CAMBRIDGE, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced its upcoming company presentation at the Cell & Gene Meeting on the Mesa, taking place on October 7 in Phoenix, Arizona, and virtually online. “We are honored to participate in the Cell & Gene Meeting on the Mesa, one of the most important gatherings for advancing cell and gene therapies,” said Sanjeev Luther ...

CAMBRIDGE, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced that its President and CEO, Sanjeev Luther, will participate in a featured panel discussion at the upcoming 5th Annual iPSC Drug Development Summit on October 1 in Boston. “Participation in the iPSC Drug Development Summit provides Ernexa the opportunity to contribute to important conversations shaping the f ...

Core Insights - Ernexa Therapeutics is advancing its lead program, ERNA-101, which is a synthetic, off-the-shelf cell therapy aimed at treating advanced ovarian cancer by activating and regulating the immune system [1][6] - The company will present preclinical data at the AACR Special Conference, highlighting the potential of engineered iPSC-derived MSCs to reshape the tumor microenvironment in ovarian cancer [2][3] - The presentation will be made by Dr. Michael Andreeff, a leading expert in cell therapy, emphasizing the importance of this research in expanding treatment options for patients [2][3] Company Overview - Ernexa Therapeutics focuses on developing innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create induced mesenchymal stem cells (iMSCs) [5][6] - The company's technology allows for scalable, allogeneic treatment solutions without the need for patient-specific cell harvesting [5] - ERNA-201 is another product aimed at treating inflammation and autoimmune diseases, but the primary focus remains on ERNA-101 for ovarian cancer [6] Upcoming Events - The oral presentation titled "Gene-modified iPS-derived MSC restore a 'Hot' immune microenvironment in high-grade serous ovarian cancer" is scheduled for September 20, 2025, at the Grand Hyatt Denver Hotel [8]

The company’s operating loss declined by 51% year-over-year, reflecting a laser focus on relentless execution and significant progress in expense reductionCAMBRIDGE, Mass., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today provided an update on its operational excellence and performance for the first half of 2025. The company reported its financial results in its Quarterly Report on F ...

Core Viewpoint - Ernexa Therapeutics is an innovator in developing novel cell therapies for advanced cancer and autoimmune diseases, and will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [1][5]. Company Overview - Ernexa Therapeutics (NASDAQ: ERNA) focuses on engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs) for scalable, off-the-shelf treatments without the need for patient-specific cell harvesting [6]. - The company is advancing two lead programs: ERNA-101, aimed at stimulating immune response against ovarian cancer, and ERNA-201, which targets inflammation to treat autoimmune diseases [4][7]. Presentation Details - Sanjeev Luther, President and CEO, along with Robert Pierce, M.D., Chief Scientific Officer, will provide an overview of the company's business, recent milestones, and pipeline during the conference [3]. - The presentation will emphasize Ernexa's proprietary iMSC platform, which enables scalable cell therapies for cancer and autoimmune diseases [3]. Future Outlook - The company aims to advance ERNA-101 toward clinical trials by 2026, highlighting its potential to change treatment paradigms for cancer and autoimmune diseases [5].

PART I – FINANCIAL INFORMATION Presents the unaudited financial statements and related disclosures for the company's interim period [Item 1. Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for Ernexa Therapeutics Inc., including the balance sheets, statements of operations, changes in stockholders' equity (deficit), and cash flows, along with detailed notes explaining the company's financial position, performance, and significant accounting policies for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Provides a snapshot of the company's assets, liabilities, and equity at specific reporting dates **Condensed Consolidated Balance Sheets (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash | $4,315 | $1,729 | | Total current assets | $4,792 | $2,352 | | Total assets | $7,584 | $5,269 | | Total current liabilities | $2,651 | $2,938 | | Total liabilities | $3,140 | $3,568 | | Total stockholders' equity | $4,444 | $1,701 | - Cash increased significantly from **$1.7 million** at December 31, 2024, to **$4.3 million** at June 30, 2025, reflecting improved liquidity[15](index=15&type=chunk) - Total stockholders' equity more than doubled from **$1.7 million** to **$4.4 million**, primarily due to recent equity financing activities[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Details the company's revenues, expenses, and net loss over specific interim periods **Condensed Consolidated Statements of Operations (in thousands, except per share amounts):** | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $0 | $47 | $0 | $94 | | Gross loss | $0 | $(48) | $0 | $(62) | | Total operating expenses | $2,501 | $4,883 | $5,231 | $10,656 | | Loss from operations | $(2,501) | $(4,931) | $(5,231) | $(10,718) | | Total other expense, net | $(635) | $(595) | $(6,099) | $(1,451) | | Net loss | $(3,139) | $(5,529) | $(11,341) | $(12,176) | | Net loss per common share - basic and diluted | $(0.61) | $(15.34) | $(2.61) | $(33.75) | | Weighted average shares outstanding - basic and diluted | 5,179 | 361 | 4,350 | 361 | - The Company reported **no revenue** for the three and six months ended June 30, 2025, compared to **$47 thousand** and **$94 thousand** in the prior year periods, respectively, due to the assignment of its customer contract[17](index=17&type=chunk)[41](index=41&type=chunk) - Net loss decreased for both the three-month period (from **$5.5 million** to **$3.1 million**) and six-month period (from **$12.2 million** to **$11.3 million**) year-over-year, despite the absence of revenue[17](index=17&type=chunk) - Net loss per common share significantly improved from **$(15.34)** to **$(0.61)** for the three months and from **$(33.75)** to **$(2.61)** for the six months, primarily due to a substantial increase in weighted average shares outstanding[17](index=17&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) Outlines the changes in the company's equity components over the reporting period **Changes in Stockholders' Equity (Deficit) (in thousands):** | Metric | Balances at January 1, 2025 | Balances at June 30, 2025 | | :------------------------------------ | :-------------------------- | :------------------------ | | Common Stock (Shares) | 3,426 | 7,483 | | Common Stock (Amount) | $17 | $37 | | Additional Paid-in Capital | $233,219 | $247,291 | | Accumulated Deficit | $(231,536) | $(242,885) | | Total Stockholders' Equity | $1,701 | $4,444 | - Total stockholders' equity increased from **$1.7 million** at January 1, 2025, to **$4.4 million** at June 30, 2025, driven by significant increases in common stock and additional paid-in capital from private placements and stock-based compensation[20](index=20&type=chunk) - The Company issued **3,965 thousand shares** of common stock and prefunded warrants in connection with a private placement, contributing **$13.0 million** to additional paid-in capital[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes the cash inflows and outflows from operating, investing, and financing activities **Condensed Consolidated Statements of Cash Flows (in thousands):** | Activity | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(4,597) | $(6,006) | | Net cash used in investing activities | $0 | $(346) | | Net cash provided by financing activities | $7,183 | $1,363 | | Net increase (decrease) in cash and cash equivalents | $2,586 | $(4,989) | | Cash, cash equivalents and restricted cash at end of period | $4,315 | $6,681 | - Net cash used in operating activities decreased by **$1.4 million**, from **$6.0 million** in 2024 to **$4.6 million** in 2025[22](index=22&type=chunk)[140](index=140&type=chunk) - Net cash provided by financing activities significantly increased from **$1.4 million** in 2024 to **$7.2 million** in 2025, primarily due to proceeds from promissory notes and a private placement of common stock and prefunded warrants[22](index=22&type=chunk)[142](index=142&type=chunk) - The Company experienced a net increase in cash and cash equivalents of **$2.6 million** for the six months ended June 30, 2025, a reversal from a **$5.0 million** decrease in the prior year period[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and additional information supporting the condensed consolidated financial statements [1) Description of Business and Basis of Presentation](index=10&type=section&id=1)%20DESCRIPTION%20OF%20BUSINESS%20AND%20BASIS%20OF%20PRESENTATION) Describes the company's core business and the accounting principles used in financial statement preparation - Ernexa Therapeutics Inc. is a preclinical-stage synthetic allogeneic iMSC therapy company focused on developing scalable, affordable, off-the-shelf cell therapies for cancer and autoimmune diseases[25](index=25&type=chunk) - The Company effected a **1-for-15 reverse stock split** of its common stock on June 12, 2025, and all share and per share data in the report have been adjusted to reflect this[29](index=29&type=chunk)[31](index=31&type=chunk) - The number of authorized common shares was increased from **100,000,000** to **150,000,000** on June 2, 2025[30](index=30&type=chunk) [2) Liquidity and Capital Resources](index=11&type=section&id=2)%20LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Assesses the company's ability to meet its short-term and long-term financial obligations and funding needs - As of June 30, 2025, the Company had **$4.3 million** in cash and an accumulated deficit of **$242.9 million**, incurring net losses of **$3.1 million** and **$11.3 million** for the three and six months ended June 30, 2025, respectively[32](index=32&type=chunk) - Management concluded there is substantial doubt about the Company's ability to continue as a going concern for the next twelve months without raising additional capital[37](index=37&type=chunk) - During the three months ended June 30, 2025, the Company raised **$7.2 million** in gross proceeds from the sale of common stock and prefunded warrants[36](index=36&type=chunk) [3) Contract with Customer](index=11&type=section&id=3)%20CONTRACT%20WITH%20CUSTOMER) Details the company's revenue-generating agreements and their impact on financial performance - The Company had an exclusive option and license agreement with a customer, which was assigned to Factor Bioscience on September 24, 2024[39](index=39&type=chunk)[40](index=40&type=chunk) - No revenue was recognized from this contract for the three and six months ended June 30, 2025, compared to less than **$0.1 million** and **$0.1 million**, respectively, in 2024[41](index=41&type=chunk) - Factor Bioscience will pay the Company **30%** of amounts received if the customer exercises its Option Right and **20%** for customization activities[40](index=40&type=chunk) [4) Fair Value of Financial Instruments](index=12&type=section&id=4)%20FAIR%20VALUE%20OF%20FINANCIAL%20INSTRUMENTS) Explains the valuation methodologies and inputs used for financial instruments measured at fair value - The Company measures warrant liabilities and contingent consideration liability at fair value using **Level 3 inputs** (Black-Scholes and Monte Carlo models, respectively)[46](index=46&type=chunk) - A forward sales contract liability of **$5.3 million** was recorded at inception on March 31, 2025, and subsequently reclassified to additional paid-in capital upon settlement of shares during Q2 2025[47](index=47&type=chunk)[50](index=50&type=chunk) **Liabilities Measured at Fair Value (in thousands):** | Description | Level | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :---- | :------------ | :---------------- | | Warrant liabilities - Q1-22 warrants | 3 | $0 | $1 | | Contingent consideration | 3 | $41 | $41 | [5) Goodwill](index=13&type=section&id=5)%20GOODWILL) Discusses the accounting treatment and impairment testing for goodwill arising from acquisitions - Goodwill of **$2.0 million**, related to a 2018 acquisition, is not amortized but tested for impairment annually[52](index=52&type=chunk) - As of June 30, 2025, no potential triggering events were identified that would indicate impairment[52](index=52&type=chunk) [6) Accrued Expenses](index=14&type=section&id=6)%20ACCRUED%20EXPENSES) Provides a breakdown of the company's accrued liabilities at the balance sheet dates **Accrued Expenses (in thousands):** | Category | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Professional fees | $362 | $238 | | Accrued compensation | $108 | $12 | | Legal matters | $30 | $323 | | Other | $438 | $434 | | Total accrued expenses | $938 | $1,007 | - Total accrued expenses decreased from **$1.0 million** at December 31, 2024, to **$0.9 million** at June 30, 2025, primarily due to a reduction in legal matters accruals[53](index=53&type=chunk) [7) Leases](index=14&type=section&id=7)%20LEASES) Outlines the company's lease arrangements and associated expenses - The Company has operating leases for offices in New York and Cambridge, expiring in 2027 and 2028, respectively[54](index=54&type=chunk) **Total Lease Expense (in thousands):** | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total lease expense | $54 | $1,944 | $106 | $3,890 | - Total lease expense significantly decreased from **$1.9 million** to **$0.05 million** for the three months and from **$3.9 million** to **$0.1 million** for the six months ended June 30, 2025, primarily due to the termination of a sublease effective August 31, 2024[55](index=55&type=chunk) [8) Promissory Notes](index=15&type=section&id=8)%20PROMISSORY%20NOTES) Details the company's short-term debt obligations and their repayment - The Company issued two promissory notes totaling **$2.3 million** to Charles Cherington in March 2025, accruing interest at **5.0%** per annum[59](index=59&type=chunk) - These notes were repaid in full for **$2.3 million**, including accrued interest, by offsetting with a receivable from Mr. Cherington's purchase of shares in a private placement, resulting in no outstanding balances as of June 30, 2025[60](index=60&type=chunk) [9) Stock-Based Compensation](index=15&type=section&id=9)%20STOCK-BASED%20COMPENSATION) Explains the accounting for equity-settled compensation plans and related expenses **Stock Options Granted (in thousands):** | Period | 2025 | 2024 | | :-------------------------- | :--- | :--- | | Three months ended June 30, | 5 | 33 | | Six months ended June 30, | 127 | 158 | **Stock-Based Compensation Expense (in thousands):** | Category | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $15 | $15 | $31 | $61 | | General and administrative | $353 | $408 | $839 | $644 | | Total | $368 | $423 | $870 | $705 | - Total stock-based compensation expense increased from **$705 thousand** in the six months ended June 30, 2024, to **$870 thousand** in the same period of 2025, primarily driven by general and administrative expenses[67](index=67&type=chunk) - As of June 30, 2025, approximately **293,000 shares** of common stock were subject to outstanding stock options[63](index=63&type=chunk) [10) Net Loss Per Share](index=16&type=section&id=10)%20NET%20LOSS%20PER%20SHARE) Describes the calculation of basic and diluted net loss per common share - Basic and diluted net loss per share are calculated using the two-class method for participating securities, but the two-class method is not applicable during periods with a net loss[68](index=68&type=chunk) - Diluted net loss per share is the same as basic net loss per share when potentially dilutive shares are anti-dilutive[70](index=70&type=chunk) **Potential Common Shares Excluded from Diluted Net Loss Per Share (in thousands):** | Category | Three and six months ended June 30, 2025 | Three and six months ended June 30, 2024 | | :------------------------------------ | :--------------------------------------- | :--------------------------------------- | | Stock options | 293 | 169 | | Warrants | 32 | 1,359 | | Preferred stock converted into common stock | 5 | 1 | | Convertible Notes converted into common stock | 0 | 542 | | Total potential common shares excluded | 330 | 2,071 | [11) Commitments and Contingencies](index=17&type=section&id=11)%20COMMITMENTS%20AND%20CONTINGENCIES) Discloses the company's contractual obligations and potential liabilities - The Company settled litigation with John Westman on April 22, 2025, which included the issuance of **20,000 shares** of common stock and a cash payment of less than **$0.1 million**[74](index=74&type=chunk) - Under the Factor L&C Agreement, the Company obtained exclusive licenses for certain technology in cancer, autoimmune disorders, and rare diseases, with an initial term of one year, automatically renewable[76](index=76&type=chunk)[77](index=77&type=chunk) - The Company is obligated to pay Factor Bioscience approximately **$0.2 million** per month for the first twelve months, **$0.1 million** per month for patent costs, milestone payments, and royalties[78](index=78&type=chunk) [12) Equity Transactions](index=18&type=section&id=12)%20EQUITY%20TRANSACTIONS) Reports on significant changes in the company's equity structure, including stock issuances and warrants - The Company increased its authorized common stock from **100 million** to **150 million shares** effective June 2, 2025[80](index=80&type=chunk) - On March 31, 2025, the Company entered into a private placement agreement (SPA) to sell approximately **4,621,000 shares** of common stock (or pre-funded warrants) at **$1.569 per share**, raising approximately **$7.2 million** in gross proceeds[81](index=81&type=chunk)[83](index=83&type=chunk) - The SPA was accounted for as a forward sales contract, initially recording a **$5.3 million** liability and expense, which was reclassified to additional paid-in capital upon settlement[82](index=82&type=chunk)[84](index=84&type=chunk) **Warrants Outstanding (in thousands):** | Type | Outstanding | Exercise Price | Issuance Date | Expiration Date | Classification | | :-------------------- | :---------- | :------------- | :------------ | :-------------- | :------------- | | Q1-22 Warrants | 23 | $572.98 | 03/09/22 | 09/09/27 | Liability | | December 2022 Warrants | 9 | $21.45 | 12/02/22 | 06/02/28 | Equity | | Prefunded warrants | 75 | $0.075 | 10/29/24 | None | Equity | | Prefunded warrants | 34 | $0.075 | 04/02/25 | None | Equity | | Prefunded warrants | 622 | $0.075 | 06/09/25 | None | Equity | | Total | 763 | | | | | [13) Related Party Transactions](index=20&type=section&id=13)%20RELATED%20PARTY%20TRANSACTIONS) Details financial transactions and relationships with parties having significant influence over the company - Charles Cherington, a former board member and current owner of approximately **37%** of the Company's common stock, participated in the September 2024 and March 2025 financings under the same terms as other investors[89](index=89&type=chunk)[90](index=90&type=chunk) - Mr. Cherington provided **$2.3 million** in promissory notes to the Company in March 2025, which were fully repaid by offsetting with his purchase of shares in the private placement[90](index=90&type=chunk)[91](index=91&type=chunk) [14) Segment Reporting](index=20&type=section&id=14)%20SEGMENT%20REPORTING) Identifies the company's operating segments and how resources are allocated and performance is evaluated - The Company operates within a single reportable operating segment: the research and development of cellular therapies[92](index=92&type=chunk) - The Chief Operating Decision Maker (CODM) reviews performance and allocates resources at the consolidated entity level, using consolidated net loss and cash as key measures[92](index=92&type=chunk)[93](index=93&type=chunk) **Significant Operating Expenses (in thousands):** | Category | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,136 | $987 | $2,445 | $2,445 | | General and administrative | $1,365 | $3,896 | $2,786 | $8,211 | | Total operating expenses | $2,501 | $4,883 | $5,231 | $10,656 | [15) Recent Accounting Pronouncements](index=21&type=section&id=15)%20RECENT%20ACCOUNTING%20PRONOUNCEMENTS) Discusses the impact of newly issued accounting standards on the company's financial reporting - No new Accounting Standards Updates have been issued by the FASB since January 1, 2025, that would apply to the Company and are not already disclosed in the 2024 10-K[98](index=98&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition and results of operations for the three and six months ended June 30, 2025, compared to the same periods in 2024. It covers the business overview, recent corporate developments, detailed analysis of revenue and expenses, liquidity, capital resources, and cash flow, highlighting the Company's preclinical stage, ongoing losses, and need for additional capital [Overview](index=22&type=section&id=Overview) Provides a high-level summary of the company's business, strategic focus, and product pipeline - Ernexa Therapeutics Inc. is a preclinical-stage synthetic allogeneic iMSC therapy company focused on developing cell therapies for cancer and autoimmune diseases[100](index=100&type=chunk) - The lead product candidate, ERNA-101 (IL-7 and IL-15-secreting iMSCs), is being developed for platinum-resistant ovarian cancer, with IND submission expected by 2026 and Phase I clinical trials in H2 2026[101](index=101&type=chunk) - The Company is also investigating ERNA-201 (IL-10-secreting iMSCs) for inflammatory/auto-immune disorders like rheumatoid arthritis and actively seeking strategic partnerships[102](index=102&type=chunk)[103](index=103&type=chunk) [Recent Developments](index=22&type=section&id=Recent%20Developments) Highlights significant corporate events and strategic actions undertaken by the company - Effective June 2, 2025, the Company increased authorized common stock from **100 million** to **150 million shares** and allowed stockholder action by written consent[104](index=104&type=chunk)[105](index=105&type=chunk) - A **1-for-15 reverse stock split** became effective on June 12, 2025, which helped the Company regain compliance with Nasdaq's minimum bid price requirement[105](index=105&type=chunk)[110](index=110&type=chunk) - The Company completed a private placement on March 31, 2025, selling approximately **4,621,000 shares** of common stock (or pre-funded warrants) and raising approximately **$7.2 million** in gross proceeds[107](index=107&type=chunk)[108](index=108&type=chunk) - As of June 30, 2025, the Company's stockholders' equity was **$4.4 million**, complying with Nasdaq's **$2.5 million** minimum requirement[109](index=109&type=chunk) [Basis of Presentation](index=23&type=section&id=Basis%20of%20Presentation) Explains the accounting policies and principles applied in preparing the financial statements - Revenue for 2024 was from an exclusive option and license agreement, which was assigned to Factor Bioscience on September 24, 2024, resulting in **no revenue** for the three and six months ended June 30, 2025[112](index=112&type=chunk)[113](index=113&type=chunk) - Cost of revenues includes direct labor and supplies for customization activities and fees paid to Factor Bioscience under a previous license agreement, with no such costs recognized in 2025[114](index=114&type=chunk) - Research and development costs are expensed as incurred, comprising salaries, stock-based compensation, supplies, preclinical study costs, and licensed technology expenses[115](index=115&type=chunk)[116](index=116&type=chunk) - General and administrative expenses include salaries, benefits, equity-based compensation, legal and professional fees, travel, and insurance[118](index=118&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Analyzes the company's financial performance by comparing revenues and expenses over different periods **Summary of Results of Operations (in thousands):** | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Change (3M) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Change (6M) | | :------------------------------------ | :------------------------------- | :------------------------------- | :---------- | :----------------------------- | :----------------------------- | :---------- | | Revenue | $0 | $47 | $(47) | $0 | $94 | $(94) | | Gross loss | $0 | $(48) | $48 | $0 | $(62) | $62 | | Research and development expenses | $1,136 | $987 | $149 | $2,445 | $2,445 | $0 | | General and administrative expenses | $1,365 | $3,896 | $(2,531) | $2,786 | $8,211 | $(5,425) | | Loss from operations | $(2,501) | $(4,931) | $2,430 | $(5,231) | $(10,718) | $5,487 | | Forward sales contract expense | $(512) | $0 | $(512) | $(5,847) | $0 | $(5,847) | | Net loss | $(3,139) | $(5,529) | $2,390 | $(11,341) | $(12,176) | $835 | - Total operating expenses decreased by **$2.4 million** for the three months and **$5.4 million** for the six months ended June 30, 2025, primarily due to a significant reduction in general and administrative expenses[120](index=120&type=chunk) - General and administrative expenses decreased by **$2.5 million** (3M YoY) and **$5.4 million** (6M YoY), mainly due to reduced rent expense from a terminated sublease, lower professional fees, and decreased payroll-related expenses[126](index=126&type=chunk)[127](index=127&type=chunk) - The Company recognized a forward sales contract expense of **$0.5 million** for the three months and **$5.8 million** for the six months ended June 30, 2025, related to the private placement[128](index=128&type=chunk) - Interest expense decreased by **$0.9 million** (3M YoY) and **$1.7 million** (6M YoY) due to a reduction in interest-bearing debt[130](index=130&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet its short-term and long-term financial obligations and funding needs - As of June 30, 2025, the Company had **$4.3 million** in cash and an accumulated deficit of **$242.9 million**, with net losses of **$3.1 million** and **$11.3 million** for the three and six months ended June 30, 2025, respectively[133](index=133&type=chunk) - The Company used **$4.6 million** in cash for operating activities during the six months ended June 30, 2025[133](index=133&type=chunk) - Management believes there is substantial doubt about the Company's ability to continue as a going concern for the next 12 months without additional capital, which may be sought through equity offerings, debt financings, or strategic partnerships[136](index=136&type=chunk)[138](index=138&type=chunk) - During Q2 2025, the Company raised **$7.2 million** in gross proceeds from a private placement, which was used for general working capital and to repay **$2.3 million** in promissory notes[135](index=135&type=chunk) **Cash Flows Summary (in thousands):** | Activity | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Change | | :------------------------------------ | :----------------------------- | :----------------------------- | :----- | | Operating activities | $(4,597) | $(6,006) | $1,409 | | Investing activities | $0 | $(346) | $346 | | Financing activities | $7,183 | $1,363 | $5,820 | | Net increase (decrease) in cash and cash equivalents | $2,586 | $(4,989) | $7,575 | [Off-Balance Sheet Arrangements](index=29&type=section&id=Off-Balance%20Sheet%20Arrangements) Discloses any material off-balance sheet transactions, arrangements, obligations, or other relationships - The Company did not have any off-balance sheet arrangements during the periods presented or currently[143](index=143&type=chunk) [Critical Accounting Estimates](index=29&type=section&id=Critical%20Accounting%20Estimates) Identifies accounting estimates that require significant judgment and could materially impact financial results - There were no significant changes in critical accounting estimates during the three and six months ended June 30, 2025, from those described in the 2024 10-K[144](index=144&type=chunk) [Recent Accounting Pronouncements](index=29&type=section&id=Recent%20Accounting%20Pronouncements) Discusses the impact of newly issued accounting standards on the company's financial reporting - No new Accounting Standards Updates have been issued by the FASB since January 1, 2025, that would apply to the Company and are not disclosed in the 2024 10-K[145](index=145&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Ernexa Therapeutics Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The Company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[146](index=146&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the Company's evaluation of its disclosure controls and procedures and reports on any changes in internal control over financial reporting. Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The Company's management, including the CEO and SVP of Finance, concluded that disclosure controls and procedures were effective as of June 30, 2025, providing reasonable assurance of achieving desired control objectives[148](index=148&type=chunk)[149](index=149&type=chunk) - There were no material changes in the Company's internal control over financial reporting during the most recent fiscal quarter[150](index=150&type=chunk) PART II – OTHER INFORMATION Presents additional non-financial and legal information required for interim reporting [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the litigation matters discussed in Note 11 to the financial statements, confirming the Company's involvement in ordinary course legal proceedings and the absence of other material legal proceedings - Information on legal proceedings is incorporated from Note 11 to the condensed consolidated financial statements[152](index=152&type=chunk) - The Company is not a party to any material legal proceedings other than those described in Note 11[152](index=152&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) This section advises investors to consider the risks outlined in the Company's 2024 Form 10-K and this Quarterly Report, noting that there have been no material changes to the previously described risk factors - An investment in the Company's common stock involves a high degree of risk, as detailed in the 2024 10-K and this Quarterly Report[153](index=153&type=chunk) - There have been no material changes to the risk factors described in the 2024 10-K[153](index=153&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on unregistered sales of equity securities, specifically the issuance of 20,000 shares of common stock in May 2025 for litigation settlement, relying on the Section 4(a)(2) exemption from registration - On May 19, 2025, the Company issued **20,000 shares** of common stock to John Westman in connection with a litigation settlement[155](index=155&type=chunk) - This issuance relied on the exemption from registration provided by Section 4(a)(2) under the Securities Act for transactions not involving a public offering[156](index=156&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[157](index=157&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - This item is not applicable[158](index=158&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report under sub-items (a) and (b), and confirms that no directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter[160](index=160&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including certificates of amendment to the Company's Restated Certificate of Incorporation, certifications of principal executive and financial officers, and XBRL documents - Exhibits include Certificates of Amendment for Authorized Shares, Written Consent, and Reverse Stock Split, filed on June 2, 2025, and June 10, 2025, respectively[161](index=161&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are filed or furnished[161](index=161&type=chunk) - The report includes Inline XBRL Document Set for financial statements and accompanying notes[161](index=161&type=chunk) Signatures Certifies the accuracy and completeness of the financial report by authorized officers [Signatures](index=32&type=section&id=Signatures) Contains the official certifications by the company's principal executive and financial officers - The report is signed by Sanjeev Luther, President and Chief Executive Officer, and Sandra Gurrola, Senior Vice President of Finance, on August 13, 2025[164](index=164&type=chunk)

Core Viewpoint - Ernexa Therapeutics has regained compliance with Nasdaq for continued listing, allowing its stock to continue trading on the Nasdaq Stock Market [1][2]. Company Overview - Ernexa Therapeutics is focused on developing innovative stem cell therapies for advanced cancer and autoimmune diseases, utilizing engineered induced pluripotent stem cells (iPSCs) to create allogeneic synthetic induced mesenchymal stem cells (iMSCs) [4]. - The company’s lead product, ERNA-101, aims to activate and regulate the immune system to target cancer cells, while ERNA-102 is designed to address inflammation in autoimmune diseases [5]. Future Plans - The company is on track to initiate its first clinical trial in early 2026, emphasizing its commitment to advancing its programs for patients with ovarian cancer and autoimmune diseases [3].

Core Insights - Ernexa Therapeutics is transitioning from research to clinical-stage development, focusing on innovative cell therapies for advanced cancer and autoimmune diseases [1][3] - The company has expanded its Scientific Advisory Board to include distinguished medical leaders to guide its clinical programs [2][3] Company Developments - Ernexa has strengthened its financial position, which supports its strategy to accelerate lead programs toward clinical trials [1] - The newly formed advisory board will assist in trial design, biomarker development, and regulatory engagement as the company prepares for IND-enabling studies [3][6] Advisory Board Composition - Dr. Amir Anthony Jazaeri, an expert in gynecologic oncology, will guide the ovarian cancer program [2][4] - Dr. Anna Helena Jonsson, a specialist in autoimmune diseases, will lead the translational strategy for the autoimmune pipeline [2][5] Product Focus - The lead product, ERNA-101, aims to activate and regulate the immune system to target cancer cells, with an initial focus on ovarian cancer [8] - ERNA-102 is designed to address inflammation in autoimmune diseases [8] Scientific Approach - Ernexa's core technology involves engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs), providing scalable treatment options [7]

Core Points - Ernexa Therapeutics has completed a second closing under a securities purchase agreement, raising total gross proceeds to $7.1 million to support working capital initiatives [1][3] - The company issued 3,181,145 shares of common stock and 622,134 prefunded warrants in the second closing, generating approximately $6.0 million in gross proceeds [2] - The initial closing occurred on April 2, 2025, where the company raised approximately $1.1 million by issuing 662,269 shares of common stock and 33,983 prefunded warrants [2] - The financing was approved by stockholders at the 2025 Annual Meeting held on June 2, 2025, as required by Nasdaq listing rules [3] Financial Details - The total gross proceeds from the financing amount to $7.1 million, which includes the initial and second closings [1] - A remaining subscription amount of $190,248 for 121,255 shares of common stock is still pending [2] Company Overview - Ernexa Therapeutics focuses on developing innovative cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) [5] - The lead product, ERNA-101, aims to activate the immune system to target cancer cells, while ERNA-102 is designed to address inflammation in autoimmune diseases [6] - The company's initial focus is on developing ERNA-101 for ovarian cancer treatment [6] Warrant Details - The prefunded warrants have a nominal exercise price of $0.075 per share and are subject to ownership limitations of 4.99% or 9.99% of the company's outstanding common stock [4]

Core Viewpoint - Ernexa Therapeutics announced a reverse stock split at a ratio of 1-for-15 to comply with Nasdaq's minimum bid price requirement for continued listing [1][2][7] Group 1: Reverse Stock Split Details - The reverse stock split will take effect on June 12, 2025, at 12:01 a.m. Eastern Time, with trading on a split-adjusted basis commencing the same day [1] - Every 15 shares of Common Stock will be reclassified into one new share, with no modification to the rights or preferences of the shares [2] - The company had 110,418,022 shares outstanding prior to the split, which will reduce to approximately 7,361,201 shares post-split [4] Group 2: Shareholder Impact - No fractional shares will be issued; stockholders will receive one whole share instead of fractional shares [3] - Stockholders holding pre-split certificates will receive instructions from Computershare on how to surrender their certificates [5] Group 3: Company Background and Strategy - Ernexa Therapeutics focuses on developing innovative stem cell therapies for advanced cancer and autoimmune diseases, utilizing induced pluripotent stem cells [8] - The company’s lead product, ERNA-101, aims to activate the immune system against cancer cells, with an initial focus on ovarian cancer [9][10] - The reverse stock split is part of a broader strategy to strengthen the company's financial foundation and maintain access to capital markets for advancing clinical programs [7]