Microbot Medical Inc. — FY2021 Form 10-K Summary
Reporting period: Fiscal year ended December 31, 2021; filed March 31, 2022. This is an annual report, not a standalone fourth-quarter report. Microbot is a pre-clinical medical-device company developing robotic devices for minimally invasive procedures.
Financial performance and liquidity
| Metric | FY2021 | FY2020 | Change |
|---|---|---|---|
| Product revenue | None | None | No commercial sales |
| Research and development expense | $6.153 million | $3.396 million | Increased $2.757 million |
| General and administrative expense | $5.204 million | $5.693 million | Decreased $0.489 million |
| Operating loss | $11.357 million | $9.089 million | Loss increased |
| Net loss | $11.313 million | $9.169 million | Loss increased |
| Basic and diluted loss per share | $1.59 | $1.29 | Loss per share increased |
| Cash used in operating activities | $9.354 million | $7.252 million | Use increased |
Amounts are U.S. dollars. The company reported no revenue, so revenue-based margins are not meaningful. R&D expense rose mainly with LIBERTY-related salaries, recruitment, professional services and materials. G&A fell primarily due to lower salaries, share-based compensation and government fees, partly offset by higher insurance and professional-service costs.
At year-end, cash and cash equivalents were $13.493 million and marketable securities were $1.999 million; restricted cash was $0.087 million. Management cited $15.492 million of unrestricted cash, cash equivalents and marketable securities and expected this to fund operations for more than 12 months from the report date. Net working capital was approximately $13.895 million, down from $23.908 million in 2020. Cash, cash equivalents and restricted cash declined by $6.154 million during 2021.
Total liabilities were $2.386 million, principally lease liabilities and accrued liabilities; the filing reports no material borrowings at year-end. Lease liabilities totaled $0.680 million, including $0.278 million current and $0.402 million long-term. No income tax provision was recorded; deferred tax assets were fully offset by a valuation allowance.
Business developments, outlook and risks
- LIBERTY: The company continued animal feasibility work on its disposable endovascular robotic system. In December 2021 it entered a technology co-development collaboration with Stryker’s Neurovascular Division to integrate certain Stryker instruments for selected neurovascular procedures. Each party bears its own costs. Management planned an FDA pre-submission as early as Q1 2022 and an FDA submission in the first half of 2023.
- Self-Cleaning Shunt (SCS): FDA discussions in 2021 indicated the company could apply for an Early Feasibility Study without further animal studies based on existing preclinical data. The filing projected beginning the IDE submission process for a first-in-human EFS in Q1 2023. FDA authorization, clinical requirements and timing remain uncertain. Some laboratory results were encouraging, but a Wayne State follow-up study did not show statistically significant differences among groups, and the company described animal-trial results as inconclusive for assessing safety.
- TipCAT and One & Done: TipCAT development was not being pursued for colonoscopy; the company was exploring neurosurgical and endovascular uses. One & Done guidewire technology was being refined for potential integration with LIBERTY, but was not expected in the next LIBERTY version.
- Funding and dilution: Management expected continued losses and said R&D spending would likely rise as programs advance. The company may seek grants, debt or equity financing, including through a $10 million at-the-market facility and an existing registration statement. No shares had been sold under the ATM by year-end. Financing may dilute shareholders or constrain operations; the filing gives no revenue or profitability guidance.
- Litigation: Empery and Hudson Bay seek rescission of a 2017 financing and return of $6.75 million. Management could not assess the likelihood of success or estimate the outcome; no loss provision was recorded at December 31, 2021. The auditor identified this litigation assessment as a critical audit matter. Microbot had previously paid approximately $3.7 million to resolve the related Sabby matter. Separately, a $484,614 judgment in Microbot’s favor against Joseph Mona was under appeal, and related proceedings remained pending.
- Other principal risks: Regulatory clearance and clinical outcomes are uncertain; the company depends on external manufacturers and has no commercial sales infrastructure. Other risks include additional capital needs, Stryker collaboration execution, CardioSert buy-back provisions, IIA technology-transfer restrictions and sales royalties, foreign-exchange exposure, COVID-related disruption, and political or operating risks in Israel. The company reported effective disclosure controls and effective management-assessed internal control over financial reporting; the auditor did not attest to internal-control effectiveness.
Important facts for investors to verify
- Confirm current cash and marketable securities, cash burn and runway; the stated runway is management’s estimate and depends on operating costs and litigation outcomes.
- Track FDA interactions, IDE/EFS filings and actual regulatory milestones for SCS and LIBERTY; the dates in the filing are plans, not approvals.
- Monitor the $6.75 million Empery/Hudson Bay claim, potential legal costs and any change to the unaccrued contingency assessment.
- Review progress and terms of the Stryker development plans, including intellectual-property ownership and the timing of joint work.
- Assess future financing and dilution: 997,148 options were outstanding at year-end, in addition to warrants, and the company had not used its ATM facility as of the filing.