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Kiromic Biopharma, Inc. (KRBP)·Q4 2021 Earnings Summary

Executive Summary

  • No revenue reported; FY 2021 net loss widened to $25.59M as R&D spending more than doubled, while diluted EPS improved to $(2.26) from $(4.42) on higher share count .
  • Guidance/timeline slipped: management previously targeted first-in-human dosing in Q1 2022, but now aims to begin clinical trial activation by the end of Q4 2022, reflecting extended FDA engagement and CMC work .
  • Operational progress in Q4: cGMP facility ~90% complete; DIAMOND AI 2.0 launched with 300+ million data points added in Q4 and ~600 million added in 2021 (database now “nearly two billion data points”) .
  • Stock-relevant risk event in Q4: Nasdaq deficiency notice for late Q3 10-Q; company had to submit a plan by January 18, 2022, with potential extension to May 16, 2022 .

What Went Well and What Went Wrong

What Went Well

  • cGMP progress: “approximately 90%” of in-house facility expansion and redesign completed, improving manufacturing readiness .
  • DIAMOND AI 2.0 launch with modular architecture, integrated data mining, proteomic validation; 300+ million data points added in Q4 2021; ~600 million added in 2021 .
  • Headcount scaled meaningfully to “nearly 60” employees by year-end, strengthening R&D and clinical preparation capabilities .
  • CEO tone: “extremely encouraged” and focused on activating the first oncology cell therapy candidate by end of Q4 2022 .

What Went Wrong

  • Regulatory timing slipped: after FDA comments on INDs (reagent tracing, manufacturing flow chart, COA), management shifted from targeting first-in-human in Q1 2022 to activation by Q4 2022 .
  • Late filing: Nasdaq notice for failure to timely file Q3 10-Q; potential delisting risk if compliance plan not accepted or executed .
  • Management turnover: CFO resigned on Sept 29, 2021; interim CFO appointed; Chief Operating & Manufacturing Officer resigned on Dec 6, 2021 .

Financial Results

Annual view (reported with Q4 press release)

MetricFY 2020FY 2021
Revenues ($USD)$0 (no revenues to date) $0 (no revenues to date)
R&D Expenses ($USD)$5,052,900 $11,367,800
G&A Expenses ($USD)$14,144,000 $13,937,900
Total Operating Expenses ($USD)$19,196,900 $25,735,700
Net Loss ($USD)$(19,200,200) $(25,588,700)
Diluted EPS ($USD)$(4.42) $(2.26)
Weighted Avg Shares (basic & diluted)4,505,867 11,417,083
Cash and Equivalents (Year-end, $USD)$10,150,500 $25,353,900
Cash from Operations (Year, $USD)$(6,126,600) $(20,321,500)

Notes: KRBP has not generated revenue; diluted EPS improved year-over-year due to higher share count despite wider net loss .

Quarterly trend (prior two quarters for context)

MetricQ1 2021Q2 2021
Revenues ($USD)$0 (no revenues to date) $0 (no revenues to date)
R&D ($USD)$1,885,600 $2,658,100
G&A ($USD)$2,071,000 $2,314,100
Net Loss ($USD)$(3,854,500) $(4,974,300)
Diluted EPS ($USD)$(0.53) $(0.68)
Cash and Equivalents (period-end, $USD)$7,335,300 $3,070,400

KRBP did not provide Q4 2021 quarterly line items in the press release; annual figures were disclosed alongside Q4 corporate highlights .

KPIs and Operating metrics

KPIFY 2020FY 2021
Year-end shares outstanding7,332,999 15,488,516
Headcount19 (as of Dec 31, 2020) Nearly 60 (as of Dec 31, 2021)
cGMP facility progress—~90% complete
DIAMOND AI data points added—300+ million in Q4; ~600 million in 2021

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
First-in-human dosing / clinical activation timeline2022Expected first-in-human dosing in Q1 2022 Aim to begin activation of the clinical trial by end of Q4 2022 Lowered (delayed)
FDA Type A meeting & IND amendments2022Plan to request Type A meeting H1’22; submit IND amendment after feedback Continuing FDA engagement; targeting end-Q4’22 activation Clarified/extended timeline
GMP-2 manufacturing center2022Start construction Q4’21; complete by H2’22 Ongoing facility expansion (in-house cGMP ~90% complete) Maintained/Progress update

Earnings Call Themes & Trends

(No Q4 2021 earnings call transcript available; themes derived from Q1/Q2 2021 releases and Q4 press/investor materials.)

TopicPrevious Mentions (Q1 & Q2 2021)Current Period (Q4 2021)Trend
AI/technology initiativesEmphasis on DIAMOND target discovery; MD Anderson validation grant for Iso-Mesothelin DIAMOND AI 2.0 launched; modular architecture, proteomic validation; 300M+ data points added in Q4 Strengthening
Manufacturing / cGMPFacility expansion lease signed; manufacturing approach descriptions; progressing GMP capability ~90% of in-house cGMP expansion complete; manufacturing efficiency improvements Positive execution
Regulatory / FDAIND re-submissions in May 2021; FDA comments; Type A meeting pursued to address clinical hold Target moved to Q4’22 activation amid ongoing FDA engagement Timeline extended
R&D executionR&D ramp supporting ALEXIS platform Headcount scaled to ~60; process innovations incl. pooled donor cell bank and non-viral engineering Scale-up
Clinical dataPreclinical/early-stage; no in-human yet Reported pilot Phase 1 KiroVax/BSK01 PFS benefit in a metastatic pancreatic cancer patient (7m vs 3.9m) Initial clinical signal (separate program)
Corporate governance / filings—Nasdaq notice for late Q3 10-Q; audit committee change; leadership turnover Mixed/risk flag

Management Commentary

  • Pietro Bersani (Interim CEO, Q4 release): “We are extremely encouraged by the progress… focused on achieving our goal of beginning the activation of the clinical trial for our first oncology cell therapy candidate by the end of the fourth quarter of 2022.”
  • Maurizio Chiriva-Internati (CEO, Q2 release): “Kiromic achieved important scientific and operational milestones… positioned for first in-human dosing during the first quarter of 2022,” citing IND submissions and FDA dialogue .
  • Q1 release: Management highlighted facility expansion and planned IND submissions by end of May 2021, underscoring the DIAMOND AI-led discovery approach .

Q&A Highlights

  • No Q4 2021 earnings call transcript was available; therefore, there are no Q&A highlights or analyst clarification points to report for this period [List search returned none].

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2021 EPS and revenue was unavailable due to missing CIQ mapping for KRBP; we could not retrieve estimates for comparison. As a result, there is no beat/miss analysis versus consensus for this quarter [SpgiEstimatesError].

Key Takeaways for Investors

  • Regulatory timing extended: watch for FDA Type A meeting outcomes and IND amendments; the goal shifted from Q1’22 first-in-human to Q4’22 clinical activation, signaling additional CMC/regulatory workstreams .
  • Cash and burn: YE cash of $25.35M vs 2021 operating cash outflow of $20.32M; closely monitor liquidity amid continued R&D and manufacturing investments .
  • Manufacturing readiness: in-house cGMP expansion ~90% complete improves control and scalability; pooled donor and non-viral engineering efforts may lower cost and enhance consistency .
  • Platform traction: DIAMOND AI 2.0 with major dataset expansion and proteomic validation is a differentiator; investor focus should be on target selection quality translating to clinical milestones .
  • Governance/filing risk: Nasdaq notice for late Q3 10-Q is a headline risk until compliance is regained; track audit committee changes and filing cadence .
  • Early clinical signal: reported pilot Phase 1 KiroVax/BSK01 PFS benefit in one patient provides a proof point, albeit from a separate vaccine program; near-term value creation depends on ALEXIS platform’s clinical initiation .
  • Headcount ramp: scaling to ~60 employees supports execution but raises opex; investors should watch expense discipline against milestone delivery .