Exhibit 99.2
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:
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our ability to continue as a going concern;
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our history of losses and need for additional capital to fund our operations and our ability to obtain additional capital on acceptable terms, or at all;
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our dependence on the success of our initial product candidate, PRF-110;
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the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates;
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our limited experience managing clinical trials;
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our ability to retain key personnel and recruit additional employees;
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our reliance on third parties for the conduct of clinical trials, product manufacturing and development;
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the impact of competition and new technologies;
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our ability to comply with regulatory requirements relating to the development and marketing of our product candidates;
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our ability to establish and maintain strategic partnerships and other corporate collaborations;
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the implementation of our business model and strategic plans for our business and product candidates;
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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;
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the overall global economic environment;
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our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile;
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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; and
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those factors referred to in our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, or the 2023 Annual Report, in “Item 3. Key Information - D. Risk Factors,” “Item 4. Information on the
Company,” and “Item 5. Operating and Financial Review and Prospects,” as well as in our 2023 Annual Report generally, which is incorporated by reference into this prospectus.
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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.
Our strategy is to incorporate generic drugs with our proprietary extended-release drug-delivery system in order to create extended release drug products and to take advantage of
the 505(b)(2) regulatory pathway created by the U.S. Food and Drug Administration, or FDA. The 505(b) (2) new drug application, or NDA, process, provides for FDA approval of a new drug based in part on data that was developed by others,
including published literature references and data previously reviewed by the FDA in its approval of a separate application. PRF-110, our first product candidate, is based on the local anesthetic ropivacaine, targeting the post-operative 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 post-operative analgesia.
In March 2023, we initiated our first Phase 3 clinical trial of PRF-110 in the United States, for pain treatment of patients undergoing bunionectomy, successfully completing the
first part of the Phase 3 clinical study soon thereafter in a pharmacokinetics study of 15 patients undergoing a bunionectomy.
In May 2023, we announced that our supplier of active pharmaceutical
ingredient, or API, received a deficiency notice from the FDA related to the supplier’s Drug Master File—the file on record with FDA representing the manufacturing process and facility to produce the API. As a result of this notice, the second part
of our first Phase 3 clinical trial was delayed until September 2023, once the required information was provided to the FDA, resolving the deficiency notice. None of the issues raised were related to our PRF-110 product. In October 2023, we
reactivated our clinical study, enrolling the first patients in the second part of the Phase 3 trial. We expect our study will ultimately include up to 415 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). In total, over 200 patients have been enrolled at eight clinical sites across the U.S. and we expect to publish the preliminary top-line results in the third
quarter of 2024.
After the successful completion of our first Phase 3 clinical trial of patients undergoing a bunionectomy, we plan to initiate a second trial for pain treatment of hernia repair
operations.
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:
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continue the ongoing and planned preclinical and clinical development of our drug candidates;
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build a portfolio of drug candidates through the acquisition or in-license of drugs, drug candidates or technologies;
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initiate preclinical studies and clinical trials for any additional drug candidates that we may pursue in the future;
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seek marketing approvals for our current and future drug candidates that successfully complete clinical trials;
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establish a sales, marketing and distribution infrastructure to commercialize any drug candidate for which we may obtain marketing approval;
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develop, maintain, expand and protect our intellectual property portfolio;
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implement operational, financial and management systems; and
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attract, hire and retain additional administrative, clinical, regulatory and scientific personnel.
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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:
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employee-related expenses, including salaries, benefits and stock-based compensation expense;
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fees paid to consultants for services directly related to our drug development and regulatory effort;
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expenses incurred under agreements with contract research organizations, as well as contract manufacturing organizations, and consultants that conduct preclinical studies and clinical
trials;
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costs associated with preclinical activities and development activities; and
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costs associated with technology and intellectual property licenses.
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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:
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number of clinical trials required for approval and any requirement for extension trials;
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per patient trial costs;
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number of patients that participate in the clinical trials;
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number of sites included in the clinical trials;
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countries in which the clinical trial is conducted;
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length of time required to enroll eligible patients;
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potential additional safety monitoring or other studies requested by regulatory agencies; and
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efficacy and safety profile of the drug candidate.
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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
Financial income (expenses), net, primarily consists of interest income from deposits, bank management fees and commissions and exchange rate differences.
Results of Operations
The table below provides our results of operations for the three months ended March 31, 2024 and 2023.
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Three Months Ended
March 31,
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2024
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2023
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(US$ thousands)
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Statements of comprehensive loss data:
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Research and development
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(4,742
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(1,454
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General and administrative
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(823
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(962
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Total operating loss
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(5,565
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(2,416
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Financial income (expenses), net
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59
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108
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Net loss
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(5,506
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(2,308
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Research and development expenses. 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 of our Phase 3 trial.
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.
We have incurred significant losses and negative cash flows from
operations since our inception. For the three months ended March 31, 2024, and 2023 we incurred losses of $5.5 million, and $2.3 million, respectively, and had negative operating cashflows of $3.7 million, and $2.0 million for the three months
ended March 31, 2024 and 2023 respectively. As of March 31, 2024, we had an accumulated deficit of approximately $47.4 million. We have funded our operations to date primarily through equity financing and, as of March 31, 2024, we had cash and cash
equivalents (including restricted cash) of approximately $4.3 million and a positive working capital of approximately $2.0 million. In April 2024, we closed a public offering of our securities resulting in gross proceeds of $4 million.
We expect to continue incurring losses, and negative cash flows from operations until our product, PRF-110, reaches commercial profitability. As a result of these expected losses and negative cash
flows from operations, along with our current cash position, we believe we only have sufficient resources to fund operations through Q4 2024, and we will be required to raise additional capital in the future to complete our clinical trials.
Therefore, there is substantial doubt about our ability to continue as a going concern.
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.
These factors raise substantial doubt about the Company’s ability to continue to operate as a going concern. The financial statements have been prepared assuming that the Company
will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
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.
We expect to continue incurring losses, and negative cash flows from operations until our product, PRF-110, reaches commercial profitability. As a result of these expected losses
and negative cash flows from operations, along with our current cash position, we believe we only have sufficient resources to fund operations through the fourth quarter of 2024, and we will be required to raise additional capital in the future
to complete our clinical trials. Therefore, there is substantial doubt about our ability to continue as a going concern.
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:
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the costs, timing and outcome of manufacturing clinical trial and commercial quantities of PRF-110;
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the scope, progress, results and costs of our current and future clinical trials of PRF-110 for our current targeted uses;
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the costs, timing and outcome of regulatory review of PRF-110;
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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;
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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;
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the amount of revenue, if any, received from commercial sales of PRF-110, should it receive marketing approval;
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the costs of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights and defending intellectual property-related claims;
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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;
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our headcount growth and associated costs as we expand our business operations and our research and development activities;
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the costs of operating as a public company;
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maintaining minimum shareholders’ equity requirements under the Nasdaq rules; and
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fluctuations in inflation and interest in Israel and the United States, which may exacerbate the magnitude of the factors discussed above.
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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
The following table summarizes our statements of cash flows for the three months ended March 31, 2024 and 2023.
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Three Months Ended March 31,
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(US$ thousands)
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2024
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2023
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Net cash used in operating activities
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(3,695
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(1,952
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Net cash provided by (used in ) investing activities
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(7
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6,000
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Net cash provided by financing activities
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-
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Effect of Exchange rate differences on cash, cash equivalents and restricted cash
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-
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(3
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Increase (Decrease) in cash and cash equivalents and restricted cash
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(3,702
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4,045
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Cash and cash equivalents and restricted cash, at the beginning of the year
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8,036
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4,106
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Cash and cash equivalents and restricted cash, at the end of the year
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4,334
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8,151
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Net cash used in operating activities
For the three months ended March 31, 2024 and 2023, net cash used in operating activities was approximately $3.7 million and $2.0 million, respectively. The increase was due to an
increase in the Company’s research and development expenses resulting from expenses associated with the Company’s Phase 3 trial.
Net cash used in investing activities
For the three months ended March 31, 2024, net cash used in investing activities was approximately $7,000. For the three months ended March 31,
2023, net cash provided by investing activities was approximately $6.0 million. The decrease was due to proceeds from deposits .
Net cash provided by financing activities
For the three months ended March 31, 2024 and 2023, we had no cash from financing activities.
Trend Information.
We are a development stage company with regard to different products. It is not possible for us to predict with any degree of accuracy the outcome of our research, development or
commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any significant trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our net sales or
revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause financial information to not necessarily be indicative of future operating results or financial condition. However, to the extent
possible, certain trends, uncertainties, demands, commitments and events are identified in the preceding subsections.
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
Our statements are prepared in accordance with GAAP. Some of the accounting methods and policies used in preparing our financial statements under GAAP are based on complex and
subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the circumstances concerned. The actual value of our assets, liabilities and shareholders’ equity and of
our accumulated deficit could differ from the value derived from these estimates if conditions change and these changes have an impact on the assumptions adopted. See Note 3 to the accompanying financial statements.
