Oncosec Medical (ONCS) Provides 2018 Business Outlook

OncoSec Medical Incorporated ("OncoSec" or the "Company") (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, announced its anticipated operational milestones for 2018 and a review of business highlights for year-end 2017.

"The momentum we achieved in late 2017 provides the foundation for a transformational year in 2018," said Daniel J. O'Connor, Chief Executive Officer of OncoSec. "The year ahead is critical for OncoSec with preliminary data expected in key clinical programs; preliminary feedback from regulators on an accelerated approval pathway for ImmunoPulse® IL-12 in unresectable metastatic melanoma patients who have progressed or are progressing on an anti-PD-1 therapy; and advances in our intratumoral delivery platform."

He continued, "Operational execution will dominate 2018, with a focus on laying the groundwork for future BLA and IND filings. We plan to conduct a second clinical trial in triple negative breast cancer (TNBC), as well as two investigator sponsored trials in squamous cell carcinoma of the head and neck (SCCHN) and in the melanoma neoadjuvant setting. These trials will be in combination with anti-PD-1 therapy. We look forward to sharing progress toward our vision throughout the year: to have multiple products that will make a dramatic patient impact and an innovative pipeline driven by a sustainable product engine."

2018 OPERATIONAL MILESTONES

OncoSec anticipates the following operational milestones in 2018:

Clinical Operations

ImmunoPulse IL-12 Melanoma

• Complete stage 1 enrollment of PISCES/KEYNOTE-695; a Phase 2b registration-directed clinical trial of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), in combination with KEYTRUDA® (pembrolizumab) for patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy
• Present preliminary data from PISCES/KEYNOTE-695 at a medical meeting
• Seek preliminary FDA feedback on an accelerated approval pathway for ImmunoPulse IL-12 Biologics License Application (BLA) in patients with unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy
• Apply for classification as an Advanced-Therapy Medicinal Product (ATMP) for the treatment of unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy by the European Medicines Agency's Committee for Advanced Therapies (CAT)
• Prepare to commercially launch ImmuoPulse IL-12 in the U.S.
• Initiate a Phase 2 investigator-sponsored clinical trial in combination with an anti-PD-1 therapy in the neoadjuvant setting

ImmunoPulse IL-12 Triple Negative Brest Cancer (TNBC)

• Provide update of preliminary clinical observations for OMS-I140 TNBC pilot study conducted in collaboration with the Stanford University Medical Center
• Present preliminary data for OMS-I140 TNBC study at a medical meeting
• Initiate a Phase 2 clinical trial in combination with an anti-PD-1 therapy in the recurrent and/or metastatic setting

ImmunoPulse IL-12 Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Initiate a Phase 2 investigator-sponsored clinical study in combination with two other immunotherapies in the recurrent and/or metastatic setting

Business Development

• Seek partner for the development, registration and commercialization of ImmunoPulse IL-12 in metastatic melanoma in the U.S. and EU, as well as in other important regions
• Pursue multiple partnerships and collaborations for cancer immunotherapy platform to enable additional research in combination with other cancer therapies and novel immunotherapies

Expanding Clinical Pipeline

• Prepare an IND for a second product candidate utilizing our proprietary, multi-gene expression Polycistronic Interleukin-12 Immune Modulator (PIIM) platform technology

Enhanced Platform Engineering and Manufacturing

• Advance second-generation proprietary GENESIS™ generator to be ready for introduction into the clinic
• Advance proprietary applicators in cancer indications beyond cutaneous and subcutaneous tumors
• Undertake technology transfers with partners and install new innovative technologies to improve the overall supply chain

2017 OPERATIONAL MILESTONE REVIEW

OncoSec achieved several important clinical, regulatory, business and operational milestones during 2017.

Clinical Operations

ImmunoPulse IL-12 Metastatic Melanoma

• Presented updated positive long-term follow-up data from our Phase 2 trial of ImmunoPulse IL-12 in combination with KEYTRUDA (pembrolizumab) at the 2017 Society for Immunotherapy of Cancer Annual Meeting
  • Selected as a Late Breaking Abstract and Oral Poster Presentation, OncoSec presented updated clinical and correlative immune-focused biomarker data demonstrating a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response, median PFS not yet reached, and a best overall response rate (BORR) of 50% (41% complete response [CR] rate) in patients selected to not respond to anti-PD-1 monotherapy
  • Data indicate that ImmunoPulse IL-12 coordinates innate and adaptive anti-tumor immune responses, converting "cold" tumors to "hot," which drives adaptive resistance and strongly suggests a synergistic relationship between ImmunoPulse IL-12 and anti-PD-1 combination.
• Presented preclinical data demonstrating multigene platform for delivery of multiple cancer immunotherapies at the 2017 Society for Immunotherapy of Cancer Annual Meeting
  • Emerging data was presented from our novel, multi-gene (PIIM) expression platform, demonstrating enhanced therapeutic potential
• Announced the initiation of global, multi-center, registration-directed open-label PISCES/KEYNOTE-695 Phase 2b clinical trial, evaluating the combination of ImmunoPulse IL-12 and pembrolizumab in patients with unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy
  • First patient dosed and multiple sites opened in the U.S. and Australia
• Granted Orphan Drug Designation for ImmunoPulse IL-12 for the treatment of unresectable metastatic melanoma from U.S. Food and Drug Administration (FDA)
• Granted Fast Track designation from the FDA for ImmunoPulse IL-12 in combination with pembrolizumab for stage III/IV melanoma patients who are progressing or who have progressed on either pembrolizumab or nivolumab treatment

Technology Access Program

• Established the OncoSec Technology Access Program (TAP) using OncoSec's proprietary GENESIS™ research generator, which was developed specifically for gene electro-transfer and features customizable electroporation parameters for construct-specific optimization of expression. It is the only in vivo electroporation device enabled with TRACE™ Technology (Tissue-Based, Real-Time Adaptive Control Electroporation)
  • Entered into a preclinical agreement through TAP with Jounce Therapeutics, Inc., InhibRx, LP, and others

Corporate

• Appointed Daniel J. O'Connor, JD, as Chief Executive Officer and Director
• Expanded intellectual property estate for ImmunoPulse Platform
• Completed two successful public offerings of common stock and warrant exercise, raising net proceeds of $17.5 million
• Promoted Christopher G. Twitty, Ph.D. to Chief Scientific Officer

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

ImmunoPulse® is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.

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