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 | |
● | Completion of merger with | |
● | Appointment of Dr. |
Liquidity and Capital Resources
Increase in Line of Credit
On
On
Balance Sheet Information
Cash, cash equivalents, and restricted cash totaled
First Quarter 2023 Operating Results
Revenues: Revenues comprised entirely of grant revenues in the amount of
Operating expenses: Operating expenses for the three months ended
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Other expense, net: Net other expense for the three months ended
Net loss: The net loss for the three months ended
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
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 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
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
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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value amounts)
(unaudited)
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, | - | 36,404 | ||||||
Stockholders’ deficit: | ||||||||
Preferred stock, | - | - | ||||||
Common stock, | 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 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except par value amounts)
(unaudited)
Three Months Ended | ||||||||
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
Source:
2024 GlobeNewswire, Inc., source