Checkpoint Therapeutics, Inc. (CKPT)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 was operationally dominated by two catalysts: FDA approval of UNLOXCYT (cosibelimab-ipdl) in December and a definitive merger agreement with Sun Pharma in March 2025 valued up to ~$416M including a CVR .
• Financially, Q4 showed no revenue and a sharp spike in G&A, driving an estimated quarterly net loss of ~$$23.5M; the spike was largely due to non-cash stock expense recognized in Q4 (FY G&A included $11.0M non-cash) .
• Year-end cash was $6.6M, with ~$38.1M raised subsequently via warrant exercises, improving liquidity into commercialization planning .
• No numeric 2025 guidance and no Q4 earnings call transcript were available; estimate comparisons via S&P Global were unavailable due to missing mapping .

What Went Well and What Went Wrong

What Went Well

• FDA approval: UNLOXCYT became the first and only PD-L1 blocking antibody approved for advanced cSCC, establishing CKPT as commercial-stage and opening a >$1B U.S. market opportunity (company commentary) .
• Strategic transaction: Signed merger agreement with Sun Pharma, total potential value up to ~$416M, expected to close in Q2 2025 pending approvals; strengthens commercialization prospects .
• Clinical momentum: Longer-term pivotal data for cosibelimab presented at ESMO showed deepening responses with higher objective and complete response rates over time .

What Went Wrong

• Q4 operational P&L: No revenue; estimated Q4 net loss (~$23.5M) surged, driven by a large non-cash G&A item (FY G&A included $11.0M of non-cash stock expense) .
• Quarterly visibility: Company furnished full-year results in the Q4 8‑K, limiting direct quarter-level disclosure (no Q4 EPS provided), and there was no transcript of a Q4 earnings call .
• Manufacturing/CMO dependencies: Prior year complete response letter (CRL) was tied to multi-sponsor CMO inspection findings (resolved via BLA resubmission and acceptance), highlighting ongoing reliance on third-party manufacturing quality systems .

Financial Results

Income Statement and Liquidity (Quarterly)

Notes: Q4 values are derived as FY 2024 minus nine months ended 9/30/2024 where applicable .

Liquidity and Capitalization KPIs

Segment Breakdown

• No commercial revenue segments reported; revenue consisted of related-party revenue with no Q4 contribution .

Guidance Changes

Commentary: No formal numeric guidance was issued in the Q4 8‑K press release; company commentary focused on regulatory approval, merger process, and commercialization steps .

Earnings Call Themes & Trends

No Q4 earnings call transcript or slides were available in the document catalog; themes are synthesized from company press releases.

Management Commentary

• “With the PDUFA goal date set for next month, we await the decision by the U.S. Food and Drug Administration… We are now fully focused on preparing for the potential approval of cosibelimab…” — James Oliviero, President & CEO (Nov 2024) .
• “Today’s FDA approval of UNLOXCYT… is a significant milestone both for Checkpoint and for patients with advanced cSCC… a U.S. market estimated to exceed $1 billion annually” — James Oliviero (Dec 2024) .
• “We are excited about the approval of UNLOXCYT and are currently developing a commercial launch plan.” — James Oliviero (Dec 2024) .

Q&A Highlights

• No Q4 2024 earnings call transcript was found in the document catalog; as such, there are no Q&A highlights or clarifications to report [functions.ListDocuments returned none for earnings-call-transcript].

Estimates Context

• Consensus EPS and revenue estimates for Q4 2024 via S&P Global were unavailable due to missing CIQ company mapping (tool returned error when requested). Values retrieved from S&P Global: unavailable (attempted but mapping missing).
• Implication: We could not benchmark actual Q4 results to Wall Street consensus. Company did not provide numeric quarterly EPS; Q4 revenue was $0, so any revenue estimate comparison would reflect a miss or inline only if consensus was $0.00, but we cannot validate without S&P data [GetEstimates error].

Key Takeaways for Investors

• FDA approval of UNLOXCYT (PD‑L1, dual MoA with ADCC) is the pivotal de-risking event; commercial execution and payer/access dynamics now become central to the thesis .
• The Sun Pharma transaction (up to ~$416M value including CVR) provides a strategic path and potential liquidity event; closing risk centers on standard approvals and shareholder votes .
• Q4 P&L featured a large non-cash G&A item (FY G&A included $11.0M of non-cash stock expense), which materially inflated quarterly loss; this is not necessarily indicative of ongoing operating cash burn .
• Liquidity improved post-year-end with ~$38.1M in warrant exercise proceeds, supporting near-term launch readiness and operational runway .
• No numeric guidance and no call transcript limit near-term visibility; watch for post-merger disclosures or launch updates to frame 2025 revenue ramp and OpEx cadence .
• Clinical narrative continues to be constructive with ESMO data showing deepening responses; positioning versus PD‑1 competitors may hinge on ADCC and safety profile claims .
• Trading setup: near-term stock moves likely driven by merger milestones (proxy, vote, regulatory clearance) and early UNLOXCYT launch metrics; absent guidance, sell-side models may rely on qualitative updates until S&P mapping and estimate coverage normalize .