AgeX Therapeutics(AGE)

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AgeX Therapeutics(AGE) - 2025 Q2 - Quarterly Results
2025-08-11 20:10
Exhibit 99.1 • Advancement of SER-270 for Tardive Dyskinesia: In July 2025, Serina announced the advancement of SER-270 (POZ- VMAT2i), a once-weekly injectable therapy for tardive dyskinesia (TD), enabled by the POZ Platform. The program aims to address unment needs in TD treatment, particularly for institutional use and adherence challenges. SER-270 may also be evaluated for Huntington's disease chorea, a high need indication with limited long-acting injectable (LAI) options. • Board Appointments: In May 2 ...
AgeX Therapeutics(AGE) - 2025 Q2 - Quarterly Report
2025-08-11 20:05
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR o 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) Delaware 82-1 ...
Alligator Energy (AGE) Conference Transcript
2025-07-23 07:05
Summary of Alligator Energy (AGE) Conference Call - July 23, 2025 Company Overview - **Company**: Alligator Energy (AGE) - **Industry**: Uranium mining - **Key Projects**: Sandfire uranium project, Big Lake uranium project Core Points and Arguments 1. **Project Development**: Alligator Energy is focused on derisking the Sandfire uranium project near Whyalla, South Australia, utilizing in situ recovery (ISR) methods similar to oil and gas extraction [2][4] 2. **Financial Position**: The company recently raised approximately $17 million, bringing total cash reserves to around $30 million, which will support necessary studies over the next 6 to 12 months [4] 3. **Resource Estimates**: The Blackbush deposit has delineated 18 million pounds of uranium, supporting a projected mine life of 12 years at an annual production rate of 1.2 million pounds [6][7] 4. **Market Conditions**: Current long-term uranium prices are around $78 per pound, making the project economically viable [10] 5. **Exploration Potential**: The company estimates a total potential range of 15 to 75 million pounds of uranium in the system, with only 30% of the area drill-tested so far [12] 6. **Field Recovery Trial**: A field recovery trial is planned for Q4 to Q1 next year to validate the ISR process, with construction of the trial plant expected to begin soon [14][18] 7. **Regulatory Pathway**: The mining lease approval process for uranium mines typically takes 4 to 5 years, but the company has streamlined many technical approvals, potentially expediting this timeline [19][20] Additional Important Information 1. **Community Impact**: The mining operation is expected to benefit the local community in Whyalla, which is a steel town with existing infrastructure to support mining activities [5] 2. **Geological Insights**: The uranium is located in paleo channels, which are ancient riverbeds, and the extraction process involves drilling wells into these channels [8][9] 3. **Future Plans**: The company plans to continue exploration at the Big Lake project, which has shown promising initial drilling results, although recent floods have delayed further exploration [16][17] This summary encapsulates the key aspects of Alligator Energy's current status, project developments, financial health, and future plans as discussed in the conference call.
Alligator Energy (AGE) Earnings Call Presentation
2025-07-23 06:05
Company Overview - Alligator Energy Limited has a market capitalization of A$128.5 million as of June 30, 2025 [5] - The company's cash reserves stood at A$30.1 million as of June 30, 2025, which includes A$16.2 million from a June share placement [5] - Retail investors hold 35.9% of the company's shares, institutions hold 37.6%, brokers and banks hold 22.4%, and directors and executives hold 4.1% [6] Samphire Uranium Project - The Blackbush Mineral Resource is located at a depth of 80m (260ft) [22] - The project has a resource of 18 Mlbs, including 14.2 Mlbs Indicated and 3.8 Mlbs Inferred, to support a startup mining operation with staged expansion [26] - A December 2023 scoping study indicates a 12-year mine life at a production rate of 1.2 Mlbs per annum [26] - At a uranium price of US$75/lb, the project has a post-tax, real, ungeared IRR of 42%, a payback period of 2.45 years, and a post-tax, real, ungeared NPV8 of A$257 million [28] - At a uranium price of US$90/lb, the project has a post-tax, real, ungeared IRR of 55%, a payback period of 1.93 years, and a post-tax, real, ungeared NPV8 of A$371 million [30] - The Exploration Target Range estimates an additional 14 to 75 Mlbs of uranium [35] Field Recovery Trial - A Field Recovery Trial (FRT) is planned for October to December 2025, involving three producing well patterns and a containerized pilot plant [38] Big Lake Uranium Project - Initial drilling program intersected significant thicknesses of anomalous uranium mineralization, including 20m (65ft) @ 110 ppm U from 347ft (106m) in AC24-021 and 35m (114ft) @ 117 ppm U from 305ft (93m) in AC24-022 [47]
AgeX Therapeutics(AGE) - 2025 Q1 - Quarterly Results
2025-05-08 20:12
[Business Highlights](index=1&type=section&id=Recent%20Highlights) Serina Therapeutics advanced its lead Parkinson's candidate, secured $15 million in financing, and presented promising POZ Platform data in Q1 2025 - The company is on track to begin dosing the first patient for its lead candidate, **SER-252**, in a Phase 1b clinical trial for advanced Parkinson's disease by the **fourth quarter of 2025**[2](index=2&type=chunk)[6](index=6&type=chunk) - Strengthened the balance sheet by securing **$15 million in equity financing** since late 2024, including a **$10 million investment** from JuvVentures and a **$5 million private placement**[7](index=7&type=chunk) - Appointed two new experienced biotech leaders, Karen J. Wilson and Dr. Jay Venkatesan, to the Board of Directors[7](index=7&type=chunk) - Presented new data demonstrating that its POZ-lipid did not trigger an antibody response after repeat dosing in rats, unlike standard PEG-lipids, suggesting potential for safer LNP formulations[7](index=7&type=chunk) [Financial Results](index=1&type=section&id=First%20Quarter%20Operating%20Results) Serina reported a reduced net loss of $4.8 million in Q1 2025, driven by other income gains despite increased operating expenses [Operating Results](index=1&type=section&id=Operating%20Results) Q1 2025 operating expenses rose to $5.9 million due to R&D and G&A increases, but net loss narrowed to $4.8 million from other income gains Q1 2025 vs. Q1 2024 Operating Results (in millions, except EPS) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $0.0M | $0.005M | ($0.005M) | | R&D Expenses | $3.0M | $1.1M | +$1.9M | | G&A Expenses | $2.9M | $1.2M | +$1.7M | | Total Operating Expenses | $5.9M | $2.3M | +$3.6M | | Net Loss | ($4.8M) | ($15.0M) | +$10.2M | | Net Loss Per Share | ($0.49) | ($5.38) | +$4.89 | - The increase in R&D expenses was primarily due to higher salaries from increased headcount, professional fees for patent and intellectual property maintenance, and spending on outside research services[5](index=5&type=chunk) - The increase in G&A expenses was mainly due to higher salaries and stock-based compensation from new hires, consulting fees for finance functions, and increased directors and officers insurance costs[6](index=6&type=chunk)[8](index=8&type=chunk) - Other income increased by **$13.7 million** year-over-year, primarily due to a **$6.6 million gain** from the change in fair value of Merger Warrants and a favorable **$7.0 million change** related to Convertible Notes[9](index=9&type=chunk) [Liquidity and Financial Position](index=2&type=section&id=Liquidity%20Information) Serina held $4.3 million in cash as of March 31, 2025, projecting sufficient liquidity through Q3 2025 with recent financing - Cash and cash equivalents totaled **$4.3 million** as of March 31, 2025[11](index=11&type=chunk) - The company projects its cash on hand as of March 31, 2025, combined with **$5.0 million** raised in April 2025, will be sufficient to fund operations through the **third quarter of 2025**[11](index=11&type=chunk) [Corporate and Platform Overview](index=2&type=section&id=About%20Serina%20Therapeutics) Serina Therapeutics is a clinical-stage biotech company leveraging its POZ Platform to develop neurological disease treatments, including lead candidate SER-252 [About Serina Therapeutics](index=2&type=section&id=About%20Serina%20Therapeutics_1) Serina is a clinical-stage biotechnology company developing wholly-owned drug candidates for neurological diseases using its POZ Platform technology - Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug candidates for neurological diseases and other indications[12](index=12&type=chunk) - The company's POZ Platform has the potential to improve the efficacy and safety of multiple modalities, including small molecules, RNA therapeutics, and ADCs[12](index=12&type=chunk) [About the POZ Platform™](index=2&type=section&id=About%20the%20POZ%20Platform%E2%84%A2) The POZ Platform, based on poly(2-oxazoline), enhances drug stability and release, aiming to improve drug profiles and is open to partnerships - The POZ technology is based on a synthetic, water-soluble, low-viscosity polymer called poly(2-oxazoline)[13](index=13&type=chunk) - The platform is designed to improve drugs with narrow therapeutic windows by enabling more desirable and stable blood levels, potentially reducing side effects and toxicity[13](index=13&type=chunk) - Serina intends to advance the platform through partnerships, such as its non-exclusive license agreement with Pfizer, Inc. for use in lipid nanoparticle (LNP) drug delivery formulations[14](index=14&type=chunk) [About SER-252 (POZ-apomorphine)](index=2&type=section&id=About%20SER-252%20(POZ-apomorphine)) SER-252 is an investigational POZ-apomorphine therapy for Parkinson's disease, designed for continuous dopaminergic stimulation with planned 2025 clinical testing - SER-252 is an investigational apomorphine therapy developed with the POZ platform, designed to provide continuous dopaminergic stimulation (CDS) for Parkinson's disease[15](index=15&type=chunk) - Preclinical studies support the potential of SER-252 to provide CDS without causing skin reactions[15](index=15&type=chunk) - Serina plans to advance SER-252 to clinical testing in 2025[15](index=15&type=chunk) [Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Consolidated%20Financial%20Statements%20(Unaudited)) This section presents Serina Therapeutics' unaudited Q1 2025 consolidated financial statements, detailing assets, net loss, and cash flow changes [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2025, Serina's total assets were $6.73 million, with increased cash and equity, and reduced liabilities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $4,267 | $3,672 | | Total Assets | $6,731 | $6,724 | | Total Liabilities | $5,172 | $6,216 | | Total Stockholders' Equity | $1,559 | $508 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Q1 2025 net loss significantly narrowed to $4.8 million, or ($0.49) per share, driven by positive other income despite higher operating expenses Condensed Consolidated Statement of Operations (in thousands, except per share data) | Metric | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Total revenues | $— | $5 | | Total operating expenses | $5,858 | $2,326 | | Loss from operations | ($5,858) | ($2,321) | | Total other income (expense), net | $1,036 | ($12,694) | | Net Loss | ($4,822) | ($15,015) | | Net Loss Per Share | ($0.49) | ($5.38) | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Net cash used in Q1 2025 operating activities was $4.3 million, offset by $4.9 million from financing, resulting in a $0.6 million cash increase Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,322) | ($1,577) | | Net cash used in investing activities | $— | ($14) | | Net cash provided by financing activities | $4,917 | $2,728 | | Net change in cash and cash equivalents | $595 | $1,137 | | Cash and cash equivalents, end of period | $4,267 | $8,756 |
AgeX Therapeutics(AGE) - 2025 Q1 - Quarterly Report
2025-05-08 20:10
Financial Performance - The company reported an operating loss of $5.9 million for the three months ended March 31, 2025, compared to a loss of $2.3 million for the same period in 2024, reflecting an increase of $3.6 million [117]. - The total operating expenses for the three months ended March 31, 2025, were $5.9 million, up from $2.3 million in the same period in 2024, indicating an increase of $3.5 million [138]. - The net loss for the three months ended March 31, 2025, was $4.8 million, with a difference of $0.5 million between net loss and net cash used in operating activities due to non-cash items [152]. - Other income, net was $1.0 million for the three months ended March 31, 2025, compared to a net expense of $12.7 million for the same period in 2024, resulting in a $13.7 million improvement [141]. Expenses - Research and development expenses increased to $3.0 million for the three months ended March 31, 2025, up from $1.1 million in the same period in 2024, representing a rise of $1.9 million [139]. - General and administrative expenses rose to $2.9 million for the three months ended March 31, 2025, compared to $1.2 million in the same period in 2024, an increase of $1.7 million [138]. - General and administrative expenses increased to $2.9 million for the three months ended March 31, 2025, from $1.2 million in the same period in 2024, representing a 141.7% increase [140]. - The company anticipates continued increases in research and development expenses, general and administrative expenses, and capital expenditures [148]. Cash Position - Cash and cash equivalents stood at $4.3 million as of March 31, 2025 [117]. - The company had $4.3 million in cash and cash equivalents as of March 31, 2025, and expects to require additional financing to continue operations beyond the first quarter of 2026 [144][149]. - Net cash used in operating activities was $4.3 million for the three months ended March 31, 2025, compared to $1.6 million for the same period in 2024, reflecting a 174.1% increase [151]. - Net cash provided by financing activities was $4.9 million for the three months ended March 31, 2025, compared to $2.7 million for the same period in 2024, indicating an 80.2% increase [155]. Financing and Future Outlook - The company expects to incur substantial expenditures for the development of product candidates and will require additional financing to continue this development [118]. - The company plans to seek additional funds through equity offerings, debt financings, or other capital sources to support ongoing operations and product development [149]. - The accumulated deficit as of March 31, 2025, was $49.1 million, raising substantial doubt about the company's ability to continue as a going concern [146]. - The company anticipates that research and development expenses will continue to increase significantly as it advances its product candidates through clinical development [128]. Corporate Changes - The company completed a merger on March 26, 2024, changing its name to "Serina Therapeutics, Inc." [116].
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