Executive Summary

Q2 2021 was a pre-revenue quarter with operating execution but regulatory friction: R&D rose to $2.66M (+109% YoY) while G&A normalized to $2.31M (-77% YoY), driving EPS of $(0.68) vs $(3.80) YoY and $(0.53) in Q1; cash ended at $3.07M .
The company re-submitted two INDs in May; after FDA comments (manufacturing traceability, process flow, product COAs), management opted for a Type A meeting and reset first-in-human dosing to Q1 2022 (from prior Q1 guide of Q3 2021) — a key timing reset for the story .
Liquidity significantly improved post-quarter with $37.12M in net proceeds from a July equity offering to fund IND responses, clinical trials, and GMP buildout .
No S&P Global Wall Street consensus was available for Q2 (micro-cap, pre-revenue), so no beat/miss framing; near-term stock catalysts center on FDA Type A meeting outcomes and IND clearance timing .

What Went Well and What Went Wrong

What Went Well
- InSilico Solutions acquisition ($0.54M consideration) brings bioinformatics/AI expertise in-house to strengthen target discovery and analytics .
- Strengthened operating bench with a manufacturing-focused COO/COMO (ex-UPenn Gene Therapy Program, Novartis), aligning with GMP/CMC readiness for allogeneic programs .
- External/academic validation and visibility: MD Anderson biomarker validation grant in pancreatic cancer and six AACR 2021 posters; management emphasized positioning for first-in-human dosing in Q1 2022 (“well positioned for… first in-human dosing during the first quarter of 2022”) .
What Went Wrong
- FDA returned comments on the allogeneic CAR-T INDs (reagent traceability, manufacturing flow charts, product COAs), prompting a Type A meeting and delaying dosing to Q1 2022 — a material timeline slip from prior guidance of Q3 2021/Q3 2021 plans .
- Operating loss widened QoQ with R&D ramp to support ALEXIS-ISO-1 and associated manufacturing/experimentation, pushing EPS to $(0.68) vs $(0.53) in Q1 .
- Quarter-end cash of $3.07M (pre-raise) underscored near-term funding dependence (later addressed in July), highlighting execution risk tied to regulatory milestones and clinical initiation .

Financial Results

Primary P&L and liquidity (oldest → newest):

Metric	Q3 2020	Q1 2021	Q2 2021
Revenue ($USD)	$0 (pre-revenue)	$0 (pre-revenue)	$0 (pre-revenue)
Research & Development ($USD)	$1,225,700	$1,885,600	$2,658,100
General & Administrative ($USD)	$1,190,000	$2,071,000	$2,314,100
Total Operating Expenses ($USD)	$2,415,700	$3,956,600	$4,972,200
Loss from Operations ($USD)	$(2,415,700)	$(3,956,600)	$(4,972,200)
Net Loss ($USD)	$(2,415,700)	$(3,854,500)	$(4,974,300)
Diluted EPS ($)	$(0.65)	$(0.53)	$(0.68)
Net Income Margin %	N.M. (no revenue)	N.M. (no revenue)	N.M. (no revenue)
Cash & Equivalents (end of period, $USD)	$469,300	$7,335,300	$3,070,400
Weighted Avg Shares (basic & diluted)	3,719,132	7,332,999	7,345,147

YoY context for Q2:

R&D increased to $2,658,100 from $1,272,300 (+108.9% YoY) on headcount/manufacturing/experimentation for ALEXIS-ISO-1 .
G&A decreased to $2,314,100 from $10,094,600 (-77.1% YoY) as prior-period stock comp normalized .
EPS improved to $(0.68) from $(3.80) YoY .

Segment breakdown: N/A (pre-clinical, no revenue segments disclosed) .

KPIs (operational)

IND status: Two INDs re-submitted in May (ALEXIS-PRO-1 PD-L1; ALEXIS-ISO-1 Iso-Mesothelin) .
FDA feedback: Comments on reagent traceability, manufacturing process flow, and COAs; decision to hold a Type A meeting to resolve clinical hold issues .
First-in-human dosing: Targeted for Q1 2022 .
Post-quarter financing: $37,121,200 net proceeds on July 2, 2021 .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
First-in-human dosing (ALEXIS programs)	Initial dosing start	“Q3 2021” aspiration from prior communications	Q1 2022 target	Lowered/Delayed
IND interaction/next steps	2H21	Written response contemplated [implied]; no prior meeting plan disclosed	Type A meeting with FDA; respond to comments (reagents tracing, process flow, COAs) with planned submission in 1H Sep 2021	Formalized FDA meeting plan
Liquidity runway (implied)	2H21	$3.07M cash at Q2-end	+$37.12M net equity raised July 2, 2021	Strengthened balance sheet

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4/FY2020 and Q1 2021)	Current Period (Q2 2021)	Trend
Regulatory/FDA	Two INDs filed Dec-2020; resubmission planned; aim for first-in-human; prior dosing expectation Q3 2021	Re-submitted May; FDA comments (reagents, process flow, COAs); Type A meeting planned	More regulatory engagement; timelines extended
Manufacturing/GMP/CMC	GMP suite completion noted; facility expansion to ~38k sq ft starting Aug 1, 2021	New COMO hired to lead manufacturing and GMP scale-up	Capability build-out continues
AI/Technology	DIAMOND AI central to discovery; emphasis on AI-enabled development	InSilico Solutions acquired to internalize bioinformatics/AI	Capability in-housing
R&D execution	External validation of targets; MD Anderson validation grant (pancreatic) initiated	IND resubmission; conference presence (AACR 6 posters)	Continued external validation
Capital/Financing	$15M IPO (Oct-2020)	$37.12M net equity raise (July 2021)	Liquidity improved

Note: No earnings-call transcript located for Q2 2021 in the document catalog (Q&A not available).

Management Commentary

“Kiromic achieved important scientific and operational milestones during the first half of the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing during the first quarter of 2022.” — Dr. Maurizio Chiriva-Internati, CEO .
“From their efforts, we submitted two investigational new drug applications to the United States Food and Drug Administration in May 2021.” .
On FDA process adjustments: the company received comments focused on reagent traceability, manufacturing process flow charts, and product COAs; elected to pursue a Type A meeting to address clinical hold issues and clarify path to dosing .
Operating drivers: R&D increase tied to headcount, manufacturing, and experimentation for ALEXIS-ISO-1; G&A decline driven by lower stock compensation vs prior-year period .

Q&A Highlights

No Q2 2021 earnings-call transcript was available in the document set; therefore, no Q&A themes or guidance clarifications can be provided from a call recording/transcript.

Estimates Context

S&P Global (Capital IQ) consensus estimates for KRBP Q2 2021 were unavailable; as a result, no beat/miss analysis vs Street is provided. Future estimate frameworks will likely focus on timing milestones (IND clearance, first-in-human dosing) rather than P&L while the company remains pre-revenue .
S&P Global consensus data unavailable for KRBP.

Key Takeaways for Investors

The critical near-term catalyst is regulatory: outcomes from the Type A meeting and the FDA’s response to the company’s September submission will determine whether first-in-human dosing can start in Q1 2022; the slip from prior Q3 2021 aspirations is a key timeline reset to monitor .
Operating spending is increasing where it matters (R&D) as the company advances ALEXIS-ISO-1/PRO-1, while G&A normalized from a high stock-comp base; expect opex to remain elevated through IND clearance and trial start .
Liquidity risk eased meaningfully with $37.12M net proceeds post-quarter; deployment priorities include ALEXIS trials, GMP expansion, IP, and working capital .
Strategic capability build: acquisition of InSilico internalizes AI/bioinformatics, and the hiring of a seasoned manufacturing leader supports CMC-readiness for allogeneic CAR-T .
Absence of Street coverage/consensus reduces typical near-term “beat/miss” trading dynamics; stock likely trades on regulatory milestones, manufacturing readiness, and trial initiation updates .
Scientific/BD validation continues (MD Anderson grant; AACR presence), supporting the target selection thesis while regulatory interactions de-risk CMC expectations ahead of FIH .

Sources

Q2 2021 8-K and press release (Aug 13, 2021): financials, operating highlights, FDA interactions, and liquidity .
Q1 2021 8-K and press release (May 14, 2021): financials, facility expansion, MD Anderson grant, FIH timing aspiration .
Q3 2020 8-K and press release (Nov 30, 2020): financials, GMP completion, external validation .

Note: Company remains pre-revenue; “The Company has not generated any revenues to date.” .

Kiromic Biopharma, Inc. (KRBP)·Q2 2021 Earnings Summary