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ONCOSEC MEDICAL Inc (ONCSQ)·Q4 2017 Earnings Summary

Executive Summary

  • OncoSec reported Q4 FY2017 GAAP net loss of $5.8M and $(0.28) EPS; no revenue was recorded, consistent with prior quarters as the company advances clinical programs .
  • Operationally, the company initiated the registration-directed PISCES/KEYNOTE-695 trial of ImmunoPulse IL-12 (tavo) plus pembrolizumab, and highlighted positive Phase 2 combination data with a 50% BORR in predicted anti-PD-1 non-responder melanoma patients; initial PISCES data is anticipated mid-2018 .
  • Opex trended higher sequentially on R&D and G&A in Q4, but was lower year-over-year; cash was $11.4M at July 31, 2017 with runway expected to the third calendar quarter of 2018 .
  • Funding actions and commitments totaling $8.1M were noted alongside Fast Track and Orphan Drug designations for tavo, positioning the program for an accelerated approval pathway in refractory melanoma .

What Went Well and What Went Wrong

What Went Well

  • Initiated the global, registration-directed PISCES/KEYNOTE-695 Phase 2b trial in unresectable metastatic melanoma, with KEYNOTE status through Merck collaboration and U.S. Fast Track and Orphan designations for ImmunoPulse IL-12 .
  • Positive Phase 2 combination data: best overall response rate 50% (11/22) at 24 weeks, with 41% complete responders; safety profile remained favorable with <10% SAEs, supporting the mechanistic rationale to convert “cold” tumors to “hot” .
  • CEO emphasized focus on accelerated pathway to address unmet need: “advancing the development of our lead clinical program… through an innovative accelerated pathway” .

What Went Wrong

  • PISCES initial data timing shifted from “targeted for fourth quarter of 2017” (prior quarter guidance) to “anticipate initial data mid-2018,” indicating a delay versus prior expectations .
  • Operating losses continued with no revenue generation; Q4 net loss widened sequentially to $5.8M from $4.6M in Q3, reflecting higher quarter-end spend as programs progress .
  • Cash decreased to $11.4M (from $16.1M in Q3 and $20.5M in Q2), requiring continued capital planning despite noted $8.1M commitments; management previously indicated potential need for capital in early 2018 before extending runway guidance in Q4 .

Financial Results

Quarterly Trend (oldest → newest)

MetricQ2 FY2017 (ended Jan 31, 2017)Q3 FY2017 (ended Apr 30, 2017)Q4 FY2017 (ended Jul 31, 2017)
Revenue ($USD Millions)$0.00 $0.00 $0.00
Net Loss ($USD Millions)$5.39 $4.56 $5.80
Diluted EPS ($USD)$(0.27) $(0.22) $(0.28)
R&D Expense ($USD Millions)$2.88 $2.66 $3.30
G&A Expense ($USD Millions)$2.50 $1.90 $2.60
Cash & Equivalents ($USD Millions)$20.54 $16.11 $11.44

Year-over-Year (Q4 FY2017 vs Q4 FY2016)

MetricQ4 FY2016Q4 FY2017
Revenue ($USD Millions)$0.00 $0.00
Net Loss ($USD Millions)$6.60 $5.80
Diluted EPS ($USD)$(0.39) $(0.28)
R&D Expense ($USD Millions)$3.60 $3.30
G&A Expense ($USD Millions)$3.00 $2.60

KPIs (Clinical efficacy and trial status)

KPIQ3 FY2017Q4 FY2017
Combination ORR/BORR at 24 weeksObjective response 43%; BORR 48% BORR 50% (11/22); RECIST v1.1 BORR 42.9% (9/21)
Complete Response rateN/A disclosed41% (9/22)
Disease Control RateN/A disclosed59%
Safety (SAE rate)N/A disclosed<10%
PISCES/KEYNOTE-695 statusOpen for enrollment in June 2017; drug supply agreement in place Initiated; global, open-label Phase 2b (KEYNOTE)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PISCES initial data timingRegistration-directed trialTop-line data targeted for Q4 2017 Initial data anticipated mid-2018 Lowered/Delayed
PISCES enrollment statusRegistration-directed trialOpen for enrollment in June 2017 Initiated global KEYNOTE-695 trial Achieved/Maintained
Regulatory designationsU.S.Fast Track designation Fast Track and Orphan Drug Designation Strengthened
Cash runwayCorporateMay need additional capital in 1Q 2018 Funds sufficient to 3Q 2018 Raised/Extended
FinancingCorporateN/ARaised/commitments for $8.1M, priced at or above market New

Earnings Call Themes & Trends

  • No earnings call transcript was available via our document tools for Q4 FY2017. External transcript listings exist (Seeking Alpha transcripts page) but the full content could not be read via tools for inclusion and citation in this report .
TopicPrevious Mentions (Q2→Q3)Current Period (Q4)Trend
R&D executionQ2: Fast Track secured; objectives to initiate Phase IIb and finalize supply agreement . Q3: drug supply agreement completed; PISCES open for enrollment .PISCES/KEYNOTE-695 initiated; initial data mid-2018 Progressing; timeline extended
Regulatory/legalQ3: FDA Fast Track Fast Track and Orphan Drug Designations Strengthening designations
Clinical efficacyQ3: 43% objective response; BORR 48% BORR 50%; 41% CR; <10% SAEs Positive efficacy maintained
Capital and liquidityQ2: $20.5M cash; sufficient for at least 12 months . Q3: $16.1M cash; may need capital in 1Q18 .$11.4M cash; runway to 3Q18; $8.1M commitments Runway extended; continued need to finance

Management Commentary

  • “We have made significant progress this past quarter in advancing the development of our lead clinical program, ImmunoPulse IL-12… Our organization remains focused on advancing our PISCES/KEYNOTE-695 registration-directed trial to address this significant unmet medical need through an innovative accelerated pathway.” — Punit Dhillon, President and CEO .
  • Prior quarter tone: “With a clinical collaboration and drug supply agreement for pembrolizumab and FDA Fast Track designation in hand, we are working diligently on the site start-up and initiation activities related to our registration-directed study… favorable position to secure the first approval in the anti-PD-1 non-responder patient population in advanced melanoma.” — Punit Dhillon .
  • Earlier quarter: “We are confident in our clinical and regulatory pathway… objectives are focused on initiating the Phase IIb registration-directed trial… and finalizing a drug supply agreement.” — Punit Dhillon .

Q&A Highlights

  • A full Q4 FY2017 earnings call transcript was not available via our document tools; we identified external listings but could not read the transcript in full via tools for verifiable inclusion. As such, Q&A themes and clarifications cannot be reliably synthesized for this report .

Estimates Context

  • We attempted to retrieve S&P Global (Capital IQ) consensus for Q4 FY2017 (EPS, Revenue, Target Price, Recommendation), but ONCSQ was missing from the CIQ mapping and consensus could not be fetched. Therefore, Wall Street consensus estimates are unavailable for comparison in this report [GetEstimates error].
  • Given the lack of S&P Global consensus data, estimate comparisons and beat/miss determinations cannot be made for Q4 FY2017.

Key Takeaways for Investors

  • Registration-directed PISCES/KEYNOTE-695 is underway with Fast Track and Orphan status and Merck collaboration, providing a potential accelerated pathway in anti-PD-1 non-responder melanoma—core to the near-term thesis .
  • Clinical efficacy signals remain compelling (BORR 50%, CR 41%) with favorable safety (<10% SAEs), supporting the mechanism to convert “cold” tumors to “hot” and sustain investor confidence in the combination strategy .
  • Data timing was pushed to mid-2018 from prior Q4 2017 target; manage expectations for catalysts and consider timing risk around interim readouts and enrollment pace .
  • Liquidity improved versus prior quarter guidance, with runway now to 3Q 2018 and $8.1M commitments—reducing near-term financing overhang but leaving continued capital needs as a watch item .
  • Operating losses will persist absent revenue; monitor quarterly opex trends (R&D and G&A) as the company balances spend against trial progress .
  • Without consensus estimates, trading setups should center on clinical milestones and regulatory updates rather than beat/miss dynamics; potential stock reaction catalysts include PISCES enrollment progress and mid-2018 initial data .
  • Year-over-year improvements in net loss and opex underscore cost discipline aligned with program prioritization (KEYNOTE-695), an important factor for medium-term sustainability .