Filing identity and reporting period
Important: The supplied filing is Angion Biomedica Corp.’s Form 10-Q, not an Elicio Therapeutics, Inc. filing. It covers the quarter and nine months ended September 30, 2021; the filing was signed November 12, 2021.
Business context
Angion is a clinical-stage biopharmaceutical company developing treatments for acute organ injuries and fibrotic diseases. It had no products approved for sale and no product-sales revenue. Its lead candidate is ANG-3777; ANG-3070 and other candidates were also in development.
Financial results and liquidity
| Metric (USD millions, except per-share data) | Q3 2021 | Q3 2020 | Nine months 2021 | Nine months 2020 |
|---|---|---|---|---|
| Total revenue | 1.46 | 0.83 | 2.37 | 2.42 |
| Research and development | 13.29 | 6.09 | 42.03 | 27.91 |
| General and administrative | 3.93 | 5.98 | 14.28 | 14.87 |
| Operating loss | (15.76) | (11.59) | (53.94) | (41.42) |
| Net loss | (15.70) | (17.67) | (69.46) | (51.23) |
| Net loss per share | (0.53) | (1.19) | (2.51) | (3.51) |
At September 30, 2021, cash and cash equivalents were $102.7 million, total assets $109.9 million, total liabilities $45.4 million, and stockholders’ equity $64.5 million. Accumulated deficit was $230.0 million. The company reported no convertible notes or preferred stock outstanding after their conversion in the February 2021 IPO. Lease liabilities totaled $4.6 million; warrant liability was $0.4 million.
Operating cash use for the first nine months was $38.3 million, investing cash use $0.35 million, and financing cash provided $106.8 million, mainly from the IPO and concurrent private placement. Cash increased $68.1 million from year-end 2020. Management said available cash was expected to fund planned operations for at least 12 months from the financial-statement issuance date, while warning that additional capital would be needed to advance development and that financing might not be available on acceptable terms.
Material changes and unusual items
- Q3 R&D expense rose 118% year over year, primarily from clinical and preclinical costs for ANG-3777 and ANG-3070 and increased personnel costs. Nine-month R&D rose 51%.
- Q3 G&A fell 34%, mainly because professional fees declined after completion of the IPO. Nine-month G&A declined 4%.
- Revenue shifted from government grant revenue in 2020 to Vifor license contract revenue in 2021. The nine-month revenue total was nearly unchanged, but the mix changed substantially.
- In February 2021, Angion raised approximately $110.6 million net through its IPO and concurrent private placement; convertible notes and preferred shares converted to common stock.
- A $0.9 million gain was recorded after the PPP loan and accrued interest were forgiven in May 2021. Fair-value changes in warrants and previously outstanding financing instruments contributed to non-cash expenses.
- A revised estimate of the Vifor license performance period increased Q3 and nine-month contract revenue by $1.0 million and reduced net loss by the same amount. Deferred revenue under the agreement was $27.4 million at quarter-end.
Outlook, developments, and risks
- ANG-3777 DGF: On October 26, 2021, Angion announced its Phase 3 trial did not meet its primary endpoint and was not expected to support an indication in the studied population. The company said the result reduced Vifor post-approval milestones from approximately $260 million to $130 million; total potential sales milestones were revised to $1.795 billion. The filing reported the trial’s safety profile as consistent with prior program experience and published literature.
- Other programs: The Phase 2 ANG-3777 COVID-19 pneumonia trial did not meet primary or secondary efficacy endpoints, announced in June. Angion expected a Phase 2 CSA-AKI data readout in Q4 2021. It reported positive Phase 1 healthy-volunteer results for ANG-3070 and expected to begin its Phase 2 trial in primary proteinuric diseases in Q4 2021.
- Collaborations: Vifor holds global rights outside Greater China for ANG-3777 renal indications; Angion remains responsible for specified CSA-AKI development activities. Sinovant notified Angion that it intended to terminate its ANG-3777 license effective November 25, 2021.
- Risks: The company expects ongoing losses and relies on third parties, including single-source manufacturers. COVID-19 restrictions had affected clinical-trial enrollment and monitoring. Development, regulatory approval, funding, commercialization, intellectual-property protection, and collaborator performance remain uncertain.
- Controls: Management concluded disclosure controls were ineffective at September 30, 2021 because of unremediated material weaknesses involving complex accounting expertise and financial close/accrual controls. Remediation was underway but not yet validated.
- Angion reported no material legal proceedings and no off-balance-sheet arrangements. Related-party arrangements included its office/laboratory lease with NovaPark, in which Angion held a 10% interest and which was affiliated with the Executive Chairman’s family.
Important facts for investors to verify
- Confirm the intended company: this source identifies Angion Biomedica Corp. (Nasdaq: ANGN), not Elicio Therapeutics.
- Review the full DGF Phase 3 results and implications for ANG-3777, the Vifor agreement, and any remaining milestone or royalty prospects.
- Check the CSA-AKI and ANG-3070 trial updates, timelines, costs, and whether subsequent results changed the stated plans.
- Assess cash runway against continuing operating cash use and the company’s stated need for additional financing.
- Track remediation and subsequent testing of the disclosed internal-control material weaknesses.
- Verify the status and consequences of Sinovant’s planned license termination and any other collaboration changes.