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Share Name | Share Symbol | Market | Type |
---|---|---|---|
PainReform Ltd | NASDAQ:PRFX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.81 | 0.78 | 0.96 | 0 | 09:21:53 |
99.1
|
Unaudited Condensed Financial Statements as of September 30, 2023
|
|
|
99.2
|
Operating and Financial Review as of September 30, 2023 and for the nine months then ended
|
99.3 |
Press Release dated November 15, 2023 |
Exhibit No.
|
|
Description
|
Date: November 15, 2023
|
PAINREFORM LTD.
|
|
|
|
|
|
By:
|
/s/ Ilan Hadar
|
|
|
Ilan Hadar
|
|
|
Chief Executive Officer
|
|
Page
|
|
|
F-2
|
|
|
|
F-3
|
|
|
|
F-4
|
|
|
|
F-5-F-6
|
|
|
|
F-7 - F-13
|
|
|
|
|
|
As of
September 30,
|
|
|
As of
December 31,
|
|
|||
|
|
Note
|
|
|
2023
|
|
|
2022
|
|
|||
Assets
|
|
|
|
|
|
|
|
|
|
|||
Current assets:
|
|
|
|
|
|
|
|
|
|
|||
Cash and cash equivalents
|
|
|
|
|
$
|
7,551
|
|
|
$
|
4,096
|
|
|
Short term deposit
|
|
|
|
|
|
1,029
|
|
|
|
6,085
|
|
|
Restricted cash
|
|
|
|
|
|
9
|
|
|
|
10
|
|
|
Prepaid clinical trial expenses and deferred clinical trial costs
|
|
|
|
|
|
1,938
|
|
|
|
1,728
|
|
|
Prepaid expenses and other current assets
|
|
|
|
|
|
214
|
|
|
|
365
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
|
|
|
10,741
|
|
|
|
12,284
|
|
|
Non-current assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease right of use asset
|
|
|
4 |
|
|
|
103
|
|
|
|
-
|
|
Property and equipment, net
|
|
|
|
|
|
|
43
|
|
|
|
44
|
|
Total long term assets
|
|
|
|
|
|
|
146
|
|
|
|
44
|
|
Total assets
|
|
|
|
|
|
$
|
10,887
|
|
|
$
|
12,328
|
|
Liabilities and shareholders’ equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade payables
|
|
|
|
|
|
$
|
214
|
|
|
$
|
209
|
|
Employees and related liabilities
|
|
|
|
|
|
|
366
|
|
|
|
499
|
|
Operating lease liability
|
|
|
4
|
|
|
|
55
|
|
|
|
-
|
|
Accrued expenses
|
|
|
|
|
|
|
460
|
|
|
|
356
|
|
Total current liabilities
|
|
|
|
|
|
|
1,095
|
|
|
|
1,064
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
|
|
|
5g
|
|
|
863
|
|
|
|
-
|
|
|
Operating lease liability
|
|
|
4
|
|
|
|
39
|
|
|
|
-
|
|
Provision for uncertain tax positions
|
|
|
|
|
|
|
249
|
|
|
|
243
|
|
Total non-current liabilities
|
|
|
|
|
|
|
1,151
|
|
|
|
243
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
|
|
|
|
2,246
|
|
|
|
1,307
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments (Note 7)
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders’ equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares, NIS 0.3 par value; Authorized: 5,000,000 shares as of September 30, 2023, 2,666,667 as of December 31, 2022;
Issued and outstanding: 1,558,347 and 1,081,755 shares as of September 30, 2023, and December 31, 2022, respectively. (*)
|
|
|
|
|
|
|
133
|
|
|
|
94
|
|
Additional paid-in capital
|
|
|
5e,5f
|
|
|
45,480
|
|
|
|
43,446
|
|
|
Accumulated deficit
|
|
|
|
|
|
|
(36,972
|
)
|
|
|
(32,519
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders’ equity
|
|
|
|
|
|
|
8,641
|
|
|
|
11,021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders’ equity
|
|
|
|
|
|
$
|
10,887
|
|
|
$
|
12,328
|
|
|
|
|
|
|
For the Nine Months Ended
September 30, |
|
||||||
|
|
Note
|
|
|
2023
|
|
|
2022
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|||
Research and development expenses
|
|
|
|
|
$
|
(3,289
|
)
|
|
$
|
(2,473
|
)
|
|
General and administrative expenses
|
|
|
|
|
|
(2,731
|
)
|
|
|
(3,140
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
|
|
|
(6,020
|
)
|
|
|
(5,613
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income, net
|
|
|
8
|
|
|
|
1,567
|
|
|
|
(13
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
$
|
(4,453
|
)
|
|
$
|
(5,626
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share(*)
|
|
|
6
|
|
|
$
|
(3.64
|
)
|
|
$
|
(5.20
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares of Ordinary Shares used in computing basic and diluted net loss per share(*)
|
|
|
|
|
|
|
1,221,695
|
|
|
|
1,081,755
|
|
|
Ordinary shares(**)
|
Additional paid-in
capital
|
Accumulated
deficit
|
Total
shareholders’ equity
|
||||||||||||||||
|
Number
|
Amount
|
||||||||||||||||||
|
||||||||||||||||||||
Balance as of January 1, 2022
|
1,066,544
|
$
|
94
|
$
|
41,715
|
$
|
(23,727
|
)
|
$
|
18,082
|
||||||||||
|
||||||||||||||||||||
Share-based compensation to employees and directors
|
-
|
-
|
653
|
-
|
653
|
|||||||||||||||
|
||||||||||||||||||||
Share-based compensation to service providers
|
-
|
-
|
309
|
-
|
309
|
|||||||||||||||
Share issuance to service providers
|
15,211
|
*
|
*
|
|||||||||||||||||
Net loss and comprehensive loss
|
-
|
-
|
-
|
(5,626
|
)
|
(3,517
|
)
|
|||||||||||||
|
||||||||||||||||||||
Balance as of September 30, 2022
|
1,081,755
|
$
|
94
|
$
|
42,677
|
$
|
(29,353
|
)
|
$
|
13,418
|
||||||||||
Balance as of January 1, 2023
|
1,081,755
|
$
|
94
|
$
|
43,446
|
$
|
(32,519
|
)
|
$
|
11,021
|
||||||||||
|
||||||||||||||||||||
Share-based compensation to employees and directors
|
-
|
-
|
623
|
-
|
623
|
|||||||||||||||
Share issuance to service providers
|
8,697
|
*
|
-
|
-
|
*
|
|||||||||||||||
|
||||||||||||||||||||
Issuance of common stock and pre-funded warrants upon private placement, net of underwriting commissions and other offering costs. (***)
|
467,895
|
39
|
$
|
1,411
|
-
|
1,450
|
||||||||||||||
|
||||||||||||||||||||
Net loss and comprehensive loss
|
-
|
-
|
(4,453
|
)
|
(4,453
|
)
|
||||||||||||||
Balance as of September 30, 2023
|
1,558,347
|
$
|
133
|
$
|
45,480
|
$
|
(36,972
|
)
|
$
|
8,641
|
|
For the Nine Months Ended
September 30, |
|||||||
|
2023
|
2022
|
||||||
Cash flows from operating activities
|
||||||||
|
||||||||
Net loss
|
$
|
(4,453
|
)
|
$
|
(5,626
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
9 |
9
|
||||||
Exchange rate differences on cash, cash equivalents and restricted cash
|
5
|
-
|
||||||
Net change in operating lease asset and liability
|
(9
|
)
|
-
|
|||||
Warrant issuance costs
|
368
|
-
|
||||||
Share-based compensation to employees and directors
|
623
|
653
|
||||||
Share-based compensation to service providers
|
-
|
309
|
||||||
Interest income
|
55
|
-
|
||||||
Change in:
|
||||||||
Other current assets
|
(59
|
)
|
621
|
|||||
Change in warrant liability valuation
|
(1,648
|
)
|
||||||
Trade payables
|
5
|
249
|
||||||
Other accounts payable
|
(23
|
)
|
194
|
|||||
|
||||||||
Net cash used in operating activities
|
(5,127
|
)
|
(3,591
|
)
|
||||
|
||||||||
Cash flows from investing activities
|
||||||||
|
||||||||
Purchase of property and equipment
|
(8
|
)
|
-
|
|||||
Purchase of short-term deposit
|
(1,000
|
)
|
(6,034
|
)
|
||||
Proceeds from short term deposit
|
6,000
|
-
|
||||||
|
||||||||
Net cash provided by (used in) investing activities
|
4,992
|
(6,034
|
)
|
|||||
|
||||||||
Cash flows from financing activities
|
||||||||
Proceeds from Issuance of warrants
|
2,511
|
-
|
||||||
Proceeds from Issuance of shares and pre-funded warrants
|
1,703
|
-
|
||||||
Issuance costs
|
(620
|
)
|
-
|
|||||
Net cash provided by financing activities
|
3,594
|
-
|
||||||
|
||||||||
Effect of Exchange rate changes on cash, cash equivalents and restricted cash
|
(5
|
)
|
-
|
|||||
Change in cash, cash equivalents and restricted cash
|
3,454
|
(9,625
|
)
|
|||||
Cash, cash equivalents and restricted cash at the beginning of the period
|
4,106
|
16,571
|
||||||
|
||||||||
Cash, cash equivalents and restricted cash at the end of the period
|
$
|
7,560
|
$
|
6,946
|
|
As of September 30,
|
|||||||
|
2023
|
2022
|
||||||
Cash and cash equivalents
|
$
|
7,551
|
$
|
6,922
|
||||
Restricted cash
|
9
|
24
|
||||||
Total cash, cash equivalents and restricted cash
|
$
|
7,560
|
$
|
6,946
|
||||
Non cash activity | ||||||||
Acquisition of right-of-use assets by means of lease liabilities
|
$ |
113 |
$ |
- |
a.
|
PainReform Ltd. ("the Company") was incorporated and started business operations 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.
|
Liquidity
Since its inception, the Company has devoted substantially all 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 significant losses and negative cash flows from operations and incurred losses of $4,453 and $5,626 for the nine-month periods ended on September 30, 2023, and
2022, respectively. During the nine months ended September 30, 2023, and 2022, the Company had negative operating cash outflows of $5,127, and $3,591, respectively. The Company expects to continue to incur losses and negative cash flows
from operations until its products reach profitability. As of September 30, 2023, the Company’s accumulated deficit was $36,972. The Company has funded its operations to date primarily through equity financing and has cash on hand
(including restricted cash and deposits) in the amount of $8,589 as of September 30, 2023.
In July 2023, the Company consummated two registered direct offerings of its ordinary shares and simultaneous private placements of warrants to purchase its ordinary shares that resulted in aggregate gross
proceeds of $4.2 million and net proceeds of $3.6 million (Note 5).
The Company expects to continue incurring losses and negative cash flows from operations until its product, PRF-110, reaches commercial profitability. As a result of the initiation of the Company's Phase III
clinical trial, along with its current cash position, the Company does not have sufficient resources to fund operations until the end of its Phase III study nor to continue as a going concern for at least one year from the issuance date
of these financial statements.
Management's plans include continued capital raising through the sale of additional equity securities, debt, or capital inflows from strategic partnerships. There are no assurances, however, that the
Company will successfully obtain the level of financing needed for its operations. If the Company is unsuccessful in raising capital, it may need to reduce activities or curtail or abandon some or all of its operations, which could
materially harm the Company’s business, financial condition and results of operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared
assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business and does not include any adjustments that might result from the
outcome of this uncertainty.
|
c.
|
In June 2023, the Company’s supplier of the API (active pharmaceutical ingredient) received a deficiency notice from the FDA related to its Drug Master File
(DMF). The DMF is the file on record with FDA representing the manufacturing process and facility for the production of the API. As a result, the second part of Phase 3 trial was delayed. The supplier completed the review with the FDA
and the deficiency notice has been resolved. None of the issues raised relate to the Company’s PRF-110 product. Following the FDA review process of the DMF and early in September 2023, the Company received a letter from the FDA,
removing any objections for use of the API manufactured by the DMF holder. In October 2023, the Company reactivated the clinical study and enrolled the first patients in the second part of the Phase 3 trial with its contract research
organization (the "CRO"), which will include up to 400 patients in the double-blind study multiple clinical sites in the U.S., measuring pain reduction by PRF-110 over 72 hours compared with placebo and Naropin® (ropivacaine).
|
d.
|
The Company reports its financial results in U.S. dollars. A portion of research, development, general and administrative
expenses of its Israeli operations are incurred in New Israeli Shekel ("NIS"). As a result, the Company is exposed to exchange rate risks that may materially and adversely affect its financial results. If the NIS appreciates against the
U.S. dollar, or if the value of the NIS declines against the U.S. dollar at a time when the rate of inflation in the cost of Israeli goods and services exceeds the rate of decline in the relative value of the NIS, then the U.S.
dollar-denominated cost of its operations in Israel would increase and its results of operations could be materially and adversely affected. Inflation in Israel compounds the adverse impact of a devaluation of the NIS against the U.S.
dollar by further increasing the amount of its Israeli expenses. Israeli inflation may also (in the future) outweigh the positive effect of any appreciation of the U.S. dollar relative to the NIS, if and to the extent that, it outpaces or
precedes such appreciation. The Israeli rate of inflation did not have a material adverse effect on its financial condition during the nine months ended September 30, 2023 and 2022, respectively. Given its general lack of currency hedging
arrangements to protect it from fluctuations in the exchange rates of the NIS in relation to the U.S. dollar (and/or from inflation of such non-U.S. currencies), the Company may be exposed to material adverse effects from such movements.
The Company cannot predict any future trends in the rate of inflation in Israel or the rate of devaluation (if any) of the U.S. dollar against the NIS.
|
e.
|
In June 2023, the Company effected a reverse share split of its shares at the ratio of 1-for-10 (Note 5d).
|
f.
|
U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the military conflict between Russia and Ukraine. The conflict in Ukraine could lead to
market disruptions, including significant volatility in commodity prices, credit and capital markets. Any of the abovementioned factors could affect its business, prospects, financial condition, and operating results. The extent and
duration of the military action, sanctions and resulting market disruptions are not possible to predict.
|
a.
|
Warrants and warrants units
|
Type
|
Issuance Date
|
Number of warrants
|
Exercise price(**)
|
Exercisable through
|
August 2019 warrants
|
August 22, 2019
|
205,268
|
$67.20 (*)
|
August 22, 2024
|
December 2019 warrants
|
December 9, 2019
|
92,321
|
$67.20 (*)
|
December 8, 2024
|
Warrants 2019 Convertible Notes to placement agent
|
December 9, 2019
|
55,785
|
$67.20 (*)
|
December 8, 2024
|
Warrants to underwriters
|
September 3, 2020
|
125,000
|
$100.00
|
September 1, 2025
|
Warrants to underwriters
|
October 5, 2020
|
375,000
|
$88.00
|
September 3, 2025
|
IPO warrants
|
September 3, 2020
|
2,812,170
|
$88.00
|
September 3, 2025
|
PIPE warrants
|
March 11, 2021
|
232,500
|
$46.00
|
September 10, 2026
|
Warrants to PIPE placement agent
|
March 11,2021
|
52,173
|
$50.60
|
March 8, 2026
|
Warrants issued by F-1 (***)
|
July 2023
|
467,896
|
$9.00
|
July 14-18,2028
|
TOTAL
|
|
4,418,113
|
|
|
b.
|
Share-based compensation:
|
1.
|
The 2008 Plan:
Share options outstanding and exercisable to employees and directors under the 2008 Share Option Plan (the “2008 Plan”) as of September 30, 2023 and December 31, 2022 were as follows:
|
|
Number
of options(*)
|
Weighted
average
exercise
price(*)
|
Weighted
average
remaining
contractual
life
|
|||||||||
|
||||||||||||
Options outstanding as of December 31, 2022
|
15,388
|
$
|
2.40
|
1.25
|
||||||||
Options granted
|
-
|
-
|
-
|
|||||||||
Options exercised
|
-
|
-
|
-
|
|||||||||
Options forfeited
|
-
|
-
|
-
|
|||||||||
Options outstanding as of September 30, 2023
|
15,388
|
$
|
2.40
|
0.50
|
||||||||
|
||||||||||||
Options exercisable as of September 30, 2023
|
15,388
|
$
|
2.40
|
0.50
|
2.
|
The 2019 Plan:
Share options outstanding and exercisable to employees and directors under the 2019 Share Option Plan (the “2019 Plan”) as of September 30, 2023 and December 31, 2022, were as follows:
|
|
Number
of options(*)
|
Weighted
average
exercise price(*)
|
Weighted
average
remaining
contractual
life
|
|||||||||
|
||||||||||||
Options outstanding as of December 31, 2022
|
133,994
|
$
|
14.4
|
9.39
|
||||||||
Options granted
|
54,000
|
5.89
|
9.70
|
|||||||||
Options exercised
|
-
|
-
|
-
|
|||||||||
Options forfeited
|
-
|
-
|
-
|
|||||||||
Options outstanding as of September 30, 2023
|
187,994
|
$
|
11.94
|
8.94
|
||||||||
|
||||||||||||
Options exercisable as of September 30, 2023
|
127,344
|
$
|
13.33
|
8.81
|
c.
|
In April 2022, the Company issued 15,211 ordinary shares to a consultant pursuant to an agreement signed in August 2020. Since August 2020 and until December 31, 2022, the Company has
recognized $822 as share-based compensation expense related to the shares issued to the consultant. In May 2022, the Company’s board of directors approved an additional grant of 8,697 shares. During 2022, the Company recognized $67 as
share-based compensation expense. In February 2023, the Company issued 8,697 ordinary shares, par value NIS 0.3, to the consultant in connection with the second grant.
|
d.
|
In June 2023, the Company effected a reverse share split of its shares at the ratio of 1-for-10, such that each ten (10) ordinary shares, par value NIS 0.03 per share, were consolidated
into one (1) ordinary share, par value NIS 0.30. As a result of rounding of fractional shares as part of the reverse share split, 18,338 ordinary shares were added, bringing the Company’s total outstanding shares on a post-split basis to
1,090,452. All related share and per share data have been retroactively applied to the financial statements and their related notes for all periods presented.
|
e.
|
On July 14, 2023, the Company sold to a certain institutional investor an aggregate of 117,930 ordinary shares in a registered direct offering at a purchase price of $9.00 per share and pre-funded warrants
to purchase up to 183,300 ordinary shares at a purchase price of $8.999, resulting in gross proceeds of approximately $2.7 million. In addition, the Company issued to the investor unregistered warrants to purchase up to an aggregate of
301,230 ordinary shares in a concurrent private placement. The warrants are immediately exercisable and will expire five years from the issuance date at an exercise price of $9.00 per ordinary share, subject to adjustments as set forth
therein. The warrants may be exercised on a cashless basis if at the time of exercise thereof, there is no effective registration statement registering the ordinary shares underlying the warrants. The Company paid an aggregate of $176.2
in placement agent fees and reimbursed the placement agent’s actual out-of-pocket expenses up to $50.0. The net proceeds from the transaction were $2.3 million. The pre-funded warrants to purchase up to 183,300 ordinary shares were
exercised immediately in full on July 14, 2023.
|
f.
|
On July 18, 2023, the Company sold to a certain institutional investor an aggregate of 145,000 ordinary shares in a registered direct offering at a purchase price
of $9.00 per share and pre-funded warrants to purchase up to 21,666 ordinary shares at a purchase price of $8.999, resulting in gross proceeds of approximately $1.5 million. In addition, the Company issued to the investor unregistered
warrants to purchase up to an aggregate of 166,666 ordinary shares in a concurrent private placement. The warrants are immediately exercisable and will expire five years from the issuance date at an exercise price of $9.00 per ordinary
share, subject to adjustments as set forth therein. The warrants may be exercised on a cashless basis if at the time of exercise thereof, there is no effective registration statement registering the ordinary shares underlying the
warrants. The Company paid an aggregate of $97.5 in placement agent fees and reimbursed the placement agent’s actual out-of-pocket expenses up to $30.0. The net proceeds from the transaction were $1.3 million. The pre-funded warrants to
purchase up to 21,666 ordinary shares were exercised immediately in full on July 18, 2023.
|
g.
|
The Company determined that the ordinary share warrants issued in July 2023 (the “Common Warrants”) are not indexed to the Company’s own ordinary shares and also, the investor possesses a right to
receive any additional consideration that investors of common shares may be entitled to upon a fundamental transaction (as defined in the agreement), therefore are precluded from equity classification. The Common Warrants are
measured at fair value at inception and in subsequent reporting periods with changes in fair value recognized as financial income or expense as change in fair value of warrant liabilities in the period of change in the condensed
statements of comprehensive loss. The Company had recorded the value of the warrants that were issued in the July 2023 transactions (Note 5e -5f) as a long-term liability. The Company used the Black-Scholes option pricing model to
calculate the valuation with standard deviation of 85.45%, which was based on a share price of $9.00 and a risk-free rate of 4.0%. The valuation of the warrants was $5.48 on July 14, 2023, and $5.17 on July 18, 2023, which
resulted in a total valuation of the warrants of $2.5 million as of July 2023. The Company revalued these warrants as of September 30, 2023, with standard deviation of 87.46%, which was based on a share price of $3.48 and a risk
free rate of 4.62%. Each warrant valuation was $1.85, which resulted in a total valuation of the warrants of $0.9 million. The change of $1.6 million was recorded as finance income. The contractual term of the warrants is five
years.
|
|
Nine Months ended
September 30,
|
|||||||
|
2023
|
2022
|
||||||
|
||||||||
Bank fees
|
(13
|
)
|
(9
|
)
|
||||
Interest income
|
305
|
65
|
||||||
Warrant issuance costs
|
(368
|
)
|
-
|
|||||
Changes in warrant liability valuation
|
1,648
|
-
|
||||||
Exchange rate differences
|
(5
|
)
|
(69
|
)
|
||||
Total financial income, net
|
$
|
1,567
|
$
|
(13
|
)
|
•
|
our ability to continue as a going concern;
|
•
|
our history of losses and needs for additional capital to fund our operations and our ability to obtain additional capital on acceptable terms, or at all;
|
•
|
our dependence on the success of our initial product candidate, PRF-110;
|
•
|
the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates;
|
•
|
fluctuations in inflation and interest in Israel and the United States;
|
•
|
our limited experience managing clinical trials;
|
•
|
our ability to retain key personnel and recruit additional employees;
|
•
|
our reliance on third parties for the conduct of clinical trials, product manufacturing and development;
|
•
|
the impact of competition and new technologies;
|
•
|
our ability to comply with regulatory requirements relating to the development and marketing of our product candidates;
|
•
|
our ability to establish and maintain strategic partnerships and other corporate collaborations;
|
•
|
the implementation of our business model and strategic plans for our business and product candidates;
|
•
|
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to
operate our business without infringing the intellectual property rights of others;
|
•
|
the overall global economic environment;
|
•
|
our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is
volatile; and
|
•
|
statements as to the impact of the political and security situation in Israel on our business, including due to the current war between Israel
and Hamas.
|
•
|
continue the ongoing and planned preclinical and clinical development of our drug candidates;
|
•
|
build a portfolio of drug candidates through the acquisition or in-license of drugs, drug candidates or technologies;
|
•
|
initiate preclinical studies and clinical trials for any additional drug candidates that we may pursue in the future;
|
•
|
seek marketing approvals for our current and future drug candidates that successfully complete clinical trials;
|
•
|
establish a sales, marketing and distribution infrastructure to commercialize any drug candidate for which we may obtain marketing approval;
|
•
|
develop, maintain, expand and protect our intellectual property portfolio;
|
•
|
implement operational, financial and management systems; and
|
•
|
attract, hire and retain additional administrative, clinical, regulatory and scientific personnel.
|
•
|
employee-related expenses, including salaries, benefits and stock-based compensation expense;
|
•
|
fees paid to consultants for services directly related to our drug development and regulatory effort;
|
•
|
expenses incurred under contract manufacturing organizations, as well as contract manufacturing organizations and consultants that conduct preclinical studies and
clinical trials;
|
•
|
costs associated with development activities;
|
•
|
costs associated with technology and intellectual property licenses; and
|
•
|
milestone payments and other costs under licensing agreements.
|
•
|
number of clinical trials required for approval and any requirement for extension trials;
|
•
|
per patient trial costs;
|
•
|
number of patients that participate in the clinical trials;
|
•
|
number of sites included in the clinical trials;
|
•
|
countries in which the clinical trial is conducted;
|
•
|
length of time required to enroll eligible patients;
|
•
|
potential additional safety monitoring or other studies requested by regulatory agencies; and
|
•
|
efficacy and safety profile of the drug candidate.
|
|
Nine Months Ended
September 30,
|
|||||||
|
2023
|
2022
|
||||||
|
(US$ thousands)
|
|||||||
Statements of comprehensive loss data:
|
||||||||
Research and development
|
(3,289
|
)
|
(2,473
|
)
|
||||
General and administrative
|
(2,731
|
)
|
(3,140
|
)
|
||||
Total operating loss
|
(6,020
|
)
|
(5,613
|
)
|
||||
Financial income (expenses), net
|
1,567
|
(13
|
)
|
|||||
Net loss
|
(4,453
|
)
|
(5,626
|
)
|
•
|
the costs, timing and outcome of regulatory review of PRF-110;
|
•
|
the scope, progress, results and costs of our current and future clinical trials of PRF-110 for our current targeted uses;
|
•
|
the extent to which we acquire or invest in businesses, products and technologies, including entering into or maintaining licensing or collaboration arrangements for PRF-110 on
favorable terms, although we currently have no commitments or agreements to complete any such transactions;
|
•
|
the costs and timing of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our product candidates for which
we receive marketing approval, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of any collaborator that we may have at such time;
|
•
|
the amount of revenue, if any, received from commercial sales of PRF-110, should it receive marketing approval;
|
•
|
the costs of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights and defending
intellectual property-related claims;
|
•
|
our ability to establish strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the
timing and amount of any future milestone, royalty or other payments due under any such agreement;
|
•
|
our headcount growth and associated costs as we expand our business operations and our research and development activities;
|
•
|
the costs of operating as a public company;
|
•
|
maintaining minimum shareholders’ equity requirements under the Nasdaq
rules; and
|
•
|
the impact of the COVID-19 pandemic, the Russian invasion of
Ukraine and war between Israel and Hamas, which may exacerbate the magnitude of the factors
discussed above.
|
|
Nine months
Ended September 30,
2023
|
Nine months
Ended September 30,
2022
|
||||||
Net cash used in operating activities
|
$
|
(5,127
|
)
|
$
|
(3,591
|
)
|
||
Net cash provided by (used in) investing activities
|
4,992
|
(6,034
|
)
|
|||||
Net cash provided by financing activities
|
3,594
|
-
|
||||||
Effect of Exchange rate changes on cash, cash equivalents and restricted cash
|
(5
|
)
|
-
|
|||||
Increase (decrease) in cash and cash equivalents and restricted cash
|
3,454
|
(9,625
|
)
|
|||||
Cash and cash equivalents and restricted cash, at the beginning of period
|
4,106
|
16,571
|
||||||
Cash and cash equivalents and restricted cash, at the end of period
|
$
|
7,560
|
$
|
6,949
|
•
|
number of clinical trials required for approval and any requirement for extension trials;
|
•
|
per patient trial costs;
|
•
|
number of patients that participate in the clinical trials;
|
•
|
number of sites included in the clinical trials;
|
•
|
countries in which the clinical trial is conducted;
|
•
|
length of time required to enroll eligible patients;
|
•
|
potential additional safety monitoring or other studies requested by
regulatory agencies; and
|
•
|
efficacy and safety profile of the drug candidate.
|
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