UNITED STATES

SAFETY AND EXCHANGES COMMISSION

Washington, D.C. 20549

Form 6-K

Foreign Private Issuer Report

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

of the Securities Exchange Act of 1934

For the month of May 2022

Board file number: 001-39481

PainReform Ltd.

(Translation of the declarant’s name in English)

4 Bruria Street Tel Aviv, 6745442

Israel

(Address of main executive offices)

Indicate with a tick whether the registered person files or will file annual reports in 20-F or 40-F envelopes.

Form 20-F ☒ Form 40-F ☐

Indicate with a check mark if the filer is submitting the Form 6-K on paper, as permitted by ST Rule 101(b)(1): ____

Indicate with a check mark if the filer is submitting the Form 6-K on paper, as permitted by ST Rule 101(b)(7): ____

On May 17, 2022, PainReform Ltd. issued a press release announcing its financial results for the quarter ended March 31, 2022. Attached is the following exhibit:

99.1

Press release of May 17, 2022

Index of exhibitions

SIGNATURE

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, duly authorized thereto.

Date: May 17, 202

PAINREFORM LTD.

By:

/s/ Ilan Hadar

Ilan Hadar

Chief executive officer



PainReform Provides First Quarter 2022 Business Update

Reports successful batch manufacturing of PRF-110 and continued progress towards

start of phase 3 clinical trials in the second half of 2022

Tel Aviv, Israel – May 17, 2022 – PainReform Ltd. (Nasdaq: PRFX) (“pain reform“or the”Company“), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutic products, yesterday provided an update on its business for the first quarter ended March 31, 2022.

Ilan Hadar, Managing Director of Pain Reform, said, “We continue our steady progress towards the initiation of the Phase 3 clinical trial of PRF-110 in bunion surgery scheduled for the second half of 2022. Having been approved for 505( b)(2) by the FDA, we expect this to be a fast and cost effective trial. It is important to note that the transfer of manufacturing technology to our selected CMO, which we have engaged for the manufacture of our clinical batches of PRF-110, is proceeding according to plan, as all batches of PRF-110 manufactured at this day are in line with expectations. Assuming we proceed as planned, we expect to manufacture the clinical batch by mid-2022.

“On the heels of the bunionectomy trial, we plan to begin our second Phase 3 trial for the treatment of pain in hernias. We believe our proprietary sustained-release drug delivery system has broad potential for a wide range of surgeries, as it is designed to provide an extended period of post-surgical pain relief without the need for repeat dosing, while reducing the potential need for opioid use.

“We have maintained a strong balance sheet and had $15.4 million in cash and no debt as of March 31, 2022. As a result, we have more than enough capital to enable us to cross a number of key milestones, including the launch of our first phase 3 trial,” concluded Hadar.

Financial results for the first quarter ended March 31, 2022

Research and development expenses amounted to $680,000 for the quarter ended March 31, 2022, compared to $1,029,000 for the quarter ended March 31, 2021, a decrease of $349,000. The decrease is mainly due to lower payments to contractors and clinical trial costs.

General and administrative expenses amounted to $992,000 for the quarter ended March 31, 2022, compared to $1,010,000 for the quarter ended March 31, 2021, a decrease of $18,000. The decrease is mainly due to a decrease in staffing costs, a decrease in insurance costs and an increase in certain professional services costs.

Finance costs, net, were $22,000 for the quarter ended March 31, 2022, compared to finance costs, net of $2,000 for the quarter ended March 31, 2021, an increase of $20,000. The increase is mainly due to an increase in foreign exchange costs.

As a result of the above, the Company incurred a net loss of $1,694,000 for the quarter ended March 31, 2022, compared to a net loss of $2,041,000 for the quarter ended March 31, 2021, representing a decrease of $347,000.

As of March 31, 2022, the Company had cash and cash equivalents of $15.4 million.

About PainReform

PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company’s flagship product, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is a clear viscous oil-based solution that is deposited directly into the surgical wound bed prior to closure to provide localized and prolonged 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 repeat doses while reducing the potential need to use opiates. For more information, visit www.painreform.com.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements about our expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “could”, “seek”, “target”, “will”, “project”, “anticipate”, “continue” or “anticipate” or their negative forms or variations of these words or other comparable words or by the fact that such statements do not relate strictly to historical matters.These forward-looking statements are based on assumptions and assessments made in light of experience and management’s perception of historical trends, current conditions, expected future developments and other factors deemed appropriate.The forward-looking statements contained in this press release are made as of the date of this press release, and we undertake no obligation to update or revise such statements, whether as of further news rations, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are beyond our control. Many factors could cause our actual operations or results to differ materially from the operations and results anticipated in the forward-looking statements, including, but not limited to, the following: our history of significant losses, our need to mobilize additional capital and our ability to obtain additional capital on acceptable terms, if at all; our dependence on the success of our initial product candidate, PRF-110; results of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates; the impact of the COVID-19 pandemic on our operations; our limited experience in managing clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, manufacturing and product development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and commercialization of our product candidates; the commercial success and market acceptance of our product candidates; our ability to establish sales and marketing capabilities or enter into agreements with third parties and our reliance on third-party distributors and resellers; our ability to establish and maintain strategic partnerships and other business collaborations; the implementation of our business model and strategic plans for our businesses and product candidates; the extent 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 common stock and whether the market price of our common stock is volatile; and statements regarding the impact of the political and security situation in Israel on our business. 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 documents we have filed and may file. with the Securities and Exchange Commission in the future.

Contact:

Crescendo Communications, LLC

Tel: 212-671-1021

Ilan Hadar

Chief executive officer

PainReform Ltd.

Tel: +972-54-5331725

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