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Serina Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Highlights
Globenewswire· 2025-11-13 11:10
Core Insights - Serina Therapeutics is advancing its lead investigational drug SER-252 for advanced Parkinson's disease, with a key milestone achieved in FDA alignment for a 505(b)(2) NDA pathway [2][6] - The company reported a net loss of $4.6 million for Q3 2025, compared to a net income of $1.4 million in Q3 2024, indicating a significant shift in financial performance [8][22] - Serina has secured up to $20 million in funding through a convertible note and warrant financing agreement, with the first tranche of $5 million already drawn [6] Financial Performance - Operating expenses for Q3 2025 were $6.4 million, up from $5.3 million in Q3 2024 [3] - Research and Development (R&D) expenses increased to $3.6 million in Q3 2025 from $2.4 million in Q3 2024, driven by higher outsourced research services and clinical activities [4] - General and Administrative expenses decreased slightly to $2.7 million in Q3 2025 from $2.9 million in Q3 2024, attributed to reduced compensation costs [5] - Other income for Q3 2025 was $1.8 million, a decrease from $6.7 million in Q3 2024, primarily due to changes in fair value of liability classified warrants [7] Liquidity and Capital Structure - As of September 30, 2025, cash and cash equivalents totaled $8.6 million, a significant increase from $3.7 million at the end of 2024 [9][20] - The company has entered into an At-the-Market (ATM) equity program allowing it to sell up to $13.3 million of common stock, with $2.8 million net proceeds from shares issued as of November 7, 2025 [6] Regulatory and Development Updates - The FDA has placed the IND for SER-252 on clinical hold pending additional information, but this does not relate to the active drug substance [6] - Serina is advancing SER-270 for tardive dyskinesia, with plans to complete formulation optimization and pre-IND activities in 2026 [6] - The SER-252 registrational study is designed to evaluate safety, tolerability, and pharmacokinetics, with a focus on motor fluctuations in Parkinson's disease [14]
Serina Therapeutics, Inc.(SER) - 2025 Q3 - Quarterly Results
2025-11-13 11:05
Financial Performance - The net loss for Q3 2025 was $4.6 million, or $0.45 per share, compared to a net income of $1.4 million, or $0.16 per share, in Q3 2024[9]. - The net loss attributable to Serina Therapeutics, Inc. for the three months ended September 30, 2025, was $4,585 thousand, compared to a net income of $1,410 thousand in 2024[24]. - Basic net loss per common share for the three months ended September 30, 2025, was $(0.45), compared to $0.16 in 2024[24]. - Total revenues for the three months ended September 30, 2025, were $14 million, compared to $0 million for the same period in 2024, representing a significant increase[24]. Operating Expenses - Operating expenses for Q3 2025 were $6.4 million, up from $5.3 million in Q3 2024, representing a 20.8% increase[4]. - General and administrative expenses decreased to $2.7 million in Q3 2025 from $2.9 million in Q3 2024, a reduction of 6.9%[7]. - Total operating expenses for the nine months ended September 30, 2025, were $17,945 thousand, compared to $11,569 thousand in 2024, indicating a 55% increase[24]. Research and Development - R&D expenses increased to $3.6 million in Q3 2025 from $2.4 million in Q3 2024, a rise of 50% driven by outsourced research services and clinical activities[6]. - Research and development expenses increased to $3,651 thousand for the three months ended September 30, 2025, up from $2,415 thousand in 2024, reflecting a 51% increase[24]. - SER-270 is on track for formulation optimization and pre-IND activities in 2026, targeting tardive dyskinesia treatment[5][16]. - The SER-252 registrational study is designed to evaluate safety and efficacy in adults with Parkinson's disease, involving 40 participants in the single-ascending-dose component[15]. Cash and Financing - Cash and cash equivalents increased to $8.6 million as of September 30, 2025, compared to $3.7 million as of December 31, 2024[10][22]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $(11,922) thousand, slightly improved from $(12,548) thousand in 2024[26]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $16,931 thousand, compared to $8,181 thousand in 2024, showing a 107% increase[26]. - Cash and cash equivalents at the end of the period on September 30, 2025, were $8,620 thousand, up from $3,235 thousand at the end of the same period in 2024[26]. - Serina secured up to $20 million in funding through a convertible note and warrant financing agreement, with the first tranche of $5 million drawn in September 2025[5]. - As of November 7, 2025, Serina issued 474,712 shares of common stock at a gross average price of $6.00, resulting in net proceeds of $2.8 million[5]. Shareholder Information - The weighted average number of common shares outstanding for the three months ended September 30, 2025, was 10,339 thousand, compared to 8,851 thousand in 2024, reflecting a 17% increase[24]. - Total other income, net for the three months ended September 30, 2025, was $1,797 thousand, down from $6,695 thousand in 2024, indicating a decrease of 73%[24]. Regulatory Milestones - The FDA supported advancing SER-252 under a 505(b)(2) NDA pathway, marking a significant regulatory milestone[3][5].
Serina Therapeutics, Inc.(SER) - 2025 Q3 - Quarterly Report
2025-11-13 11:03
Financial Performance - The company reported an operating loss of $6.4 million for the nine months ended September 30, 2025, compared to a loss of $5.3 million for the same period in 2024, indicating an increase in losses year-over-year [147]. - For the three months ended September 30, 2025, net loss was $4.6 million, compared to a net income of $1.4 million for the same period in 2024, representing a decrease of $5.98 million [168]. - The net loss for the nine months ended September 30, 2025 was $15.9 million, compared to a net loss of $8.5 million in the same period of 2024 [193][194]. - Other income for the three months ended September 30, 2025, was $1.8 million, down from $6.7 million in 2024, a decrease of $4.9 million [175]. Cash and Financing - As of September 30, 2025, the company had an accumulated deficit of $60.2 million and $8.6 million in cash and cash equivalents, raising concerns about its ability to continue as a going concern [148]. - The company had $8.6 million in cash and cash equivalents, with significant reliance on financing from stock issuances and convertible notes [178]. - The company entered into a Securities Purchase Agreement resulting in net proceeds of $4.9 million from the issuance of Series A Convertible Preferred Stock [179]. - The company has an at-the-market offering program with a potential aggregate offering price of up to $13.3 million, having sold 385,851 shares at an average price of $5.96, resulting in net proceeds of $2.2 million [181]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $16.9 million, an increase of 107.0% from $8.2 million in 2024 [195][196]. - The financing activities in 2025 included $4.9 million from the issuance of common stock to Juvenescence and $4.9 million from a securities purchase agreement [195]. Research and Development - The company expects to incur substantial expenditures for the development of its product candidates and anticipates that research and development expenses will continue to increase significantly [149]. - The company has not yet had any products approved for sale and does not expect to generate product sales until regulatory approval is obtained for its product candidates [150]. - The company announced a clinical hold on its IND application for SER-252, its lead development program for advanced Parkinson's disease, due to the FDA's request for additional information [162]. - The company plans to advance SER 252 into Phase I clinical trials and further invest in its pipeline, including hiring additional personnel to support development efforts [155]. - Research and development expenses are expected to increase substantially as the company continues to invest in clinical trials and other development activities [158]. - Research and development expenses increased to $3.6 million for the three months ended September 30, 2025, up from $2.4 million in 2024, marking a $1.2 million increase [170]. Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $17.9 million, compared to $11.6 million for the same period in 2024, an increase of $6.4 million [174]. - General and administrative expenses are projected to rise over the next several years to support ongoing research and development, manufacturing activities, and compliance with public company regulations [164]. - General and administrative expenses decreased to $2.7 million for the three months ended September 30, 2025, from $2.9 million in 2024, a net decrease of $0.2 million [173]. Risks and Uncertainties - The company faces numerous risks and uncertainties in product development, including the potential need for additional clinical trials and the unpredictability of regulatory approvals [162]. - The accumulated deficit as of September 30, 2025, was $60.2 million, raising substantial doubt about the company's ability to continue as a going concern [186].
Serina Therapeutics Provides Regulatory Update on SER-252 Program
Globenewswire· 2025-11-03 11:05
Core Viewpoint - Serina Therapeutics has announced that the FDA has placed a clinical hold on its IND application for SER-252, a treatment for advanced Parkinson's disease, due to requests for additional information regarding an excipient in the formulation, not related to the active drug substance or its mechanism of action [1][2][3] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases using its proprietary POZ Platform technology [8] - The company is headquartered in Huntsville, Alabama, and aims to improve the efficacy and safety profiles of various therapeutic modalities [8] SER-252 Development - SER-252 is an investigational apomorphine therapy designed for continuous dopaminergic stimulation via subcutaneous injection, targeting motor fluctuations in advanced Parkinson's patients [6] - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial aimed at evaluating the safety, tolerability, and pharmacokinetics of SER-252 [5] FDA Interaction - The FDA has indicated prior support for Serina's development approach for SER-252 under a 505(b)(2) NDA pathway, and the company expects to receive a formal clinical-hold letter within 30 days [2][3] - The CEO of Serina expressed confidence in the potential of SER-252 and the company's commitment to addressing the FDA's feedback promptly [3] Broader Pipeline - In addition to SER-252, Serina is advancing its POZ Platform-based pipeline, which includes SER-270, a once-weekly injectable therapy for tardive dyskinesia [4]
Serina Therapeutics Launches Enhanced Corporate Communications Platform to Strengthen Engagement with Patients, Clinicians, and Investors
Globenewswire· 2025-10-08 15:00
Core Insights - Serina Therapeutics has launched a comprehensive corporate communications platform aimed at providing timely and transparent updates to various stakeholders including patients, clinicians, investors, and the scientific community [1][2]. Communication Initiative - The new platform enhances Serina's communication channels, offering clear and accessible information regarding the company's programs, regulatory progress, and scientific advancements [2]. - It will include regular digital updates, educational resources, multimedia content, and expert commentary from company leadership and scientific advisors [2][8]. Leadership Perspective - The CEO of Serina emphasizes the importance of clear communication in biotechnology, especially as the company prepares to initiate the trial of SER-252 for Parkinson's disease [3]. - The platform is intended to be a vital resource for stakeholders, ensuring they can follow the company's progress in developing new treatment options [3][4]. SER-252 Study Overview - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial designed to evaluate the safety, tolerability, and pharmacokinetics of SER-252 in adults with Parkinson's disease [5]. - The study will involve multiple cohorts and will be conducted across sites in the U.S. and Australia [5]. SER-252 Drug Profile - SER-252 is an investigational apomorphine therapy developed using Serina's POZ platform, aimed at providing continuous dopaminergic stimulation through subcutaneous injections [6]. - This therapy is designed to reduce motor fluctuations in advanced Parkinson's patients, enhancing patient comfort and convenience through a wearable drug delivery platform [6]. Company Background - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications [7]. - The company's POZ Platform aims to improve the efficacy and safety profiles of various therapeutic modalities [7].
Serina Therapeutics Draws First $5 Million Funding Tranche to Support Registrational Trial of SER-252 in Parkinson's Disease
Globenewswire· 2025-10-06 20:15
Core Insights - Serina Therapeutics has drawn down the first $5 million tranche from a financing agreement that allows for up to $20 million in funding based on achieving specific development milestones [1][2] - The funds will be utilized to advance the registrational trial of SER-252, aimed at treating advanced Parkinson's disease [1][3] Financing and Milestones - The initial $5 million tranche was received as per the financing agreement, with future tranches contingent on meeting defined development milestones, including patient enrollment in the clinical trial [2] - The financing milestone is crucial for progressing SER-252 into the planned registrational trial, addressing the unmet needs of advanced Parkinson's disease patients [3] Clinical Trial Details - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial, consisting of single-ascending-dose and multiple-ascending-dose components, involving a total of 88 participants [4] - The study aims to evaluate the safety, tolerability, and pharmacokinetics of SER-252 compared to placebo, with exploratory efficacy measures including MDS-UPDRS motor scores [4] Product Overview - SER-252 is an investigational apomorphine therapy developed using Serina's POZ platform, designed for continuous dopaminergic stimulation via subcutaneous injection [5] - The therapy aims to reduce motor fluctuations and improve daily on time for patients with advanced Parkinson's disease, utilizing Enable Injections' enFuse wearable drug delivery platform for enhanced patient comfort [5] Company Background - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications, leveraging its POZ Platform for improved efficacy and safety profiles [6] - The company is headquartered in Huntsville, Alabama, and is positioned on the campus of the HudsonAlpha Institute of Biotechnology [6]
Serina Therapeutics Secures Up to $20 Million to Advance Registrational Trial of SER-252 in Parkinson's Disease
Globenewswire· 2025-09-09 19:20
Core Viewpoint - Serina Therapeutics has secured an agreement for up to $20 million in financing to advance its lead candidate SER-252 for advanced Parkinson's disease, with the potential for additional funds through warrants [1][2][4]. Financing Details - The financing consists of an unsecured convertible note issued in five tranches, tied to clinical and operational milestones [2][7]. - Each tranche drawn carries 100% warrant coverage, with warrants priced at $5.44, which is 105% of the closing stock price on September 8, 2025 [3][7]. - The financing structure allows for capital deployment in alignment with trial progress, maintaining flexibility for additional funding [2][4]. Clinical Development Plans - Serina plans to submit a U.S. IND application in Q4 2025, incorporating FDA recommendations, and begin patient dosing in Australia in the same quarter [5]. - Following U.S. IND clearance, enrollment in the U.S. is anticipated to start in Q1 2026 [5]. - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial designed to evaluate safety, tolerability, and pharmacokinetics [6][8]. Product Overview - SER-252 is an investigational apomorphine therapy designed for continuous dopaminergic stimulation via subcutaneous injection, aimed at reducing motor fluctuations in advanced Parkinson's patients [9]. - The therapy leverages the enFuse™ wearable drug delivery platform to enhance patient comfort and convenience [9]. - Serina's proprietary POZ Platform™ technology aims to improve drug delivery and stability, potentially applicable across various therapeutic areas [10][11].
Serina Therapeutics Announces FDA Feedback Supports Registrational Trial Design of SER-252 in Advanced Parkinson's Disease under 505(b)(2) NDA Pathway
Globenewswire· 2025-08-25 20:15
Core Insights - Serina Therapeutics is advancing SER-252 (POZ-apomorphine) for advanced Parkinson's disease under the 505(b)(2) NDA pathway, with U.S. IND filing planned for Q4 2025 and patient dosing in Australia expected to start in the same quarter [1][4] Company Developments - The FDA's feedback supports the registrational study program for SER-252, indicating that the initial study may be part of a registrational trial program [2][4] - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial designed to evaluate safety, tolerability, and pharmacokinetics of SER-252 versus placebo [5] Product Information - SER-252 is designed to provide continuous dopaminergic stimulation via subcutaneous injection, aiming to reduce motor fluctuations in advanced Parkinson's patients [6] - The POZ platform technology enhances drug delivery by providing greater control in drug loading and release rates, potentially improving the efficacy and safety profile of various therapeutic agents [7][8] Future Plans - Serina plans to initiate U.S. enrollment in Q1 2026 following IND clearance, with data from Australian patients contributing to the overall regulatory review package [4] - The company aims to advance a pipeline of POZ-enabled small molecules that may follow similar regulatory pathways [3]
Serina Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Highlights
GlobeNewswire News Room· 2025-08-11 20:30
Core Viewpoint - Serina Therapeutics is advancing its lead candidate SER-252 for advanced Parkinson's disease and has reported financial results for Q2 2025, highlighting growth in revenues and increased operating expenses due to R&D investments and administrative costs [1][3][4]. Financial Performance - Revenues for Q2 2025 were $130 thousand, up from $51 thousand in Q2 2024, entirely from NIH grant revenues [3]. - Operating expenses increased to $5.7 million in Q2 2025 from $3.9 million in Q2 2024 [3]. - R&D expenses rose to $3.2 million in Q2 2025, compared to $1.6 million in Q2 2024, driven by higher outside research services and increased headcount [4]. - General and administrative expenses were $2.5 million in Q2 2025, slightly up from $2.3 million in Q2 2024, mainly due to stock-based compensation and financial consulting expenses [5]. - The net loss for Q2 2025 was $6.4 million, or $(0.66) per share, compared to a net income of $5.2 million in Q2 2024 [8][22]. Liquidity and Funding - Cash and cash equivalents totaled $6.0 million as of June 30, 2025, projected to fund operations into Q4 2025 [9]. - In April 2025, Serina secured $5 million from strategic shareholders for the development of SER-252 and entered into a Capital on Demand™ Sales Agreement for an at-the-market offering program of $13.3 million [6]. Product Development - SER-252 is designed to provide continuous dopaminergic stimulation for Parkinson's disease and is expected to enter clinical trials in Q4 2025 [13]. - SER-270, a once-weekly injectable therapy for tardive dyskinesia, has been advanced, addressing unmet needs in treatment adherence [6][14]. Management and Board Updates - Dr. Stephen Brannan was appointed to the Board of Directors, bringing extensive experience in neuroscience and drug development [6].
Serina Therapeutics, Inc.(SER) - 2025 Q2 - Quarterly Results
2025-08-11 20:10
[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) Serina Therapeutics reported **Q2 2025** results, highlighting clinical program advancements for **SER-252** and **SER-270**, supported by the **POZ Platform** and strategic financing [Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) Serina Therapeutics announced its **Q2 2025** financial results, highlighting significant progress in its clinical development programs, particularly for **SER-252** for Parkinson's disease and the advancement of **SER-270** for tardive dyskinesia, both leveraging its proprietary **POZ Platform** - Serina Therapeutics reported **Q2 2025** financial results and business highlights, emphasizing progress in its clinical programs for **SER-252** and **SER-270**, enabled by the **POZ Platform**[1](index=1&type=chunk)[2](index=2&type=chunk) - CEO Steve Ledger highlighted the momentum in development programs, with **SER-252** on track for clinic entry later this year and **SER-270** advancing for tardive dyskinesia, demonstrating the **POZ Platform**'s ability to create differentiated, long-acting therapies for neurological conditions with high unmet needs[2](index=2&type=chunk) [Key Business Highlights](index=1&type=section&id=Key%20Business%20Highlights) Serina Therapeutics achieved several key milestones in **Q2 2025** and shortly thereafter, including advancing **SER-270** for tardive dyskinesia, appointing a new board member with extensive neuroscience experience, securing **$5 million** in funding for **SER-252**, and initiating an "at-the-market" (ATM) offering program [Advancement of SER-270 for Tardive Dyskinesia](index=1&type=section&id=Advancement%20of%20SER-270%20for%20Tardive%20Dyskinesia) Serina advanced **SER-270**, a once-weekly injectable for tardive dyskinesia, also exploring its potential for Huntington's disease chorea - In **July 2025**, Serina advanced **SER-270** (**POZ-VMAT2i**), a once-weekly injectable therapy for tardive dyskinesia, designed to address unmet needs in TD treatment, particularly for institutional use and adherence challenges[4](index=4&type=chunk) - **SER-270** is also being considered for evaluation in Huntington's disease chorea, an indication with high need and limited long-acting injectable options[4](index=4&type=chunk) [Board Appointments](index=1&type=section&id=Board%20Appointments) Stephen Brannan, M.D., a neuroscience and neuropsychiatry drug development expert, joined Serina's Board of Directors in **May 2025** - Stephen (Steve) Brannan, M.D., with over three decades of experience in neuroscience and neuropsychiatry drug development, was appointed to Serina's Board of Directors in **May 2025**[4](index=4&type=chunk) - Dr. Brannan's experience includes leading clinical programs from early development through regulatory approval and commercialization, notably at Karuna Therapeutics where he led the clinical strategy for KarXT, contributing to Karuna's **$14 billion** acquisition[4](index=4&type=chunk) [Funding and Financing Activities](index=1&type=section&id=Funding%20and%20Financing%20Activities) Serina secured **$5 million** in funding for **SER-252** development and initiated an "at-the-market" offering program for up to **$13.3 million** in common stock - Serina secured **$5 million** in funding from strategic shareholders in **April 2025** to support the continued development of **SER-252**, its lead clinical candidate for Advanced Parkinson's disease, ahead of a planned Phase 1 clinical trial in **Q4 2025**[4](index=4&type=chunk) - In **April 2025**, Serina entered an ATM offering program to sell up to **$13.3 million** of common stock, and as of August 8, **2025**, had issued **199,562 shares** at an average price of **$5.95**, generating **$1.2 million** in net proceeds[4](index=4&type=chunk) [Second Quarter 2025 Financial Performance](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Serina Therapeutics reported increased revenues but significantly higher operating expenses, leading to a net loss for **Q2 2025** [Operating Results Summary](index=1&type=section&id=Operating%20Results%20Summary) Serina Therapeutics reported increased revenues for **Q2 2025**, primarily from grant revenues, but also saw a significant rise in operating expenses, leading to a higher operating loss compared to the same period in **2024** Q2 2025 vs Q2 2024 Operating Results (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :------------------ | :------ | :------ | :----------- | | Revenues | $130 | $51 | +$79 | | Operating Expenses | $5,695 | $3,917 | +$1,778 | | Loss from Operations| $(5,565)| $(3,866)| $(1,699) | - Revenues were entirely comprised of grant revenues from the **National Institutes of Health**[3](index=3&type=chunk) [Detailed Operating Expenses](index=2&type=section&id=Detailed%20Operating%20Expenses) Both Research and Development (R&D) and General and Administrative (G&A) expenses increased significantly in **Q2 2025** compared to **Q2 2024**, driven by increased research services, headcount, stock-based compensation, and financial consulting, partially offset by decreases in patent maintenance and legal fees [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D expenses increased significantly in **Q2 2025** due to higher outside research services, consultant spend, and increased headcount, partially offset by reduced patent maintenance R&D Expenses (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :------------------ | :------ | :------ | :----------- | | R&D Expenses | $3,152 | $1,594 | +$1,558 | - The increase was primarily driven by increases in outside research services, consultant spend for research programs, and an increase in salaries, payroll-related expenses, and stock-based compensation due to increased headcount[5](index=5&type=chunk) - These increases were partially offset by decreases in professional fees for patent and intellectual property maintenance and severance-related costs[5](index=5&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) G&A expenses rose in **Q2 2025** primarily due to increased stock-based compensation and financial consulting, partially offset by lower legal fees G&A Expenses (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :------------------ | :------ | :------ | :----------- | | G&A Expenses | $2,543 | $2,323 | +$220 | - The increase was primarily due to increases in stock-based compensation expenses from new option grants and financial consulting expenses related to new platforms and software[6](index=6&type=chunk) - These increases were partially offset by a decrease in legal fees following the conclusion of post-merger compliance and reporting activities[6](index=6&type=chunk) [Other (Expense) Income, Net](index=2&type=section&id=Other%20(Expense)%20Income,%20Net) Serina reported a net other expense of **$0.9 million** in **Q2 2025**, a significant shift from a **$9.0 million** net income in **Q2 2024**, primarily due to a **$10.3 million** change in the fair value of liability classified warrants Other (Expense) Income, Net (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--------------------------------- | :------ | :------ | :----------- | | Total other (expense) income, net | $(897) | $9,043 | $(9,940) | | Change in fair value of warrants | $(956) | $9,294 | $(10,250) | - The **$9.9 million** increase in expenses was primarily attributable to a **$10.3 million** change in the fair value of liability classified warrants, partially offset by a **$0.3 million** decrease in interest expense[7](index=7&type=chunk) [Net (Loss) Income](index=2&type=section&id=Net%20(Loss)%20Income) Serina Therapeutics reported a net loss of **$6.4 million**, or **$(0.66)** per basic and diluted share, for **Q2 2025**, a significant decline from a net income of **$5.2 million**, or **$0.61** per basic share, in **Q2 2024** Net (Loss) Income (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--------------------------------- | :------ | :------ | :----------- | | Net (Loss) Income attributable to Serina | $(6,448)| $5,204 | $(11,652) | | Basic EPS | $(0.66) | $0.61 | $(1.27) | | Diluted EPS | $(0.66) | $0.51 | $(1.17) | [Liquidity and Financial Position](index=2&type=section&id=Liquidity%20and%20Financial%20Position) Serina Therapeutics held **$6.0 million** in cash and cash equivalents as of **June 30, 2025**, projected to fund operations into the **fourth quarter of 2025** [Liquidity Information](index=2&type=section&id=Liquidity%20Information) As of **June 30, 2025**, Serina Therapeutics had **$6.0 million** in cash and cash equivalents and projects this to fund operations into the **fourth quarter of 2025** Cash and Cash Equivalents (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :---------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $6,041 | $3,672 | +$2,369| - The Company projects its cash and cash equivalents as of **June 30, 2025**, to fund operations into the **fourth quarter of 2025**[10](index=10&type=chunk) [Company and Platform Overview](index=2&type=section&id=Company%20and%20Platform%20Overview) Serina Therapeutics is a clinical-stage biotechnology company developing drug candidates for neurological diseases using its proprietary **POZ Platform** [About Serina Therapeutics](index=2&type=section&id=About%20Serina%20Therapeutics) Serina Therapeutics is a clinical-stage biotechnology company based in Huntsville, Alabama, focused on developing a pipeline of wholly-owned drug candidates for neurological diseases and other indications, utilizing its proprietary **POZ Platform** - Serina Therapeutics is a clinical-stage biotechnology company developing a pipeline of wholly-owned drug product candidates to treat neurological diseases and other indications[11](index=11&type=chunk) - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology[11](index=11&type=chunk) [About the POZ Platform™](index=2&type=section&id=About%20the%20POZ%20Platform%E2%84%A2) Serina's proprietary **POZ Platform**, based on poly(2-oxazoline), is designed to optimize drug delivery by providing greater control in drug loading and precision in release rates for subcutaneous injections, aiming to improve efficacy and safety profiles of various therapeutic modalities. The platform has potential for broad applications, including a non-exclusive license agreement with Pfizer for LNP drug delivery - Serina's **POZ technology** uses a synthetic, water-soluble, low-viscosity polymer called poly(2-oxazoline) to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection[12](index=12&type=chunk) - The platform aims to improve the integrated efficacy and safety profile of multiple modalities, including small molecules, RNA-based therapeutics, and antibody-based drug conjugates (ADCs), by maintaining more desirable and stable drug levels in the blood[11](index=11&type=chunk)[12](index=12&type=chunk) - Serina intends to advance additional applications of the **POZ Platform** through out-licensing, co-development, or other partnerships, including a non-exclusive license agreement with Pfizer, Inc. for use in lipid nanoparticle drug (LNP) delivery formulations[13](index=13&type=chunk) [Pipeline Candidates](index=2&type=section&id=Pipeline%20Candidates) Serina is advancing **SER-252** for advanced Parkinson's disease and **SER-270** for tardive dyskinesia, both utilizing its **POZ Platform** for improved drug delivery [About SER-252 (POZ-apomorphine)](index=2&type=section&id=About%20SER-252%20(POZ-apomorphine)) **SER-252** (**POZ-apomorphine**) is an investigational therapy for advanced Parkinson's disease, designed to provide continuous dopaminergic stimulation and reduce motor complications - **SER-252** (**POZ-apomorphine**) is an investigational therapy designed to provide continuous dopaminergic stimulation (CDS) for advanced Parkinson's disease, which has been shown to reduce the severity of levodopa-related motor complications[14](index=14&type=chunk) - Preclinical studies indicate **SER-252**'s potential to provide CDS without skin reactions, and Serina plans to advance it to clinical testing in **2025**[14](index=14&type=chunk) [About SER-270 (POZ-VMAT2i)](index=3&type=section&id=About%20SER-270%20(POZ-VMAT2i)) **SER-270** (**POZ-VMAT2i**) is an investigational once-weekly VMAT2 inhibitor developed with the **POZ Platform** to address adherence and access challenges in tardive dyskinesia - **SER-270** (**POZ-VMAT2i**) is an investigational once-weekly VMAT2 inhibitor developed with the **POZ Platform** to address adherence and access challenges in tardive dyskinesia (TD)[15](index=15&type=chunk) - The subcutaneous formulation is designed for patients on long-acting injectable antipsychotics, those with dysphagia, and institutionalized populations, and Serina is also exploring its development for Huntington's disease chorea[16](index=16&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents Serina Therapeutics' condensed consolidated balance sheets, statements of operations, and statements of cash flows for the reported periods [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Serina Therapeutics' balance sheet as of **June 30, 2025**, shows an increase in total assets and liabilities compared to **December 31, 2024**, with a notable increase in cash and cash equivalents and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :-------------- | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $6,041 | $3,672 | | Total current assets | $7,991 | $5,676 | | TOTAL ASSETS | $8,941 | $6,724 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $3,561 | $2,366 | | Warrant liability | $3,549 | $3,582 | | TOTAL LIABILITIES | $7,295 | $6,216 | | Total stockholders' equity | $1,646 | $508 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $8,941 | $6,724 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three and six months ended **June 30, 2025**, Serina Therapeutics reported increased revenues but also significantly higher operating expenses, leading to a net loss for both periods, contrasting with a net income in the prior year's three-month period Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Grant revenues | $130 | $51 | $130 | $56 | | Total operating expenses | $5,695 | $3,917 | $11,553 | $6,243 | | Loss from operations | $(5,565) | $(3,866) | $(11,423) | $(6,187) | | Total other (expense) income, net | $(897) | $9,043 | $139 | $(3,651) | | NET (LOSS) INCOME attributable to Serina | $(6,448) | $5,204 | $(11,261) | $(9,811) | | Basic EPS | $(0.66) | $0.61 | $(1.15) | $(1.74) | | Diluted EPS | $(0.66) | $0.51 | $(1.15) | $(1.74) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended **June 30, 2025**, Serina Therapeutics experienced a net cash outflow from operating activities but a significant net cash inflow from financing activities, resulting in a positive net change in cash and cash equivalents, increasing its cash balance compared to the beginning of the period Condensed Consolidated Statements of Cash Flows (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(8,072) | $(9,586) | | Net cash used in investing activities | $(46) | $(14) | | Net cash provided by financing activities | $10,487 | $8,095 | | NET CHANGE IN CASH AND CASH EQUIVALENTS | $2,369 | $(1,505) | | Cash and cash equivalents at end of period | $6,041 | $6,114 | [Additional Information](index=3&type=section&id=Additional%20Information) This section provides important disclosures regarding forward-looking statements and contact information for investor inquiries [Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) This section advises readers that the release contains forward-looking statements subject to substantial risks and uncertainties, including those related to R&D, clinical trials, regulatory approvals, and financing. Actual results may differ materially, and Serina disclaims any obligation to update these statements - The release contains forward-looking statements regarding future plans, beliefs, and forecasts, which are subject to substantial risks and uncertainties that could cause actual results to differ materially[19](index=19&type=chunk) - Risks include uncertainties inherent in research and development, ability to meet clinical endpoints, regulatory approval processes, Serina's ability to continue as a going concern, and competitive developments[19](index=19&type=chunk) - Serina disclaims any intent or obligation to update these forward-looking statements, which speak only as of the date they are made[19](index=19&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) Provides contact details for investor inquiries, specifically Stefan Riley, with an email address and phone number - For inquiries, contact Stefan Riley at sriley@serinatherapeutics.com or (256) 327-9630[20](index=20&type=chunk)