Full Press Release Details
Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Highlights
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.
| 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. |
and Capital Resources
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.
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.
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.
Quarter 2023 Operating Results
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.
expenses: Operating expenses for the three months ended March 31, 2024 were $2.3 million, as compared with $1 million for the same
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.
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.
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.
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.
Concern Considerations
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.
SER-252 (POZ-apomorphine)
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.
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
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.
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.
more information, please visit https://serinatherapeutics.com.
Statement Regarding Forward-Looking Statement
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.
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.
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
thousands, except par value amounts)
| 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 |
THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except par value amounts)
| 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 |
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