Part I – FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's net loss increased to $11.3 million in H1 2025, with a going concern qualification issued due to insufficient funding Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | 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 & Equity** | | | | Total current liabilities | $3,561 | $2,366 | | 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 Highlights (in thousands, except per share data) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $130 | $56 | | Research and development | $6,103 | $2,700 | | General and administrative | $5,450 | $3,543 | | Loss from operations | $(11,423) | $(6,187) | | NET LOSS | $(11,284) | $(9,838) | | NET LOSS PER COMMON SHARE (BASIC & DILUTED) | $(1.15) | $(1.74) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six months ended June 30, 2025 | Six 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) | - Management has concluded there is **substantial doubt about the Company's ability to continue as a going concern**, as cash and cash equivalents of **$6.0 million** are not expected to be sufficient to fund operations for the next twelve months[35](index=35&type=chunk)[37](index=37&type=chunk) [Note 1. Organization, Business Overview and Liquidity](index=11&type=section&id=Note%201.%20Organization%2C%20Business%20Overview%20and%20Liquidity) Serina is a clinical-stage biotechnology company that faces substantial doubt about its ability to continue as a going concern due to significant operating losses - The company's **POZ drug delivery technology** is designed to improve the efficacy and safety of existing drugs by enabling greater control in drug loading and precision in the rate of release[29](index=29&type=chunk) - On March 26, 2024, the company completed a **reverse merger** with AgeX Therapeutics, Inc, with Legacy Serina surviving as the primary business[27](index=27&type=chunk)[28](index=28&type=chunk) - The company's financial condition, including a **net loss of $11.3 million** for the six months ended June 30, 2025, and cash usage of **$8.1 million** in operating activities, has led to a going concern warning[34](index=34&type=chunk)[35](index=35&type=chunk) [Note 7. Stockholders' Equity](index=19&type=section&id=Note%207.%20Stockholders'%20Equity) The company raised capital through a $4.9 million private placement of preferred stock and initiated a $13.3 million At-the-Market (ATM) offering - On April 8, 2025, the company raised net proceeds of **$4.9 million** from a private placement of 965,250 shares of Series A Convertible Preferred Stock at $5.18 per share[79](index=79&type=chunk) - On April 25, 2025, the company initiated an At-the-Market (ATM) offering to sell up to **$13.3 million** of its common stock; as of June 30, 2025, it had sold 124,454 shares for net proceeds of **$0.6 million**[91](index=91&type=chunk) - The company has several classes of warrants outstanding, including Post-Merger Warrants and Incentive Warrants, which are classified as liabilities and subject to fair value adjustments[83](index=83&type=chunk)[86](index=86&type=chunk)[88](index=88&type=chunk) [Note 11. Commitments and Contingencies](index=22&type=section&id=Note%2011.%20Commitments%20and%20Contingencies) The company's commitments include operating leases totaling $0.4 million and a $2.0 million partnership with Enable Injections, Inc - In May 2024, the company partnered with Enable Injections, Inc to develop and commercialize SER-252 (POZ-apomorphine) for Parkinson's disease, paying **$2.0 million** for the arrangement[113](index=113&type=chunk) - The company leases its lab and office facilities under non-cancelable operating lease agreements expiring between October 2025 and January 2028[103](index=103&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Operating expenses increased significantly, and the company's cash position of $6.0 million is insufficient to fund operations for the next year Comparison of Operating Results (in thousands) | Period | Research & Development | General & Administrative | Loss from Operations | | :--- | :--- | :--- | :--- | | **Three months ended June 30, 2025** | $3,152 | $2,543 | $(5,565) | | **Three months ended June 30, 2024** | $1,594 | $2,323 | $(3,866) | | **Six months ended June 30, 2025** | $6,103 | $5,450 | $(11,423) | | **Six months ended June 30, 2024** | $2,700 | $3,543 | $(6,187) | - The increase in R&D expenses for H1 2025 was primarily due to a **$1.8 million increase in outside research services** and a **$1.3 million increase in salaries** and related costs from higher headcount[150](index=150&type=chunk)[151](index=151&type=chunk) - The increase in G&A expenses for H1 2025 was driven by a **$1.2 million increase in salaries and stock-based compensation** and a **$0.8 million increase in consulting fees** for finance functions[153](index=153&type=chunk) - The company's cash on hand of **$6.0 million is not sufficient** to fund operations for the next twelve months, necessitating additional capital raising to avoid curtailing planned operations[162](index=162&type=chunk)[165](index=165&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Serina Therapeutics, Inc is not required to provide the information for this item - The company is not required to provide quantitative and qualitative disclosures about market risk because it qualifies as a **smaller reporting company**[174](index=174&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were not effective as of June 30, 2025, due to several material weaknesses - Management determined that **disclosure controls and procedures were not effective** as of June 30, 2025[175](index=175&type=chunk) - Identified **material weaknesses** include insufficient qualified accounting personnel, lack of segregation of duties, reliance on manual reporting processes, and lack of experience in monitoring internal controls[178](index=178&type=chunk) - The company has begun a **remediation plan**, which includes hiring professionals with public company accounting experience and implementing enhanced processes and system automation[180](index=180&type=chunk)[184](index=184&type=chunk) Part II – OTHER INFORMATION [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) As of the reporting date, the company is not a party to any material legal proceedings - The company is **not currently involved in any material legal proceedings**[186](index=186&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) Key risks include potential stock price decline from the ATM offering and unpredictable FDA regulatory approval timelines - Sales of a substantial number of shares under the **$13.3 million ATM offering** could cause the company's stock price to decline[187](index=187&type=chunk) - The company faces risks from the inherently unpredictable and lengthy **FDA regulatory approval process**, which could be impacted by external factors like government agency disruptions[188](index=188&type=chunk)[189](index=189&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Information regarding unregistered sales of equity securities has been previously reported - This item was **previously reported**[190](index=190&type=chunk) [Other Information](index=41&type=section&id=Item%205.%20Other%20Information) During the second quarter of 2025, none of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement - No directors or officers adopted or terminated a **Rule 10b5-1 trading plan** during the three months ended June 30, 2025[193](index=193&type=chunk) [Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications and agreements related to recent securities purchases - A list of exhibits filed with the report is provided, including the Certificate of Designations for the Series A Preferred Stock and the associated Securities Purchase Agreement[194](index=194&type=chunk)

Group 1 - The article does not provide any specific company or industry insights, focusing instead on the author's qualifications and disclosures [1][2][3]

Core Insights - Serina Therapeutics is advancing SER-270, a novel once-weekly injectable VMAT2 inhibitor aimed at treating tardive dyskinesia (TD), addressing significant adherence and access challenges for patients [1][2][3] Group 1: Product Development - SER-270 utilizes Serina's proprietary POZ polymer technology for long-acting, subcutaneous administration, providing a transformative alternative to existing oral VMAT2 inhibitors [2] - The product is designed specifically for underserved TD patients who struggle with daily medication adherence, including those on long-acting injectable antipsychotics [2][7] Group 2: Market Opportunity - TD is a disabling movement disorder primarily affecting patients with chronic psychiatric conditions, with less than 30% of U.S. TD patients diagnosed and fewer than half receiving treatment [3] - The U.S. TD market exceeded $3.7 billion in sales in 2024 and is projected to grow to $5.4 billion by 2030, highlighting the demand for therapies that improve adherence and access [3] Group 3: Expansion Plans - Serina plans to explore the development of POZ-VMAT2i for chorea associated with Huntington's disease, which may offer significant advantages over current oral therapies for affected patients and caregivers [5][6] Group 4: Patient-Centric Approach - The once-weekly injectable format is critical for non-compliant patients, including those in institutional settings and those with dysphagia, thereby improving access to treatment [7]

Core Insights - Serina Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications using its proprietary POZ Platform™ technology [2] Company Overview - Serina Therapeutics is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [2] - The company is developing a pipeline of wholly owned drug product candidates aimed at improving the efficacy and safety profiles of various therapeutic modalities, including small molecules, RNA-based therapeutics, and antibody-drug conjugates (ADCs) [2] Upcoming Events - Steve Ledger, the CEO of Serina, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference scheduled for July 29-30, 2025, with his discussion set for July 29, 2025, at 2:00 p.m. ET [1]

Core Insights - Serina Therapeutics, Inc. is advancing its lead IND candidate SER-252 for advanced Parkinson's disease using its proprietary POZ Platform drug optimization technology [1][4] - The company granted options to purchase 12,500 shares of common stock to a new non-executive employee as an inducement for employment [1][2] - The exercise price for the options is set at the closing price of Serina's common stock on the date of the grant [2] Company Overview - Serina is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications [4] - The POZ Platform aims to enhance the efficacy and safety profiles of various therapeutic modalities, including small molecules, RNA-based therapeutics, and antibody-drug conjugates [4] - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [4]

Core Points - Serina Therapeutics, Inc. has scheduled its 2025 annual meeting of stockholders for November 7, 2025 [1] - The deadline for stockholder proposals under Rule 14a-8 is set for August 15, 2025, due to the change in the meeting date [2] - Stockholder proposals and director nominations must be submitted in writing between July 10, 2025, and August 9, 2025, to be considered timely [3] Company Overview - Serina is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications [4] - The company utilizes its POZ Platform to enhance the efficacy and safety profiles of various therapeutic modalities, including small molecules and RNA-based therapeutics [4] - Serina is headquartered in Huntsville, Alabama, at the HudsonAlpha Institute of Biotechnology [4]

Core Insights - Serina Therapeutics, Inc. is set to present its innovative drug optimization technology at a webinar focused on Parkinson's care, highlighting the limitations of current treatments and the potential of its proprietary drug candidate SER-252 [1][2][3] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company developing drug candidates aimed at treating neurological diseases and other indications, utilizing its proprietary POZ Platform for drug optimization [5] - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [5] Product and Technology - SER-252 is a polymer conjugate of apomorphine designed to provide continuous dopaminergic stimulation (CDS), aiming for smoother and longer-lasting symptom control for Parkinson's patients [2] - The POZ Platform is a next-generation drug optimization system that has the potential to enhance the safety, duration, and tolerability of various therapeutics, including small molecules and RNA-based therapeutics [2][5] Event Details - The webinar titled "New Drug Optimization Platform to Transform Parkinson's Care" will take place on June 26, 2025, featuring a presentation by CEO Steve Ledger and a Q&A session for attendees [1][3]

Core Insights - Serina Therapeutics, Inc. has announced a strategic partnership with Juvenescence Ltd., which has successfully closed the first tranche of a $76 million Series B financing round, targeting a total of $150 million [2][3] - The partnership aims to establish a drug development hub in Abu Dhabi, integrating AI-enabled drug discovery with advanced clinical infrastructure to expedite the development of innovative therapeutics [3][4] - Serina is focused on developing its proprietary POZ Platform™ for drug optimization, targeting neurological diseases and other indications, and is positioned as a core portfolio company of Juvenescence [5][4] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company headquartered in Huntsville, Alabama, specializing in drug candidates for neurological diseases and other conditions [5] - The POZ Platform™ developed by Serina has the potential to enhance the efficacy and safety profiles of various therapeutic modalities, including small molecules and RNA-based therapeutics [5] - Juvenescence, the strategic partner, is an AI-enabled biotech company focused on developing medicines to extend healthy lifespan by targeting aging mechanisms [7][9] Strategic Partnerships - The collaboration between Juvenescence and M42, a global health company based in Abu Dhabi, signifies a commitment to building a leading life-sciences hub and developing a pipeline of innovative therapeutics [4][11] - M42 operates over 480 facilities across 26 countries and employs more than 20,000 people, integrating advanced technologies in healthcare [12]

Core Insights - Serina Therapeutics congratulates its strategic partner Juvenescence Ltd. for securing $150 million in Series B financing led by M42, which will enhance their drug development capabilities [1][2][3] - The partnership aims to establish a drug development hub in Abu Dhabi, integrating AI-enabled drug discovery with advanced clinical infrastructure to expedite the creation of innovative therapies targeting age-related diseases [2][3] - Juvenescence's leadership has a proven track record in biopharma, having previously led significant deals and developed medicines with peak annual sales totaling $30 billion [7][8] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications, utilizing its proprietary POZ Platform to enhance the efficacy and safety of various therapeutic modalities [4] - Juvenescence is an AI-enabled biotech company dedicated to extending healthy lifespan by targeting core aging mechanisms to treat age-related diseases [6][8] - M42, a global health company, combines AI, technology, and genomics to innovate healthcare solutions, operating over 480 facilities across 26 countries [9][11]

Company Overview - Serina Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications using its proprietary POZ Platform™ technology [7] - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [7] Industry Context - The biotechnology sector is currently experiencing a bear market, with approximately 25% of the 700 to 800 publicly traded US biotech companies having negative enterprise values [3] - The upcoming webinar event titled "Is the Beaten Down Biotech Sector the Smartest Bet in Today's Volatile Market?" aims to discuss investment opportunities in this challenging environment [2][3] Event Details - Serina's CEO, Steven A. Ledger, will present at the Tribe Public's Webinar on June 11, 2025, at 8:30 am Pacific / 11:30 am Eastern [2] - Participants can submit questions for the CEO before and during the event, which will be hosted by Tribe Public's Managing Member, John F. Heerdink, Jr. [6]