Executive Summary

CKPT delivered a pre-commercial Q3 focused on regulatory progress: FDA accepted the cosibelimab BLA resubmission and set a PDUFA goal date of December 28, 2024; management emphasized preparations for potential approval and commercialization .
Liquidity was tight at quarter-end ($4.7M cash), but subsequent warrant exercises in November added $9.2M, extending cash runway “beyond our PDUFA date and into 2025” .
Operating expenses rose year over year as CKPT advanced regulatory and pre-commercial readiness (R&D $6.4M vs $5.5M; G&A $3.4M vs $2.2M), widening the quarterly net loss to $9.7M ($0.23 per share) from $5.7M ($0.29 per share) in Q3 2023 .
Key catalysts heading into year-end and early 2025 centered on FDA action for cosibelimab and the company’s readiness to commercialize if approved; longer-term pivotal data presented at ESMO showed deepening responses (higher ORR/CR) vs primary analyses, supporting the clinical profile .

What Went Well and What Went Wrong

What Went Well
- FDA accepted the cosibelimab BLA resubmission and assigned a PDUFA date (Dec 28, 2024); CEO: “We are now fully focused on preparing for the potential approval of cosibelimab” .
- Longer-term pivotal cSCC data at ESMO demonstrated deepening responses: ORR 54.8% (locally advanced) and 50.0% (metastatic); CR 25.8% and 12.8%, respectively, with median DOR not yet reached .
- Balance sheet reinforced post-quarter: $9.2M in warrant exercises in November; management said proceeds extend runway beyond the PDUFA date and into 2025 .
What Went Wrong
- No product revenue in Q3; net loss widened to $(9.7)M (vs $(5.7)M YoY) as OpEx increased with advancement toward potential approval .
- G&A escalated to $3.4M (vs $2.2M YoY), including $1.4M non-cash stock expense (vs $0.6M YoY), reflecting public company and pre-commercial readiness costs .
- Regulatory/manufacturing dependence persists: filings caution on FDA review uncertainties and third-party CMO inspection/quality risks as key execution factors towards approval and commercialization .

Financial Results

Metric (USD, $000s unless noted)	Q3 2023	Q1 2024	Q2 2024	Q3 2024
Revenue - related party	31	0	41	0
R&D expense	5,496	8,497	4,480	6,366
G&A expense	2,236	2,451	2,234	3,358
Total operating expenses	7,732	10,948	6,714	9,724
Net loss	(5,724)	(10,945)	(6,670)	(9,725)
Diluted EPS ($)	(0.29)	(0.33)	(0.18)	(0.23)
Weighted avg shares (000s)	19,988	33,931	36,526	43,152

KPIs and Balance Sheet

KPI (USD, $000s)	Q1 2024	Q2 2024	Q3 2024
Cash & cash equivalents	11,241	4,951	4,703
Accounts payable & accrued expenses	19,159	18,115	15,635
Stockholders’ equity (deficit)	(10,250)	(15,749)	(12,590)

Notes and estimate comparison:

Wall Street consensus estimates (S&P Global) for Q3 2024 were unavailable for CKPT (no CIQ mapping in our S&P Global feed). As a result, no beat/miss analysis vs consensus can be presented for revenue or EPS.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance (Q3)	Change
Cosibelimab BLA timeline	2024 regulatory	Q1: Targeting mid‑year BLA resubmission	Q3: FDA accepted resubmission; PDUFA Dec 28, 2024	Increased specificity from plan to action date
Cash runway	Liquidity	Q2: Cash $5.0M at 6/30; ~$12M gross proceeds raised in July	Q3: Cash $4.7M at 9/30; $9.2M Nov warrant exercises extend runway “beyond PDUFA and into 2025”	Improved runway post-quarter

No formal quantitative guidance was issued for revenue, margins, OpEx, OI&E, tax rate, or dividends .

Earnings Call Themes & Trends

Note: No Q3 2024 earnings call transcript was available in our document catalog (company furnished results via press release and 8‑K) .

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3 2024)	Trend
Regulatory path (FDA/CRL/CMO)	Q1: Planning mid‑year BLA resubmission after CMO remediation . Q2: FDA accepted resubmission; PDUFA set .	Preparing for potential approval; PDUFA Dec 28, 2024 .	Progressing toward approval
Clinical data (cSCC efficacy/safety)	—	ESMO: deeper responses over time; ORR 54.8%/50.0%, CR 25.8%/12.8% with median DOR not reached .	Strengthening clinical validation
Financing/liquidity	Q1 cash $11.2M ; Q2 raised ~$12M gross .	Q3 cash $4.7M; +$9.2M warrant exercises in Nov .	Liquidity supplemented post‑Q3
Partnerships	—	GC Cell collaboration announced in July .	New combination strategy
Commercial readiness	Q1: Anticipating ability to shorten timeline (forward‑looking) .	“Fully focused on preparing for the potential approval” .	Building readiness

Management Commentary

“With the PDUFA goal date set for next month… The $9.2 million in cash proceeds received this month from the exercise of existing warrants has strengthened our balance sheet to extend beyond our PDUFA date and into 2025. We are now fully focused on preparing for the potential approval of cosibelimab…” — James Oliviero, CEO .
On ESMO data: “Longer-term results… demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses.” — James Oliviero .
On regulatory progress: “We are pleased that the FDA has accepted our BLA resubmission as a complete response… We look forward to… the potential opportunity to deliver cosibelimab’s unique dual mechanism of action to patients suffering from cSCC.” — James Oliviero .

Q&A Highlights

No Q3 2024 earnings call transcript was published; therefore, no analyst Q&A items or clarifications are available .

Estimates Context

S&P Global consensus estimates for Q3 2024 were unavailable for CKPT (no CIQ mapping returned for the ticker). In the absence of consensus, investors should anchor analysis on reported OpEx, cash runway updates, and the PDUFA timeline while monitoring for initiation of formal sell‑side coverage post‑regulatory milestones.

Key Takeaways for Investors

Near-term binary turned operational: The quarter centered on FDA review and commercialization prep for cosibelimab with a defined PDUFA date (Dec 28, 2024) .
Clinical profile strengthened: Longer-term pivotal data at ESMO showed deeper responses and rising CR rates, reinforcing the efficacy case in advanced cSCC .
Liquidity tightened intra‑quarter but improved post‑Q3: Cash was $4.7M at 9/30; $9.2M from warrant exercises in November extended runway into 2025 per management .
OpEx variability reflects regulatory and pre‑launch activity: R&D ($6.4M) and G&A ($3.4M) rose vs last year as the company advanced the BLA and pre‑commercial readiness .
Execution risk tied to third‑party CMO and FDA review remains a watch‑item per forward‑looking disclosures (inspection, quality, and review uncertainties) .
No formal financial guidance; the focus remains regulatory approval and launch readiness; monitor additional financing, partnering, or ex‑U.S. strategies to support commercialization .
With no consensus estimates available, stock movement likely hinged on regulatory news flow and liquidity updates rather than quarterly “beats/misses.”

Sources: Q3 2024 press release and 8-K (including financial statements), plus Q1–Q2 results and Q3‑period press releases on BLA acceptance, financing, and ESMO data .

Checkpoint Therapeutics, Inc. (CKPT)·Q3 2024 Earnings Summary