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]

CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Eterna Therapeutics Inc. (Nasdaq: ERNA) (“Eterna” or the “Company”) announced today that it has regained compliance with Nasdaq for continued listing and that its stock will continue to trade on The Nasdaq Stock Market. Eterna received formal confirmation on November 12th, 2024 from Nasdaq’s Office of General Counsel, verifying that Eterna has met the market value of listed securities standard of at least $35 million, outlined in Listing Rule 5550(b)(2), a ...

CAMBRIDGE, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Eterna Therapeutics Inc. (Nasdaq: ERNA) ("Eterna" or the "Company") today announced the successful completion of a comprehensive financial restructuring of the Company with the aim to accelerate its developmental activities and long-term success. This restructuring includes reduction of its liabilities by discontinuing a longstanding lease, reducing the debt on its balance sheet and a new round of financing through a private investment in public equity (PI ...

CAMBRIDGE, Mass., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Eterna Therapeutics Inc. (Nasdaq: ERNA) ("Eterna" or the "Company") and Factor Bioscience Limited ("Factor") today announced an exclusive license and collaboration agreement aimed at accelerating the development of advanced cell therapy candidates for oncology, rare diseases, and autoimmune disorders. Under the terms of the agreement, Eterna has secured a worldwide, exclusive, non-transferable, royalty-bearing license, with the right to grant sublicenses, ...

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)

Financing Activities - The company has entered into a private placement of $8.7 million in convertible notes, with an interest rate of 6% per annum, maturing on July 14, 2028[129][130]. - The company has entered into a Standby Equity Purchase Agreement allowing for the sale of up to $10 million in common stock, with gross proceeds of approximately $0.3 million recognized to date[140]. - The company closed a Private Placement of $8.7 million in aggregate principal amount of Notes, intending to use the net proceeds for general working capital purposes[169]. - Net cash provided by financing activities for the six months ended June 30, 2023, included $0.3 million of gross proceeds received under the SEPA with Lincoln Park[181]. Revenue Generation - The company has not generated any revenues from product sales to date, as it is still in the pre-clinical stage[142]. - A cell line customization and license agreement with Lineage Cell Therapeutics may lead to additional revenues, although no assurances can be made[142]. - The company received a $0.3 million upfront, nonrefundable payment under the Lineage Agreement for an option right to obtain a sublicense of intellectual property, with potential future payments based on customer requests[165]. Research and Development - Research and development expenses are recognized as incurred, with major components including preclinical study costs and clinical trial expenses[144][145]. - The company acquired intellectual property assets from Exacis Biotherapeutics, enhancing its mRNA technology platform[138]. - The mRNA technology platform includes over 100 patents, focusing on mRNA cell reprogramming and gene editing technologies[121][122]. - The company anticipates developing product candidates for neurological indications and acute myeloid leukemia using its mRNA technology platform[122]. - The company expensed approximately $0.5 million for the Purchased License acquired in the Exacis Acquisition during the three and six months ended June 30, 2023[155]. Operating Expenses - Total operating expenses for the three months ended June 30, 2023, were $4.549 million, a decrease of $9.331 million compared to $13.880 million in the same period of 2022[149]. - Research and development expenses decreased to $1.579 million for the three months ended June 30, 2023, down from $1.685 million in 2022, reflecting a reduction of $106,000[152]. - General and administrative expenses significantly decreased to $2.510 million for the three months ended June 30, 2023, compared to $6.205 million in 2022, a reduction of $3.695 million[153]. Financial Performance - The net loss for the three months ended June 30, 2023, was $4.508 million, compared to a net loss of $3.398 million in the same period of 2022, an increase in loss of $1.110 million[149]. - Cash, cash equivalents, and restricted cash totaled approximately $5.9 million as of June 30, 2023, with $4.1 million classified as restricted cash[163]. - The change in fair value of warrant liabilities resulted in a credit of $0.191 million for the three months ended June 30, 2023, compared to a credit of $10.792 million in the same period of 2022[157]. - The company recognized a contingent consideration liability of $0.2 million for future payments related to the Exacis Acquisition, with a credit of $0.1 million recognized for the change in fair value as of June 30, 2023[158]. - Loss on non-controlling investment in NoveCite was approximately $8,000 for the three months ended June 30, 2023, compared to $296,000 in the same period of 2022[159]. Future Outlook - The company expects to continue incurring operating losses as it develops product programs and operates as a publicly traded company[175]. - Future funding requirements will depend on various factors, including the cost of regulatory approvals and the scope of clinical trials[176]. - The company may need to raise substantial additional funds to pursue product development, which could result in dilution to stockholders[176]. - The increase in cash used in operating activities was primarily driven by MSA fees and accrued severance payments for the six months ended June 30, 2023[179]. Lease Agreement - The company entered into a sublease agreement for approximately 45,500 square feet of office and laboratory space in Somerville, Massachusetts, with a total base rental payment of approximately $63.0 million over a 10-year term[164]. Licensing Agreements - An amendment to the Exclusive Factor License Agreement has expanded the field of use to include veterinary applications and reduced sublicense fees from 30% to 20%[136].