Filing identity and reporting period
The supplied filing is Angion Biomedica Corp.’s Form 10-Q for the quarter ended June 30, 2021, filed August 12, 2021 (Nasdaq: ANGN). It is not identified as a filing by Elicio Therapeutics, Inc.; investors should confirm the intended company and filing.
Angion is a clinical-stage biopharmaceutical company developing treatments for acute organ injuries and fibrotic diseases. It had no approved products and no product-sales revenue.
Financial performance and liquidity
Amounts below are in millions of dollars unless otherwise stated.
| Metric | Three months ended June 30, 2021 | Six months ended June 30, 2021 | Prior-year comparable period |
|---|---|---|---|
| Total revenue | $0.54 | $0.91 | $0.73 and $1.59, respectively |
| Research and development expense | $14.44 | $28.74 | $12.23 and $21.83, respectively |
| General and administrative expense | $4.34 | $10.35 | $5.44 and $8.89, respectively |
| Operating loss | $18.24 | $38.18 | $17.27 and $29.84, respectively |
| Net loss | $17.07 | $53.76 | $20.34 and $33.56, respectively |
| Net loss per share | $0.58 | $2.02 | $1.40 and $2.32, respectively |
Revenue was contract revenue from the Vifor license; there were no product sales. No profit margin is meaningful given the company’s operating losses and minimal revenue. Six-month operating cash use was $23.08 million, investing cash use was $0.29 million, and financing provided $106.07 million, primarily from the IPO and concurrent private placement. Cash and cash equivalents were $117.31 million at June 30, 2021, versus $34.61 million at December 31, 2020. Management said cash was expected to fund planned operations for at least 12 months from issuance of the financial statements.
Total liabilities were $48.17 million, including $4.78 million of operating lease liabilities and $28.90 million of deferred revenue. Convertible notes and preferred stock converted to common stock at the February 2021 IPO; no such balances remained at quarter-end. The $0.9 million PPP loan was forgiven, producing a gain.
Material changes versus the prior period
- Second-quarter net loss narrowed to $17.07 million from $20.34 million, despite an $0.98 million increase in operating loss. The improvement primarily reflected lower other expense, including the $0.9 million PPP forgiveness gain and reduced fair-value effects after the IPO.
- For the first half, net loss widened to $53.76 million from $33.56 million. R&D expense rose 32%, driven mainly by higher personnel costs and clinical and preclinical activity; G&A rose 16% for the half.
- Grant revenue ceased in the reported periods, while Vifor license revenue began. The company raised approximately $110.6 million net through its IPO and concurrent private placement and ended the period with positive stockholders’ equity of $77.19 million.
Outlook, developments, and risks
- Management expected substantial losses and expenses to continue as programs advanced, and stated that additional capital would eventually be required. Future financing may not be available on acceptable terms and could dilute stockholders or require development cuts.
- ANG-3777’s exploratory Phase 2 COVID-19-related lung injury trial did not meet primary or secondary efficacy endpoints, as announced June 29, 2021. The company expected the next ANG-3777 data readout from its Phase 3 delayed-graft-function trial. It shifted its expected IND filing for ANG-3777 in acute CNS injury to 2022 from 2021.
- After quarter-end, Angion reported positive Phase 1 healthy-volunteer results for ANG-3070 and FDA acceptance of an IND supporting a planned 2021 Phase 2 trial. The filing reported no serious adverse events in that study; non-serious events at higher doses included mild-to-moderate gastrointestinal symptoms.
- COVID-19 restrictions had affected trial enrollment and monitoring. Angion relied on third parties, including single-source suppliers, for manufacturing and clinical work.
- The Vifor agreement grants rights to ANG-3777 renal indications outside Greater China. Potential deal value is up to $1.925 billion, including contingent milestones and royalties; these amounts are not assured. The company retains specified development responsibilities and Vifor has termination rights.
- Disclosure controls were judged ineffective at June 30 because of unremediated material weaknesses involving complex accounting expertise and period-end expense accrual and review controls. Remediation was ongoing.
- The company disclosed related-party relationships involving office and laboratory landlord NovaPark and other affiliates. It reported no material legal proceedings.
Important facts for investors to verify
- Whether this Angion 10-Q is the intended filing, given the request names Elicio Therapeutics.
- Current cash runway and projected spending, including how clinical trial timing or results may change funding needs.
- ANG-3777 Phase 3 design and endpoint: the filing says FDA had not agreed with the revised primary endpoint rationale, creating regulatory risk.
- Progress and results for ANG-3070’s planned Phase 2 trial, and the full context of the post-quarter Phase 1 announcement.
- Vifor and Sinovant agreement conditions, contingent milestone likelihood, royalties, and termination provisions.
- Status of remediation and testing of the disclosed internal-control material weaknesses.