Elicio Therapeutics, Inc. quarterly report, Q3 FY2022

Filing summary

Entity discrepancy: The request identifies Elicio Therapeutics, Inc., but the supplied Form 10-Q is for Angion Biomedica Corp. (Nasdaq: ANGN). The summary below describes the supplied filing, not an Elicio filing.

Business context and reporting period

Unaudited quarterly report for the three and nine months ended September 30, 2022, filed November 14, 2022. Angion was a clinical-stage biopharmaceutical company with no approved products or product-sales revenue. In July 2022, it began exploring strategic alternatives and halted ANG-3070 development and most other development work while the process continued.

Financial performance and liquidity

MetricQ3 2022Q3 2021Nine months 2022Nine months 2021
Revenue$0$1.46 million$2.30 million$2.37 million
Research and development$2.94 million$13.29 million$17.94 million$42.03 million
General and administrative$3.32 million$3.93 million$10.89 million$14.28 million
Restructuring expense$2.80 million$0$6.04 million$0
Net loss$8.99 million$15.70 million$32.37 million$69.46 million
Net loss per share, basic and diluted$0.30$0.53$1.08$2.51

Operating loss was $9.05 million in Q3 and $32.57 million for the first nine months. Operating margins are not meaningful given the company’s lack of product sales and minimal contract revenue. Nine-month operating cash outflow was $33.96 million, compared with $38.28 million in 2021; investing cash flow was zero and financing cash flow was a $0.05 million outflow. Cash and cash equivalents fell to $55.14 million at September 30 from $88.76 million at December 31, 2021.

Total assets were $61.32 million and total liabilities $11.11 million. Current assets of $56.68 million exceeded current liabilities of $8.18 million. The filing reports no convertible notes outstanding; financing obligations were $0.25 million, apart from operating lease liabilities of $3.71 million.

Material changes versus prior periods

  • Q3 revenue fell to zero from $1.46 million; nine-month revenue was down 3% to $2.30 million. Revenue was from the Vifor ANG-3777 license, and all remaining deferred revenue was recognized by June 2022.
  • R&D expense declined 78% in Q3 and 57% year to date, mainly because ANG-3777 trials ended and staffing and development activity were reduced.
  • Q3 net loss narrowed by $6.72 million year over year despite $2.80 million of restructuring charges. Nine-month net loss narrowed by $37.10 million, also reflecting lower operating costs and the absence of significant 2021 fair-value losses on financing instruments.
  • Cash decreased by $33.61 million over the first nine months of 2022; the prior-year period included substantial IPO and private-placement proceeds.

Outlook, commentary, and risks

Management said available cash was expected to fund planned operations for at least 12 months after issuance of the financial statements; elsewhere, the risk discussion estimated funding would last “well into 2023.” The filing cautions that projections may be wrong and says the strategic process, its duration, and related costs make future capital needs difficult to estimate. Management expects lower near-term R&D spending while development is suspended. No specific transaction, operating forecast, or financial guidance was provided.

Strategic alternatives under consideration include a merger, reverse merger, business combination, asset sale, licensing, or another strategic transaction; completion is not assured. ANG-3777’s Phase 3 DGF and Phase 2 CSA-AKI trials missed their primary endpoints, and the company said it did not expect further Vifor milestones or royalties under the planned development path. ANG-3070 development was discontinued following safety concerns in its kidney-disease study and the strategic realignment. A majority of the workforce was subject to a July reduction in force; the company recorded $2.80 million of related Q3 charges.

Other notable risks include potential Nasdaq listing noncompliance: the filing cited a November 9, 2022 share price as low as $0.81, below the $1.00 minimum bid-price requirement. Management stated prior material weaknesses in financial-reporting controls had been remediated and controls were effective as of September 30, 2022. The company disclosed no material litigation. It also rents its principal office and laboratory space from related-party NovaPark under a lease through June 2026.

Important facts for investors to verify

  • Confirm the intended issuer: this source is Angion Biomedica Corp., not Elicio Therapeutics, Inc.
  • Check subsequent filings for the outcome, timing, costs, and any dilution or liabilities arising from the strategic-alternatives process.
  • Reconcile the stated cash runway estimates with actual cash burn, restructuring payments, and public-company costs.
  • Review subsequent disclosures on suspended or discontinued programs, Vifor collaboration analyses, and any potential ANG-3777-related payments.
  • Monitor Nasdaq listing compliance and whether the reported remediation of material weaknesses remains effective.