Executive Summary

Q1 2023 was a heavy investment quarter as CNSP accelerated its potentially pivotal Berubicin GBM trial: R&D rose to $3.57M (+89% YoY), total OpEx to $4.93M, and net loss widened to $4.93M (EPS $(2.59)) as CRO costs ramped for trial execution .
Clinical execution progressed: >100 patients dosed; 45 of 60 sites opened across U.S. and Europe; interim analysis now expected in Q3 2023 (slipped from prior H1 2023/Mid-2023 indications) .
Liquidity: Cash fell to $5.11M at 3/31, but subsequent ATM sales ($2.0M) and warrant exercises ($0.72M) extended runway “beyond the interim analysis and into Q4 2023” (management’s expectation) .
Key near-term catalyst: DSMB interim analysis of OS-driven pivotal trial in Q3 2023; management highlighted “flawless operational execution” and is “planning for success” as it approaches the interim readout .

What Went Well and What Went Wrong

What Went Well

Clinical execution accelerated: “100 patients now dosed” in the global Berubicin GBM trial; 45 of 60 sites opened across U.S., Italy, France, Spain, and Switzerland .
Clear milestone path: Company “expected” to report interim analysis Q3 2023; reiterated plan to complete enrollment and then report topline results thereafter .
Governance strengthened: Board additions of Faith L. Charles (Chair) and Dr. Bettina M. Cockroft (independent director) add capital markets and clinical development depth .

Quote: “Our team has continued its flawless operational execution ... boasting 100 patients now dosed … [and] we continue to plan for success as we approach our highly anticipated interim analysis … expected in the third quarter of this year.” – CEO John Climaco .

What Went Wrong

Expense intensity and losses increased: R&D jumped to $3.57M (from $1.89M YoY) as CRO spend rose with trial progress; net loss widened to $4.93M (from $3.15M YoY) .
Guidance slip on interim timing: Prior updates had pointed to H1 2023/mid-2023; current timing moved to Q3 2023 .
Going-concern risk remains a factor: 10-Q notes substantial doubt and need for additional financing; though subsequent ATM/warrant proceeds extend runway, further capital will be required to complete programs .

Financial Results

Note: CNSP is a clinical-stage biotech with no product revenue to date .

Metric (USD)	Q1 2022	Q3 2022	Q1 2023
R&D Expense ($M)	$1.89	$2.21	$3.57
G&A Expense ($M)	$1.26	$1.21	$1.36
Total Operating Expenses ($M)	$3.15	$3.42	$4.93
Net Loss ($M)	$(3.15)	$(3.42)	$(4.93)
Diluted EPS ($)	$(2.44)	$(0.09)	$(2.59)
Weighted Avg Shares (M)	1.29	40.03	1.91

Footnote: The company effected a 1-for-30 reverse stock split on Nov 28, 2022; historical share counts are not directly comparable across periods .

Liquidity

Metric (USD)	Q3 2022	Q4 2022	Q1 2023
Cash & Cash Equivalents ($M)	$7.03	$10.06	$5.11
Working Capital ($M)	$7.46	—	$3.05

KPIs and Operations

KPI	Q1 2022	Q2 2022	Q1 2023
Patients Dosed (trial-to-date)	—	—	>100 patients
Clinical Sites Open (of planned)	—	23 of 54	45 of 60
Interim Analysis Timing	Expected H1 2023	Expected mid-2023	Expected Q3 2023
Cash Runway (Mgmt view)	—	Into Q1 2023	Beyond interim and into Q4 2023 (post-ATM/warrants)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Berubicin interim analysis	2023	H1 2023 / “mid-2023”	Q3 2023	Lowered (schedule slipped)
Cash runway	2023	Into Q1 2023 (as of 9/30/22) ; Into but not beyond Q3 2023 (as of 12/31/22)	Beyond interim and into Q4 2023 (post Q1 raises)	Raised (improved)
Site activation/enrollment	2022–2023	23 sites open (of 54)	45 sites open (of 60)	Raised (progressed)
WP1244/WP1874 IND	2023	File IND in 2023	No change disclosed	Maintained

Earnings Call Themes & Trends

No earnings call transcript was located for Q1 2023. Themes are drawn from the earnings press release and 10-Q/10-K filings.

Topic	Previous Mentions (Q2 2022 and Q3 2022)	Current Period (Q1 2023)	Trend
Trial execution/enrollment	EU clinical approvals; 23 sites open; enrollment progressing	>100 patients dosed; 45/60 sites open; interim in Q3 2023	Improving execution; timeline pushed
Regulatory/designations	Fast Track and Orphan Drug reiterated	Reiterated pivotal design (OS primary) and DSMB futility framework	Consistent
Financing/runway	Runway into Q1 2023 (9/30/22)	Post-Q1 ATM/warrant proceeds extend runway into Q4 2023 (mgmt expectation)	Improved
Governance/talent	—	Chair (Faith Charles) and independent director (Dr. Cockroft) appointed	Strengthened board
R&D portfolio (WP1244/1874)	Plan to file IND in 2023	No new timing change disclosed	Maintained

Management Commentary

“Our team has continued its flawless operational execution … boasting 100 patients now dosed … we continue to plan for success as we approach our highly anticipated interim analysis … expected in the third quarter of this year.” – John Climaco, CEO .
On governance: appointments of Faith L. Charles (Chair) and Dr. Bettina M. Cockroft to bring “deep … expertise” and proven development/operational backgrounds .
On capital: subsequent ATM issuance of 659,677 shares for $1.97M net and 238,958 warrants exercised for $0.72M net; runway “beyond the interim analysis and into the fourth quarter of 2023” (expectation) .

Q&A Highlights

No Q1 2023 earnings call transcript or Q&A session was found in company documents during the quarter. As such, no analyst Q&A themes or management clarifications were available for extraction [functions search results showed none].

Estimates Context

Wall Street consensus via S&P Global for Q1 2023 EPS and revenue was unavailable (tool access limit exceeded). As a result, we cannot provide comparison vs consensus for this quarter. Where comparisons to estimates are not shown, treat consensus as unavailable from S&P Global for Q1 2023.

Key Takeaways for Investors

Interim analysis in Q3 2023 is the primary stock catalyst; the pivotal design uses OS as primary endpoint versus lomustine with 2:1 randomization and a non-binding DSMB futility analysis at ~30–50% interim population; management anticipates timing in Q3 based on enrollment/assessments .
Liquidity extended: Q1-end cash was $5.11M, and subsequent ATM/warrant proceeds are expected by management to fund “beyond the interim analysis and into Q4 2023,” mitigating near-term financing risk through the catalyst window .
Expense intensity rising with execution: R&D nearly doubled YoY to $3.57M; total OpEx $4.93M; quarterly net loss $(4.93)M—consistent with an advancing pivotal trial .
Ongoing financing needs: The 10-Q/MD&A and filings highlight substantial doubt/going concern and the need for additional capital to complete the program, implying potential dilution risk post-interim .
No revenue yet: CNSP remains a clinical-stage company with no product revenues; valuation hinges on clinical outcomes and financing capacity .
Governance upgrades (new Chair and independent director) and increased site activations suggest stronger execution bandwidth ahead of data readouts .
If interim analysis is favorable, expedited paths (Fast Track, OS endpoint) could support regulatory momentum, but negative or inconclusive outcomes would likely necessitate additional capital and strategy reassessment .

Source Documents

Q1 2023 8-K 2.02 and press release (Ex. 99.1): enrollment progress, interim timing, OpEx detail, cash and subsequent financing, runway .
Q1 2023 10-Q: financial statements, EPS, cash flows, working capital, going concern, MD&A .
Prior quarters: Q2 2022 8-K (sites open, milestones) ; Q3 2022 10-Q (OpEx, net loss, cash, runway) .
2022 10-K: pivotal trial design, OS endpoint, DSMB plan, regulatory designations, company has had no revenues .

CNS Pharmaceuticals, Inc. (CNSP)·Q1 2023 Earnings Summary