Full Press Release Details
Therapeutics Announces Completion of Merger with AgeX Therapeutics
| Shares of Serina to commence trading on NYSE American under the ticker symbol "SER" on March 27, 2024 | ||
| Lead candidate SER-252, POZ-apomorphine preclinical studies anticipated to be completed in the fourth quarter of 2024; IND submission to the FDA for the initiation of a Phase I clinical trial planned for 2025 |
March 26, 2024 (GlobeNewswire) - Serina Therapeutics (NYSE American: SER), a clinical-stage biotechnology company developing a
pipeline of therapies for the treatment of Parkinson's Disease and other neurological diseases, today announced the closing of
its previously announced merger with a wholly-owned subsidiary of AgeX Therapeutics, Inc. The combined company will operate under the
name Serina Therapeutics and will trade on the NYSE American market under the ticker symbol "SER" effective with the open
of business on Wednesday, March 27, 2024. The new CUSIP number for the combined company following the merger is 81751A108.
Board Chair J. Milton Harris, Ph.D., stated, "This merger is the culmination of years of work on the part of the Serina team and
enables us to move our lead polyoxazoline-drug conjugate into clinical trials. We will endeavor to advance additional clinical candidates,
further develop our LNP and ADC platforms, and look forward to presenting the Serina opportunity to a new investor audience."
will focus on the advancement of its lead drug candidate, SER-252 (POZ-apomorphine) for the treatment of advanced Parkinson's Disease
through pre-clinical studies towards the goal of an investigational new drug submission or "IND" to the Food and Drug Administration
for the initiation of a Phase I clinical trial during the fourth quarter of 2024.
management team of the combined company is led by Steven Ledger as Interim Chief Executive Officer. Following the reverse stock split
and closing of the merger, there will be approximately 10.1 million shares of the combined company's common stock outstanding on
a fully-diluted basis, excluding warrants, with prior Serina shareholders owning approximately 75% and prior AgeX shareholders owning
Arant Boult Cummings LLP provided legal counsel to Serina. Gibson, Dunn & Crutcher LLP provided legal counsel to AgeX.
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 certain challenging small molecules, while addressing the
limitations of polyethylene glycol ("PEG") and other biocompatible polymers. Serina's POZ PlatformTM partners
are at the forefront in advancing LNP delivery technology to develop novel RNA therapeutics.
lead candidate, SER-252 (POZ-apomorphine), has entered IND-enabling preclinical studies that were initiated in August 2023 and are anticipated
to be completed in the fourth quarter of 2024. Serina intends to advance SER 252 into Phase I clinical trials in 2025 for patients with
advanced Parkinson's disease. Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.
the Pipeline of Product Candidates
business is largely focused on the development of a wholly-owned pipeline of POZ-enabled drug candidates for central nervous system (CNS)
indications, including Parkinson's disease, epilepsy, and pain. A key element of Serina's strategy is to use and expand its
POZ Platform drug delivery technology to build a pipeline of product candidates and progress these product candidates through preclinical
and clinical development for the treatment of various diseases.
SER-252 (POZ-apomorphine)
252 (POZ-apomorphine) is a POZ conjugate of the potent dopamine agonist apomorphine being developed for the treatment of Parkinson's
disease and is in preclinical development. SER 252 is designed to provide continuous dopaminergic stimulation (CDS) via a subcutaneous
injection delivered one to two times per week. The treatment of advanced Parkinson's disease relies on multiple therapies, including
levodopa (L-DOPA), compounds that inhibit the breakdown of L-DOPA in the brain (catechol-O-methyl transferase, or COMT; for example,
opicopone), dopamine agonists (transdermal rotigotine; for example, NeuproTM) and others. L-DOPA in escalating doses is the mainstay
of therapy for advanced Parkinson's Disease but is also the proximate cause of levodopa-induced dyskinesias (LIDS), one of the
most troubling complications of prolonged high dose L-DOPA therapy. Approximately 90% of Parkinson's disease patients who use L-DOPA
for ten years will develop irreversible LIDS. An infusion therapy known as Apo-go (apomorphine) is available in the European Union, or
EU, but is not yet available in the United States. Apo-go must be administered as a 12-16-hour continuous infusion through an electronic
pump and a standard insulin infusion set. While effective in reducing daily "OFF" time, and simultaneously increasing daily
"ON" time without troublesome dyskinesia, its use frequently requires a healthcare provider to connect the device and infusion
set each day and remove it at night. "OFF" time refers to the time period the patient is unable to perform routine daily
activities. "ON" time refers to those periods where the patient is able to perform routine daily activities. Apo-go administration
is accompanied by significant skin reactions in approximately 40% of patients, often leading to permanent scarring (nodules) on the abdomen.
Serina's preclinical studies in monkeys suggest SER 252 may be administered as a single subcutaneous injection twice a week, provides
continuous delivery of apomorphine and has no skin liabilities. Its use is designed to be administered in the convenience of the patient's
home without the need for a healthcare provider. Serina believes that SER 252 may allow some patients to titrate completely off L-DOPA,
thus simultaneously addressing the LIDS that is associated with its prolonged use.
early 2018, Serina initiated work on developing a polymer conjugate of apomorphine that could be delivered as a subcutaneous injection
that is devoid of any skin reactions. The first step was attachment of apomorphine to the polymer. The chemistry of attachment and controlled
release required attachment of ester-linked groups to both of the hydroxyl groups in apomorphine; one ester linkage attaches the apomorphine
to the polymer backbone (linking group) and the other ester linkage caps the second hydroxyl (capping group). In the course of these
studies, Serina discovered that the rate-limiting step in the release of apomorphine from the polymer was the release of the "capping
linker." After three and a half years of dedicated efforts to control the release kinetics of apomorphine, Serina identified SER
252 as the IND candidate. Importantly, SER 252 provides linear dose kinetics when administered in preclinical multi-dose studies in monkeys.
studies in humans are required for confirmation, Serina conducted a simulation of human PK based on the results from its preclinical
studies in monkeys. The PK parameters of SER 252 in monkeys were modeled with a standard one-compartment fit of the data with V/F (volume
of distribution) derived from imputed data from NeuroDerm, Ltd. published human PK on ND0701, an apomorphine product being developed
by NeuroDerm; the V/F was 13 L/kg. The simulation demonstrated that doses from 0.25 mg eq Apo/kg to 1 mg eq Apo/kg would cover the PK
profile of Apo-go and provide a range of doses that Serina intends to evaluate in early studies in humans.
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.
Statement Regarding Forward-Looking Statements
statements contained in this communication regarding matters that are not historical facts are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities
and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements
regarding the anticipated effects of the merger and related timing, the combined company's planned preclinical and clinical programs,
including planned clinical trials, the potential of the combined company's product candidates, the expected trading of the combined
company's stock on the NYSE American under the ticker symbol "SER," management of the combined company and other statements
regarding management's intentions, plans, beliefs, expectations or forecasts for the future. All forward-looking statements are
based on assumptions or judgments about future events and economic conditions that may or may not be correct or necessarily take place
and that are by their nature subject to significant risks, uncertainties and contingencies. You are cautioned not to place undue reliance
on these forward-looking statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those
projected. Statements that contain words such as "anticipates," "believes," "plans," "expects,"
"projects," "future," "intends," "may," "will," "should," "could,"
"estimates," "predicts," "potential," "continue," "guidance," and similar
expressions to identify these forward-looking statements are intended to be covered by the safe-harbor provisions of the PSLRA.
are a number of risks and uncertainties that could cause actual results to differ materially from the forward-looking statements included
in this communication. The merger could cause additional risks, including risks associated with conducting clinical trials of Serina
product candidates and obtaining Food and Drug Administration or other regulatory approvals to market product candidates, including risks
with respect to the timing of initiation of Serina's planned clinical trials, the timing of the availability of data or other results
from clinical trials, and the timing of any planned investigational new drug application or new drug application; risks associated with
the combined company's ability to identify additional products or product candidates with significant commercial potential; risks
associated with the combined company's ability to protect its intellectual property position; product liability risks; the risk
that the cash balance of the combined company following the closing of the merger will be lower than expected or reduced; the risk that
the combined company's anticipated sources and related timing of financing following the closing of the merger will not provide
proceeds necessary to fund the operations of the combined company for as long as anticipated; risks associated with the combined company's
estimates regarding future revenue, expenses, capital requirements, and need for additional financing following the merger; risks associated
with the ability of the combined company to remain listed on the NYSE American; the risk that products may not be successfully commercialized
or that the combined company might not otherwise be able to generate sufficient revenues to operate at a profit; potential adverse changes
to business or employee relationships, including those resulting from the announcement or completion of the merger; the ability of Serina
to retain customers and retain and hire key personnel and maintain relationships with their suppliers and customers; risks associated
with the combined company's ability to successfully collaborate with Serina's existing collaborators or enter into new collaborations,