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ONCOSEC MEDICAL Inc (ONCSQ)·Q2 2017 Earnings Summary

Executive Summary

  • Q2 FY2017 was pre-revenue and showed improved loss metrics YoY: net loss narrowed to $5.39M (EPS -$0.27) vs $7.04M (EPS -$0.42) in Q2 FY2016, driven primarily by lower R&D and stock comp; sequentially, net loss improved from Q1 FY2017’s $5.60M (EPS -$0.29) .
  • Cash and equivalents were $20.54M as of Jan 31, 2017; management stated funds are sufficient to continue operations for at least the next 12 months, but the 10-Q highlights expected monthly cash outflows of ~$1.7M for the remainder of FY2017 and the need for additional financing to fund future operations .
  • Strategic focus remained on initiating the Phase IIb registration-directed trial (PISCES) in anti-PD-1 non-responder melanoma; OncoSec secured FDA Fast Track for ImmunoPulse IL‑12, and aimed to finalize a drug supply agreement to support PISCES .
  • No formal financial guidance or Wall Street consensus estimates were available for revenue/EPS; key stock reaction catalysts are clinical/regulatory milestones (Fast Track, PISCES site start-up/initiations) rather than near-term fundamentals .

What Went Well and What Went Wrong

What Went Well

  • Net loss and EPS improved YoY, reflecting reduced R&D spending and lower stock-based compensation; management explicitly cited lower trial activity and stock comp as drivers of the decline in net loss .
  • Regulatory momentum: FDA Fast Track designation for ImmunoPulse IL‑12 in metastatic melanoma following progression on anti‑PD‑1 therapy; management expressed confidence in the clinical and regulatory pathway and focus on initiating a registration-directed Phase IIb trial .
  • Platform/device progress continued, with advancements toward prototypes of next-generation electroporation devices and focus on multi-gene constructs for solid tumors .

Quote: “We are confident in our clinical and regulatory pathway for the development of our lead candidate, ImmunoPulse IL‑12…” — Punit Dhillon, President & CEO .

What Went Wrong

  • Persistent pre-revenue status and ongoing losses; Q2 had no revenue and posted a $5.39M net loss (EPS -$0.27) .
  • Trial enrollment challenges impacted costs and progress: R&D expenses decreased partly due to a lower number of actively enrolling trials and fewer patient enrollments; TNBC pilot study protocol was amended to improve slow enrollment .
  • Liquidity trajectory shows meaningful burn: cash fell to $20.54M (from $24.35M in Q1 and $28.75M at FY2016 year-end); management disclosed monthly cash outflows of ~$1.7M for the remainder of FY2017 and a need for additional financing to fund future operations .

Financial Results

MetricQ2 2016Q1 2017Q2 2017
Revenue ($USD Millions)$0.00 $0.00 $0.00
Net Loss ($USD Millions)$7.04 $5.60 $5.39
Diluted EPS ($USD)$(0.42) $(0.29) $(0.27)
R&D Expense ($USD Millions)$4.11 $3.10 $2.88
G&A Expense ($USD Millions)$2.92 $2.50 $2.50

Cash and liquidity (quarter-end):

MetricQ1 2017Q2 2017
Cash and Equivalents ($USD Millions)$24.35 $20.54
Weighted Avg Shares (Millions)19.02 19.73

Segment breakdown:

SegmentDescription
Single segmentDiscovery and development of novel immunotherapeutic product candidates (company operates in one segment)

KPIs:

KPIQ1 2017Q2 2017
Cash and Equivalents ($USD Millions)$24.35 $20.54
Working Capital ($USD Millions)$17.92
Monthly Cash Outflows Guidance ($USD Millions)~$1.70 (remainder of FY2017)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayNext 12 months“Sufficient to operate business for at least next 12 months” (as of Q1 FY2017) “Sufficient to operate business for at least next 12 months” (as of Q2 FY2017) Maintained
Monthly cash outflowsRemainder of FY2017Not provided~$1.7M per month expected New disclosure
Registration-directed study (PISCES)H1 2017Target to submit study design by end of 2016 Focus on initiating Phase IIb registration-directed trial; finalize drug supply agreement Progressing toward initiation
Drug supply agreement (pembrolizumab)2017Not providedWorking to finalize supply agreement for PISCES New disclosure

Earnings Call Themes & Trends

Note: No earnings call transcript was available in company filings for Q2; themes reflect press releases and 10‑Q MD&A.

TopicPrevious Mentions (Q4 FY2016, Q1 FY2017)Current Period (Q2 FY2017)Trend
Regulatory pathwayPlan to submit registration-directed study design by end of 2016 ; focus on initiating melanoma registration-directed study Fast Track designation for IL‑12; confidence in clinical/regulatory pathway; aim to initiate Phase IIb Accelerating regulatory path
Trial execution/enrollment>20 patients enrolled in combo trial; interim data planned ; early response data noted Lower enrollments reduced R&D; TNBC pilot protocol amended to improve enrollment Mixed: execution continues, enrollment challenges
Liquidity/financingCash $28.75M at FY2016 YE ; $24.35M at Q1 Cash $20.54M; 12‑month runway; ~$1.7M monthly outflows disclosed; need for future financing highlighted Cash burn ongoing; financing likely
Technology/device R&DBroaden engineering on new devices Advancements toward next-gen electroporation prototypes; multi-gene candidates Continued progress
PartnershipsUCSF investigator-sponsored combo study Finalize pembrolizumab supply agreement for PISCES Formalizing key collaborations

Management Commentary

  • Strategy focus: “Main objectives are focused on initiating the Phase IIb registration-directed trial in Stage III/IV melanoma anti‑PD‑1 non‑responder population and finalizing a drug supply agreement for this trial” — Punit Dhillon .
  • Commitment to melanoma program: “We are delivering on our commitment to address an unmet medical need in melanoma… Our primary focus for the next year is to initiate a melanoma registration-directed clinical study” — Punit Dhillon .
  • Execution update (prior quarter): “We have enrolled over 20 patients in our Phase II combination clinical study… expect to submit a registration directed study design… by the end of 2016” — Punit Dhillon .

Q&A Highlights

  • No formal Q&A transcript was available in company filings for Q2 FY2017; investor communications were via the 8‑K press release and the 10‑Q .

Estimates Context

  • Wall Street consensus estimates via S&P Global for Q2 FY2017 were unavailable for ONCSQ; as a result, no comparison vs estimates can be made at this time (S&P Global data unavailable).

Key Takeaways for Investors

  • Loss metrics improved YoY as R&D and stock comp declined; watch if reduced trial activity is temporary versus structural given upcoming PISCES initiation .
  • Liquidity runway of ~12 months with ~$1.7M average monthly cash outflows for the remainder of FY2017; expect financing risk and timing to be a key overhang and potential catalyst .
  • Regulatory momentum (Fast Track) and near-term operational milestones (finalizing pembrolizumab supply, PISCES site start-up) are the primary stock narrative drivers in a pre‑revenue context .
  • Enrollment dynamics matter: management cited fewer enrollments and fewer actively enrolling trials as drivers of lower R&D; TNBC study enrollment required protocol adjustments .
  • Device/platform optionality continues (next‑gen electroporation, multi‑gene constructs), but clinical readouts will dictate medium-term thesis strength .
  • With no revenue and negative operating cash flow, trading setup is catalyst‑driven; monitor PISCES initiation/timeline, any top‑line data releases, and financing updates closely .