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ONCOSEC MEDICAL Inc (ONCSQ)·Q1 2017 Earnings Summary

Executive Summary

  • Q1 FY2017 delivered no revenue and a narrowed net loss of $5.6M ($0.29 per share) vs $7.0M ($0.47) in Q1 FY2016, driven by lower R&D, G&A, and stock-based compensation as programs and device prototypes completed .
  • Cash and equivalents were $24.4M at October 31, 2016, down from $28.7M at July 31, 2016; management reiterated runway of at least 12 months to meet clinical and regulatory milestones into calendar 2018 .
  • Operationally, focus remained on initiating a registration-directed Phase IIb in anti-PD-1 non-responder melanoma; prior quarter progress included enrollment of 20+ patients in the KEYTRUDA (pembrolizumab) combo study and plans to submit study design by end of 2016 .
  • Wall Street consensus estimates via S&P Global were unavailable for ONCSQ this quarter; no formal financial guidance (revenue/margins/OpEx) was provided [GetEstimates error; S&P Global data unavailable].

What Went Well and What Went Wrong

What Went Well

  • Reduced quarterly net loss and EPS: Net loss improved to $5.6M and EPS to $(0.29) vs $(7.0)M and $(0.47) in the prior year, reflecting lower trial, engineering, outside services, and stock-based comp costs .
  • Clear strategic focus and timelines: “Our primary focus for the next year is to initiate a melanoma registration-directed clinical study...generate meaningful data in 2017 and 2018 to support discussions with the FDA and a future BLA” — Punit Dhillon, CEO .
  • Cash runway supports milestones: Management expects funds to cover operations for at least 12 months, aligning with planned Phase IIb initiation and platform expansion .

What Went Wrong

  • Continued zero revenue: The company reported no revenues in Q1 FY2017 and Q1 FY2016, consistent with its pre-commercial stage .
  • Ongoing cash burn: Net cash used in operating activities was $4.4M in Q1 FY2017, underscoring the financing needs typical of clinical-stage biotech .
  • Dilution and equity burn: Weighted average shares increased to 19.0M in Q1 FY2017 (from 14.8M in Q1 FY2016), with stockholders’ equity declining from $28.1M (July 31, 2016) to $23.6M (October 31, 2016) .

Financial Results

Income Statement and Operating Metrics (USD Millions, EPS in USD)

Periods ordered oldest → newest

MetricQ3 2016Q4 2016Q1 2017
Revenue$0.00 N/A$0.00
Net Loss$(6.25) $(6.60) $(5.60)
Diluted EPS$(0.37) $(0.39) $(0.29)
R&D Expense$3.38 $3.70 $3.10
G&A Expense$2.87 $2.90 $2.50
Weighted Avg Shares (Millions)16.97 N/A19.02

Notes:

  • Q4 2016 revenue not explicitly disclosed (company reported no revenues for FY2016) .
  • Quarter-level weighted average shares for Q4 2016 not disclosed in the 8-K; annual WA shares provided .

Cash Position and Operating Cash Flow (USD Millions)

MetricQ3 2016Q4 2016Q1 2017
Cash & Equivalents (End of Period)$24.02 $28.75 $24.35
Net Cash Used in Operating Activities(Nine months) $(13.75) (Year) $(17.81) (Quarter) $(4.42)

Actuals vs Estimates (Q1 FY2017)

MetricActualS&P Global Consensus# of Estimates
Revenue$0.00 Unavailable*Unavailable*
EPS$(0.29) Unavailable*Unavailable*

*S&P Global consensus estimates for ONCSQ were unavailable due to missing mapping in CIQ; values could not be retrieved (Values retrieved from S&P Global).

Segment Breakdown

  • Not applicable; company reports consolidated results with no revenue .

KPIs

KPIQ3 2016Q4 2016Q1 2017
Melanoma combo trial enrollment“Over 20 patients enrolled” “Over 20 patients enrolled” Not updated in Q1 PR
Device prototype statusAdvancements highlighted Next-gen electroporation prototypes completed Completed; lower engineering costs
Cash runway commentary“Sufficient funds...at least next 12 months” “At least next 12 months” “At least next 12 months; milestones into 2018”

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial Guidance (Revenue/Margins/OpEx/Tax)FY2017Not provided Not provided Maintained (no formal financial guidance)
Clinical – Registration-Directed Trial (Melanoma anti-PD-1 non-responders)FY2016→FY2017Submit study design by end of 2016 Initiate Phase IIb registration-directed trial; finalize drug supply agreement (Q2 update) Progressing (timeline execution)
Regulatory – Fast TrackFY2017Not previously statedSecured Fast Track designation (Q2 PR) Raised (regulatory status improved)
Cash RunwayNext 12 months“Sufficient for at least next 12 months” “Sufficient for at least next 12 months; milestones into 2018” Maintained/Expanded narrative

Earnings Call Themes & Trends

Public transcript for Q1 FY2017 was not available in our document system; company announced a call on Dec 8, 2016, but full transcript access is unavailable within tools .

TopicPrevious Mentions (Q3 & Q4)Current Period (Q1 FY2017)Trend
Registration-directed trial in melanomaPlan to submit design by end of 2016; KEYTRUDA combo enrollment >20 patients “Primary focus...initiate a melanoma registration-directed clinical study” Advancing toward initiation
Platform/device developmentAdvancements in technology; engineering efforts for new devices Next-gen electroporation prototypes completed; engineering costs down Prototype completion; cost efficiency
Cash runway & fundingSufficient funds for at least 12 months Runway covers milestones into 2018 Stable runway; clarity on milestones
Regulatory pathwayRegistration-directed study planning Strategy to support BLA discussions in 2017–2018 More specific BLA path
Trial enrollment/intake>20 patients enrolled (melanoma combo) No new enrollment figures provided Await updates

Management Commentary

  • “We are delivering on our commitment to address an unmet medical need in melanoma with ImmunoPulse® IL-12...we are focused on advancing our lead program...Based on our current cash runway, we are positioned to meet our value-driving clinical and regulatory milestones into calendar 2018” — Punit Dhillon, CEO .
  • “Our primary focus for the next year is to initiate a melanoma registration-directed clinical study. We believe we will generate meaningful data in 2017 and 2018 to support the discussions with the FDA and a future biologics license application (BLA) to attract a partner” — Punit Dhillon .
  • Prior quarter context: “We have enrolled over 20 patients...and remain on track to announce interim data...later this quarter...expect to submit a registration directed study design by the end of 2016” — Punit Dhillon .

Q&A Highlights

  • The Q1 FY2017 earnings call transcript was not available in the document system; while a call was scheduled on Dec 8, 2016, full Q&A content could not be retrieved within tools .

Estimates Context

  • S&P Global Wall Street consensus estimates for ONCSQ were unavailable due to missing CIQ mapping; comparisons vs consensus could not be performed this quarter (Values retrieved from S&P Global).
  • Given the absence of revenue and non-commercial status, near-term estimate dispersion would likely focus on OpEx and EPS; with R&D and G&A trending lower in Q1, estimates may require downward revisions to expense assumptions if sustained .

Key Takeaways for Investors

  • Expense discipline is evident: R&D and G&A reductions narrowed the net loss and improved EPS vs prior year; monitor sustainability of lower engineering/outside services post prototype completion .
  • Cash runway extends through key clinical milestones into 2018, reducing near-term financing risk but watch dilution as WA shares have been rising year over year .
  • The melanoma registration-directed Phase IIb initiation is the primary catalyst; prior combo trial enrollment and planned interim data support near-term news flow .
  • Regulatory momentum: Fast Track designation (Q2) strengthens the pathway; Q1 commentary emphasizes BLA discussions potential in 2017–2018 .
  • No financial guidance and no revenue: investment case hinges on clinical execution, regulatory milestones, and partnership prospects rather than near-term financials .
  • Watch for Q2 updates: operational objectives include drug supply agreements and Phase IIb initiation; expense trends and cash usage should be tracked closely .
  • Absence of consensus estimates limits beat/miss framing; traders should anchor on clinical/regulatory event timing and any interim data disclosures (e.g., KEYTRUDA combo) .