Directors

Eric Teague, our Chief Financial Officer, and Erik Emerson, our Chief Commerical Officer, resigned from such positions, during the three months ended March 31, 2019. On April 4, 2019, we appointed Nancy Phelan as Chief Executive Officer. In connection with the appointment of Ms. Phelan, Robert J. Moscato, Jr., a director and officer, resigned from his positions as CEO, Secretary, and as a director. These management changes are more fully described in Note 5 – Related Party Transaction herein.

Results of Operations

 

Comparison of the Three Months Ended March 31,June 30, 2019 to the Three Months Ended March 31,June 30, 2018

 

Net Sales

 

NetWe recorded net sales were $2,881of approximately $66,000, net of related discounts for the three months ended March 31,June 30, 2019 andcompared to no sales for the three-month period ended June 30, 2018. The increase in sales represents revenues from the sale of Prestalia net of discounts. We had no sales during the three months ended March 31, 2018. The majority of our licensing deals provide for clinical and regulatory milestones, so significant revenues could result from the existing licenses, but are uncertain as to timing or probability. We will continue to seek research and development collaborations as well as licensing transactions to fund business operations.®.

 

Cost of Sales

 

Cost of sales were $116,933$81,000 for the three months ended March 31,June 30, 2019 and represents cost of sales from the sale of Prestalia.Prestalia®. We had no sales or cost of sales during the three months ended March 31,June 30, 2018.

 

Operating Expenses

 

Our operating expenses for the three months ended March 31,June 30, 2019 and 2018 are summarized as follows:

  Three Months Ended 
  June 30, 2019  June 30, 2018 
  (in thousands) 
Sales and marketing $1,148  $2,586 
General and administrative expenses  1,599   1,059 
Amortization  17   123 
Total operating expenses $

2,764

  $3,768 

Sales, Marketing and Commercial Operations

For the three months ended June 30, 2019, sales, marketing and commercial operations expense decreased by approximately $1.4 million, as compared to the prior period, primarily due to the 2018 commercial launch including marketing and sales activities related to Prestalia® and a reduction in costs associated with our go to market model.

General and Administrative

General and administrative (“G&A”) expense increased by approximately $0.5 million for the three months ended June 30, 2019, as compared to the three months ended June 30, 2018, primarily due to an increase in share-based compensation of approximately $0.2 million and an increase in personnel related expenses including severance payments made to former executive management.

Amortization Expense

Amortization of intangible assets decreased by approximately $106,000 for the three-month period ended June 30, 2019 primarily due to the write-off of intangibles in 2018 as a result of our decision to divest assets that no longer align with our strategic objectives.

Other Expense

  Three Months Ended 
  June 30, 2019  June 30, 2018 
Interest expense $(1) $(5)
Loss on settlement  -   (875)
Total other expense, net $(1) $(880)

Total net other expense for the three months ended June 30, 2019 decreased $0.9 million compared to the three months ended June 30, 2018 primarily due to a loss on settlement of a related party liability during the three months ended June 30, 2018.

Comparison of the Six Months Ended June 30, 2019 to the Six Months Ended June 30, 2018

Net Sales

We recorded net sales of approximately $69,000 for the six months ended June 30, 2019 and represents revenues from the sale of Prestalia®. We had no sales during the six months ended June 30, 2018.

Cost of Sales

Cost of sales were approximately $198,000 for the six months ended June 30, 2019 and represents cost of sales from the sale of Prestalia®. We had no sales or cost of sales during the six months ended June 30, 2018.

Operating Expenses

Our operating expenses for the six months ended June 30, 2019 are summarized as follows in comparison to our expenses for the threesix months ended March 31,June 30, 2018.

 

 Three Months Ended  Six Months Ended 
 March 31, 2019  March 31, 2018  June 30, 2019  June 30,2018 
      (in thousands) 
Sales, marketing and commercial operations $1,059,222  $- 
Sales and marketing $2,207  $2,586 
Research and development  -   173,256   -   173 
General and administrative expenses  1,367,303   919,908   2,966   1,979 
Amortization  17,575   123,261   35   247 
Total operating expenses $2,444,100  $1,216,425  $

5,208

  $4,985 

 

Sales, Marketing and Commercial Operations

 

For the threesix months ended March 31,June 30, 2019, sales, marketing and commercial operations expense increaseddecreased by approximately $1.1 million,$379,000, as compared to the prior period, primarily due to thea reduction in commercial launch activities related to the launch and ongoing of sales of Prestalia.Prestalia® and a reduction in costs associated with our go to market model.

 

Research and Development

 

For the threesix months ended March 31,June 30, 2019, research and development (“R&D”) expense decreased by approximately $0.2 million,$173,000, as compared to the threesix months ended March 31,June 30, 2018 due to the transition of our primarystrategic focus from R&D activities to sales, marketing and commercial operations activities beginning in the second quarter of 2018.

General and Administrative

 

General and administrative (“G&A”) expense increased by approximately $0.4$1.0 million for the threesix months ended March 31,June 30, 2019, as compared to the threesix months ended March 31,June 30, 2018, primarily due to an increase in share based compensation of approximately $0.3 million.

$0.2 million and an increase in personnel related expenses including severance payments made to executive management.

Amortization Expense

 

Amortization expenses relate to amortization of intangible assets acquired indecreased by approximately $212,000 for the asset purchases onsix-month period ended June 5, 2017 and July 21, 2017, with an aggregate estimated fair value of $0.7 million (reduced by the impairment loss of $0.2 million30, 2019 primarily due to the finalizationwrite-off of the purchase price allocation during the year ended December 31, 2018).intangibles in 2018 as a result of our decision to divest assets that no longer align with our strategic objectives.

 

Other Expense

 

 Three Months Ended  Six Months Ended 
 March 31, 2019 March 31, 2018 
(in thousands) June 30, 2019  June 30, 2018 
Interest expense $      -  $(144,744) $(1) $(149)
Loss on settlement  -   (875)
Total other expense, net $-  $(144,744) $(1) $

(1,024

)

 

Total net other expense for the threesix months ended March 31,June 30, 2019 decreased $0.1approximately $1.0 million compared to the six months ended June 30, 2018 primarily due to a loss on settlement of a related party liability and interest expense on notes payable during the three months ended March 31,June 30, 2018 dueas compared to the eliminationsame period of notes payable during 2018.2019.

 

Liquidity & Capital Resources

 

Working Capital

 

 March 31, 2019 December 31, 2018 
(in thousands) June 30, 2019  December 31, 2018 
Current assets $2,617,048  $4,677,179  $2,154  $4,677 
Current liabilities  (2,760,236)  (2,214,126)  (5,160)  (2,214)
Working capital (deficit) $(143,188) $2,463,053  $(3,006) $2,463 

 

WorkingNegative working capital as of March 31,June 30, 2019 was approximately negative $0.1$3.0 million as compared to comparedworking capital of approximately $2.5 million as of December 31, 2018. As of March 31, 2019, current assets were approximately $2.6 million,The decrease in working capital is primarily attributablerelated to cash of approximately $1.8 million. As of December 31, 2018, current assets were approximately $4.7 million primarily attributable to cash of approximately $3.9 million.

As of March 31, 2019,an increase in our current liabilities wereas of June 30, 2019 including approximately $2.8 million, comprised of accounts payable of approximately $0.3 million, due to related party of approximately $0.1 million, accrued expenses of approximately $0.9 million, approximately $0.1$1.3 million of current portion of operating lease liability, and accrued dividends of approximately $1.4 million. Comparatively, as of December 31, 2018, current liabilities were $2.2 million, primarily consisting of approximately $0.3 million of accountsnotes payable, accrued expenses of approximately $0.9 million and accrued dividends of approximately $1.0 million. Current liabilities increased by approximately $0.6 million, which was primarily attributable to an increase in accrued dividends for our convertible preferred stock of approximately $0.8 million and the current portion of thean increase in accounts payable and accrued expenses related to our operating lease liability.activities.

25

 

Cash Flows and Liquidity

 

Net cash used in Operating Activities

 

Net cash used in operating activities was approximately $2.1$3.5 million during the threesix months ended March 31,June 30, 2019. This was primarily due to our net operating loss of approximately $2.6$5.3 million, partially offset by non-cash share basedshare-based compensation of approximately $0.4 million.$0.6 million and other changes in operating assets and liabilities including an increase in accounts payable and accrued expenses.

 

Comparatively, net cash used in operating activities was approximately $59,000$3.9 million during the threesix months ended March 31,June 30, 2018. This was primarily due to the net operating loss of approximately $1.4$6.0 million offset by non-cash charges of approximately $0.6$2.5 million and changeother changes in working capital of approximately $0.7$0.3 million. The non-cashNon-cash charges were comprisedfor the three-months ended June 30, 2018 included the fair value of equity issued for settlement of an outstanding liability including a loss on the settlement of approximately $0.1 million of share based compensation, $0.1 million of amortization of intangibles, $0.1 million of non-cash interest expense and deferred revenue of approximately $0.2$0.9 million.

Net cash used in Investing Activities

 

There was no cash used in or provided by investing activities for the threesix months ended March 31, 2019 or 2018.June 30, 2019. Cash used in investing activities for the period ended June 30, 2018 was approximately $10,000 for the purchase of furniture for the corporate office.

 

Net cash provided by Financing Activities

 

There was noNet cash used in or provided by financing activities for the threesix months ended March 31,June 30, 2019 or 2018.was approximately $1.3 million from the issuance of promissory notes to certain accredited investors on June 28, 2019. For the six months ended June 30, 2018, cash provided by financing activities was $12.1 million primarily due to the issuance of preferred stock.

 

We will need to raise additional operating capital during the secondthird quarter of 2019 in order to maintain our operations and to realize our business plan. Without additional sources of cash and/or the deferral, reduction, or elimination of significant planned expenditures, we will not have the cash resources to continue as a going concern thereafter.

 

Future Financing

 

We will require immediate substantial additional funds to implement our strategic initiatives and continue the growth strategy for our business. As mentioned above,commercialization of Prestalia®. Historically, we have in the past, raised additional capital to supplement our commercialization, clinical development and operational expenses. We will need to raise substantial additional funds required through equity financing, debt financing, strategic alliances or other sources, which may result in further dilution in the equity ownership of our shares. There can be no assurance that additional financing will be available when needed or, if available, that it can be obtained on commercially reasonable terms. If we are not ableFailure to obtain theraise additional financingcapital through one or more financings, divesting development assets or reducing discretionary spending could have a material adverse effect on our ability to achieve our intended business objectives. These factors raise substantial doubt about our ability to continue as a timely basis as required, or generate significant material revenues from operations, we will not be able to meet our other obligations as they become due and will be forced to scale down, modify or perhaps even cease our operations.going concern.

 

Off-Balance Sheet Arrangements

 

As of March 31,June 30, 2019, we did not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.

 

Critical Accounting Policies and Estimates

 

Our significant accounting policies are more fully described in the notes to our financial statements included herein for the period ended March 31,June 30, 2019 and in the notes to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018.

 

26

New and Recently Adopted Accounting Pronouncements

 

Any new and recently adopted accounting pronouncements are more fully described in Note 1 to our financial statements included herein for the period ended March 31,June 30, 2019.

 

ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

ITEM 4 CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures 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. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives.

 

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based upon that evaluation and subject to the foregoing, our principal executive officer and principal financial officer concluded that, our disclosure controls and procedures were not effective due to the material weakness(es) in internal control over financial reporting described below.

 

Material Weakness in Internal Control over Financial Reporting

 

Management conducted an assessment of the effectiveness of our internal control over financial reporting as of March 31,June 30, 2019 based on the framework established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management has determined that our internal control over financial reporting as of March 31,June 30, 2019 was not effective.

 

A material weakness, as defined in the standards established by the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

 

The ineffectiveness of our internal control over financial reporting was due to the following material weaknesses which are indicative of many small companies with small number of staff:

 

 Inadequate segregation of duties consistent with control objectives;
 Lack of qualified accounting personnel to prepare and report financial information in accordance with GAAP; and
 Lack of documentation on policies and procedures that are critical to the accomplishment of financial reporting objectives.

 

27

Management’s Plan to Remediate the Material Weakness

 

Management has been implementing and continues to implement measures designed to ensure that control deficiencies contributing to the material weakness are remediated, such that these controls are designed, implemented, and operating effectively. The remediation actions planned include:

 

 Identify gaps in our skills base and the expertise of our staff required to meet the financial reporting requirements of a public company; and
 Continue to develop policies and procedures on internal control over financial reporting and monitor the effectiveness of operations on existing controls and procedures.

 

During the three months ended March 31,June 30, 2019, we continued to execute upon our planned remediation actions which are all intended to strengthen our overall control environment. Our Company and all subsidiaries use a well-regarded accounting software which restricts personnel access and standardizes daily accounting procedures on journal entries. The software includes built-in controls and documentation to facilitate accounting review of the books and records. Our Audit Committee continues to exercise oversight responsibilities related to financial reporting and internal control, and we have commenced a search to replace our Chief Financial Officer, who recently resigned. In the meantime, the Company’s Chief Executive Officer will assume the responsibilities of the Chief Financial Officer until we hire a full-time executive. We have hired an external consultant with GAAP expertise to assist in the preparation of financial reporting under management oversight.

oversight as of May 2, 2019.

The aforementioned measures taken are expected to lead to an improvement in the timely preparation of financial reports and to strengthen our segregation of duties at the Company. We are committed to maintaining a strong internal control environment, and we believe that these remediation efforts will represent significant improvements in our control environment. Our management will continue to monitor and evaluate the relevance of our risk-based approach and the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the fiscal quarter ended March 31,June 30, 2019 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II – OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

Paragraph IV Challenge

 

Our Prestalia product was involved in a paragraph IV challenge regarding patents issued to perindopril arginine. This challenge, which was pending in the United States District Court for the District of Delaware (No. 1:17-cv-00276), was captionedApotex Inc. and Apotex Corp. v. Symplmed Pharmaceuticals, LLC and Les Laboratoires Servier. The challengers (Apotex Inc. and Apotex Corp. (“Apotex”)) filed an Abbreviated New Drug Application seeking FDA approval to market a generic version of Prestalia and included a Paragraph (IV) certification. In the litigation, Apotex sought a declaratory judgment that no valid claims of the two patents Symplmed listed in the FDA Orange Book as having claims covering Prestalia, U.S. Patent No. 6,696,481 and 7,846,961, will be infringed by the Apotex proposed generic version of Prestalia and that the claims of those patents are invalid. The challenge was designed to provide Apotex with an opportunity to enter the market with a generic version of Prestalia, ahead of the expiration of the patents with claims covering that product.

 

Apotex entered into negotiations with Symplmed Pharmaceuticals, LLC (which entity sold its assets relating to Prestalia to us in June 2017, including its License and Commercialization Agreement with Les Laboratories Servier) and Les Laboratories Servier (which entity owns or controls intellectual property rights relating to pharmaceutical products containing as an active pharmaceutical ingredient perindopril in combination with other active pharmaceutical ingredients, which rights have been licensed to Symplmed Pharmaceuticals) to resolve the challenge in the second quarter of 2017. Such parties, along with us, have reached an agreement on terms that result in a delay to the challengers’ ability to enter the market with a generic version of Prestalia, while still providing the challenger with the right to enter the market prior to the expiration of the patent covering such product. Specifically, the parties have entered into a Confidential Settlement Agreement in connection with the settlement of the matter, pursuant to which, among other things, the parties entered into a Confidential License Agreement, whereby Symplmed, Servier and our company agreed to grant to Apotex a non-transferable, non-sublicensable, perpetual, irrevocable, royalty-free, non-exclusive license to the two patents listed in the FDA Orange Book as having claims covering Prestalia to make, use and market a generic version of Prestalia, or import a generic version of Prestalia from India into the United States, on or after January 1, 2021.

As a result of the foregoing, the matter is now settled.

 

General

 

Currently, there is no material litigation pending against our company other than as disclosed above. From time to time, we may become a party to litigation and subject to claims incident to the ordinary course of our business. Although the results of such litigation and claims in the ordinary course of business cannot be predicted with certainty, we believe that the final outcome of such matters will not have a material adverse effect on our business, results of operations or financial condition. Regardless of outcome, litigation can have an adverse impact on us because of defense costs, diversion of management resources and other factors.

ITEM 1A. RISK FACTORS

 

An investment in our common stock involves a number of very significant risks. You should carefully consider the risk factors included in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (the “Annual Report”), as filed with the SEC on April 16, 2019, in addition to other information contained in those documents and reports that we have filed with the SEC pursuant to the Securities Act and the Exchange Act since the date of the filing of the Annual Report, including, without limitation, this Quarterly Report on Form 10-Q, and the additional risk factor noted below, in evaluating our company and its business before purchasing shares of our common stock. Our business, operating results and financial condition could be adversely affected due to any of those risks.

Risks Relating to Inventory and Product Supply

The company may experience inventory outages as a result of increased demand for Prestalia. The company’s efforts to mitigate this risk may not be successful, resulting in patient supply interruption. Any interruption in the supply of this product could have a material adverse effect on our financial condition, business performance and the results of an investment in our securities.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

In April 2019, we issued 107,846 unregistered shares of our common stock to a holder of our Series E Convertible Preferred Stock in connection with the conversion of $53,923 of “Stated Value” of our Series E Convertible Preferred Stock. These shares were issued in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder.

Item 6. Exhibits

 

Exhibit No. Description
   
4.1Form of Secured Promissory Note issued by Adhera Therapeutics, Inc. to select accredited investors on each of June 28, 2019, July 3, 2019, July 17, 2019 and August 5, 2019 (filed as Exhibit 4.1 to our Current Report on Form 8-K dated June 28, 2019, and incorporated herein by reference).
10.1#Employment Agreement, dated April 4, 2019, by and between Adhera Therapeutics, Inc. and Nancy R. Phelan (filed as Exhibit 10.1 to our Current Report on Form 8-K dated April 4, 2019, and incorporated herein by reference).
10.2#Settlement Agreement, dated April 4, 2019, by and between Adhera Therapeutics, Inc. an Robert. C. Moscato, Jr. (filed as Exhibit 10.2 to our Current Report on Form 8-K dated April 4, 2019, and incorporated herein by reference).
10.3Security Agreement, dated as of June 28, 2019, among Adhera Therapeutics, Inc., IThenaPharma, Inc., Cequent Pharmaceuticals, Inc., MDRNA Research, Inc., the purchasers of secured promissory notes identified on the signature pages thereto, and Jeff S. Phillips as agent (filed as Exhibit 10.1 to our Current Report on Form 8-K dated June 28, 2019, and incorporated herein by reference).
10.4Form of Subscription Agreement used in connection with the issuance by Adhera Therapeutics, Inc. of Secured Convertible Promissory Notes on each of June 28, 2019, July 3, 2019, July 17, 2019 and August 5, 2019 (filed as Exhibit 10.2 to our Current Report on Form 8-K dated August 5, 2019, and incorporated herein by reference).
31.1 Certification of our Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. (1)
   
32.1 Certification of our Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (2)
   
101INS XBRL Instance Document (1)
   
101SCH XBRL Taxonomy Extension Schema Document (1)
   
101CAL XBRL Taxonomy Extension Calculation Linkbase Document (1)
   
101DEF XBRL Taxonomy Extension Definition Linkbase Document (1)
   
101LAB XBRL Taxonomy Extension Label Linkbase Document (1)
   
101PRE XBRL Taxonomy Extension Presentation Linkbase Document (1)
   
(1) Filed herewith.
(2) Furnished herewith.
#Indicates management contract or compensatory plan or arrangement.

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 ADHERA THERAPEUTICS, INC.
  
Date: May 15,August 14, 2019By:/s/ Nancy R. Phelan.
  Nancy R. Phelan
  Chief Executive Officer and Director
  (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)