Business context and reporting period
This is BiondVax Pharmaceuticals Ltd.’s unaudited Form 10-Q for the three months ended March 31, 2023. The request identifies Scinai Immunotherapeutics Ltd., but the supplied filing is for BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV); confirm the issuer before relying on this summary.
BiondVax is a development-stage biotechnology company transitioning from its discontinued M-001 influenza vaccine to a NanoAb pipeline developed under agreements with the Max Planck Society and University Medical Center Göttingen. It reported no revenue for the quarter.
Financial results and liquidity
Unless otherwise stated, amounts are U.S. dollars in thousands.
| Metric | Q1 2023 | Q1 2022 / comparison |
|---|---|---|
| Revenue | None reported | None reported |
| Research and development expense | $1,995 | $1,163 |
| Marketing, general and administrative expense | $1,191 | $1,452 |
| Operating loss | $3,186 | $2,615 |
| Financial loss (income), net | $329 loss | $140 income |
| Net loss | $3,515 | $2,475 |
| Net loss per share, basic and diluted | $0.003 | $0.003 |
| Operating cash used | $3,059 | $1,105 |
| Investing cash used | $6 | $521 |
Margins are not meaningful because the company reported no revenue. Cash and cash equivalents were $10,799 at March 31, 2023, plus restricted cash of $127, compared with cash and equivalents of $14,075 at December 31, 2022. Cash, equivalents and restricted cash together declined by $3,289 during the quarter to $10,926. Management reported working capital of $8.4 million and an accumulated deficit of $119.350 million.
At March 31, 2023, the balance sheet showed a $21.851 million non-current “loan from others,” $2.664 million of warrant liabilities, and a shareholders’ deficit of $4.810 million. The filing describes the EIB loan restructuring: maturity extended to December 2027, interest accrues at 7% annually and is deferred, and 10% of future capital raises is to be applied to repayment. The loan is secured by a first-ranking floating charge over substantially all company assets, subject to stated exceptions.
Material changes versus the prior comparable period
- Net loss increased by $1.040 million year over year, as higher R&D expense and a swing from net financial income to net financial expense outweighed lower general and administrative expense.
- R&D expense rose $832,000, which management attributed primarily to launching NanoAb development. General and administrative expense fell $261,000; management cited lower share-based payment and professional-services costs, partly offset by higher salaries and marketing expense.
- Operating cash use increased by $1.954 million. Cash use was partly offset in the operating-cash reconciliation by a $2.568 million warrant revaluation gain; the filing also reports $2.354 million of financial expenses related to the loan.
- Shares outstanding increased from 989,290,784 at December 31, 2022 to 1,313,623,184 at March 31, 2023, following exercise of warrants for 324 million ordinary shares. The filing lists 1.041 billion warrants and 121.3 million employee RSUs and options excluded from diluted loss per share as anti-dilutive.
Outlook, risks and unusual items
- Management expects continued operating losses and says additional financing will be needed to advance development and meet longer-term objectives. It stated existing resources and operating plans, including a potential cost-saving plan, were expected to cover liquidity needs for at least 12 months from the filing date. It also warned that additional financing is not assured or secured; absent funding, the company may reduce or delay development and other activities.
- The board-approved cost-saving plan may include headcount reductions and postponing or cancelling capital expenditures, at management’s discretion as required.
- The $2.568 million warrant revaluation gain reduced reported financial expense; warrants are liability-classified and remeasured through earnings. The EIB loan revaluation contributed $1.769 million of financial expense in the quarter, according to the notes.
- The company’s prior M-001 Phase 3 trial failed its primary and secondary efficacy endpoints. Management does not expect M-001 revenue and therefore does not currently expect royalties on M-001 sales to the EIB or Israeli Innovation Authority. The EIB retains contractual rights, including potential acceleration upon specified defaults.
- The NanoAb strategy remains early-stage and subject to scientific, clinical, regulatory, manufacturing, commercialization and financing risks. Management described potential development and licensing plans, but provided no quantified revenue, earnings or cash-flow guidance.
- Management reported disclosure controls and procedures were effective as of March 31, 2023, with no material changes in internal control over financial reporting during the quarter. The filing reports no material legal proceedings and no material changes to previously disclosed risk factors.
Key facts investors should verify
- Confirm the issuer: the supplied filing is BiondVax Pharmaceuticals Ltd., not Scinai Immunotherapeutics Ltd.
- Reconcile cash runway assumptions with the $3.059 million quarterly operating cash burn, planned R&D spending and the contingent cost-saving plan.
- Review EIB loan carrying value, nominal principal, interest accrual, security and repayment terms. The notes’ nominal-principal disclosure says “as of March 31, 2022,” while appearing in the Q1 2023 filing; confirm the applicable date and current amount.
- Assess potential dilution from the 1.041 billion warrants and other excluded potential shares, including exercise terms and expirations.
- Track NanoAb candidate selection, development milestones, collaboration costs, financing requirements and any clinical-trial plans; the filing’s forward-looking development expectations are conditional on capital and other factors.