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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (date of earliest event reported): May 14, 2024

 

Serina Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   1-38519   82-1436829
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)

 

601 Genome Way, Suite 2001

Huntsville, Alabama 35806

(Address of principal executive offices)

 

(256) 327-9630

(Registrant’s telephone number, including area code)

 

Not applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of exchange on which registered
Common Stock, par value $0.0001 per share   SER   NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 
 

 

Explanatory Note

 

On March 26, 2024, the Delaware corporation formerly known as “AgeX Therapeutics, Inc.” completed its previously announced merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger and Reorganization, dated as of August 29, 2023 (the “Merger Agreement”), by and among AgeX Therapeutics, Inc. (“AgeX”), Canaria Transaction Corporation, a wholly owned subsidiary of AgeX (“Merger Sub”), and Serina Therapeutics, Inc. (“Serina”), pursuant to which Merger Sub merged with and into Serina, with Serina surviving the merger as a wholly owned subsidiary of AgeX (the “Merger”). Additionally, on March 26, 2024, AgeX changed its name from “AgeX Therapeutics, Inc.” to “Serina Therapeutics, Inc.” (the “Company”).

 

Item 2.02 Results of Operations and Financial Condition

 

On May 14, 2024, the Company announced its financial results for the quarter ended March 31, 2024. The full text of the press release is furnished as Exhibit 99.1 hereto.

 

The information in the attached Exhibit 99.1 is being furnished pursuant to Item 2.02 “Results of Operations and Financial Condition” on Form 8-K. The information shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, each as amended, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 - Financial Statements and Exhibits.

 

Exhibit Number   Description
99.1   Press Release of Serina Therapeutics, Inc. issued on May 14, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  SERINA THERAPEUTICS, INC.
     
Date: May 14, 2024 By: /s/ Steven Ledger
    Interim Chief Executive Officer

 

 

 

 

 

 

 

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

 

  Advancement of SER-252. The Company is advancing its lead drug candidate, SER-252 (POZ-apomorphine), for the treatment of advanced Parkinson’s Disease. The Company anticipates submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration with plans to initiate a Phase 1 clinical trial in 2025.
     
  Completion of merger with AgeX Therapeutics. The Company closed its merger with a wholly owned subsidiary of AgeX Therapeutics, Inc. The management team of the combined company is led by Steven Ledger as Interim Chief Executive Officer. The combined company began trading on the NYSE American market under the ticker symbol “SER” on March 27, 2024.
     
  Appointment of Dr. Simba Gill as Executive Chairman. Dr. Gill brings a wealth of biotech and pharma experience in building companies and transformative platforms as well as developing products, having served in key roles at Maxygen, Systemix, Boehringer Mannheim and Celltech. He earned his MBA at INSEAD and received his Ph.D. from King’s College, London. Dr. Gill will play a pivotal role in guiding Serina through its next phase of growth and development, leveraging his expertise to drive strategic expansion initiatives.

 

Liquidity and Capital Resources

 

Increase in Line of Credit

 

On March 26, 2024, the Company’s secured, convertible line of credit from Juvenescence Limited was increased by $2,400,000, which was drawn entirely on March 29, 2024.

 

On May 8, 2024, the repayment date of the Company’s borrowings under the Juvenescence line of credit was extended from May 9, 2024 to December 31, 2024 and the line of credit increased by an additional $525,000 which we received entirely on May 9, 2024.

 

Balance Sheet Information

 

Cash, cash equivalents, and restricted cash totaled $8.8 million as of March 31, 2024. As of March 31, 2024, the Company owed Juvenescence Limited $10.4 million in principal and origination fees on account of loans extended to the Company.

 

First Quarter 2023 Operating Results

 

Revenues: Revenues comprised entirely of grant revenues in the amount of $5,000 and $30,000 for the first quarter of 2024 and in the same period in 2023, respectively.

 

 
 

 

Operating expenses: Operating expenses for the three months ended March 31, 2024 were $2.3 million, as compared with $1 million for the same period in 2023.

 

Research and development expenses for the three months ended March 31, 2024 increased by approximately $0.7 million to $1.1 million from $0.4 million during the same period in 2023. The net increase was primarily attributable to increases of $0.5 million in outside research and services allocable to research and development expenses, $0.1 million in patent related professional fees, and $0.1 million in salaries and payroll related expenses and consulting services allocable to research and development expenses.

 

General and administrative expenses for the three months ended March 31, 2024 increased by $0.6 million to $1.2 million as compared to $0.6 million during the same period in 2023. The net increase is attributable to increases of $0.5 million in professional legal and accounting services incurred in connection with the Merger which consummated on March 26, 2024, $0.1 million in consulting services and noncash stock-based compensation to consultants allocable to general and administrative expenses, and $0.1 million in investment and public relations related expenses. These increases were offset to some extent by a $0.1 million decrease for database subscription fee.

 

Other expense, net: Net other expense for the three months ended March 31, 2024 is primarily comprised of $7 million change in fair value of convertible promissory notes which was converted to common stock on March 26, 2024.

 

Net loss: The net loss for the three months ended March 31, 2024 was $9.4 million, or ($3.38) per share (basic and diluted) compared to net income of $1.7 million, or $0.77 per share (basic) and $0.20 per share (diluted), for 2023. Net loss for the three months ended March 31, 2024 as compared to net income in 2023 is partially attributable to expenses related to the Merger which consummated on March 26, 2024 and net change in fair value of convertible promissory notes and warrants.

 

Going Concern Considerations

 

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), the Company evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on the Company’s most recent projected cash flows, the Company believes that its cash and cash equivalents and the additional $0.5 million borrowings from Juvenescence received on May 9, 2024 would not be sufficient to satisfy the Company’s anticipated operating and other funding requirements for the twelve months following the filing of the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024. These factors raise substantial doubt regarding the ability of the Company to continue as a going concern.

 

About SER-252 (POZ-apomorphine)

 

SER 252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation (CDS). CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) in Parkinson’s disease. Preclinical studies support the potential of SER 252 to provide CDS without skin reactions. Serina plans to advance SER 252 to clinical testing in 2025.

 

 
 

 

About the POZ Platform™

 

Serina’s proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina’s POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection. The therapeutic agents in Serina’s product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include toxicity, side effects and short half-life. Serina believes that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood.

 

Serina’s POZ platform delivery technology has potential for use across a broad range of payloads and indications. Serina intends to advance additional applications of the POZ platform via out-licensing, co-development, or other partnership arrangements, including the non-exclusive license agreement with Pfizer, Inc. to use Serina’s POZ polymer technology for use in lipid nanoparticle drug (LNP) delivery formulations.

 

About Serina Therapeutics

 

Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and pain. Serina’s POZ PlatformTM delivery technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs, enabling the potential of challenging small molecules, while addressing the limitations of PEG (polyethylene glycol) and other biocompatible polymers. In addition, our POZ PlatformTM partners are at the forefront in advancing lipid nanoparticle (LNP) delivery technology to develop novel RNA therapeutics. Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.

 

For more information, please visit https://serinatherapeutics.com.

 

Cautionary Statement Regarding Forward-Looking Statement

 

This release contains forward-looking statements within the meaning of federal securities laws. These statements are based on management’s current expectations, plans, beliefs or forecasts for the future, and are subject to uncertainty and changes in circumstances. Any express or implied statements in this press release that are not statements of historical fact, including statements about the potential of Serina’s POZ polymer technology, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; uncertainties regarding the impact of COVID-19 on Serina’s business, operations and financial results; and competitive developments. These risks as well as other risks are more fully discussed in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, the company’s Current Report on Form 8-K that was filed with the SEC on April 1, 2024, and the company’s other periodic reports and documents filed from time to time with the SEC.

 

The Information contained in this release Is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

 

 
 

 

SERINA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par value amounts)

(unaudited)

 

  

March 31,

2024

   December 31, 2023 
ASSETS          
Current assets:          
Cash and cash equivalents  $8,706   $7,619 
Accounts and grants receivable, net   65    - 
Prepaid expenses and other current assets   166    - 
Total current assets   8,937    7,619 
           
Restricted cash   50    - 
Property and equipment, net   564    573 
Right of use assets - operating leases   627    666 
Right of use assets - finance leases   104    110 
Intangible assets, net   574    - 
TOTAL ASSETS  $10,856   $8,968 
           
LIABILITIES, REDEEMABLE CONVERTIBLE PREFFERED STOCK, AND STOCKHOLDERS’ DEFICIT          
Current liabilities:          
Accounts payable and accrued liabilities  $4,013   $1,163 
Loans due to Juvenescence, net of debt issuance costs   9,746    - 
Related party payables, net   66    - 
Current portion of operating lease liabilities   207    214 
Current portion of finance lease liabilities   24    36 
Other current liabilities   3    - 
Total current liabilities   14,059    1,413 
           
Loans due to Juvenescence   693    - 
Convertible promissory notes, at fair value   -    2,983 
Operating lease liabilities, net of current portion   413    461 
Finance lease liabilities, net of current portion   -    1 
TOTAL LIABILITIES   15,165    4,858 
           
Commitments and contingencies          
           
Redeemable Convertible Preferred Stock:          
Redeemable convertible preferred stock, $0.01 par value; 10,000 authorized; nil and 3,438 issued and outstanding at March 31, 2024 and December 31, 2023, respectively   -    36,404 
           
Stockholders’ deficit:          
Preferred stock, $0.0001 par value, 5,000 shares authorized; none issued and outstanding   -    - 
           
Common stock, $0.0001 par value, 40,000 shares authorized; and 8,414 and 2,410 shares issued and outstanding   1    25 
Additional paid-in capital   1,125    858 
Accumulated deficit   (5,435)   (33,177)
Total stockholders’ deficit   (4,309)   (32,294)
TOTAL LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ DEFICIT  $10,856   $8,968 

 

 

 
 

 

SERINA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except par value amounts)

(unaudited)

 

  

Three Months

Ended March 31,

 
   2024   2023 
REVENUES          
Grant revenues  $5   $30 
Total revenues   5    30 
           
OPERATING EXPENSES          
Research and development   1,106    399 
General and administrative   1,220    593 
Total operating expenses   2,326    992 
           
Loss from operations   (2,321)   (962)
           
OTHER INCOME (EXPENSE), NET:          
Interest expense, net   (99)   (86)
Fair value inception adjustment on convertible promissory note   -    2,240 
Change in fair value of convertible promissory notes   (7,017)   294 
Change in fair value of warrants   -    172 
Total other income (expense), net   (7,116)   2,620 
           
NET INCOME (LOSS)  $(9,437)  $1,658 
           
NET EARNINGS (LOSS) PER COMMON SHARE:          
BASIC  $(3.38)  $0.77 
DILUTED  $(3.38)  $0.20 
           
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:          
BASIC   2,790    2,167 
DILUTED   2,790    8,569 

 

For inquiries, please contact:

 

Investor.relations@serinatherapeutics.com

(256) 327-9630

 

 

 

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