Cellect(QNRX) - 2025 Q1 - Quarterly Report

PART I - FINANCIAL INFORMATION Financial Statements The unaudited statements show a widening net loss to $3.8 million and an accumulated deficit of $59.0 million, raising substantial doubt about its going concern status Condensed Consolidated Balance Sheets (USD) | | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $3,822,122 | $3,623,343 | | Total current assets | $12,496,819 | $14,926,004 | | Total assets | $12,955,153 | $15,709,338 | | Liabilities and Equity | | | | Total current liabilities | $4,855,611 | $4,180,932 | | Total liabilities | $7,029,344 | $6,504,665 | | Accumulated deficit | $(58,977,971) | $(55,165,792) | | Total shareholders' equity | $5,925,809 | $9,204,673 | Condensed Consolidated Statements of Operations (USD) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $2,374,139 | $885,298 | | Total operating expenses | $3,957,177 | $2,458,284 | | Net loss | $(3,812,179) | $(2,327,280) | | Loss per ADS (Basic & Diluted) | $(6.50) | $(38.73) | - The company is a late-stage clinical specialty pharmaceutical firm focused on rare diseases, with no commercialized products or revenue to date[22] - Management has concluded there is substantial doubt about the company's ability to continue as a going concern due to a history of net losses and negative cash flows[23][25] - A 1-for-35 reverse ADS split was executed on April 9, 2025, to regain Nasdaq minimum bid price compliance, with financial data retroactively adjusted[21][32] Management's Discussion and Analysis of Financial Condition and Results of Operations R&D expenses rose 168.2% to $2.4 million, widening the net loss to $3.8 million and reinforcing substantial doubt about the company's going concern status - The company's strategy focuses on completing clinical testing for its lead product QRX003 and preparing for commercialization[78][79] - Research and development expenses increased by $1.5 million (168.2%) in Q1 2025 compared to Q1 2024, primarily due to increased clinical study expenditures for QRX003[95] - Management reiterates substantial doubt about its ability to continue as a going concern and the need to raise additional capital for future operations[98][99] Condensed Consolidated Statements of Cash Flows (USD) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,594,179) | $(1,434,372) | | Net cash provided (used) in investing activities | $2,770,000 | $(4,465,774) | | Net cash provided by financing activities | $22,958 | $5,332,472 | Quantitative and Qualitative Disclosures About Market Risk The company is exempt from market risk disclosure requirements as a smaller reporting company - The company is a smaller reporting company as defined in Rule 12b-2 of the Exchange Act and is not required to provide the information otherwise required under this Item 3[114] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Based on an evaluation as of the end of the period, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[115] - There were no material changes in the company's internal control over financial reporting during the quarter ended March 31, 2025[116] PART II - OTHER INFORMATION Legal Proceedings The company is not a party to any material legal proceedings - The company is currently not a party to any material legal or administrative proceedings and is not aware of any pending or threatened material proceedings against it[118] Risk Factors Key risks include potential Nasdaq delisting and the substantial doubt about its ability to continue as a going concern without additional capital - The company's failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of its ADSs[120][121][122] - The company must raise additional capital to continue as a going concern, given its $59.0 million accumulated deficit and limited cash[126] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities were reported during the period - None[127] Defaults Upon Senior Securities No defaults upon senior securities were reported - None[128] Mine Safety Disclosures This item is not applicable to the company - Not applicable[129] Other Information No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements in Q1 2025 - During the first quarter of 2025, none of the company's directors or executive officers adopted or terminated any "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement"[130] Exhibits This section lists filed exhibits, including CEO/CFO certifications and financial data in Inline XBRL format - The exhibits filed with the report include CEO and CFO certifications and financial statements in Inline XBRL format[131]