Business Context and Reporting Period
This unaudited Form 10-Q covers the three months ended March 31, 2019. The filing registrant is Amarillo Biosciences, Inc. (ABI), not Ainos, Inc.; investors should verify the issuer identity. ABI describes a diversified healthcare business spanning pharmaceutical, medical and consumer products, with operations in the U.S. and Taiwan.
Key Financial Metrics
| Metric | Q1 2019 | Q1 2018 or prior balance |
|---|---|---|
| Revenue | $4,076 | $56,590 |
| Gross profit and margin | $1,358; 33% | $13,251; 23% |
| Operating expenses | $391,862 | $199,309 |
| Operating loss | $390,504 | $186,058 |
| Net loss | $391,389 | $187,438 |
| Net loss attributable to common shareholders | $391,389 | $192,430 |
| Basic and diluted loss per share | $0.01 | $0.01 |
| Cash used in operating activities | $216,202 | $76,524 |
| Cash and cash equivalents | $1,046,314 at March 31 | $1,276,654 at December 31, 2018 |
| Working capital | $397,523 at March 31 | $569,613 at December 31, 2018 |
| Total assets | $1,225,840 at March 31 | $1,463,700 at December 31, 2018 |
| Total liabilities | $673,755 at March 31 | $733,621 at December 31, 2018 |
All liabilities were classified as current. Related-party convertible notes totaled $475,856 at quarter-end. Cash declined by $230,340 during the quarter; financing included $37,500 of note repayments and $25,000 of private-placement proceeds. ABI reported a monthly cash burn rate of $65,000–$75,000.
Material Changes Versus Prior Period
- Revenue fell approximately 93% year over year, while cost of revenue declined to $2,718 from $43,339. Gross margin increased to 33% from 23%.
- SG&A increased by $190,167, which management attributed primarily to salary increases, accounting and consulting services, stock-option expense, and executive consulting. R&D expense was $2,386 versus none in Q1 2018.
- Operating loss increased by $204,446; the company reported a 103% increase in net loss attributable to common shareholders.
- Operating cash use rose to $216,202 from $76,524. Cash and working capital also declined from year-end 2018.
- ABI issued shares during the quarter, including shares for private-placement proceeds, a finder’s fee and compensation. Common shares outstanding were 39,568,524 at March 31 and 39,664,199 as of May 17, 2019.
Outlook, Risks and Unusual Items
- Going concern: ABI has not achieved sustained operating income, anticipates continuing losses and says its operations depend primarily on related-party convertible debt and equity financings. Management states that these factors raise substantial doubt about the company’s ability to continue as a going concern. Short-term project financing needs were estimated at $3 million–$5 million.
- Product development: Further clinical trials and commercialization of low-dose oral interferon are on hold until ABI finds a new cGMP interferon supplier. A new source may require comparability studies and additional clinical trials.
- Other business plans: ABI described plans involving pulsatile insulin therapy in Taiwan, wound-care distribution and liposomal nutraceuticals, but did not provide quantified revenue or earnings guidance. Management cautioned that first-quarter results are not necessarily indicative of full-year results.
- Risks: The filing cites regulatory approval, clinical-trial outcomes and costs, patient enrollment, commercial-partner timing, financing availability and the ability to continue as a going concern. Additional equity financing could dilute shareholders.
- Controls: Management concluded disclosure controls were not effective and identified material weaknesses involving accounting expertise and segregation of duties. ABI said it had engaged an accounting-services provider and intended to add technical accounting resources.
- Subsequent events: After quarter-end, ABI issued 95,675 shares for previously accrued compensation and fees. A director, general counsel and corporate secretary resigned effective April 30, 2019; the company’s only outstanding private-placement offer expired April 25.
Investor Verification Priorities
- Confirm the issuer identity and whether this filing relates to the requested company, Ainos, Inc.; the filing names Amarillo Biosciences, Inc.
- Assess financing needs, cash burn, related-party debt terms and repayment demands in light of the stated going-concern doubt.
- Track progress toward securing an interferon manufacturer and the costs, timing and funding of required studies and trials.
- Review the causes of the sharp revenue decline and whether the medical and consumer product initiatives are generating sustainable sales.
- Monitor dilution from shares reserved, issued or potentially issuable, and the remediation of disclosed material weaknesses.