AgeX Therapeutics(AGE)
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AgeX Therapeutics(AGE) - 2024 Q4 - Annual Results
2025-03-24 20:20
Parkinson's Disease Treatment - SER-252 (POZ-Apomorphine) is projected to address a significant unmet need in the advanced Parkinson's disease market, with a commercial opportunity estimated between $2.1 billion and $3.3 billion[10]. - The lead program SER-252 is expected to enter clinical trials in 2025, focusing on continuous dopaminergic stimulation for advanced Parkinson's disease[4]. - The market for advanced Parkinson's disease treatments is growing at approximately 1.5% per year, with around 210,000 patients in the US and 150,000 in the EU and UK inadequately controlled on oral therapies[18]. - SER-252 aims to provide a differentiated treatment option with a dosing regimen of twice per week via subcutaneous injection, avoiding the need for electronic infusion pumps[10]. - The product development plan includes a Phase 1b trial in advanced Parkinson's disease patients, with interim data expected in the second half of 2026[30]. - Phase 1 trial of SER-252 in Advanced Parkinson's Disease is set to initiate in 3Q 2025, with interim readouts expected in 1Q 2026[47]. - Phase 1b trial for SER-252 in advanced Parkinson's patients is scheduled for 2H 2025, providing early efficacy readout[49]. - The small molecule pipeline includes SER-252 for Advanced Parkinson's and other candidates in CNS and cardiology indications[50]. Drug Development and Partnerships - The partnership with Pfizer in the RNA vaccine field represents a strategic collaboration to enhance the development of RNA-based therapeutics[34]. - The company has a strong history of drug development, with cumulative sales across 32 FDA-approved PEGylated drugs exceeding $25 billion[4]. - The first license deal for RNA products was executed in Q4 2023, indicating a proactive approach to expanding partnerships in the therapeutic landscape[34]. - POZ platform partnerships in RNA and ADCs are anticipated to be established by 2025/26[47]. - Company is exploring partnering opportunities in RNA delivery/targeting and ADC optimization[48]. POZ Platform and Technology - The POZ platform enables optimized drug delivery with reduced immunogenicity and improved safety profiles, addressing limitations of existing biocompatible polymers[7]. - Anticipated regulatory pathway for SER-252 includes a potential 505(b)(2) NDA submission, which could expedite the approval process[10]. - Preclinical data for POZ platform optimization of ADCs is expected in 1Q 2025[47]. - POZ-RNA and POZ-ADCs are under research and development with partners for RNA therapeutics and oncology, respectively[51]. Financial Position - Preliminary cash position at year-end 2024 is projected to be $3.4 million, with recent funding of $10 million extending runway through 1H 2025[48]. - Sale of UniverXome subsidiary in 4Q 2024 eliminates all corporate debt[49]. - Lead IND candidate SER-252 has a peak sales potential of $2.1 billion to $3.3 billion[48].
AgeX Therapeutics(AGE) - 2024 Q4 - Annual Report
2025-03-24 20:14
Part I [Business](index=7&type=section&id=Item%201.%20Business) Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases using its proprietary POZ platform, a polymer drug delivery technology designed to improve the efficacy and safety of small molecules [Overview and POZ Platform](index=7&type=section&id=Overview%20and%20POZ%20Platform) Serina Therapeutics is a clinical-stage biotech company utilizing its proprietary POZ platform to develop treatments for neurological diseases - The company is a clinical-stage biotechnology firm developing a pipeline of wholly-owned drug candidates for neurological and other diseases using its POZ platform[29](index=29&type=chunk) - The POZ platform is designed to improve upon existing polymer delivery technologies like PEG, offering advantages in synthesis, stability, reduced immunogenicity, higher drug loading, programmable release, and no tissue accumulation[31](index=31&type=chunk)[32](index=32&type=chunk)[36](index=36&type=chunk) [Development Pipeline and Strategy](index=8&type=section&id=Development%20Pipeline%20and%20Strategy) The company's strategy centers on developing polymer therapeutics using its POZ platform, with a primary focus on advancing its lead program, SER-252, for late-stage Parkinson's disease Development Pipeline | Drug Candidate | Indication | Research | Preclinical | Phase 1 | Phase 2 | Phase 3 | | --- | --- | --- | --- | --- | --- | --- | | SER-252 (POZ-apomorphine) | Advanced Parkinson's | IND-enabling studies | | | | | | SER-2xx (POZ-undisclosed) | CNS | Proof of concept | | | | | | SER-2xx (POZ-undisclosed) | Cardiology | Proof of concept | | | | | | POZ-RNA | RNA therapeutics | R&D with partners | | | | | | POZ-ADCs | Oncology | Proof of concept | | | | | - The company's core strategy includes advancing the lead program SER-252, seeking partnerships for POZ LNP and ADC applications, expanding the POZ platform's use, and building a network of collaborations[40](index=40&type=chunk) [Product Candidates](index=10&type=section&id=Product%20Candidates) Serina's pipeline is led by SER-252 (POZ-apomorphine) for advanced Parkinson's disease, currently in IND-enabling preclinical studies with Phase I trials planned for the second half of 2025 - SER-252 (POZ-apomorphine) is the lead product candidate for advanced Parkinson's disease, with IND-enabling preclinical studies initiated in August 2023 and expected to complete in Q2 2025. Phase I clinical trials are planned for H2 2025[37](index=37&type=chunk)[48](index=48&type=chunk) - SER-214 (POZ-rotigotine) completed a Phase Ia trial, demonstrating proof-of-principle for the POZ platform by providing continuous drug delivery. However, it is not being advanced internally and the company will seek a partner for further development[46](index=46&type=chunk)[64](index=64&type=chunk) - The company is advancing preclinical research on POZ-lipids as a non-immunogenic alternative to PEG-lipids in LNP formulations for RNA therapeutics and has entered into feasibility studies with two major pharmaceutical companies[48](index=48&type=chunk) [Licensing and Collaboration Agreements](index=18&type=section&id=Licensing%20and%20Collaboration%20Agreements) In October 2023, Serina entered into a significant non-exclusive license agreement with Pfizer for the use of its POZ polymer technology in LNP drug delivery formulations - The company entered into a non-exclusive license agreement with Pfizer in October 2023 for the use of its POZ polymer technology in LNP drug delivery formulations[82](index=82&type=chunk) Pfizer License Agreement Financial Terms | Term | Amount/Rate | | :--- | :--- | | Upfront Payment | $3.0 million (received Dec 15, 2023) | | Milestone Payments | Undisclosed, upon achievement of specific development, regulatory, and commercial milestones | | Royalties on Net Sales | 2.75% – 3.5% (tiered) | [Intellectual Property](index=18&type=section&id=Intellectual%20Property) Serina maintains an extensive intellectual property portfolio crucial to its business, focusing on patent protection for its proprietary POZ technology and product candidates - The company owns an extensive patent estate covering its POZ technology and product candidates, with patent families protecting various forms and applications of the technology[84](index=84&type=chunk)[86](index=86&type=chunk) - The SER 03/07 patent family, expiring in 2029, is particularly broad, covering multifunctional POZ copolymers and their attachment to various molecules including small molecules, proteins, oligonucleotides, and lipids[92](index=92&type=chunk) - The SER-16 patent family, expiring in 2032, specifically covers poly(oxazoline) conjugates of dopamine agonists (including SER-214 and SER-252) for subcutaneous delivery in treating conditions like Parkinson's disease[95](index=95&type=chunk)[96](index=96&type=chunk) - The SER 22 patent family, with patents pending or granted and expiring in 2039, covers cleavable conjugates of catechol compounds, which is relevant to the SER-252 (POZ-apomorphine) program[100](index=100&type=chunk) [Competition](index=23&type=section&id=Competition) Serina faces substantial competition from a wide range of large and specialty pharmaceutical, biopharmaceutical, and biotechnology companies, as well as academic and research institutions - The company faces competition from large pharmaceutical and biotech companies, academic institutions, and other research organizations in the fields of CNS disorders and drug delivery[112](index=112&type=chunk)[113](index=113&type=chunk) - A key competitive technology is PEGylation, a clinically proven drug delivery approach used in over 30 FDA-approved drugs, which is marketed by several companies[114](index=114&type=chunk)[115](index=115&type=chunk) [Government Regulation](index=24&type=section&id=Government%20Regulation) The company's operations are subject to extensive government regulation in the U.S. and other countries, covering drug testing, manufacturing, labeling, and marketing - The FDA drug approval process is extensive, requiring preclinical studies and three phases of clinical trials to establish safety and efficacy before an NDA or BLA can be submitted for review[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) - The company may be eligible for expedited FDA programs such as Fast Track, Breakthrough Therapy, or Accelerated Approval, which are designed to facilitate and speed up the development and review of drugs for serious conditions[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) - Sales and pricing are subject to significant regulation and pressure from third-party payors, including government programs (Medicare, Medicaid, 340B) and private insurers, which are increasingly implementing cost-containment measures[149](index=149&type=chunk)[155](index=155&type=chunk) - The company is also subject to healthcare fraud and abuse laws, such as the Anti-Kickback Statute and the False Claims Act, as well as federal and state "sunshine" provisions requiring disclosure of financial interactions with healthcare providers[158](index=158&type=chunk)[160](index=160&type=chunk) [Human Capital and Facilities](index=33&type=section&id=Human%20Capital%20and%20Facilities) As of December 31, 2024, Serina Therapeutics had thirteen employees and its headquarters is a 7,600 square foot leased facility in Huntsville, Alabama - As of December 31, 2024, the company had **thirteen employees** (twelve full-time, one part-time)[163](index=163&type=chunk) - The company's headquarters is a **7,600 sq. ft. leased facility** in Huntsville, Alabama, with the laboratory space lease expiring in January 2028[164](index=164&type=chunk) [Risk Factors](index=33&type=page&id=Item%201A.%20Risk%20Factors) The company faces significant risks, including a history of operating losses, dependence on additional financing to continue as a going concern, and the early stage of its product candidates - The company has a history of operating losses (**$44.3 million accumulated deficit** as of Dec 31, 2024) and expects them to continue, raising substantial doubt about its ability to continue as a going concern without additional financing[169](index=169&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - All current product candidates are in preclinical development and face a high risk of failure at any stage of development. Success in early trials is not predictive of later-stage results[184](index=184&type=chunk)[185](index=185&type=chunk)[186](index=186&type=chunk) - The company relies on contract manufacturing organizations (CMOs) for clinical supplies and will for commercial supplies, creating risks related to manufacturing compliance (cGMP), supply chain disruptions, and protection of trade secrets[229](index=229&type=chunk)[230](index=230&type=chunk) - Juvenescence Limited owns approximately **40.5%** of the company's common stock and can substantially influence corporate matters, which may create conflicts of interest[387](index=387&type=chunk)[389](index=389&type=chunk) [Unresolved Staff Comments](index=82&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that there are no unresolved staff comments - Not Applicable[390](index=390&type=chunk) [Cybersecurity](index=82&type=section&id=Item%201C.%20Cybersecurity) The company has implemented cybersecurity measures through third-party providers, which are periodically assessed and reported to the Audit Committee - The company utilizes third-party providers for its cybersecurity systems and measures, which are periodically assessed and reported to the Audit Committee[391](index=391&type=chunk) - Serina is not aware of any cybersecurity incidents that have materially affected or are reasonably likely to materially affect its business[392](index=392&type=chunk) [Properties](index=82&type=section&id=Item%202.%20Properties) The company's principal place of business is a leased 7,600 square foot facility in Huntsville, Alabama, containing both office and laboratory space - The company leases approximately **7,600 square feet** of office and laboratory space in Huntsville, Alabama. The laboratory space lease expires on January 31, 2028[393](index=393&type=chunk) [Legal Proceedings](index=82&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, the company is not a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[394](index=394&type=chunk) [Mine Safety Disclosures](index=82&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[395](index=395&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=83&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the NYSE American under the symbol "SER", with Juvenescence providing significant capital through warrant exercises and stock purchases in 2024 - The company's common stock is listed on the NYSE American under the symbol "**SER**"[398](index=398&type=chunk) - In June 2024, Juvenescence exercised warrants to purchase **377,865 shares** for **$5.0 million**[399](index=399&type=chunk) - In November 2024, Juvenescence entered into a stock purchase agreement to buy **1,000,000 shares** for **$10.0 million**, paid in two tranches (November 2024 and January 2025)[400](index=400&type=chunk)[401](index=401&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=83&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $11.2 million for 2024, a significant increase from 2023, primarily due to increased R&D and G&A expenses and the absence of one-time license revenue - The company's financial statements raise substantial doubt about its ability to continue as a going concern due to operating losses, negative cash flows, and the need for additional capital to fund operations within the next year[408](index=408&type=chunk)[444](index=444&type=chunk) Comparison of Years Ended December 31, 2024 and 2023 (in thousands) | | 2024 | 2023 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | **Total revenues** | **$ 56** | **$ 3,153** | **$ (3,097)** | | License revenues | $ — | $ 3,000 | $ (3,000) | | **Total operating expenses** | **$ 17,104** | **$ 6,282** | **$ 10,822** | | Research and development | $ 7,480 | $ 2,388 | $ 5,092 | | General and administrative | $ 9,624 | $ 3,894 | $ 5,730 | | **NET (LOSS) INCOME** | **$ (11,207)** | **$ 5,269** | **$ (16,476)** | - Research and development expenses increased by **$5.1 million** in 2024, primarily due to a **$1.9 million** increase in outside services for the SER-252 program and a **$1.8 million** increase in compensation expenses[437](index=437&type=chunk) - General and administrative expenses increased by **$5.7 million** in 2024, driven by a **$2.5 million** increase in compensation (including **$2.0 million** in stock-based compensation), and higher consulting, insurance, and legal fees associated with being a public company[438](index=438&type=chunk) [Financial Statements and Supplementary Data](index=94&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The audited consolidated financial statements for 2024 and 2023 are presented, with the auditor highlighting substantial doubt about the company's ability to continue as a going concern - The report from the independent registered public accounting firm includes a paragraph expressing substantial doubt about the company's ability to continue as a going concern[464](index=464&type=chunk) Key Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $ 3,672 | $ 7,619 | | Total Assets | $ 6,724 | $ 8,968 | | Total Liabilities | $ 6,216 | $ 4,858 | | Accumulated deficit | $ (44,318) | $ (33,177) | | Total stockholders' equity (deficit) | $ 508 | $ (32,294) | - The merger with AgeX was accounted for as a reverse recapitalization, with Legacy Serina as the accounting acquirer. The historical financial statements prior to the merger are those of Legacy Serina[542](index=542&type=chunk)[543](index=543&type=chunk) - The company classifies warrants issued in connection with the merger as liabilities, which are remeasured to fair value each reporting period. For the year ended Dec 31, 2024, this resulted in a **$13.2 million non-cash gain** from the change in fair value[595](index=595&type=chunk) [Controls and Procedures](index=143&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of December 31, 2024, due to identified material weaknesses in internal control over financial reporting - Management determined that the company's disclosure controls and procedures were **not effective** as of December 31, 2024[662](index=662&type=chunk) - Material weaknesses were identified, including: insufficient qualified accounting personnel, lack of data validation, inadequate controls and segregation of duties, and reliance on manual reporting processes[666](index=666&type=chunk)[667](index=667&type=chunk) - A remediation plan has been initiated, which involves hiring experienced professionals, engaging consultants, developing standardized processes, and improving financial IT systems[669](index=669&type=chunk)[673](index=673&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=146&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) This section details the composition of the company's Board of Directors and executive leadership team, including key committee assignments and governance policies - The Board of Directors is composed of **seven members**, including CEO Steve Ledger and representatives with ties to major shareholder Juvenescence (Dr. Gregory H. Bailey and Dr. Richard Marshall)[678](index=678&type=chunk)[680](index=680&type=chunk)[682](index=682&type=chunk) - The executive team includes Steve Ledger as CEO, Gregory S. Curhan as CFO (via FLG Partners), Dr. Randall Moreadith as Chief Development Officer, and Dr. Srini Tenjarla as SVP of CMC & Formulation[691](index=691&type=chunk) - The company has established an Audit Committee, adopted a Code of Business Conduct and Ethics, and implemented an Insider Trading Policy in line with public company governance standards[685](index=685&type=chunk)[688](index=688&type=chunk)[689](index=689&type=chunk) [Executive Compensation](index=150&type=section&id=Item%2011.%20Executive%20Compensation) As a smaller reporting company, Serina provides reduced executive compensation disclosure, detailing salaries, bonuses, and stock option awards for its named executive officers in 2024 2024 Summary Compensation Table | Name and principal position | Year | Salary ($) | Bonus ($) | Option Awards ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Steve Ledger, CEO | 2024 | 326,250 | 144,949 | 3,232,422 | — | 3,703,621 | | Gregory S. Curhan, CFO | 2024 | — | — | 1,447,750 | 252,663 | 1,700,413 | | Dr. Srinivas Tenjarla, SVP | 2024 | 171,875 | 89,453 | 1,519,960 | — | 1,781,288 | - CEO Steve Ledger's employment agreement provides for an annual base salary of **$450,000** and a target bonus of up to **50% of base salary**[704](index=704&type=chunk) - A new director compensation policy was adopted in 2024, providing non-employee directors with annual cash retainers (e.g., **$40,000 for board members**) and initial and annual stock option grants[714](index=714&type=chunk)[718](index=718&type=chunk)[720](index=720&type=chunk) [Security Ownership of Certain Beneficial Owners and Management, and Related Stockholder Matters](index=156&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details the beneficial ownership of the company's common stock as of March 1, 2025, highlighting Juvenescence Limited as the largest beneficial owner Security Ownership of 5% Stockholders | Name of Beneficial Owner | Number of Shares Beneficially Owned | Percentage of Shares Beneficially Owned | | :--- | :--- | :--- | | Juvenescence Limited and certain affiliates | 4,530,374 | 40.5 % | | Puffinus L.P. | 980,025 | 9.8 % | | Helen W. McMillan | 842,404 | 8.4 % | | Barbara M. Fisk | 536,279 | 5.4 % | | Randall Moreadith | 614,961 | 5.8 % | | Miguel Loya | 497,242 | 5.0 % | - As of March 1, 2025, all executive officers and directors as a group beneficially owned approximately **13.5%** of the company's common stock[728](index=728&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=159&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has extensive and complex related-party transactions, primarily with its largest shareholder, Juvenescence Limited, and confirms the independence of five board members - In connection with the merger, AgeX's legacy assets and certain liabilities, including secured debt owed to Juvenescence, were transferred to a subsidiary, UniverXome[732](index=732&type=chunk)[733](index=733&type=chunk) - In December 2024, the company sold the UniverXome subsidiary to Juvenescence. As consideration, Juvenescence assumed approximately **$11.3 million** of secured debt that UniverXome owed to it[763](index=763&type=chunk) - Prior to the merger, AgeX provided Legacy Serina with **$10.0 million** in financing via a convertible note, which was converted into equity and treated as a capital contribution at the time of the merger[764](index=764&type=chunk)[765](index=765&type=chunk) - Five directors (Gregory H. Bailey, Remy Gross, Richard Marshall, Karen J. Wilson, and Jay Venkatesan) are determined to be independent under NYSE American Company Guide rules[770](index=770&type=chunk) [Principal Accountant Fees and Services](index=165&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Following the merger, the company appointed Frazier & Deeter, LLC as its independent registered public accounting firm, with aggregate fees for 2024 and 2023 totaling $355,500 and $235,000 respectively Accountant Fees Billed (Fiscal Years 2024 & 2023) | | 2024 | 2023 | | :--- | :--- | :--- | | Audit Fees | $ 282,500 | $ 235,000 | | Audit Related Fees | $ 73,000 | $ — | | Tax Fees | $ — | $ — | | All Other Fees | $ — | $ — | | **Total Fees** | **$ 355,500** | **$ 235,000** | - On April 29, 2024, the Audit Committee appointed Frazier & Deeter, LLC as the company's independent registered public accounting firm, replacing WithumSmith+Brown, PC[771](index=771&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=167&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides a comprehensive list of all exhibits filed with or incorporated by reference into the Form 10-K, including merger agreements and corporate governance documents - The report includes a detailed list of exhibits, such as the Agreement and Plan of Merger, Amended Certificate of Incorporation, various debt and warrant agreements with Juvenescence, and the company's equity incentive plans[776](index=776&type=chunk)[777](index=777&type=chunk)[778](index=778&type=chunk) [Form 10-K Summary](index=173&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for its Form 10-K - None[784](index=784&type=chunk)
AgeX Therapeutics(AGE) - 2024 Q3 - Quarterly Results
2024-11-12 22:05
[Serina Therapeutics Third Quarter 2024 Financial Results and Business Highlights](index=1&type=section&id=Serina%20Therapeutics%20Reports%20Third%20Quarter%202024%20Financial%20Results%20and%20Provides%20Business%20Highlights) [Recent Highlights](index=1&type=section&id=Recent%20Highlights) The company highlighted a collaboration with Enable Injections to enhance drug delivery for its Parkinson's disease candidate - The company is partnering with Enable Injections to combine its lead candidate **SER-252** with the **enFuse™ wearable drug delivery platform** for Advanced Parkinson's Disease treatment[2](index=2&type=chunk) [Third Quarter Operating Results](index=1&type=section&id=Third%20Quarter%20Operating%20Results) Net income decreased to $1.4 million in Q3 2024, as a significant rise in operating expenses offset higher other income Q3 2024 vs. Q3 2023 Financial Summary (in millions, except per share data) | Metric | Q3 2024 | Q3 2023 | Change | | :--- | :--- | :--- | :--- | | Grant Revenues | $0.014 | $0.029 | -51.7% | | Operating Expenses | $5.3 | $1.5 | +253.3% | | Other Income, net | $6.7 | $3.2 | +109.4% | | Net Income | $1.4 | $1.8 | -22.2% | | Diluted EPS | $0.13 | $0.23 | -43.5% | - **Research and development (R&D) expenses increased by $1.8 million** year-over-year to $2.4 million, driven by higher costs for headcount, patents, and outside research services[4](index=4&type=chunk) - **General and administrative (G&A) expenses grew by $2.0 million** year-over-year to $2.9 million, primarily due to stock compensation, consulting, and severance costs[5](index=5&type=chunk) [Liquidity and Going Concern](index=2&type=section&id=Liquidity%20and%20Going%20Concern) The company's current cash position is insufficient to fund operations for the next twelve months, raising going concern doubts - Cash, cash equivalents, and restricted cash totaled **$3.2 million** as of September 30, 2024[8](index=8&type=chunk) - Management has determined there is **substantial doubt about its ability to continue as a going concern** due to insufficient funding for the next twelve months[9](index=9&type=chunk) [Company and Technology Overview](index=2&type=section&id=Company%20and%20Technology%20Overview) [About SER-252 (POZ-apomorphine)](index=2&type=section&id=About%20SER-252%20(POZ-apomorphine)) SER-252 is an investigational therapy for Parkinson's disease designed for continuous stimulation, with clinical trials planned for 2025 - SER-252 is an investigational therapy for Parkinson's disease designed for **continuous dopaminergic stimulation (CDS)** to reduce motor complications[10](index=10&type=chunk) - Serina plans to advance **SER-252 to clinical testing in 2025**[10](index=10&type=chunk) [About the POZ Platform™](index=2&type=section&id=About%20the%20POZ%20Platform%E2%84%A2) The proprietary POZ Platform™ uses a synthetic polymer to improve drug profiles and is being pursued for licensing opportunities - The POZ technology uses a synthetic polymer to control drug release, aiming to **improve the safety and efficacy profiles** of drugs with narrow therapeutic windows[11](index=11&type=chunk) - The company's strategy includes out-licensing, highlighted by a **non-exclusive license agreement with Pfizer** for use in lipid nanoparticle (LNP) drug delivery[12](index=12&type=chunk) [About Serina Therapeutics](index=2&type=section&id=About%20Serina%20Therapeutics) Serina is a clinical-stage biotech company using its POZ Platform to develop drug candidates for neurological diseases - Serina is a clinical-stage biotechnology company developing drug candidates for neurological diseases using its **POZ Platform**[13](index=13&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decline in assets and a significant increase in liabilities, widening the stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2024 (unaudited) | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,185 | $7,619 | | Total current assets | $5,423 | $7,619 | | **Total Assets** | **$7,435** | **$8,968** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $13,514 | $1,413 | | Warrant liability | $6,744 | $— | | **Total Liabilities** | **$21,263** | **$4,858** | | Total stockholders' deficit | ($13,828) | ($32,294) | | **Total Liabilities & Stockholders' Deficit** | **$7,435** | **$8,968** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net income of $1.4 million for Q3 2024 but a significant net loss of $8.4 million for the nine-month period Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $14 | $29 | $70 | $66 | | Total Operating Expenses | $5,326 | $1,492 | $11,569 | $3,436 | | Loss from Operations | ($5,312) | ($1,463) | ($11,499) | ($3,370) | | Total Other Income, net | $6,695 | $3,215 | $3,044 | $7,588 | | **Net Income (Loss)** | **$1,383** | **$1,752** | **($8,455)** | **$4,218** | | **Diluted EPS** | **$0.13** | **$0.23** | **($1.24)** | **$0.57** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash used in operations increased significantly, and a net decrease in cash of $4.4 million was recorded for the nine-month period Cash Flow Summary for the Nine Months Ended September 30 (in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,548) | ($2,597) | | Net cash used in investing activities | ($17) | ($434) | | Net cash provided by financing activities | $8,181 | $10,080 | | **Net change in cash** | **($4,384)** | **$7,049** | | Cash at beginning of period | $7,619 | $532 | | **Cash at end of period** | **$3,235** | **$7,581** |
AgeX Therapeutics(AGE) - 2024 Q3 - Quarterly Report
2024-11-12 21:03
Part I – FINANCIAL INFORMATION This section presents the company's financial statements, management's discussion, market risk disclosures, and controls and procedures [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The financial statements for the period ended September 30, 2024, reflect the company's post-merger status, showing a **net loss of $8.5 million**, **significant liabilities of $21.3 million**, and a **going concern issue** [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2024, total assets were **$7.4 million**, total liabilities significantly increased to **$21.3 million**, leading to a **$13.8 million** stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2024 (Unaudited) | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,185 | $7,619 | | Total current assets | $5,423 | $7,619 | | **Total Assets** | **$7,435** | **$8,968** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $13,514 | $1,413 | | Warrant liability | $6,744 | $— | | **Total Liabilities** | **$21,263** | **$4,858** | | Total stockholders' deficit | ($13,828) | ($32,294) | | **Total Liabilities and Stockholders' Deficit** | **$7,435** | **$8,968** | [Condensed Consolidated Statements of Operations](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the nine months ended September 30, 2024, the company reported an **$8.5 million net loss**, driven by increased operating expenses, a significant shift from prior year's net income Statement of Operations Summary (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Total revenues | $70 | $66 | | Research and development | $5,115 | $1,481 | | General and administrative | $6,454 | $1,955 | | **Loss from operations** | **($11,499)** | **($3,370)** | | Total other income, net | $3,044 | $7,588 | | **Net Income (Loss)** | **($8,455)** | **$4,218** | | **Net Loss per Share (Basic & Diluted)** | **($1.24)** | **$1.94 (Basic), $0.57 (Diluted)** | [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2024, net cash used in operating activities significantly increased to **$12.5 million**, resulting in a **$4.4 million** net decrease in cash Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,548) | ($2,597) | | Net cash used in investing activities | ($17) | ($434) | | Net cash provided by financing activities | $8,181 | $10,080 | | **Net change in cash** | **($4,384)** | **$7,049** | | Cash at end of period | $3,235 | $7,581 | [Notes to Condensed Consolidated Interim Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Interim%20Financial%20Statements) The notes detail the reverse merger, the company's **POZ drug delivery technology**, significant **going concern issues**, related-party transactions, and a new partnership with Enable Injections - On March 26, 2024, AgeX Therapeutics, Inc. completed a reverse merger with Legacy Serina, and changed its name to Serina Therapeutics, Inc. **Legacy Serina was deemed the accounting acquirer**[35](index=35&type=chunk) - Management has **substantial doubt** about the Company's ability to continue as a going concern, as cash of **$3.2 million** as of September 30, 2024, plus an expected **$10 million** from warrant exercises, are **not sufficient** to fund operations for the next twelve months[44](index=44&type=chunk)[46](index=46&type=chunk) - The company is a **clinical-stage biotech firm focused on its proprietary POZ drug delivery technology**, which uses a poly(2-oxazoline) polymer to improve the pharmacokinetic profiles of existing drugs for neurological diseases and pain[38](index=38&type=chunk)[39](index=39&type=chunk) - In May 2024, the company **partnered with Enable Injections, Inc. to develop and commercialize SER-252 (POZ-apomorphine) with enFuse® for Parkinson's disease**, **paying $2.0 million for the arrangement**[176](index=176&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=40&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, highlighting increased operating losses to **$11.5 million**, critical liquidity concerns with cash of **$3.2 million**, and **substantial doubt** about its ability to continue as a going concern [Overview](index=40&type=section&id=Overview) Serina is a clinical-stage biotech company using its **POZ drug delivery technology** to develop treatments for neurological diseases and pain, facing significant financial challenges post-merger, with an **accumulated deficit of $13.8 million** and **substantial doubt** about its ability to continue as a going concern - The company's **POZ technology is based on a synthetic, water-soluble polymer designed to improve the efficacy and safety of existing drugs** by controlling drug loading and release rates[186](index=186&type=chunk) - As of September 30, 2024, the company had an **accumulated deficit of $13.8 million** and cash and cash equivalents of **$3.2 million**, with **operating losses of $11.5 million** for the first nine months of the year[189](index=189&type=chunk) - **Losses from operations and negative cash flows raise substantial doubt about the company's ability to continue as a going concern**[190](index=190&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) Operating expenses significantly increased for the three and nine months ended September 30, 2024, compared to 2023, with R&D expenses rising to **$5.1 million** and G&A expenses to **$6.5 million**, while other income decreased by **$4.6 million** Operating Expense Comparison (Nine Months Ended Sep 30, in thousands) | Expense Category | 2024 | 2023 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | Research and development | $5,115 | $1,481 | $3,634 | | General and administrative | $6,454 | $1,955 | $4,499 | - The **$3.6 million increase in nine-month R&D expenses was driven by a $1.2 million rise in salaries, $0.9 million in professional fees for IP maintenance, and $0.9 million in outside research services**[214](index=214&type=chunk) - The **$4.5 million increase in nine-month G&A expenses was primarily due to $1.2 million in stock-based compensation, $0.9 million in merger-related professional fees, $0.8 million in consulting, and $0.5 million in salaries**[218](index=218&type=chunk) - The **$4.6 million decrease in nine-month 'Other income, net' was mainly caused by a $13.7 million loss from the change in fair value of convertible notes, partially offset by a $9.3 million gain from the change in fair value of liability-classified warrants**[220](index=220&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is critically low at **$3.2 million**, dependent on related-party funding, and **insufficient to fund operations through 2025**, raising **substantial doubt** about its going concern - As of September 30, 2024, the company had **$3.2 million in cash and cash equivalents**[222](index=222&type=chunk) - The company is **dependent on its controlling shareholder, Juvenescence, for funding**. Juvenescence is **committed to exercising warrants that will provide an additional $10.0 million in proceeds by June 30, 2025**[222](index=222&type=chunk)[224](index=224&type=chunk) - Management believes that **current cash plus the expected $10.0 million from warrant exercises will not be sufficient to fund operations through calendar year 2025, necessitating additional capital raises**[228](index=228&type=chunk) Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,548) | ($2,597) | | Net cash provided by financing activities | $8,181 | $10,080 | [Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is **exempt from this disclosure requirement** due to its status as a smaller reporting company - The company is **exempt from this disclosure requirement** due to its status as a smaller reporting company[238](index=238&type=chunk) [Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were **not effective** as of September 30, 2024, due to **material weaknesses**, with a **remediation plan underway** - Management determined that disclosure controls and procedures were **not effective** as of September 30, 2024[239](index=239&type=chunk) - **Material weaknesses** were identified, including: - **Lack of sufficient in-house qualified accounting staff** - **Inadequate controls and segregation of duties** due to limited resources - **Substantial reliance on manual reporting processes and spreadsheets** - **Lack of experience in monitoring internal controls**[242](index=242&type=chunk) - A **remediation plan is underway**, including the **engagement of financial operations consultants** and the **appointment of a new Controller** in July 2024[244](index=244&type=chunk) Part II – OTHER INFORMATION This section covers legal proceedings, updated risk factors, unregistered sales of equity securities, other information, and exhibits [Legal Proceedings](index=51&type=section&id=Item%201.%20Legal%20Proceedings) The company may be party to litigation and claims in the ordinary course of business, but management is **not aware of any material adverse effects** - The company is **not currently aware of any legal proceedings that would have a material adverse effect** on its financials[173](index=173&type=chunk)[249](index=249&type=chunk) [Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) A new key risk factor highlights the critical **need for additional financing** to execute the operating plan and continue as a going concern, as current funds are **insufficient to last beyond the next twelve months** - A key risk factor is the company's **need for additional financing** to continue as a going concern. Current cash and expected proceeds from warrant exercises are **not sufficient to fund operations for the next twelve months**[250](index=250&type=chunk) - The company's **accumulated deficit of $21.8 million** as of September 30, 2024, and continued operating losses increase the difficulty of obtaining necessary capital[251](index=251&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) **No new information is provided** under this item - **No new information is provided** under this item[252](index=252&type=chunk) [Other Information](index=52&type=section&id=Item%205.%20Other%20Information) **No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement** during the three months ended September 30, 2024 - **No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement** during the three months ended September 30, 2024[253](index=253&type=chunk) [Exhibits](index=52&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including new employment and consulting agreements, and standard certifications
DiagnaMed Expands with Drug and Clinical Research AI Platform
GlobeNewswire News Room· 2024-08-21 12:00
BRAIN AGE® Brain Health AI Platform - DiagnaMed Holdings Corp is expanding the use of its BRAIN AGE® Brain Health AI Platform by leveraging EEG data from research studies and future data collection to build a potential drug discovery and clinical research AI platform [1] - BRAIN AGE® estimates brain age by recording brain-wave activity from multiple brain regions and calculating the data with a proprietary machine-learning model [2] - The platform can assess if a brain is aging more quickly or slowly than typical for healthy individuals and can evaluate brain health by scoring brain resilience, vulnerability, and performance functions [2] - BRAIN AGE® has the potential to accelerate patient recruitment for clinical trials, data analysis, drug development decisions, and new treatment options for neurological, psychiatric, and infectious diseases [1] Clinical Applications and Validation - BRAIN AGE® can classify and identify drugs according to their mechanism of action on brain activity, which is useful for developing novel drug analogs and potential drug repurposing ideas [2] - The platform can be used as an inexpensive way to screen large numbers of people for vulnerability to age-related cognitive decline and to test the effectiveness of medications and lifestyle changes [3] - A peer-reviewed paper in Frontiers in Neuroergonomics highlights the effectiveness of BRAIN AGE® for large-scale screening and brain optimization using a low-cost EEG headset [3] Company Overview - DiagnaMed Holdings Corp is a healthcare technology company focused on brain health using AI, commercializing the BRAIN AGE® Brain Health AI Platform, which estimates brain age and provides a brain health score [4] - The company is leveraging its proprietary EEG data to accelerate clinical trial development and discover potential novel treatments for neurological, psychiatric, and infectious diseases [1]
AgeX Therapeutics(AGE) - 2024 Q2 - Quarterly Results
2024-08-09 20:25
[Business Highlights](index=1&type=section&id=Business%20Highlights) The company reported a debt extension, a strategic partnership, positive technology data, and a key leadership addition - The repayment date for borrowings under the Juvenescence Secured Note was extended to December 31, 2024, and the line of credit was increased by an additional **$525,000**[3](index=3&type=chunk) - Entered a partnership with Enable Injections to develop and commercialize **SER-252** for Parkinson's disease, with plans to initiate a **Phase 1 trial in 2025**[5](index=5&type=chunk) - Presented data showing its proprietary **POZ-lipid technology does not induce an IgM or IgG antibody response**, unlike PEG-lipids used in current mRNA vaccines[5](index=5&type=chunk) - Appointed **Dr. Srini Tenjarla**, formerly of Takeda and Shire, as Senior Vice President of CMC & Formulation[5](index=5&type=chunk) Liquidity Position as of June 30, 2024 | Metric | Amount (USD) | | :--- | :--- | | Cash, cash equivalents, and restricted cash | $6.1 million | | Principal and fees owed to Juvenescence Limited | $11.2 million | [Financial Results](index=2&type=section&id=Financial%20Results) The company reported Q2 net income of $5.2 million due to non-cash gains, despite rising operating expenses and a going concern warning [Second Quarter Operating Results](index=2&type=section&id=Second%20Quarter%20Operating%20Results) Q2 2024 net income of $5.2 million was driven by a $9.3 million non-cash gain, offsetting a significant rise in operating expenses Q2 2024 vs. Q2 2023 Financial Highlights (in thousands, except per share data) | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Revenues | $51 | $7 | | Operating Expenses | $3,917 | $952 | | Net Income Attributable to Serina | $5,204 | $808 | | Basic EPS | $0.61 | $0.37 | | Diluted EPS | $0.51 | $0.11 | - **Research and development (R&D) expenses increased by $1.1 million** to $1.6 million YoY, primarily due to severance, increased salaries, and consulting services[7](index=7&type=chunk) - **General and administrative (G&A) expenses rose by $1.8 million** to $2.3 million YoY, mainly from merger-related legal and accounting fees[8](index=8&type=chunk) - Net other income for Q2 2024 was $9.0 million, primarily comprised of a **$9.3 million non-cash gain** from the change in fair value of derivative warrant liabilities[9](index=9&type=chunk) [Going Concern Considerations](index=2&type=section&id=Going%20Concern%20Considerations) Management expressed substantial doubt about the company's ability to continue as a going concern due to insufficient cash reserves - Management has concluded that there is **substantial doubt** regarding the Company's ability to continue as a going concern[11](index=11&type=chunk) - The company's cash and cash equivalents of **$6.1 million** as of June 30, 2024, are not expected to be sufficient to fund operations for the next twelve months[11](index=11&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows total assets of $10.7 million, total liabilities of $27.1 million, and a stockholders' deficit of $16.4 million Balance Sheet Summary (in thousands) | Account | June 30, 2024 (unaudited) | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $6,064 | $7,619 | | Total Current Assets | $8,917 | $7,619 | | **Total Assets** | **$10,708** | **$8,968** | | Total Current Liabilities | $12,633 | $1,413 | | **Total Liabilities** | **$27,101** | **$4,858** | | **Total Stockholders' Deficit** | **($16,393)** | **($32,294)** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a Q2 net income of $5.2 million but a six-month net loss of $9.8 million, reflecting high operating expenses Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total Revenues | $51 | $56 | | Total Operating Expenses | $3,917 | $6,243 | | Loss from Operations | ($3,866) | ($6,187) | | Total Other Income (Expense), Net | $9,043 | ($3,651) | | **Net Income (Loss) Attributable to Serina** | **$5,204** | **($9,811)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $9.6 million for the six-month period, with the cash balance decreasing by $1.5 million to $6.1 million Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($9,586) | ($1,573) | | Net cash used in investing activities | ($14) | ($315) | | Net cash provided by financing activities | $8,095 | $10,078 | | **Net Change in Cash** | **($1,505)** | **$8,190** | | **Cash at end of period** | **$6,114** | **$8,722** | [Pipeline and Technology](index=2&type=section&id=Pipeline%20and%20Technology) The company is advancing its pipeline, led by SER-252, by leveraging its proprietary POZ Platform™ drug delivery technology [SER-252 (POZ-apomorphine)](index=2&type=section&id=SER-252%20(POZ-apomorphine)) SER-252 is an investigational therapy for Parkinson's disease designed to provide continuous stimulation with a planned clinical start in 2025 - **SER-252** is an investigational apomorphine therapy designed to provide **continuous dopaminergic stimulation (CDS)** to reduce motor complications in Parkinson's disease[12](index=12&type=chunk) - Preclinical studies indicate SER-252 has the potential to provide CDS **without causing skin reactions**[12](index=12&type=chunk) - Serina plans to advance SER-252 to **clinical testing in 2025**[12](index=12&type=chunk) [POZ Platform™](index=3&type=section&id=POZ%20Platform%E2%84%A2) The POZ Platform™ is a proprietary polymer technology designed to improve drug delivery by enabling precise control over release rates - The POZ technology uses a synthetic, water-soluble, low-viscosity polymer to achieve **greater control in drug loading and release**[13](index=13&type=chunk) - It is designed to improve drugs with narrow therapeutic windows by **maintaining more stable blood levels** and addressing limitations like toxicity[13](index=13&type=chunk) - The platform is being advanced through partnerships, including a non-exclusive license with **Pfizer, Inc.** for use in lipid nanoparticle (LNP) drug delivery[14](index=14&type=chunk) [Corporate Overview and Forward-Looking Statements](index=3&type=section&id=Corporate%20Overview%20and%20Forward-Looking%20Statements) Serina is a clinical-stage biotech company focused on neurological diseases, and its report contains forward-looking statements with inherent risks - Serina is a clinical-stage biotechnology company developing a pipeline of drug candidates to treat **neurological diseases and pain**[15](index=15&type=chunk) - The company's POZ Platform is also being utilized by partners to advance **lipid nanoparticle (LNP) delivery technology** for novel RNA therapeutics[15](index=15&type=chunk) - The report contains **forward-looking statements** that are subject to substantial risks and uncertainties related to drug development and regulatory approvals[17](index=17&type=chunk)
AgeX Therapeutics(AGE) - 2024 Q2 - Quarterly Report
2024-08-09 20:20
Financial Performance - Revenues for the three and six months ended June 30, 2024, were not material, indicating a focus on development rather than immediate revenue generation [229]. - The company incurred a net loss of $9.8 million for the six months ended June 30, 2024, with non-cash items affecting cash flow [251]. - The company had an accumulated deficit of $23.2 million as of June 30, 2024, indicating ongoing financial challenges [243]. - The net cash used in operating activities for the six months ended June 30, 2024, was $9.6 million, a significant increase of 509.4% from $1.573 million in the same period in 2023 [250]. - Other income, net for the three months ended June 30, 2024, was $9.04 million, compared to $1.75 million in the same period in 2023, reflecting a change of $7.3 million [235]. Research and Development Expenses - Research and development expenses increased to $1.6 million for Q2 2024, up 232.8% from $0.5 million in Q2 2023, primarily due to severance and payroll-related expenses [227]. - For the six months ended June 30, 2024, research and development expenses totaled $2.7 million, reflecting a 207.5% increase from $0.9 million in the same period of 2023 [228]. - The company anticipates a substantial increase in research and development expenses as it continues to invest in clinical trials and product development [217]. - The company expects to continue incurring losses and will require additional financing to support ongoing operations and product development [246]. - The company anticipates that its research and development expenses will continue to increase, necessitating further capital raising efforts [248]. General and Administrative Expenses - General and administrative expenses rose to $2.3 million for Q2 2024, a 391.1% increase from $0.5 million in Q2 2023, driven by legal and accounting services related to the recent merger [227]. - General and administrative expenses for the six months ended June 30, 2024, were $3.5 million, a 232.4% increase from $1.1 million in the same period of 2023 [228]. - The increase in general and administrative expenses is also attributed to costs associated with being a public company, including compliance and investor relations [224]. - General and administrative expenses increased to $3.5 million for the six months ended June 30, 2024, from $1.1 million in the same period in 2023, a rise of 218.2% [234]. - A non-recurring severance expense of $0.3 million contributed to the increase in both research and development and general administrative expenses [230][233]. Cash and Financing Activities - Cash and cash equivalents stood at $6.1 million as of June 30, 2024, with additional expected proceeds of $9.975 million from the exercise of Post-Merger Warrants [241]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $8.1 million, primarily from the exercise of Post-Merger Warrants and credit facilities [253]. - The fair value of liability classified Merger Warrants resulted in a gain of $3.7 million during the six months ended June 30, 2024, compared to nil in the same period in 2023 [237]. - The company is expanding its workforce and infrastructure to support ongoing research and development efforts [223]. - The company expects to face significant costs and uncertainties in obtaining regulatory approvals for its product candidates [218].
AgeX Therapeutics(AGE) - 2024 Q1 - Quarterly Results
2024-05-14 20:25
Exhibit 99.1 Serina Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Highlights HUNTSVILLE, May 14, 2024 (GLOBE NEWSWIRE) — Serina Therapeutics ("Serina") (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug delivery technology, today reported financial results for the quarter ended March 31, 2024 and provided business highlights. Recent Highlights Liquidity and Capital Resources Increase in Line of Credit On March 26, 2024 ...
AgeX Therapeutics(AGE) - 2024 Q1 - Quarterly Report
2024-05-14 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 1-38519 Serina Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction o ...
AgeX Therapeutics(AGE) - 2023 Q4 - Annual Results
2024-03-22 21:28
Liquidity and Capital Resources Issuance of Preferred Stock to Eliminate $36 Million of Indebtedness and Conversion to Common Stock During July 2023, AgeX and Juvenescence Limited entered into an Exchange Agreement pursuant to which AgeX issued shares of Series A Preferred Stock and Series B Preferred Stock to Juvenescence in exchange for the extinguishment of a total of $36 million of indebtedness under a loan agreement and certain promissory notes. The Series A Preferred Stock and Series B Preferred Stock ...