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Kiromic Biopharma, Inc. (KRBP)·Q1 2021 Earnings Summary

Executive Summary

  • Q1 2021: Pre-revenue with net loss of $3.85M and EPS of $(0.53); operating expenses rose sharply as the company prepared for IND submissions and first-in-human dosing in Q3 2021 .
  • Cash and equivalents were $7.34M at March 31, 2021, down from $10.15M at December 31, 2020, driven by operating cash outflows; SBA PPP loan forgiveness ($105.8K) modestly offset loss .
  • Management plans to submit two INDs by end of May 2021 (ALEXIS-PRO-1 targeting PD-L1 and ALEXIS-ISO-1 targeting isomesothelin), reaffirming first-in-human dosing in Q3 2021; facility expansion adds 15,385 sq ft, enhancing GMP capacity .
  • Wall Street consensus via S&P Global was unavailable for Q1 2021; estimates comparison cannot be provided.

What Went Well and What Went Wrong

What Went Well

  • Facility expansion (+15,385 sq ft, total ~38,223 sq ft) to scale manufacturing capabilities; lease commencement August 1, 2021 .
  • Operational milestones and clear clinical path: two INDs planned by end of May 2021; first in-human dosing targeted for Q3 2021 .
  • Non-dilutive and partnership tailwinds: MD Anderson $300K research grant (pancreatic cancer biomarker validation); SBA loan forgiveness of $105.8K .

Management quote: “Kiromic BioPharma achieved important scientific and operational milestones… preparing our staff and our facilities for the first in-human dosing in Q3 2021… we plan to submit two investigational new drug applications… by the end of May 2021.”

What Went Wrong

  • Net loss widened to $3.85M (from $1.85M YoY) on higher R&D and G&A as clinical programs advanced .
  • Cash decreased to $7.34M from $10.15M in Q4 2020 due to $2.64M operating cash outflows, highlighting near-term funding needs as trials approach .
  • G&A expense surge (+151% YoY to $2.07M) largely from stock comp and professional services; R&D up 83% YoY to $1.89M as manufacturing/experimentation scaled .

Financial Results

Income Statement and EPS (quarterly)

MetricQ3 2020Q1 2021Q1 2021 Estimate
Revenues ($USD)$0 $0 N/A
Research & Development ($USD)$1,225,700 $1,885,600 N/A
General & Administrative ($USD)$1,190,000 $2,071,000 N/A
Total Operating Expenses ($USD)$2,415,700 $3,956,600 N/A
Net Loss ($USD)$(2,415,700) $(3,854,500) N/A
Net Loss per Share (EPS, $USD)$(0.65) $(0.53) N/A

Note: S&P Global Wall Street consensus was unavailable for KRBP Q1 2021, so estimate comparisons could not be provided.

Balance Sheet and Cash

MetricQ3 2020 (Sep 30)Q4 2020 (Dec 31)Q1 2021 (Mar 31)
Cash and Equivalents ($USD)$469,300 $10,150,500 $7,335,300
Total Assets ($USD)$3,180,100 $12,829,700 $10,152,700
Total Liabilities ($USD)$2,251,500 $1,467,600 $1,699,900
Total Stockholders’ Equity ($USD)$928,600 $11,362,100 $8,452,800
Accounts Payable ($USD)$1,672,900 $665,200 $1,203,200

Cash Flow Highlights

MetricQ3 2020Q1 2021
Net Cash Used in Operating Activities ($USD)$(3,557,200) $(2,635,900)
Net Cash Used in Investing Activities ($USD)$(1,013,100) $(44,700)
Net Cash (Used in)/Provided by Financing ($USD)$3,110,500 $(134,600)

KPIs and Operational Metrics

KPIQ3 2020Q4 2020Q1 2021
IND filings statusPlanned INDs by Q4 2020 Resubmission planned March 2021 Two INDs planned by end-May 2021
First in-human dosing targetN/AQ3 2021 target Reaffirmed Q3 2021
Facility expansion (sq ft)Vivarium & clean rooms completed GMP facility completion +15,385 sq ft (total ~38,223)
Partnerships/Grants—Longwood Univ. chPD1 license MD Anderson grant $300,000
SBA PPP loan forgiveness——$105,800 gain
Leon Office Asia agreement cost——$360,000 annually

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
IND submissions (ALEXIS-PRO-1, ALEXIS-ISO-1)1H 2021File two INDs in Q4 2020 Submit two INDs by end-May 2021 Lowered/Delayed timeline
IND resubmission planMar 2021Resubmit two INDs (protocols ~80% retained) Submit by end-May 2021 Revised timeline later in 2Q
First in-human dosingQ3 2021Target Q3 2021 Reaffirmed Q3 2021 Maintained
Facility footprint2021cGLP/cGMP rooms completed +15,385 sq ft expansion; start Aug 1, 2021 Raised capacity

No financial guidance was provided (revenue, margins, OpEx ranges, tax, dividends) .

Earnings Call Themes & Trends

No Q1 2021 earnings call transcript found in our document catalog; themes are drawn from the 8-K press releases.

TopicPrevious Mentions (Q-2: Q3 2020)Previous Mentions (Q-1: FY/Q4 2020)Current Period (Q1 2021)Trend
AI/technology initiatives (DIAMOND)Emphasis on DIAMOND for target discovery DIAMOND central to approach Continued AI-enabled discovery Consistent emphasis
Regulatory/INDPlanned two INDs in Q4 2020 Resubmission planned; protocols ~80% retained Two INDs planned by end-May 2021 Delay but clearer timeline
R&D executionExternal validation of isomesothelin targets Advancing CAR-T gamma-delta platform Increased experimentation/manufacturing costs (R&D +83% YoY) Scaling toward clinical
Manufacturing infrastructureVivarium/cGMP completion GMP facility completion +15,385 sq ft expansion Capacity expanding
Partnerships—Longwood Univ. chPD1 license Leon Office Asia strategic agreement ($360K/yr); MD Anderson grant ($300K) Increasing collaborations
Financing/macroIPO $15M completed Cash $10.15M YE 2020 Cash $7.34M; PPP forgiveness $105.8K Cash burn ahead of trials

Management Commentary

  • “Kiromic BioPharma achieved important scientific and operational milestones… preparing our staff and our facilities for the first in-human dosing in Q3 2021… we plan to submit two investigational new drug applications… by the end of May 2021.” — Dr. Maurizio Chiriva-Internati, CEO
  • “Developing live-cell therapies by leveraging artificial intelligence is central to transforming the cost and efficiency of the immune-oncology field… DIAMOND is central to our process…” — Dr. Chiriva-Internati on FY 2020 progress .
  • “Through their efforts… we are poised to file our two INDs… the first IND will be our chimeric PD1… the second IND will be our isoform mesothelin…” — Q3 2020 commentary .

Q&A Highlights

No Q1 2021 earnings call transcript available in our document catalog; therefore, Q&A highlights and any real-time guidance clarifications are not available.

Estimates Context

  • Wall Street consensus via S&P Global was unavailable for KRBP Q1 2021; we could not retrieve EPS or revenue estimates to compare actuals against consensus.

Key Takeaways for Investors

  • Near-term catalysts: Submission of two INDs by end-May 2021 and first-in-human dosing in Q3 2021 are the primary value inflection points; delays from original Q4 2020 plan are now framed with clearer timing .
  • Cash runway considerations: $7.34M cash at quarter-end with $2.64M operating cash outflow in Q1 suggests financing needs ahead of trial initiation; monitor capital markets and potential non-dilutive sources .
  • Increased OpEx reflects clinical readiness: R&D (+83% YoY) and G&A (+151% YoY) growth tied to headcount, manufacturing, stock comp, and professional services; expect elevated burn as trials commence .
  • Manufacturing capability scaling: Facility expansion (+15,385 sq ft) and prior cGMP/cGLP build-out support allogeneic gamma-delta CAR-T manufacturing as programs progress .
  • Strategic partnerships deepen: MD Anderson grant ($300K) and Leon Office Asia agreement ($360K/yr) broaden scientific validation and international business development reach .
  • Regulatory trajectory: Protocol continuity (~80% retained from original INDs) and reaffirmed Q3 2021 dosing indicate continuity despite timeline shifts; regulatory feedback integrated .
  • Trading implications: Stock likely sensitive to IND submission confirmations and clinical site readiness; absence of consensus estimates shifts focus to operational milestones and financing signals.