Washington, D.C. 20549

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

For the month of May 2024

Commission File Number: 001-39481

(Translation of registrant’s name into English)

65 Yigal Alon St., Tel Aviv 6744316

Israel

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒      Form 40-F ☐

This Form 6-K is incorporated by reference into the Company’s Registration Statements on Form S-8 (Registration No. 333-257968 and 333-265902) and the Company’s Registration Statements on Form F-3 (Registration No. 333-259318, 333-254982 and 333-276485).

On May 15, 2024, PainReform Ltd. (the “Company”) published its unaudited condensed financial statements, as well as its operating and financial review as of March 31, 2024 and for the three months then ended and issued a press release announcing its financial results for the three months ended March 31, 2024. Attached hereto are the following exhibits:

Exhibit Index

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.

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	Page
Condensed Balance Sheets	F-2
Condensed Statements of Comprehensive Loss	F-3
Condensed Statements of Changes in Shareholders’ Equity	F-4
Condensed Statements of Cash Flows	F-5
Notes to Condensed Financial Statements	F-6 - F-10

						As of March 31,				As of December 31,
		Note				2024				2023
Assets
Current assets:
Cash and cash equivalents						$	4,324			$	8,026
Restricted cash							10				10
Prepaid clinical trial expenses and deferred clinical trial costs							710				1,514
Prepaid expenses and other current assets							201				249
Total current assets							5,245				9,799
Non-current assets
Operating lease right of use asset			4				83				93
Property and equipment, net							41				38
Total long term assets							124				131
Total assets						$	5,369			$	9,930
Liabilities and shareholders’ equity
Current liabilities:
Trade payables						$	209			$	221
Employees and related liabilities							520				465
Operating lease liability			4				57				56
Accrued expenses							2,467				1,668
Total current liabilities							3,253				2,410
Non-current liabilities:
Operating lease liability			4				15				30
Provision for uncertain tax positions							253				251
Total non-current liabilities							268				281
Total liabilities							3,521				2,691
Commitments (Note 7)
Shareholders’ equity:
Ordinary shares, NIS 0.3 par value; Authorized: 20,000,000 shares as of March 31, 2024, 5,000,000 as of December 31, 2023; Issued and outstanding: 1,850,243 and 1,728,347 shares as of March 31, 2024, and December 31, 2023, respectively.							157				147
Additional paid-in capital			5a				49,060				48,955
Accumulated deficit							(47,369	)			(41,863	)
Total shareholders’ equity							1,848				7,239
Total liabilities and shareholders’ equity						$	5,369			$	9,930

						For the Three Months Ended March 31,
		Note				2024				2023
Operating expenses:
Research and development expenses						$	(4,742	)		$	(1,454	)
General and administrative expenses							(823	)			(962	)
Operating loss							(5,565	)			(2,416	)
Financial income, net			8				59				108
Net loss and comprehensive loss						$	(5,506	)		$	(2,308	)
Basic and diluted net loss per share			6			$	(2.72	)		$	(2.12	)(*)
Weighted average number of shares of Ordinary Shares used in computing basic and diluted net loss per share(*)							2,026,243				1,090,452

		Ordinary shares(**)								Additional paid-in capital				Accumulated deficit				Total shareholders’ equity
		Number				Amount
Balance as of January 1, 2023			1,081,755			$	94			$	43,446			$	(32,519	)		$	11,021
Share-based compensation to employees and directors			-				-				180				-				180
Share issuance to service providers			8,697				*												*
Net loss and comprehensive loss			-				-				-				(2,308	)			(2,308	)
Balance as of March 31, 2023			1,090,452			$	94			$	43,626			$	(34,827	)		$	8,893
Balance as of January 1, 2024			1,728,347			$	147			$	48,955			$	(41,863	)		$	7,239
Share-based compensation to employees and directors			-				-				115				-				115
Share issuance (Note 5)			121,896				10				(10	)			-				-
Net loss and comprehensive loss							-				-				(5,506	)			(5,506	)
Balance as of March 31, 2024			1,850,243			$	157			$	49,060			$	(47,369	)		$	1,848

		For the Three Months Ended March 31,
		2024				2023
Cash flows from operating activities
Net loss		$	(5,506	)		$	(2,308	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			4				2
Exchange rate differences on cash, cash equivalents and restricted cash			-				3
Net change in operating lease asset and liability			(3	)			-
Share-based compensation to employees and directors			115				180
Interest income			-				87
Change in:
Other current assets			852				(133)
Trade payables			(12	)			104
Other accounts payable			855				113
Net cash used in operating activities			(3,695	)			(1,952	)
Cash flows from investing activities
Purchase of property and equipment			(7	)			-
Proceeds from short term deposit							6,000
Net cash provided by (used in) investing activities			(7	)			6,000
Cash flows from financing activities
Net cash provided by financing activities			-				-
Effect of Exchange rate changes on cash, cash equivalents and restricted cash				-			(3	)
Change in cash, cash equivalents and restricted cash			(3,702	)			4,045
Cash, cash equivalents and restricted cash at the beginning of the period			8,036				4,106
Cash, cash equivalents and restricted cash at the end of the period		$	4,334			$	8,151

		As of March 31,
		2024				2023
Cash and cash equivalents		$	4,324			$	8,141
Restricted cash			10				10
Total cash, cash equivalents and restricted cash		$	4,334			$	8,151

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 $5,506 and $2,308 for the three-month periods ended March 31, 2024, and 2023, respectively. During the three months ended March 31, 2024, and 2023, the Company had operating cash outflows of $3,695, and $1,952, respectively. The Company expects to continue to incur losses and negative cash flows from operations until its products reach profitability. As of March 31, 2024, the Company’s accumulated deficit was $47,369. The Company has funded its operations to date primarily through equity financing and has cash on hand (including restricted cash) in the amount of $4,334 as of March 31, 2024.   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. (Note 10). 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.

d.	In June 2023, the Company effected a reverse share split of its shares at the ratio of 1-for-10 (Note 5c).

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	148,106	$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
December 2023 warrants (**)	December 28, 2023	935,792	$2.85	July 14-18, 2028
December 2023 warrants	December 28, 2023	32,753	$3.56
TOTAL		4,918,762

1.

The 2008 Plan: Share options outstanding and exercisable to employees and directors under the 2008 Share Option Plan (the “2008 Plan”) as of March 31, 2024 were as follows:

2.

The 2019 Plan: Share options outstanding and exercisable to employees and directors under the 2019 Share Option Plan (the “2019 Plan”) as of March 31, 2024, were as follows:

c.

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.

Basic loss per share is computed on the basis of the net loss for the period divided by the weighted average number of ordinary shares and vested ordinary shares issuable for little or no further consideration outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares include outstanding stock options, restricted shares and warrants, which are included under the treasury stock method when dilutive.   For the periods ended March 31, 2024, and 2023, 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.

		Three Months ended March 31,
		2024				2023
Bank fees			(5	)			(4	)
Interest income			64				109
Exchange rate differences			-				3
Total financial income, net		$	59			$	108

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OPERATING AND FINANCIAL REVIEW AND PROSPECTS

You should read the following selected financial data and discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K. Our financial statements are prepared in accordance with U.S. GAAP, and reported in U.S. dollars. We maintain our accounting books and records in U.S. dollars and our functional currency is the U.S. dollar. Certain amounts presented herein may not sum due to rounding. Unless the context requires otherwise, references in this report to “PainReform,” the “Company,” “we,” “us” and “our” refer to PainReform Ltd, an Israeli company. “NIS” means New Israeli Shekel, and “$,” “US$”“U.S. dollars” and “USD” mean United States dollars.

Forward Looking Statements

The following discussion contains “forward-looking statements,” including statements regarding expectations, beliefs, intentions or strategies for the future. These statements may identify important factors which could cause our actual results to differ materially from those indicated by the forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to:

All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date of the 6-K to which this discussion is attached and are expressly qualified in their entirety by the cautionary statements included herein. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

Overview

We are a clinical stage specialty pharmaceutical company focused on the reformulation of established therapeutics.  Our 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.

Since our inception in November 2007, we have devoted substantially all of our efforts to organizing and planning our business, building our management and technical team, developing our proprietary drug delivery system and PRF-110, and raising capital.

We have never generated any revenue and have funded our business primarily through the sale of our ordinary shares and issuance of convertible loans.

We expect to continue to incur significant expenses and increasing losses for the next several years. Our net losses may fluctuate significantly from period to period, depending on the timing of our planned clinical trials and expenditures on our other research and development and commercial development activities. We expect our expenses will increase substantially over time as we:

•	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.

Recent Developments

April 2024 Financing

             On April 15, 2024, we sold to certain institutional investors an aggregate of (i) 447,500 of our ordinary shares (the “Shares”), (ii) 4,552,500 pre-funded warrants to purchase 4,552,500 ordinary shares (the “Pre-Funded Warrants”), and (iii) 5,000,000 warrants to purchase 5,000,000 ordinary shares (the “Investor Warrants”), at a purchase price of $0.80 per Share and accompanying Investor Warrant, and $0.7999 per Pre-Funded Warrant and accompanying Investor Warrant, resulting in gross proceeds of approximately $4.0 million, before deducting our offering expenses.

In addition, we also amended the terms of certain existing warrants to purchase up to an aggregate of 935,792 ordinary shares that were previously issued in December 2023 (the “December 2023 Warrants”). Pursuant to the terms of the amendment (the “Warrant Amendment”), the exercise price of the December 2023 Warrants was reduced to $0.80 per share, and the expiration date was amended to April 2029.

Recent Developments Potentially Affecting Our Business.

In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in thousands of deaths and injuries, and Hamas additionally kidnapped many Israeli civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas and other terrorist organizations in parallel to their continued rocket and terror attacks.  In addition, since the commencement of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization) and southern border (with the Houthi movement in Yemen). It is possible that hostilities with Hezbollah in Lebanon will escalate, and that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other hostile countries will join the hostilities. In addition, Iran recently launched a direct attack on Israel involving hundreds of drones and missiles and has threatened to continue to attack Israel and is widely believed to be developing nuclear weapons. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria and Iraq. Such clashes may escalate in the future into a greater regional conflict. The intensity and duration of Israel’s current war against Hamas and other terror organizations, as well as additional potential crises involving hostile countries, such as Iran, are difficult to predict, as are the economic implications on the Company’s business and operations and on Israel’s economy in general. Nevertheless, our clinical and business development activities remain on track.

Financial Operations Overview

Revenue

We have not generated any revenue and do not expect to generate any revenue unless or until we obtain regulatory approval and commercialize one or more of our current or future drug candidates. In the future, we may also seek to generate revenue from a combination of research and development payments, license fees and other upfront or milestone payments.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, which include, among other things:

•	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 agreements with contract research organizations, as well as contract manufacturing organizations, and consultants that conduct preclinical studies and clinical trials;

•	costs associated with preclinical activities and development activities; and

•	costs associated with technology and intellectual property licenses.

Costs incurred in connection with research and development activities are expensed as incurred. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or other information provided to us by our vendors.

Research and development activities are and will continue to be central to our business model. We expect our research and development expenses to increase for the foreseeable future as we advance our current and future drug candidates through preclinical studies and clinical trials. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time-consuming. It is difficult to determine with certainty the duration and costs of any preclinical study or clinical trial that we may conduct. The duration, costs and timing of clinical trial programs and development of our current and future drug candidates will depend on a variety of factors that include, but are not limited to, the following:

•	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.

In addition, the probability of success for any of our current or future drug candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each drug candidate, as well as an assessment of each drug candidate’s commercial potential.

General and Administrative Expenses

General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and share-based compensation. Other general and administrative expenses include directors’ and officers’ liability insurance premiums, costs associated with being a publicly traded company, fees associated with investor relations, professional fees for consultants, tax and legal services and facility-related costs.

We expect that general and administrative expenses will increase in the future as we expand our operating activities and incur additional costs. In addition, if our current or future drug candidates are approved for sale, we expect that we would incur expenses associated with building our commercial and distribution infrastructure.

Financial Income (Expenses), Net

Results of Operations

The table below provides our results of operations for the three months ended March 31, 2024 and 2023.

General and administrative expenses. General and administrative expenses were $823,000 for the three months ended March 31, 2024 compared to $962,000 for the three months ended March 31, 2023, a decrease of $139,000. The decrease in general and administrative expenses is primarily due to a decrease in directors’ and officers’ liability insurance premiums costs and consulting expenses.

Financial income, net. Financial income, net was $59,000 for the three months ended March 31, 2024 compared to financial expenses, net of $108,000 for the three months ended March 31, 2023, an decrease in income of $49,000. The decrease was primarily due to a decrease in cash and short term deposits.

Net loss. As a result of the foregoing, we incurred a net loss of $5.5 for the three months ended March 31, 2024 compared to a net loss of $2.3 million for the three months ended March 31, 2023, an increase of $3.2 million. The increase was mainly to an increase in expenses associated with our Phase 3 trial.

Substantial Doubt About Ability to Continue as a Going Concern

Since our inception, we have devoted substantially all of our efforts to research and development, clinical trials, and capital raising activities. We are still in our development and clinical stage and have not yet generated revenues. Developing drugs, conducting clinical trials and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives.

Management's plans include continued commercialization of our products and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances, however, that we will successfully obtain the level of financing needed for our operations. If we are unsuccessful in commercializing our products or raising capital, we may need to reduce activities, curtail or cease operations.

To date, we have funded our operations primarily through proceeds from our initial public offering and private placements.

Developing drugs, conducting clinical trials and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives.

Our estimate as to how long we expect our funds to support our operations is based on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we currently expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Our future capital requirements will depend on many factors, including:

•	the costs, timing and outcome of manufacturing clinical trial and commercial quantities 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 costs, timing and outcome of regulatory review of PRF-110;

•	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

•	fluctuations in inflation and interest in Israel and the United States, which may exacerbate the magnitude of the factors discussed above.

We expect our expenses to increase in connection with our planned operations. Until such time, if ever, as we can generate substantial revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect your rights as a shareholder. In addition, debt financing, if available, would result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming shares or declaring dividends, that could adversely impact our ability to conduct our business. In addition, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technology, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, reduce and/or eliminate our product candidate development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Cash Flows

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by financing activities

Trend Information.

Off-Balance Sheet Arrangements.

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Critical Accounting Policies and Judgments and Estimates

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Exhibit 99.3

 

 

PainReform Provides Business Update for the First Quarter of 2024

 

Reaches 50% enrollment in the second part of its Phase 3 clinical trial of PRF-110 in bunionectomy

 

Remains on track to announce top-line data in Q3 2024

 

Tel Aviv, Israel – May 15, 2024 – PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided a business update for the first quarter ended March 31, 2024.

 

Ilan Hadar, Chief Executive Officer of PainReform, stated, “We are pleased to report a number of recent milestones as we advance the clinical development of PRF-110, our lead drug candidate, targeting the post-operative extended pain relief market. Importantly, we recently reached the 50% enrollment target for the second part of Phase 3 clinical trial of PRF-110 in bunionectomy.  In total, over 200 patients have been enrolled at eight clinical sites across the U.S. Moreover, there have been no reported product related serious adverse events, highlighting PRF-110’s favorable safety profile to date. Building on the success of the first part of our Phase 3 clinical trial of PRF-110, we are moving forward steadily to wrap up enrollment and looking forward to sharing the preliminary top-line results in Q3 2024.”

 

“In addition, we reported positive results from new studies, which demonstrated the superior in-vitro release (IVR) rates of PRF-110 as compared to the industry leader for topical post-surgical pain management products. These findings underscore our commitment to advancing long-lasting, best-in-class pain management solutions while reducing the potential need for the use of opiates.”

 

“Overall, we remain highly encouraged by the outlook for our ongoing Phase 3 clinical trial, given the successful first part of our Phase 3 trial, as well as our prior Phase 2 data in hernia repair. As a result, we remain confident PRF-110 has the potential to redefine the standard of care in the multi-billion dollar postoperative pain management market, by offering patients what we believe will be a far better alternative to systemic opioids, as we aim to tackle the global opioid epidemic.”

 

Financial Results for the First Quarter Ended March 31, 2024

 

Research and development expenses were $4.7 million for the three months ended March 31, 2024, compared to $1.5 million for the three months ended March 31, 2023, an increase of $3.2 million. The increase in research and development expenses was primarily due to the expenses leading to the commencement of the Company’s Phase 3 trial.

 

General and administrative expenses were $823,000 for the three months ended March 31, 2024 compared to $962,000 for the three months ended March 31, 2023, a decrease of $139,000. The decrease in general and administrative expenses is primarily due to a decrease in directors’ and officers’ liability insurance premiums costs and consulting expenses.

 

Financial income (expenses), net was $59,000 for the three months ended March 31, 2024 compared to financial expenses, net of $108,000 for the three months ended March 31, 2023, a decrease of $49,000. The decrease was primarily due to a decrease in cash and short term deposits.

 

As a result of the foregoing, the Company incurred a net loss of $5.5 million for the three months ended March 31, 2024 compared to a net loss of $2.3 million for the three months ended March 31, 2023, an increase of $3.2 million. The increase was mainly due to an increase in expenses associated with the Phase 3 trial.

 

As of March 31, 2024, the Company had cash and cash equivalents of $4.3 million. Additionally, on April 18, 2024, the Company closed a public offering for gross proceeds of $4 million before deducting the placement agent’s fees and other offering expenses.

 

A copy of the Company’s quarterly report on Form 6-K for the first quarter ended March 31, 2024 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company’s investor relations website at   https://painreform.com/investors/.

 

About PainReform

 

PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company's lead product is based on the local anesthetic ropivacaine, targeting the postoperative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended postoperative analgesia. 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. For more information, please visit www.painreform.com.

 

Notice Regarding Forward-Looking Statements

 

This press release contains forward-looking statements about our expectations, beliefs and intentions including with respect to objectives, plans and strategies and expected timing of results. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements, including, but not limited to, the following: our ability to continue as a going concern,  our history of significant losses, our need to raise additional capital 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;  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 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. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors" included in the Company's most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.

 

Contact:

 

Crescendo Communications, LLC

Tel: 212-671-1021

Email: prfx@crescendo-ir.com

 

Ilan Hadar

Chief Executive Officer

PainReform Ltd.

Tel: +972-54-5331725

Email: ihadar@painreform.com

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