Tevogen Bio Holdings Inc. (TVGN) — Form 10-K Summary
Reporting period: Fiscal year ended December 31, 2023. The report was filed April 26, 2024. Although the registrant is now Tevogen Bio Holdings Inc., the audited financial statements in this 10-K are for Semper Paratus Acquisition Corporation, the SPAC, before its February 14, 2024 business combination with Tevogen Bio. The filing says Tevogen Bio’s audited 2023 financial statements and related discussion would be provided separately in a Form 8-K amendment; this 10-K does not provide a clear set of Tevogen Bio’s standalone 2023 operating results.
Business context
Tevogen describes itself as a clinical-stage immunotherapy company developing off-the-shelf, allogeneic T-cell therapies using its ExacTcell platform. Its lead candidate, TVGN 489, is being developed for COVID-19, initially targeting high-risk and immunocompromised patients; the company is also exploring Long COVID and earlier-stage candidates for other viral diseases, cancers, and multiple sclerosis. No product is approved for commercial sale, and the company says it has never generated product revenue.
The SPAC business combination closed February 14, 2024, after the 2023 year-end. The combined company began trading on Nasdaq as TVGN and TVGNW on February 15, 2024. Accordingly, the SPAC financial results below should not be read as Tevogen Bio’s operating results.
Financial results and liquidity
| Metric | FY 2023 | FY 2022 |
|---|---|---|
| Operating revenue | None | None |
| General and administrative expense | $2.274 million | $0.953 million |
| Net income (loss) | $(67,325) | $4.408 million |
| Net cash used in operating activities | $(1.376) million | $(215,395) |
| Cash at year-end | $8,835 | $129,186 |
| Cash and marketable securities in trust | $16.681 million | $356.864 million |
The SPAC’s FY 2023 net loss included $2.734 million of unrealized trust-investment gains, offset by operating expenses, a $250,000 impairment of a related-party receivable, $256,031 of interest expense, and a $21,750 warrant fair-value loss. FY 2022 net income included $4.948 million of unrealized trust-investment gains and a $413,250 warrant fair-value gain. These non-operating items make the reported year-to-year earnings comparison less indicative of operating performance. Margins are not meaningful because there was no operating revenue.
At December 31, 2023, the SPAC reported $3.004 million of current liabilities, including a $1.632 million convertible note payable, $230,000 due to an affiliate, and $1.142 million of accounts payable and accrued expenses. It also reported $14.7 million of deferred underwriting fees; the filing says the fee was subsequently reduced to $5 million, payable in shares at the business-combination closing. The 2023 balance sheet showed a $2.648 million working-capital deficit. The filing reports no long-term debt or off-balance-sheet arrangements at year-end.
SPAC operating cash use increased from $215,395 in 2022 to $1.376 million in 2023. Large trust withdrawals reflected shareholder redemptions: approximately $333 million in February 2023 and $9.71 million in December 2023. The trust held about $16.7 million at year-end; after further January 2024 redemptions, approximately $0.8 million remained.
Management and the auditor identify substantial doubt about the company’s ability to continue as a going concern. The filing says $2 million from Series A preferred stock financing had been received and, as of April 26, 2024, only $1.2 million of the planned $6 million Series A-1 financing had been received. Management states that even receipt of the remaining expected proceeds would not fully fund its plans and that additional financing had not been secured. The auditor’s report includes a going-concern explanatory paragraph; it does not modify the financial-statement opinion.
Changes, outlook, and material risks
- Year-over-year: The SPAC moved from $4.408 million net income in 2022 to a $67,325 net loss in 2023, while G&A expense and operating cash use increased. Trust assets fell sharply, primarily due to redemptions.
- Clinical update: Tevogen reports that its Phase 1 TVGN 489 study concluded in January 2023. It enrolled 12 treated and 18 observational-arm patients at one site. The company reports no dose-limiting toxicities or significant treatment-related adverse events in the treated group, and says secondary endpoints were met. The small, early-stage study is not proof of efficacy in larger or different patient populations.
- Plans: Management hoped to begin a pivotal TVGN 489 trial in COVID-19 patients with B-cell malignancies as soon as late 2024, subject to FDA agreement. It also describes a Long COVID genetic-predisposition blood-draw study planned for Q2 2024. The filing gives differing anticipated timing for a Long COVID treatment trial—approximately Q4 2024 in one section and approximately Q1 2025 in another.
- Funding and execution: The company expects substantial ongoing research, clinical, manufacturing, and public-company costs. It has not established its own manufacturing capability and previously relied on Thomas Jefferson University for Phase 1 trial supply. Additional capital may be unavailable or dilutive; preferred stock carries cumulative dividends, and outstanding preferred securities may create further liquidity demands.
- Financial reporting controls: Management identified material weaknesses involving accounting for complex financial instruments and controls over related-party receivable collectability. Tevogen Bio also identified weaknesses involving staffing, segregation of duties, and risk assessment. Management had not completed remediation as of the filing.
- Other investor risks: Product candidates remain unapproved; FDA may require additional trials, and the Phase 1 results may not predict later results. Manufacturing scale-up, trial enrollment, HLA coverage, reimbursement, competition, intellectual-property protection, and dependence on key personnel are material risks. Dr. Saadi beneficially owned approximately 71.9% of common stock as of the ownership information provided, concentrating voting control.
Most important facts to verify
- Review the separate Form 8-K amendment for Tevogen Bio’s audited 2023 financial statements and the combined company’s pro forma financial information; the SPAC figures in this 10-K are not Tevogen Bio’s standalone operating results.
- Confirm current cash, cash burn, remaining Series A-1 proceeds received, other financing, and the company’s updated going-concern assessment.
- Check the FDA’s position on the proposed TVGN 489 pivotal-trial pathway, trial design, timing, and required patient populations.
- Reconcile the filing’s differing Long COVID treatment-trial timing and confirm whether the planned Q2 2024 study and other milestones occurred.
- Track remediation of the disclosed material weaknesses and review subsequent filings for updates to preferred-stock obligations, dilution, and related-party matters.