Name: Oncotelic Therapeutics, Inc. Q2 2015 Earnings Call
Start: 2015-08-05T06:23:07.000Z

Executive Summary

Q2 2015 net loss improved year over year to $3.3M from $3.9M, with EPS at $(0.13) vs $(0.23) in Q2 2014; operating expenses declined on lower G&A and slightly lower R&D .
Cash was $33.1M at June 30, 2015 (down from $35.7M at March 31, 2015), providing funding for near‑term clinical milestones including ovarian SPA submission, GI‑NETs interim data, and OXi4503 AML study initiation .
Management emphasized strategy to leverage fosbretabulin in combination with anti‑angiogenics (bevacizumab, pazopanib); FDA supportive of moving to Phase 3 in platinum‑resistant ovarian cancer under a Special Protocol Assessment later in 2015 .
No revenue was reported; comparison to Wall Street consensus was unavailable (S&P Global estimates could not be retrieved), making stock reaction tied to pipeline catalysts rather than financial beats/misses .
Key catalysts: SPA submission and design clarity for Phase 3 ovarian, PAZOFOS dose‑ranging update in October, GI‑NETs interim data by year‑end, and start of expanded OXi4503 AML/MDS study .

What Went Well and What Went Wrong

What Went Well

Clear strategic focus on combination anti‑vascular therapy; CEO: “compelling data showing positive results… fosbretabulin combined with Avastin… suggests biologic activity is most effective when using combination” .
Regulatory momentum: FDA supportive of moving into Phase 3 in platinum‑resistant ovarian cancer; SPA submission planned later in 2015 .
Operating discipline: G&A fell to $1.3M vs $1.8M YoY; R&D down YoY to $2.0M while increasing clinically‑related spend (lower drug supply costs) .

What Went Wrong

No topline revenue; business remains dependent on financing and external sponsorship for certain trials, elevating funding risk .
Net loss widened sequentially ($3.3M vs $2.8M in Q1) with cash burn rising as clinical activity ramps, though EPS held flat at $(0.13) .
Lack of quantifiable financial guidance and consensus estimates limits ability to benchmark vs Street; estimate fetch from S&P Global was unavailable during this review [GetEstimates error].

Financial Results

Metric	Q2 2014	Q1 2015	Q2 2015
Revenues ($USD Millions)	$0.0	$0.0	$0.0
Net Loss ($USD Millions)	$3.9	$2.8	$3.3
Diluted EPS ($USD)	$(0.23)	$(0.13)	$(0.13)
R&D Expense ($USD Millions)	$2.2	$1.7	$2.0
G&A Expense ($USD Millions)	$1.8	$1.1	$1.3
Total Operating Expenses ($USD Millions)	$3.9	$2.8	$3.3
Weighted Avg Shares (Millions)	17.3	21.1	26.5
Cash and Equivalents ($USD Millions)	n/a	$35.7	$33.1

Notes:

Q2 2014 revenue assumed $0 based on full‑year 2014 “Product revenue $—” and lack of quarterly revenue line items; quarterly statements present only operating expenses and loss from operations .
CFO reiterated Q2 figures on the call; quarter‑end cash at $33.1M .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Ovarian Phase 3 SPA submission	2H 2015	FDA feedback expected by end Q2 2015	SPA targeted “later this year”; FDA supportive of Phase 3 in platinum‑resistant ovarian cancer	Maintained timeline clarity, regulatory support
PAZOFOS (fosbretabulin + pazopanib) dose‑range data	Oct 2015	Update anticipated at ESGO in Oct	Dose‑ranging results planned for Oct in France (Christie Hospital UK)	Maintained
GI‑NETs Phase 2 interim data	By year‑end 2015	Interim analysis year‑end	Initial interim results by year‑end	Maintained
OXi4503 AML/MDS expanded Phase 1/2 initiation	2H 2015 / soon	Start enrollment 2H 2015	Protocol submitted to FDA; expect to start enrollment soon	Pulled forward operational readiness
R&D expense / burn	2H 2015	Burn ~$1.2M/mo rising to ~$1.3M/mo	Burn ~$3M per quarter; Q3 similar to H1, Q4 up slightly with patient enrollment; external funding offsets PAZOFOS costs	Raised modestly (qualitative)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2014 and Q1 2015)	Current Period (Q2 2015)	Trend
Combination therapy strategy (fosbretabulin + anti‑angiogenics)	Emphasized synergy; GOG186i PFS benefit; targeting platinum‑resistant ovarian	CEO underscores strongest path forward is combination; cites compelling randomized Phase 2 data with Avastin; exploring pazopanib combo	Strengthening, more specific execution
Ovarian Phase 3 design and SPA	Planning SPA post‑FDA feedback; PFS as primary endpoint likely	Preparing SPA later this year; three arms contemplated with possible skewed randomization; PFS primary endpoint	Advancing toward concrete design
GI‑NETs program	Enrollment ongoing; interim analysis on biomarkers/symptoms/QoL by year‑end	Protocol amended to include P‑NETs; interim data by year‑end	Broadened scope; steady progress
AML/MDS (OXi4503)	Move to company‑sponsored Phase 1/2; start 2H 2015	Protocol submitted; plan to start soon; dual‑mechanism rationale; early signals incl. complete/partial responses cited	Execution readiness; clinical confidence rising
Funding/partnerships	Open to partnerships; cash to fund current programs through 2016 (ex‑Phase 3)	Considering traditional/non‑traditional sources; external funding covers significant PAZOFOS costs	Pragmatic, diversified funding
Preclinical pipeline (Baylor)	Multiple abstracts; novel targets; metastasis/angiogenesis angle	Identified promising leads; IP work; additional animal studies planned	Continued build‑out
Immuno‑oncology combinations	Planning preclinical work on checkpoint combinations	Not specifically updated	Stable; remains exploratory

Management Commentary

“I believe… combining fosbretabulin with other anti‑angiogenic agents is the most powerful and effective path forward.” – Bill Schwieterman, President & CEO .
“For Q2 2015 we reported a net loss of $3.3M… R&D $2.0M… G&A $1.3M… cash of $33.1M. OXiGENE has 26.5M shares outstanding.” – Matt Loar, CFO .
“We’re preparing a special protocol assessment for submission to the FDA later this year.” – Bill Schwieterman (ovarian Phase 3) .
“Third quarter is probably [burn] the same order of magnitude, fourth quarter maybe up a little bit… most of [PAZOFOS] cost is external.” – Bill Schwieterman .

Q&A Highlights

AML/MDS study design: Expanded Phase 1/2 with dose escalation then broader treatment; inclusion of MDS; early efficacy signals noted; potential combinations contemplated .
Ovarian Phase 3 specifics: Three arms (combo vs chemo vs bevacizumab), skewed randomization considered to strengthen safety database and enrollment; PFS as primary endpoint under SPA .
OS data from GOG186i: Company expects ongoing OS updates through year‑end; publication timing controlled by GOG; update targeted by year‑end .
Funding approach: Openness to traditional/non‑traditional sources; leveraging external sponsorship (e.g., PAZOFOS) to reduce internal costs .
R&D spend trajectory: Burn ~$3M in Q3; slight uptick in Q4 with patient enrollment; Baylor preclinical work is relatively low cost .

Estimates Context

Wall Street consensus EPS and revenue estimates via S&P Global were unavailable for this review period; we attempted to retrieve Q2 2015 and Q1 2015 and encountered an access limit error. As a result, we cannot quantify beats/misses vs consensus for Q2 2015 [GetEstimates error].
Given no revenue and development‑stage profile, investor focus should anchor on clinical/regulatory milestones rather than traditional quarterly “beats/misses” .

Key Takeaways for Investors

Clinical/regulatory trajectory is the core driver: SPA submission for Phase 3 ovarian and clarity on design/enrollment are near‑term stock catalysts .
Strategy is coherently centered on combination anti‑vascular therapy, with translational support (GOG186i, pazopanib combo) that broadens potential indications and partnering options .
Cash of $33.1M supports multiple “shots on goal” through key 2015 milestones; monitor burn as Q4 clinical activities ramp; external sponsorship helps offset specific trial costs .
Watch for October PAZOFOS dose‑ranging update and year‑end GI‑NETs interim data; positive signals could de‑risk broader development and improve the medium‑term thesis .
OXi4503 AML/MDS program is moving into company‑sponsored expansion; any confirmed efficacy/safety signals would add optionality and valuation support .
Absence of revenue and limited estimate benchmarking means stock moves will be event‑driven; tactically position around SPA outcome, trial initiations, and data readouts .
Partnerships and non‑traditional funding remain active considerations; any collaboration or co‑development announcement could be a positive rerating catalyst .

Appendix: Additional Data Tables

KPIs and Operating Metrics

KPI	Q4 2014	Q1 2015	Q2 2015
Cash and Equivalents ($USD Millions)	$30.0	$35.7	$33.1
Burn Rate (approx.)	n/a	~$1.2M/month, potentially ~$1.3M/month	~$3.0M/quarter; Q4 slight uptick

Pipeline Milestones (from disclosures)

Program	Milestone	Timing
Ovarian (fosbretabulin + bevacizumab)	SPA submission to FDA for Phase 3	Later in 2015
Ovarian (fosbretabulin + pazopanib, PAZOFOS)	Dose‑range results presentation	October 2015
GI‑NETs (fosbretabulin)	Interim initial data	By year‑end 2015
AML/MDS (OXi4503)	Initiate expanded Phase 1/2 study	Soon/2H 2015

Cross‑Reference: Q2 2015 8‑K and Call

Q2 net loss $3.3M, R&D $2.0M, G&A $1.3M, cash $33.1M disclosed in press release and reiterated by CFO on call .
Upcoming milestones and SPA plans stated in both press release and prepared remarks .

Oncotelic Therapeutics, Inc. (OTLC)·Q2 2015 Earnings Summary