CAMBRIDGE, Mass., Jan. 28, 2025 (GLOBE NEWSWIRE) -- Eterna Therapeutics (NASDAQ:ERNA), a leader in cell therapies for the treatment of advanced solid tumors, today announced the addition of Jerome Zeldis, M.D., Ph.D., and Blythe Sather, Ph.D., to the company's scientific advisory board. "We are fortunate to welcome Dr. Zeldis and Dr. Sather," said Sanjeev Luther, President & CEO of Eterna Therapeutics. "Their extensive experience in developing transformative, high-profile cell therapies for solid tumors has ...

New data from proof-of-concept study provides roadmap for treatment of ovarian cancerCAMBRIDGE, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Eterna Therapeutics (Nasdaq: ERNA), a leader in cell therapies for the treatment of advanced solid tumors, today announced positive results from a preclinical study on the company’s lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system's response to recognize and attack ovarian cancer cells. This successful proof-of-concept study ...

Company Announcement - Eterna Therapeutics appoints Dr Elena Ratner to its Board of Directors to lead strategic efforts in ovarian cancer research and treatment [1][2] - Dr Ratner brings extensive expertise in obstetrics gynecology and reproductive sciences from Yale University [1][4] - Eterna aims to accelerate advancements in innovative therapies for ovarian and breast cancers leveraging Dr Ratner's leadership and recent collaboration with MD Anderson Cancer Center [2] Product Development - Eterna's lead product ERNA-101 is an allogeneic pro-inflammatory cytokine (IL-7/IL-15)-secreting iMSC therapy targeting platinum-resistant ovarian cancer [5] - ERNA-101 enhances immune system response against tumors by improving immune cell infiltration and activation [3] - The company is also investigating ERNA-102 anti-inflammatory cytokine (IL-10)-secreting iMSCs for inflammatory/auto-immune disorders like rheumatoid arthritis [5] Strategic Direction - Eterna is actively seeking strategic partnerships to co-develop or out-license therapeutic assets and expand developmental opportunities [5] - The company's focus on women's health is reinforced by its collaboration with MD Anderson Cancer Center and Dr Ratner's expertise [2][4] - Eterna's scientific data shows promise in addressing the challenges of ovarian cancer treatment including resistance and high recurrence rates [3]

Core Viewpoint - Eterna Therapeutics Inc. has regained compliance with Nasdaq for continued listing, confirming its market value of at least $35 million, allowing its stock to continue trading on The Nasdaq Stock Market [1]. Group 1: Company Compliance and Financial Status - Eterna received formal confirmation from Nasdaq's Office of General Counsel on November 12, 2024, verifying compliance with the market value of listed securities standard [1]. - The company is now debt-free and operates with a low burn rate, positioning itself as a fully functional preclinical stage cell therapy company [2]. Group 2: Product Development Focus - Eterna is focused on advancing its lead product, ERNA-101, targeting triple-negative breast cancer and platinum-resistant, TP53-mutant ovarian cancer [2][3]. - ERNA-101 is an induced allogenic mesenchymal stem cell product designed to deliver pro-inflammatory cytokines IL-7 and IL-15 to the tumor microenvironment, aiming to enhance anti-tumor immunity [3]. Group 3: Company Overview - Eterna Therapeutics is a publicly traded, preclinical-stage company specializing in innovative off-the-shelf cell therapies for advanced solid tumors, with a primary focus on specific cancer types [3].

Core Insights - Eterna Therapeutics Inc. has successfully completed a comprehensive financial restructuring aimed at accelerating its developmental activities and long-term success [1][2] Financial Restructuring - The company has reduced its liabilities by discontinuing a longstanding lease, resulting in estimated savings of $72 million and a reduction of approximately $700,000 in monthly cash outflow [2] - With shareholder approval, Eterna has completed transactions that significantly reduced its balance sheet debt and secured a new round of $5 million in financing through a PIPE investment [2] Strategic Focus - The financial restructuring allows Eterna to execute its strategic mission to develop innovative off-the-shelf cellular therapies, both internally and in collaboration with academic partners, with greater financial agility [3] Product Development - Eterna is advancing its lead therapeutic candidate, ERNA-101, which is designed to deliver IL-7/IL-15 selectively to tumors, focusing initially on triple-negative breast cancer (TNBC) and platinum-resistant, TP53-mutant ovarian cancer [4] - The company aims to be well-positioned for IND-enabling studies and targets IND submissions by 2026 [4] Company Overview - Eterna Therapeutics is a publicly traded, preclinical-stage company focused on innovative cell therapies for advanced solid tumors, particularly TNBC and platinum-resistant, TP53-mutant ovarian cancer [5] - The lead product, ERNA-101, utilizes a best-in-class approach to engineer allogenic induced pluripotent stem cells (iPSCs) to express genes of interest and efficiently differentiate into mesenchymal stem cells [5]

Core Viewpoint - Eterna Therapeutics Inc. and Factor Bioscience Limited have entered into an exclusive license and collaboration agreement to accelerate the development of advanced cell therapy candidates targeting oncology, rare diseases, and autoimmune disorders [1] Group 1: Agreement Details - Eterna has secured a worldwide, exclusive, non-transferable, royalty-bearing license to develop and market certain induced pluripotent stem cell (iPSC)-based cell therapy products, specifically iPSC-derived mesenchymal stem cells (iMSC) engineered to express certain cytokines [1] - The collaboration aims to generate data demonstrating the efficacy of the licensed drug candidates for development towards Investigational New Drug (IND) applications by Eterna or third-party sublicensees [2] - Factor Bioscience will receive milestone payments per product candidate and post-commercialization royalties as part of the agreement [2] Group 2: Company Focus and Pipeline - Eterna Therapeutics is a preclinical-stage company focused on innovative off-the-shelf cell therapies for advanced solid tumors, particularly triple-negative breast cancer (TNBC) and platinum-resistant, TP53-mutant ovarian cancer [3] - The lead product, ERNA-101, is designed to selectively deliver pro-inflammatory cytokines IL-7 and IL-15 to the tumor microenvironment to enhance anti-tumor immunity [3] - Eterna's technology utilizes a best-in-class approach to engineer allogenic iPSCs to express genes of interest and efficiently differentiate into iMSCs [3] Group 3: Factor Bioscience Overview - Factor Bioscience, founded in 2011, is a leading cell engineering platform technology company focused on harnessing cell engineering to treat diseases and improve health [4] - The company is privately held and headquartered in Cambridge, MA [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _____________ Commission file number: 001-11460 Eterna Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 31-11034 ...

CAMBRIDGE, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Eterna Therapeutics Inc. (NASDAQ:ERNA) ("Eterna" or the "Company"), a preclinical-stage biopharmaceutical company, committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines, today announces the appointment of Mahendra Rao, PhD, to its scientific advisory board. "We're honored to have Dr. Mahendra Rao join our Scientific Advisory Board," said Sanjeev Luther, President and CEO of Eterna. "His deep sc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 1-11460 Eterna Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 31-1103425 (State or O ...

PART I – FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended September 30, 2023, are presented [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and liabilities increased significantly due to new lease obligations, while stockholders' equity declined **Condensed Consolidated Balance Sheet Summary (in thousands)** | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $4,551 | $11,446 | | Total current assets | $7,031 | $13,681 | | Right-of-use assets - operating leases | $34,860 | $1,030 | | **Total assets** | **$52,248** | **$22,279** | | **Liabilities & Equity** | | | | Total current liabilities | $9,626 | $7,654 | | Convertible notes payable, net | $3,452 | $0 | | Operating lease liabilities, non-current | $34,998 | $887 | | **Total liabilities** | **$48,686** | **$10,172** | | **Total stockholders' equity** | **$3,562** | **$12,107** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported its first revenue and a reduced net loss for Q3 2023 compared to the prior-year period **Condensed Consolidated Statements of Operations Summary (in thousands, except per share amounts)** | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $51 | $0 | $51 | $0 | | Research and development | $1,457 | $4,963 | $4,710 | $8,430 | | General and administrative | $3,979 | $3,341 | $10,081 | $14,060 | | Impairment of IPR&D | $0 | $0 | $0 | $5,990 | | Loss from operations | $(5,505) | $(8,304) | $(15,370) | $(28,480) | | **Net loss** | **$(5,591)** | **$(7,316)** | **$(15,515)** | **$(20,090)** | | Net loss per share | $(1.03) | $(2.49) | $(2.94) | $(7.04) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations remained stable while financing activities provided less cash than the prior year **Cash Flow Summary for the Nine Months Ended September 30 (in thousands)** | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,747) | $(15,541) | | Net cash used in investing activities | $0 | $(176) | | Net cash provided by financing activities | $8,852 | $11,986 | | **Net decrease in cash and cash equivalents** | **$(6,895)** | **$(3,731)** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key disclosures include a going concern warning, recent financing, an asset acquisition, and a new facility sublease - Management concluded there is **substantial doubt about the Company's ability to continue as a going concern**, as it does not expect to have sufficient cash to fund operations for the next twelve months[34](index=34&type=chunk) - In July 2023, the company closed a financing for approximately **$8.7 million in convertible promissory notes** and warrants to purchase 6.1 million shares of common stock[33](index=33&type=chunk)[55](index=55&type=chunk) - In April 2023, the company acquired intellectual property assets from Exacis Biotherapeutics Inc for **$460,000**, which was expensed as in-process research and development (IPR&D)[36](index=36&type=chunk)[42](index=42&type=chunk) - The company recognized its **first revenue of less than $0.1 million** for cell line customization activities in Q3 2023[43](index=43&type=chunk)[51](index=51&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses reduced net losses, recent financing, and expresses substantial doubt about its going concern status [Results of Operations](index=30&type=section&id=Results%20of%20Operations) The net loss for the nine-month period decreased by $4.5 million, driven by lower operating expenses **Comparison of Operating Results (in thousands)** | Item | Nine Months 2023 | Nine Months 2022 | Change | | :--- | :--- | :--- | :--- | | Revenue | $51 | $0 | $51 | | Research and development | $4,710 | $8,430 | $(3,720) | | General and administrative | $10,081 | $14,060 | $(3,979) | | Impairment of IPR&D | $0 | $5,990 | $(5,990) | | **Loss from operations** | **$(15,370)** | **$(28,480)** | **$13,110** | | **Net loss** | **$(15,515)** | **$(20,090)** | **$4,575** | - The decrease in R&D expenses was primarily due to a reduction in MSA fees paid to Factor Bioscience and lower payroll and stock-based compensation expense from employee terminations[167](index=167&type=chunk) - The decrease in G&A expenses was due to lower payroll, reduced professional fees, and the non-recurrence of a ROU asset impairment and loss on disposal of fixed assets from 2022[170](index=170&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $4.6 million in unrestricted cash but lacks sufficient funds for the next twelve months - The company had cash, cash equivalents, and restricted cash of $8.6 million, of which **$4.6 million was unrestricted** as of September 30, 2023[181](index=181&type=chunk) - Management states that based on current financial conditions, they **do not have sufficient funds for operations for the next twelve months**, raising substantial doubt about the ability to continue as a going concern[190](index=190&type=chunk) - In July 2023, the company closed a financing of **$8.7 million in aggregate principal amount of Convertible Notes** and issued warrants[187](index=187&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Eterna Therapeutics Inc is exempt from providing this information - The company is a smaller reporting company and is not required to provide the information otherwise required by this item[202](index=202&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were not effective due to a previously identified material weakness - Management concluded that **disclosure controls and procedures were not effective** as of the end of the period covered by the report[206](index=206&type=chunk) - The ineffectiveness stems from a material weakness identified due to errors in prior financial statements, which management attributed to accounting personnel's **lack of technical proficiency in complex matters**[208](index=208&type=chunk) - Remediation plans include enhancing review processes for complex transactions, providing additional training, and consulting with an accounting advisor[215](index=215&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in ongoing litigation with former employees and faces a trademark infringement lawsuit - The company's subsidiary, Novellus, Inc, is in a legal dispute with former employees involving claims and counterclaims related to conduct that took place before Eterna's acquisition of Novellus[102](index=102&type=chunk)[103](index=103&type=chunk) - On July 31, 2023, eTheRNA Immunotherapies NV and eTheRNA Inc filed a complaint against Eterna Therapeutics Inc alleging **federal and state trademark infringement** and unfair competition[106](index=106&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) New material risks arise from restrictive covenants and potential cash redemption requirements of recent convertible notes - The Convertible Notes contain **restrictive covenants** that limit the company's ability to, among other things, create liens, pay dividends, and incur additional indebtedness[216](index=216&type=chunk) - The company is **required to redeem the Convertible Notes for cash** under certain circumstances, and failure to do so could lead to default, acceleration of debt, and potential bankruptcy or liquidation[218](index=218&type=chunk)[221](index=221&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period that were not previously disclosed - There were no unregistered sales of equity securities to report for the period[219](index=219&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists key agreements related to the July 2023 financing and other required filings - Key exhibits filed include agreements for the July 2023 financing and an amendment to the license agreement with Factor Bioscience Limited[220](index=220&type=chunk)