Name: Harvard Apparatus Regenerative Technology, Inc. Q3 2022 Earnings Call
Start: 2022-11-15T09:01:00.000Z

Executive Summary

Q3 2022 was a largely operational quarter: no revenue, net loss of $1.06M and diluted EPS of $-0.10, with cash of ~$3.0M and no debt; management reiterated cash runway “into Q2 2023.”
Corporate highlights included a new U.S. patent expanding the platform to patch-based scaffolds (“Biostage Tissue Patch”) and the previously announced appointment of CFO Joseph Damasio; both support clinical/readiness and capital markets ambitions.
Management maintained the goal to commence the FDA‑approved esophageal implant clinical trial and pursue a NASDAQ uplisting; they were in an S‑1 quiet period and did not take questions.
No Wall Street consensus estimates were available via S&P Global for Q3 2022; therefore, no beat/miss analysis could be performed.
Near-term stock catalysts: IP expansion (new patent), clinical trial start readiness, and capital raise/uplisting progress; legal headwinds have eased following the wrongful death settlement earlier in 2022.

What Went Well and What Went Wrong

New U.S. patent protecting patch-based scaffolds (“Biostage Tissue Patch”), broadening potential indications across esophagus and GI tract; CEO highlighted the potential to treat fistulas and strictures. “Biostage expects this new technology to enable it [to] treat fistulas … and damage … in other parts of the gastro-intestinal tract.”
Strengthening leadership for capital markets execution: appointment of CFO Joseph Damasio with prior uplisting/financing experience. “Joe provides Biostage with considerable experience … including uplisting to NASDAQ.”
Balance sheet clarity and runway: ~$3.0M cash, no debt, and reiterated runway into Q2 2023; management quantified quarterly cash burn. “Cash on hand of approximately $3 million and had no debt… we used approximately $1.6 million in cash for operations during the quarter.”

Continued operating losses with no revenue: net loss widened versus prior year comparable (Q3 2021), and negative EPS persisted amid higher operating expenses.
R&D and G&A cost pressures: y/y operating expenses increased, driven by consulting/legal and share-based comp; legal-related expenses remained a 2022 drag.
S&P Global estimates unavailable: lack of coverage prevents benchmark comparisons and may limit investor visibility; management also refrained from Q&A due to S‑1 quiet period, reducing disclosure depth.

Metric	Q3 2021	Q1 2022	Q2 2022	Q3 2022
Revenue ($USD Millions)	$0.00	N/A	N/A	$0.00
Net Loss ($USD Millions)	$(0.849)	$(2.177)	$(1.345)	$(1.056)
Diluted EPS ($USD)	$(0.08)	$(0.20)	$(0.12)	$(0.10)
R&D Expense ($USD Millions)	$0.250	$0.303	$0.326	$0.369
G&A Expense ($USD Millions)	$0.572	$1.902	$1.049	$0.711
Total Operating Expenses ($USD Millions)	$0.822	$2.205	$1.375	$1.080

Liquidity KPIs

Metric	Q1 2022	Q2 2022	Q3 2022
Cash and Equivalents ($USD Millions)	$0.723	$4.640	$2.971
Cash Used in Ops (Quarter) ($USD Millions)	$(0.5)	N/A	$(1.6)

Notes: Revenue was not recognized in Q3 2022 and Q3 2021; Q2 and Q1 revenue disclosures are not material/not presented in releases.

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Operating expenses & capex coverage	Through Q1 2023 (as of May 16, 2022)	Into Q2 2023 (as of Aug 4 and Nov 14, 2022)	Raised vs Q1; Maintained vs Q2
Clinical Trial Timing	BEI (FDA-approved to commence)	Trial approved to commence; timing not guided	Trial approved to commence; timing not guided	Maintained
Uplisting	NASDAQ target	Goal stated	Goal stated	Maintained

Topic	Previous Mentions (Q1 2022 and Q2 2022)	Current Period (Q3 2022)	Trend
Regulatory/Legal	Wrongful death case settled Apr 27; ~$6.0M total costs outlined; issuance of Series E preferred to HBIO in June; legal costs elevated YTD	Legal costs moderating; no new litigation; going concern risk noted given runway	Improving legal overhang; funding need persists
Financing & Uplisting	Closed $5.1M private placement in May; NASDAQ uplisting goal reiterated	S‑1 quiet period; uplisting goal maintained; CFO with capital markets experience	Building towards capital event
R&D Execution & IP	Published esophageal tissue mechanical strength data (June); FDA trial approval	New U.S. patent for patch-based scaffolds (Biostage Tissue Patch)	Strengthening platform/IP
Management Changes	N/A	Appointed CFO Joseph Damasio (Aug 8)	Enhanced leadership
Supply Chain/Macro	N/A	Company monitoring global supply chain/inflation; not materially impacting performance to date	Stable to manageable
Cash Runway	Through Q1 2023 (Q1)	Into Q2 2023 (Q2/Q3)	Extended then maintained

David Green (Interim CEO): “Biostage was issued a U.S. patent that protects the extension of the use of Biostage’s technology from hollow tubes to patches… This new technology is known as the Biostage Tissue Patch.”
David Green (Interim CEO, on call): “Biostage expects this new technology to enable it [to] treat fistulas… strictures… and damage… in other parts of the gastro-intestinal tract.”
Joseph Damasio (CFO): “Our net loss was approximately $1.1 million or $0.10 per basic and diluted share… As of September 30, 2022, we had cash on hand of approximately $3 million and had no debt… we used approximately $1.6 million in cash for operations during the quarter… we expect that our current cash will be sufficient to fund… into the second quarter of 2023.”

Management conducted the call under a legally required quiet period related to Form S‑1 and did not take questions.
No additional guidance clarifications or numerical updates beyond prepared remarks were provided due to the quiet period.

S&P Global consensus estimates (EPS and revenue) for Q3 2022 were not available for HRGN; analyst coverage appears absent, preventing beat/miss comparisons.
Implication: Investors should anchor on internal milestones (IP, clinical trial initiation, capital positioning) and actuals, rather than traditional consensus frameworks for near-term trading.

No revenue and continuing operating losses, but cash of ~$3.0M and no debt; runway maintained into Q2 2023—watch for financing updates and potential uplisting steps.
IP expansion via the Biostage Tissue Patch patent broadens addressable indications and may strengthen the platform’s value proposition ahead of first clinical trial enrollment.
Leadership bolstered for capital markets execution with the new CFO; S‑1 quiet period suggests active preparatory work—monitor for filing/transaction events.
Legal overhang substantially reduced post-settlement; 2022 legal spend elevated but trending down—removing a structural impediment to capital formation.
Short-term trading implications: catalysts likely tied to clinical trial gating, patent/IP communication, and financing/uplisting progress; lack of estimates means headline beats/misses will not drive moves.
Medium-term thesis: execution on FDA‑approved trial and sustained access to capital are critical to bridge to value inflection; watch cost discipline in R&D/G&A as the trial initiates.

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