Executive Summary

Q3 2018 was dominated by a $228.5M impairment of CNS IPR&D assets, driving net loss to $235.8M and diluted EPS to $(4.70); the impairment reflects a strategic pivot to immuno-oncology under new leadership .
Operationally, GT Biopharma advanced its core pipeline: FDA cleared the IND to initiate first-in-human Phase 1 with TriKE GTB-3550 for AML/MDS/mastocytosis, and Phase 2a GTB-1550 interim data showed clinical benefit in >50% of evaluable patients, with topline data expected Q1 2019 .
Liquidity remains constrained: cash was $1.23M at quarter-end; the company raised 10% senior convertible debentures totaling $8.0M in Aug–Sep and carries $10.6M of convertible debentures on balance sheet; management disclosed substantial doubt about going concern absent additional financing .
No formal financial guidance was provided; management outlined milestone timing (GTB-3550 Phase 1 start in H1 2019, GTB-1550 topline Q1 2019) and aspiration to uplist to a national exchange, positioning 2019 as “transformational” if funding is secured .

What Went Well and What Went Wrong

What Went Well

FDA opened the IND, authorizing initiation of the first-in-human Phase 1 study for GTB-3550 in AML/MDS/mastocytosis, a key regulatory milestone advancing the NK-engager platform .
GTB-1550 Phase 2 interim review: among 13 evaluable patients, 7 showed clinical benefit (CR=1, PR=1, SD=5), with stronger signal in ALL (3/4 benefit), supporting continued development and near-term topline readout .
Leadership strengthened and strategic focus tightened: appointment of Dr. Raymond Urbanski as CEO/Chairman; management emphasized, “We have made significant progress in building a solid foundation…position GT Biopharma for a transformational 2019” .

What Went Wrong

Massive $228.5M impairment of CNS IPR&D assets due to strategic reprioritization and limited resources, causing outsized GAAP loss; fair-value assessment indicated carrying value substantially exceeded recoverable value .
Going concern risk and thin cash balance ($1.23M), with reliance on convertible debentures and the need to secure substantial additional financing in the near term .
Disclosure of material weaknesses in internal controls (small staff, reliance on consultants, risk of override), and CFO resignation in October 2018, elevating execution risk in financial reporting .

Financial Results

Revenue and EPS (prior periods vs current; estimates unavailable)

Metric	Q1 2018	Q2 2018	Q3 2018
Revenue ($USD Millions)	$0.000	$0.000	$0.000
Diluted EPS ($USD)	$(0.20)	$(0.18)	$(4.70)

Operating Performance

Metric ($USD Millions)	Q1 2018	Q2 2018	Q3 2018
Research & Development	$3.473	$3.251	$1.111
Selling, General & Administrative	$3.687	$1.906	$5.035
Loss on Impairment	$0.000	$0.000	$228.514
Total Operating Expenses	$7.160	$5.157	$234.660
Loss from Operations	$(7.160)	$(5.157)	$(234.660)
Net Loss	$(10.091)	$(9.081)	$(235.783)

Note: Margin percentages are not meaningful due to zero revenue in all periods .

Balance Sheet and Liquidity KPIs

KPI ($USD Millions)	Q1 2018	Q2 2018	Q3 2018
Cash and Cash Equivalents	$2.870	$1.096	$1.232
Convertible Debentures (net)	$2.932	$6.856	$10.597
Accumulated Deficit	$279.589	$288.670	$524.453

Actual vs Consensus (Q3 2018)

Metric	Actual	Consensus (S&P Global)
Revenue ($USD Millions)	$0.000	Unavailable (no data)
Diluted EPS ($USD)	$(4.70)	Unavailable (no data)

S&P Global consensus estimates were unavailable for GTBP in Q3 2018 (tool access limit; no published consensus retrieved).

Clinical KPIs (current period)

Program	KPI	Value
GTB-1550 (ADC)	Enrolled patients (Phase 1/2)	18 (12 NHL, 6 ALL)
GTB-1550 (ADC)	Evaluables at interim	13
GTB-1550 (ADC)	Clinical benefit rate	7/13 (53.8%)
GTB-1550 (ADC)	CR / PR / SD counts	1 / 1 / 5
GTB-1550 (ADC)	ALL subset clinical benefit	3/4 (75%)
GTB-1550 (ADC)	Topline timing	Q1 2019
GTB-3550 (TriKE)	IND status	FDA IND open; authorized to initiate Phase 1
GTB-3550 (TriKE)	Phase 1 start timing	H1 2019 (subject to drug supply)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
GTB-3550 Phase 1 initiation	H1 2019	Second-half 2018 expectation (pre-IND amendment)	H1 2019, authorized; subject to drug supply	Deferred/clarified timeline
GTB-1550 topline data	Q4 2018–Q1 2019	Second half 2018 expected	Q1 2019	Deferred
EOP2a meeting (GTB-1550)	H1 2019	Not previously specified	Plan to conduct EOP2a in H1 2019	New milestone
Uplist to national exchange	2019+	Not previously specified	Intention to uplist	New strategic objective

No revenue, margin, OpEx, tax rate, or dividend guidance was issued; the company provided milestone timelines instead .

Earnings Call Themes & Trends

No Q3 2018 earnings call transcript was found; themes below summarize MD&A and press release narratives across quarters.

Topic	Previous Mentions (Q1 2018)	Previous Mentions (Q2 2018)	Current Period (Q3 2018)	Trend
TriKE GTB-3550 Phase 1 timing	Expect IND filing mid-2018; Phase 1 in 2H18	IND amendment filed June; expect Phase 1 in 2H18	FDA IND open; Phase 1 authorized; start H1 2019, subject to drug supply	Slight delay; regulatory clearance achieved
GTB-1550 Phase 2 status	~18 patients; Phase 2 ongoing; data 2H18	Interim review planned; data Q4’18/Q1’19	Interim data shows clinical benefit >50%; topline Q1’19	Data visibility improving
Financing/liquidity	Issued Jan convertible notes & warrants	Continued notes; adoption of ASU 2017-11	Issued 10% senior convertible debentures Aug/Sep; going concern risk	Ongoing reliance on convertibles; liquidity tight
Leadership/controls	Material weaknesses in controls -	Material weaknesses persisted -	CEO employment agreement; CFO resignation; controls still weak -	Governance evolving; controls remediation pending
Strategic focus	Broad IO + CNS portfolio	IO prioritized; CNS still active -	IO prioritized; CNS IPR&D impaired due to strategic shift -	Decisive pivot to IO

Management Commentary

Strategy and outlook: “We have made significant progress in building a solid foundation…Successfully completing a financing and bolstering our management team and Board in the near term remains a priority…We are committed to securing the necessary capital…position GT Biopharma for a transformational 2019” — Dr. Raymond Urbanski, CEO .
Regulatory progress: The company announced “FDA clearance to commence first-in-human Phase 1 study” for GTB-3550 (TriKE) targeting AML/MDS/mastocytosis .
Rationale for impairment: Management recorded a $228.5M impairment to CNS IPR&D assets “result of…prioritization of immuno-oncology…limited internal resources…favorable market conditions for immuno-oncology”; independent valuation indicated carrying value exceeded fair value -.
Liquidity and risk: “The Company has incurred substantial losses…cash of $1.2 million…Substantial additional financing will be needed…These factors raise substantial doubt about the Company’s ability to continue as a going concern” .

Q&A Highlights

No Q3 earnings call transcript was available; filings addressed common investor questions:

Funding runway and dilution: Management disclosed going concern risk and detailed convertible debenture raises (10% debentures at $2 conversion), repayment of January notes, and continued need for capital .
CNS impairment drivers: Explained strategic pivot to IO and valuation methodology (DCF/relief-from-royalty) behind the $228.5M write-down -.
Clinical timelines and dependencies: GTB-3550 Phase 1 start contingent on drug supply; GTB-1550 topline in Q1 2019; EOP2a meeting in H1 2019 .
Internal controls: Management acknowledged material weaknesses and outlined intended remediation (staffing, controls documentation) despite CFO resignation -.

Estimates Context

Wall Street consensus (S&P Global) for Q3 2018 revenue and EPS was unavailable; no consensus was retrieved for GTBP this quarter. Comparison to estimates is therefore not applicable.

Key Takeaways for Investors

The quarter’s GAAP loss was a one-time, non-cash impairment; focus on cash burn and operational runway rather than EPS optics in near-term trading .
Regulatory de-risking is a near-term catalyst: IND open for GTB-3550 with Phase 1 initiation targeted in H1 2019; watch for trial start updates and dose-escalation progress .
GTB-1550 clinical readout in Q1 2019 can validate ADC strategy; interim signals are encouraging, especially in ALL subset .
Financing overhang persists; expect continued capital raises (convertibles/equity) to fund trials, with dilution risk—stock likely trades on funding news and clinical milestones .
Governance and controls require monitoring; CFO transition and material weaknesses could add volatility around reporting -.
Strategic clarity: decisive shift from CNS to immuno-oncology aligns resources with core NK-engager/ADC platforms; impairment cleans up balance sheet and reduces future amortization uncertainty -.
Uplisting ambition signals longer-term capital markets strategy; execution depends on clinical progress and improved capitalization .

Sources: Q3 2018 8-K and press release -; Q3 2018 10-Q -; Q2 2018 10-Q -; Q1 2018 10-Q -.

GT Biopharma, Inc. (GTBP)·Q3 2018 Earnings Summary