EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1

 
Exhibit 99.1

PAINREFORM LTD.

CONDENSED FINANCIAL STATEMENTS

AS OF SEPTEMBER 30, 2022,

UNAUDITED

U.S. DOLLARS IN THOUSANDS

INDEX

 
 Page

F-2
   
F-3
   
F-4
   
F-5
   
F-6 - F-11



PAINREFORM LTD.

CONDENSED BALANCE SHEETS (UNAUDITED)
U.S. dollars in thousands (except share and per share data)
     

   
Note
   
As of
September 30,
2022
   
As of
December 31,
2021
 
Assets
                 
Current assets:
                 
Cash and cash equivalents
       
$
6,922
   
$
16,537
 
Short term deposits
         
6,034
     
-
 
Restricted cash
         
24
     
34
 
Prepaid clinical trial expenses and deferred clinical trial costs
   
7
     
1,728
     
1,728
 
Prepaid expenses and other current assets
           
100
     
721
 
Total current assets
           
14,808
     
19,020
 
                         
Property and equipment, net
           
44
     
53
 
                         
Total assets
         
$
14,852
   
$
19,073
 
                         
Liabilities and shareholders’ equity
                       
                         
Current liabilities:
                       
Trade payables
         
$
385
   
$
136
 
Employees and related liabilities
           
414
     
423
 
Accrued expenses
           
395
     
198
 
Total current liabilities
           
1,194
     
757
 
                         
Non-current liabilities:
                       
Provision for uncertain tax positions
           
240
     
234
 
                         
Total liabilities
           
1,434
     
991
 
                         
Commitments and contingencies (Note 7)
                       
                         
Shareholders’ equity:
                       
Ordinary shares, NIS 0.03 par value; Authorized: 26,666,667 shares as of September 30,
2022 and December 31, 2021; Issued and outstanding: 10,634,166 and 10,482,056
shares as of September 30, 2022 and December 31, 2021, respectively.
           
94
     
94
 
Additional paid-in capital
           
42,677
     
41,715
 
Accumulated deficit
           
(29,353
)
   
(23,727
)
                         
Total shareholders’ equity
   
4
     
13,418
     
18,082
 
                         
Total liabilities and shareholders’ equity
         
$
14,852
   
$
19,073
 
 
The accompanying notes are an integral part of the unaudited condensed financial statements.
 
F - 2


PAINREFORM LTD.
 
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands (except share and per share data)
 
          Nine months ended September 30,   
 

 
Note
   
2022
   
2021
 
                   
Operating expenses:
                 
Research and development expenses
       
$
(2,473
)
 
$
(2,304
)
General and administrative expenses
         
(3,140
)
   
(3,163
)
                       
Operating loss
         
(5,613
)
   
(5,467
)
                       
Financial expense, net
    6      
(13
)
   
(46
)
                         
Net loss and comprehensive loss
         
$
(5,626
)
 
$
(5,513
)
                         
Basic and diluted net loss per share
         
$
(0.53
)
 
$
(0.57
)
                         
 Weighted average number of shares of ordinary share used in computing basic and diluted net loss per share  
            10,634,166
       9,731,501
 

The accompanying notes are an integral part of the unaudited condensed financial statements.
 
F - 3


PAINREFORM LTD.

CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (UNAUDITED)

U.S. dollars in thousands (except share data)

   
Ordinary shares
   
Additional
paid-in
    Accumulated
    Total shareholders’
 
    Number
    Amount
    capital
    deficit
    Equity
 
Balance as of January 1, 2021
   
8,758,037
   
$
78
   
$
33,023
   
$
(16,481
)
 
$
16,620
 
Shares and warrants issuance - Private Investment in Public Equity ("PIPE"), net
   
1,304,346
     
12
     
5,542
     
-
     
5,554
 
Exercise of warrants
   
419,673
     
18
     
1,912
             
1,930
 
Share-based compensation to employees and directors
   
-
     
-
     
582
     
-
     
582
 
Share-based compensation to service providers
   
-
     
-
     
309
     
-
     
309
 
Net loss and comprehensive loss
   
-
     
-
     
-
     
(5,513
)
   
(5,513
)
Balance as of September 30, 2021
   
10,482,056
   
$
108
   
$
41,368
     
(21,994
)
 
$
19,482
 
 
    Ordinary shares
   
Additional
paid-in
capital
    Accumulated
deficit
    Total shareholders’
Equity
 

 
Number
   
Amount
             
                               
Balance as of January 1, 2022
   
10,482,056
   
$
94
   
$
41,715
   
$
(23,727
)
 
$
18,082
 
Share-based compensation to employees and directors
   
-
     
-
     
653
     
-
     
653
 
Share-based compensation to service providers
   
-
     
-
     
309
     
-
     
309
 
Shares issuance to service providers
   
152,110
     
*
     
-
     
-
     
*
 
Net loss and comprehensive loss
   
-
     
-
     
-
     
(5,626
)
   
(5,626
)
Balance as of September 30, 2022
   
10,634,166
   
$
94
   
$
42,677
   
$
(29,353
)
 
$
13,418
 
 
(*) Less than $1.

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

F - 4

 
PAINREFORM LTD.

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)

U.S. dollars in thousands
 
    Nine months ended September 30,
 
   
2022
   
2021
 
           
Cash flows from operating activities
           
             
Net loss
 
$
(5,626
)
 
$
(5,513
)
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation
   
9
     
4
 
Share-based compensation to employees and directors
   
653
     
582
 
Share-based compensation to service providers
   
309
     
309
 
Change in:
               
Other current assets
   
621
     
161
 
Trade payables
   
249
     
(550
)
Other accounts payable
   
194
     
225
 
 
Net cash used in operating activities
   
(3,591
)
   
(4,782
)
                 
Cash flows from investing activities
               
Purchase of  short term deposit
   
(6,034
)
       
Purchase of property and equipment
   
-
     
(22
)
Net cash used in investing activities
   
(6,034
)
   
(22
)
                 
Cash flows from financing activities
               
                 
Proceeds from Exercise of warrants
           
1,930
 
Proceeds from issuance of ordinary shares under Private Investment in Public Equity
   
-
     
6,000
 
Issuance costs
   
-
     
(446
)
                 
Net cash provided by financing activities
   
-
     
7,484
 
                 
Change in cash, cash equivalents and restricted cash
   
(9,625
)
   
2,680
 
Cash, cash equivalents and restricted cash at the beginning of the period
   
16,571
     
15,690
 
                 
Cash, cash equivalents and restricted cash at the end of the period
 
$
6,946
   
$
18,370
 
 
The below table reconciles cash, cash equivalents and restricted cash as reported in the balance sheets to the total of the same amounts shown in the statements of cash flows:
 
 
 
As of September 30,
 
 
 
2022
   
2021
 
Cash and cash equivalents 
 
$
6,922
   
$
18,337
 
Restricted cash
   
24
     
33
 
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows
 
$
6,946
   
$
18,370
 

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

F - 5

 
PAINREFORM LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)

U.S. dollars in thousands, except share and per share data

NOTE 1: GENERAL


a.
PainReform Ltd. (the "Company") was incorporated under the laws of the State of Israel in November 2007. The Company is a clinical stage specialty pharmaceutical company focused on the reformulation of established therapeutics. The Company’s proprietary extended release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates.


b.
As a result of issues in the manufacturing process, the Company has decided to postpone the commencement of its planned Phase 3 clinical trial. The Company is currently investigating these manufacturing issues and cannot predict the costs that may be incurred or the timeline for commencing the Phase 3 trial.


c.
Liquidity
 
Since its inception, the Company has devoted substantially all of its efforts to research and development, clinical trials, and capital raising activities. The Company is still in its development and clinical stage and has not yet generated revenues.

The Company has incurred losses of $5,626 and $5,513 for the nine months periods ended on September 30, 2022, and 2021, respectively and has negative cash outflow from operating activities. The Company expects to continue to incur losses and negative cash flows from operations until its product reaches profitability. As of September 30, 2022, the Company’s accumulated deficit was $29,353. The Company has funded its operations to date primarily through equity financing and has cash on hand (including short term deposits) of $12,956 as of September 30, 2022. Additional funding will be required to complete the Company’s research and development and clinical trials, to attain regulatory approvals, to begin the commercialization efforts of the Company’s product and to achieve a level of sales adequate to support the Company’s current and planned cost structure. The Company monitors its cash flow projections on a current basis and based on the Company's current operating plan, the Company believes that its existing capital resources will be sufficient to fund operations for at least twelve months after the date the financial statements are issued.


d.
In late 2019, a novel strain of COVID-19, was reported in Wuhan, China. While initially the outbreak was largely concentrated in China, it rapidly spread across the globe, including in Israel and the United States. The extent to which the COVID-19 pandemic impacts the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain the COVID-19 or treat its impact. Through the financial report approval date, November 14, 2022, the Company has not experienced a significant impact on its operations due to the COVID-19 pandemic.


e.
In April 2022, the Company's board of directors increased the number of reserved ordinary shares under the 2019 Plan by an additional amount of 1,000,000 ordinary shares. (Note 4b)


f.
In April 2022, the Company issued 152,110 shares to a consultant pursuant to an agreement signed in August 2020. Since August 2020, the Company has recognized $857 ($309 for the nine months ended September 30, 2022) as share-based compensation expense related to the shares issued to the consultant.

F - 6

 
PAINREFORM LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)

U.S. dollars in thousands, except share and per share data

NOTE 2: UNAUDITED CONDENSED FINANCIAL STATEMENTS
 
The unaudited condensed financial statements included herein have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and, on the same basis as the audited financial statements included in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2021 (the “2021 Form 20-F”).

Certain information and disclosures normally included in annual financial statements have been omitted in this interim period report pursuant to the rules and regulations of the Securities and Exchange Commission. Because the unaudited condensed financial statements do not include all of the information and disclosures required by U.S. GAAP for annual financial statements, they should be read in conjunction with the audited financial statements and notes included in the 2021 Form 20-F.

The year-end balance sheet data were derived from the audited financial statements as of December 31, 2021, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included.

In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair statement of the Company’s financial position as of September 30, 2022 and its results of operations and cash flows for the nine months ended September 30, 2022 and 2021 have been included. Operating results for the nine months ended September 30, 2022, are not necessarily indicative of the results that may be expected for the year ending December 31, 2022 or any other interim period or for any other future year.

NOTE 3:  SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies that have been applied in the preparation of the unaudited condensed financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements in connection with its Annual Report on Form 20-F, except for the following:
 
 
-
In August 2020, the FASB issued guidance ASU 2020-06 that is expected to reduce complexity and improve comparability of financial reporting associated with accounting for convertible instruments and contracts in an entity’s own equity. This guidance is effective for the Company from January 1, 2022 and did not have a material impact on the Company’s financial statements and disclosures.
 
F - 7


PAINREFORM LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)

U.S. dollars in thousands, except share and per share data

NOTE 4:  SHAREHOLDERS’ EQUITY


a.
Warrants and warrants units
 
The following table summarizes the warrants outstanding as of September 30, 2022:
 
Type
Issuance Date
Number of warrants
Exercise price
Exercisable through
August 2019 warrants
August 22, 2019
205,268
$6.72 (*)
August 22, 2024
December 2019 warrants
December 9, 2019
148,106
$6.72 (*)
December 8, 2024
Warrants to underwriters
September 3, 2020
125,000
$10.00
September 1, 2025
Warrants to underwriters
October 5, 2020
375,000
$8.80
September 3, 2025
IPO warrants
September 3, 2020
2,812,170
$8.80
September 3, 2025
PIPE warrants
March 11, 2021
232,500
$4.60
September 10, 2026
Warrants to PIPE placement agent
March 11,2021
52,173
$5.06
March 8, 2026
TOTAL
 
3,950,217
   
 
(*) Each warrant is exercisable into one IPO unit consisting of one share and one IPO warrant with an exercise price of $8.80.

F - 8


PAINREFORM LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)

U.S. dollars in thousands, except share and per share data

NOTE 4:  SHAREHOLDERS’ EQUITY (Cont.)
 

b.
Share-based compensation:
 
Share options outstanding and exercisable to employees and directors under the 2008 Plan as of September 30, 2022 and December 31, 2021 were as follows:
 
         
Weighted
 
   
Weighted
   
average
 
     
average
   
remaining
 
   
Number of
   
exercise
   
contractual
 
   
options
   
price
   
life
 
Options outstanding as of December 31, 2021
   
153,882
   
$
0.24
     
2.25
 
Options granted
   
-
     
-
     
-
 
Options exercised
   
-
     
-
     
-
 
Options forfeited
   
-
     
-
     
-
 
Options outstanding as of September 30, 2022
   
153,882
   
$
0.24
     
1.50
 
                         
Options exercisable as of September 30, 2022
   
153,882
   
$
0.24
     
1.50
 
 
Share options outstanding and exercisable to employees and directors under the 2019 Share Option Plan (the “2019 Plan”) as of September 30, 2022 and December 31, 2021, were as follows:
 
         
Weighted
 
   
Weighted
   
average
 
     
average
   
remaining
 
   
Number of
   
exercise
   
contractual
 
   
options
   
price
   
life
 
Options outstanding as of December 31, 2021
   
971,476
   
$
4.51
     
8.72
 
Options granted
   
164,455
     
1.06
     
9.54
 
Options exercised
   
-
     
-
     
-
 
Options forfeited
   
-
     
-
     
-
 
Options outstanding as of September 30, 2022
   
1,135,931
   
$
4.01
     
8.84
 
                         
Options exercisable as of September 30, 2022
   
560,831
   
$
4.11
     
7.72
 
 
In April 2022, the Company’s board of directors approved the grant of options to purchase 164,455 ordinary shares of the Company to employees. The options were granted under the Company's 2019 plan. The fair value of share options granted was estimated using the Black Scholes option-pricing model, which requires a number of assumptions, of which the most significant are the expected share price, volatility, and the expected option term. The options vest over a four-year period, 4/16 of the options shall vest following the lapse of a period of twelve months commencing at the date of grant. The remaining 12/16 of the options shall vest on quarterly basis, so that 1/16 of the options shall vest on the expiry of each quarter. The weighted average grant date fair value per option was $0.89.
 
F - 9

PAINREFORM LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)

U.S. dollars in thousands, except share and per share data

NOTE 4:  SHAREHOLDERS’ EQUITY (Cont.)
 
The following table summarizes information about share options that were granted in 2022 as part of the 2019 plan:
 
    2022  
Share price at grant day (USD)
  $ 1.22  
Expected life (years)
    6.12  
Risk-free interest rates   
   
2.69
%
Expected volatility          
   
79.30
%
Dividend yield  
   
-
 
Exercise price 
 
1.06  
Weighted average grant date fair value per option  
  $ 0.89  

NOTE 5:  LOSS PER SHARE

Basic loss per share is computed by dividing the loss for the period applicable to ordinary shareholders by the weighted average number of ordinary shares outstanding during the period.

For the periods ended September 30, 2022 and 2021, all outstanding share options and warrants have been excluded from the calculation of the diluted net loss per share as all such securities are anti-dilutive for all periods presented.

NOTE 6:  FINANCIAL EXPENSES, NET
 
    Nine months ended September 30,
 
    2022    
2021
 
           
Bank fees
   
(9
)
   
(6
)
Income from deposits
   
65
     
-
 
Exchange rate differences
   
(69
)
   
(40
)
Total financial expenses, net
 
$
(13
)
 
$
(46
)

 
F - 10


PAINREFORM LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)

U.S. dollars in thousands, except share and per share data

NOTE 7:  COMMITMENTS AND CONTINGENCIES

On November 13, 2020, the Company entered into a Master Clinical Research Organization Agreement (the "First Agreement"), and on December 3, 2020, the Company entered into a Master Clinical Trial Agreement (the "Second Agreement") both with Lotus Clinical Research as the Company's clinical research organization for the Company's planned Phase 3 trial of PRF-110, which was expected to commence in the fourth quarter of 2022, but has been postponed due to issues in the manufacturing process ( note 9) .
 
Under the First Agreement, the Company paid the first milestone of $581 on December 28, 2020, and paid an additional milestone of $581 during the first nine months of 2021. In addition, the Company paid a non-refundable deposit of $710 under the Second Agreement in January 2021.

As of September 30, 2022, the Company accounted for these amounts of net $1,728 as prepaid clinical trial expense and deferred clinical trial costs after recognition of $144 clinical trials expenses in 2021.
 
NOTE 8:  FINANCIAL INSTRUMENTS
 
The carrying amount of cash equivalents, restricted cash, trade payables and accrued expenses approximate their fair value due to their short-term characteristics.
 
NOTE 9:  SUBSEQUENT EVENTS

As a result of issues in the manufacturing process, the Company has decided to postpone the commencement of its planned Phase 3 clinical trial. See note 1b.
 

F - 11