Kiromic Biopharma, Inc. (KRBP)·Q1 2022 Earnings Summary

Executive Summary

• Pre-revenue biotech; Q1 2022 showed sharply higher operating spend with R&D up 55% YoY to $2.93M and G&A up 114% YoY to $4.44M; net loss widened to $7.37M (vs. $3.85M YoY); diluted EPS was $(0.48) (vs. $(0.53) YoY) .
• Cash fell to $15.12M at 3/31/22 (from $25.35M at 12/31/21) with operating cash outflow of $7.58M in Q1; cash burn accelerated and runway is limited absent financing .
• Management highlighted execution milestones across its ALEXIS gamma delta CAR-T platform, cGMP facility expansion, AI/NOEMI design tools, and a target to “begin activation of the clinical trial for…Procel by the end of the fourth quarter” 2022 .
• Governance/controls remediation continued following a February 2022 8‑K detailing disclosure control weaknesses and FDA clinical hold history; 2021 10‑K flagged substantial doubt about going concern, underscoring financing risk as a key stock driver .
• No earnings call transcript and no S&P Global Wall Street consensus were available; estimate comparisons are therefore not applicable (S&P Global consensus unavailable for KRBP).

What Went Well and What Went Wrong

What Went Well

• Progress on ALEXIS (gamma delta CAR‑T) platform: improved manufacturing efficiencies, additional pre-clinical validation, and validation of pooled donor GDT cell banking; next step is in vivo tolerability and efficacy testing .
• Manufacturing readiness: expansion and redesign of in-house cGMP facility; confirmed methodology for RVV release testing for Procel and Isocel .
• AI/tech enablement: DIAMOND AI 2.0 and NOEMI machine-learning design intended to “dramatically accelerate CAR development,” performing in hours what traditionally takes a year . Management tone: “tremendous progress… right team, capabilities, and processes… milestone of beginning the activation of the clinical trial for…Procel by the end of the fourth quarter” 2022 .

What Went Wrong

• Operating intensity and losses increased: R&D +55% YoY to $2.93M, G&A +114% YoY to $4.44M; net loss widened to $7.37M in Q1 2022 (vs. $3.85M in Q1 2021) .
• Cash burn accelerated: operating cash outflow was $7.58M in Q1 2022 (vs. $2.64M YoY), with cash down to $15.12M at quarter-end .
• Regulatory/governance overhang: 2021 10‑K disclosed substantial doubt about going concern; February 2022 8‑K outlined ineffective disclosure controls and the 2021 FDA clinical hold communications, raising litigation and financing risk .

Financial Results

Income statement and EPS (YoY and vs. consensus)

Notes: KRBP reported no revenues (pre‑revenue biotech) . S&P Global Wall Street consensus data were unavailable for KRBP this quarter (no CIQ mapping).

Cash and cash flow

Recent quarterly trend (prior two reported quarters where available)

Note: A stand‑alone Q4 2021 quarterly 8‑K (Item 2.02) was not identified; FY21 details are in the 10‑K (filed April 8, 2022) .

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1 2022 earnings call transcript was found; themes reflect 8‑K press release, February 2022 8‑K, and FY21 10‑K.

Management Commentary

• “This past quarter has seen tremendous progress…from optimizing and validating our ALEXIS Gamma Delta T (GDT) cell platform…to expanding and redesigning our cGMP manufacturing facility and deploying a master cell bank strategy…critical activities for achieving our milestone of beginning the activation of the clinical trial for our first oncology cell therapy candidate Procel by the end of the fourth quarter later this year.” – Pietro Bersani, CEO .
• “NOEMI…can do in hours what would normally take a year,” highlighting a potential acceleration in CAR design timelines via machine learning/genetic algorithms .

Q&A Highlights

• No Q1 2022 earnings call transcript was available; no Q&A items to report. Analysis is based on the 8‑K press release, February 2022 8‑K, and the FY21 10‑K .

Estimates Context

• Wall Street consensus (S&P Global) for Q1 2022 EPS and revenue was unavailable for KRBP this quarter (no CIQ mapping). As a result, comparisons to consensus cannot be made.

Key Takeaways for Investors

• Liquidity/runway is the gating factor: $15.12M cash at 3/31/22 with $(7.58)M Q1 operating cash outflow implies a short runway without near‑term financing or burn moderation; FY21 10‑K flags substantial doubt about going concern .
• Execution milestones are accumulating: manufacturing (cGMP) expansion, RVV release test methodology, pooled donor GDT bank validation, and a defined Procel trial‑activation target (Q4 2022) support near‑term catalysts tied to regulatory acceptance/activation .
• Operating spend elevated: R&D and especially G&A growth (professional fees, personnel, recruiting) drove OpEx higher YoY; monitoring spend discipline vs. financing progress is critical .
• Governance/controls remediation reduces structural risk but litigation/financing risks remain given the detailed 8‑K disclosures around prior FDA communications and ineffective controls .
• Trading setup: stock likely reacts to (1) FDA/IND progress and trial activation timing, (2) financing announcements/terms, and (3) additional manufacturing/AI milestones. With no sell‑side consensus and no revenue, narrative catalysts dominate in the near term (documents cited above).
• Comparative trend: Q3’21 to Q1’22 shows persistent losses and higher G&A; cash fell markedly from $25.35M (12/31/21) to $15.12M (3/31/22), spotlighting near‑term capital needs .

References:

• Q1 2022 8‑K and press release with financials and highlights .
• Q3 2021 8‑K press release financials and business updates .
• Feb 2, 2022 8‑K (governance, disclosure controls, FDA clinical hold communications, leadership changes) .
• FY2021 10‑K (filed April 8, 2022): balance sheet, operating results, cash flows, risk factors, going concern .