Harvard Apparatus Regenerative Technology, Inc. (HRGN)·Q2 2022 Earnings Summary

Executive Summary

• Q2 showed steady cost control and a narrower net loss as Biostage advanced toward initiating its FDA‑approved 10‑patient Phase 1/2 BEI clinical trial; net loss was $1.35M ($0.12/share) vs. $2.18M ($0.20) in Q1 and $0.38M ($0.04) in Q2’21, aided by lower legal spend and modest sublease income .
• The company raised ~$5.1M in May to fund the trial, ending Q2 with $4.64M cash and runway “into Q2 2023,” versus prior guidance of “through Q1 2023” after the financing—effectively extending runway by one quarter .
• A long‑running wrongful death litigation was settled in April (no admission of fault); Biostage issued $4.0M Series E preferred to HBIO to satisfy indemnification, removing an overhang on capital markets and operations .
• No Q2 earnings call transcript was available; a call was held Aug 5, 2022, but only the press release and 10‑Q provide details. Wall Street consensus estimates for Q2 were unavailable; the micro‑cap OTC name lacks broad analyst coverage .

What Went Well and What Went Wrong

• What Went Well

  • Financing closed ($5.1M) to accelerate BEI clinical development; management reiterated uplisting ambition: “sets the company up for initiating its FDA‑approved clinical trial… and enhances the potential attainment of our goal of uplisting to NASDAQ” .
  • Cash runway extended into Q2 2023 on $4.64M cash at 6/30; operating cash burn YTD was $1.65M (six months) .
  • Litigation resolved and off‑balance‑sheet indemnity addressed via Series E preferred, reducing legal noise and overhang (claims dismissed with prejudice; no admission of fault) .

• What Went Wrong

  • Still pre‑revenue; no commercial income to offset R&D or G&A, keeping dependency on external capital and heightening going‑concern risk .
  • G&A remained elevated year‑over‑year due to legal and public company costs (Q2 G&A $1.05M vs. $0.62M last year; +70%) .
  • No transcript/Q&A available for the quarter; limited external signaling on trial timing beyond “initiating,” which can constrain near‑term catalysts absent clinical enrollment news .

Financial Results

Quarterly P&L and expense trend (oldest → newest)

Year-over-year snapshot

KPIs and balance sheet (oldest → newest)

Notes:

• Company remained pre-revenue; “We did not recognize any revenues during the quarters ended June 30, 2022 and 2021.” .
• YoY net loss increased as 2022 reflects ongoing legal/public company costs; sequentially, legal cost intensity moderated from Q1 to Q2 .

Guidance Changes

Earnings Call Themes & Trends

No Q2’22 call transcript was available; company held a call Aug 5 per press release, but only high‑level themes are evident in filings.

Management Commentary

• “We are very pleased with our progress this quarter which sets the company up for initiating its FDA‑approved clinical trial in severe esophageal disease and enhances the potential attainment of our goal of uplisting to NASDAQ.” — David Green, Founder, Chairman & Interim CEO .
• “This is important data that supports the safety profile of the Biostage Esophageal Implant.” (on Journal of Biomechanics paper on mechanical strength of regenerated tissue) .
• “Joe’s skills and experience will help Biostage with its intended relisting on NASDAQ… as we prepare for our clinical trial…” — David Green on CFO appointment (Aug 8) .

Q&A Highlights

• No Q2’22 transcript available. Company announced a conference call for Aug 5, 2022, but a transcript was not found in the document set .

Estimates Context

• Wall Street consensus (S&P Global) for Q2’22 revenue and EPS was unavailable; the company trades OTC and lacks broad analyst coverage. As a result, no formal “vs. consensus” comparison can be made .

Key Takeaways for Investors

• Financing and runway: The $5.1M raise and $4.64M cash at quarter‑end extend runway into Q2’23—providing a window to initiate the BEI trial without immediate financing pressure .
• Overhang removal: Settlement of the wrongful death case and indemnity resolution via Series E preferred reduce legal and balance sheet uncertainty—supportive for financing and eventual uplisting efforts .
• Execution focus: Management messaging centers on initiating the FDA‑approved BEI trial; publication of supportive biomechanics data strengthens the safety narrative entering clinical execution .
• Cost profile: Sequential improvement in net loss as legal intensity eased from Q1; nevertheless, G&A remains elevated vs. prior year, and continued spend discipline will matter given pre‑revenue status .
• Catalysts: Near‑term—trial site activation/enrollment updates; mid‑term—early clinical readouts; corporate—progress toward uplisting and potential follow‑on financings to fund development .
• Risk posture: Going‑concern language persists; the company expects to need additional capital by or before Q2’23 absent new funding or partnership—timely execution on clinical and capital markets is critical .

Appendix: Additional Context

• Cash and capital structure: End‑Q2 other highlights include sublease income ($32k in Q2) and weighted average shares of 11.23M (basic/diluted); warrants outstanding and equity activity detailed in the 10‑Q .
• Corporate actions: Shareholders approved a reverse split authorization (range 1‑for‑1.25 to 1‑for‑5) on July 28, 2022—an important mechanic for potential uplisting .
• Business model reminder: Biostage remained pre‑revenue in Q2 and Q2’21 and expects to continue incurring operating losses while advancing clinical programs .