On November 8, 2017 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and reported financial results for the quarter ended September 30, 2017 (Press release, MacroGenics, NOV 8, 2017, View Source [SID1234521799]).

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"We continue to be encouraged by data we’ve seen across multiple product candidates in our diverse pipeline. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting later this week, we will have five posters relating to our various PD-1-based programs, including MGA012 (anti-PD-1) and our two PD-1-based DART molecules," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Also, in addition to the Phase 1 flotetuzumab data presented recently at the European Society for Medical Oncology Annual Congress (ESMO) (Free ESMO Whitepaper), we look forward to having two posters and an oral presentation with updated clinical data, at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December. Finally, we are thrilled to work with our new collaboration partner, Incyte, to expand the current development efforts for MGA012 and accelerate our own efforts to investigate combinations of MGA012 with multiple molecules in MacroGenics’ portfolio."

Key Pipeline Highlights

Flotetuzumab. Enrollment of the Phase 1 dose expansion study of flotetuzumab, a bispecific DART molecule that recognizes both CD123 and CD3, is ongoing in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Recent highlights include:

In September, MacroGenics presented clinical data from its ongoing Phase 1 study of flotetuzumab in an oral session at ESMO (Free ESMO Whitepaper). Flotetuzumab demonstrated acceptable tolerability in the dose escalation portion of the study with encouraging initial anti-leukemic activity observed in AML patients. As of the data cut-off date of August 1, of the 14 response-evaluable patients treated at the threshold dose, six (43%) experienced an objective response. This included four (28%) patients who achieved a CR/CRi, with one patient who had a molecular CR.
MacroGenics will present updated clinical data in an oral presentation at ASH (Free ASH Whitepaper) in December 2017.
PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which are designed to enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are:

MGA012. Enrollment in the dose escalation portion of the Phase 1 study of this anti-PD-1 antibody has been completed and the data have been accepted for poster presentation at the upcoming SITC (Free SITC Whitepaper) meeting. MGA012 is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the Phase 1 study. In October 2017, MacroGenics entered into an exclusive global collaboration and license agreement with Incyte Corporation for MGA012, in which Incyte obtained exclusive worldwide rights for the development and commercialization of MGA012. MacroGenics retains the right to pursue its core strategy to develop its pipeline assets in combination with MGA012. The Company plans to initiate the first study of MGA012 in combination with another internal program by year end 2017.
MGD013. MacroGenics is developing MGD013, a DART molecule, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company is enrolling the dose escalation portion of the Phase 1 study and will present a preclinical data poster as well as a Trials-in-Progress poster describing the Phase 1 study at SITC (Free SITC Whitepaper).
MGD019. MacroGenics continues to advance a preclinical bispecific DART molecule that provides co-blockade of PD-1 and CTLA-4, resulting in enhanced T-cell activation. The Company is conducting activities to support the potential submission of an Investigational New Drug (IND) application for MGD019 in 2018 and will present a preclinical data poster at SITC (Free SITC Whitepaper).
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:

Enoblituzumab: The Company and collaborators continue to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include a combination study with an anti-PD-1 antibody and a neoadjuvant prostate cancer study.
MGD009: This DART molecule targets B7-H3 and CD3 and is being evaluated in a Phase 1 study across multiple solid tumor types. The Company continues to explore the dose and schedule for MGD009 administration.
MGC018: The Company is conducting activities to support the potential submission of an IND application for this anti-B7-H3 antibody drug conjugate in 2018.
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:

Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics believes it is on track to complete and announce the results of an interim futility analysis by year-end 2017 or early 2018 and to complete enrollment of this study by late 2018.
Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. MacroGenics expects to complete enrollment of two 30 patient expansion cohorts in 2017 and present clinical data during the first half of 2018.
Additional DART Clinical Programs. Other DART molecules being led by MacroGenics in Phase 1 clinical development include MGD007 (gpA33 x CD3) for colorectal cancer and MGD014 (HIV x CD3) for HIV. Updates on these programs include:

MGD007. MacroGenics continues to recruit patients with colorectal cancer in a Phase 1 study and is evaluating various expansion cohorts to define a recommended dose and schedule.
MGD014. MacroGenics’ IND submission for MGD014 was cleared by FDA and the Company anticipates that a first patient will be dosed in early 2018.
Corporate Update

Incyte Collaboration. In October 2017, MacroGenics and Incyte Corporation entered into an exclusive global collaboration and license agreement for MGA012. Under this agreement, MacroGenics will receive an upfront payment of $150 million and could receive up to $750 million in potential development, regulatory and commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte. The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions.
GMP Manufacturing. Construction progress on MacroGenics’ GMP manufacturing suite remains on track. The Company anticipates that the 5 x 2,000 liter single-use bioreactor facility will be operational in 2018. As part of the MGA012 collaboration with Incyte, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012.
Third Quarter 2017 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2017, were $203.6 million, compared to $285.0 million as of December 31, 2016. MacroGenics anticipates receipt of the $150 million upfront payment from Incyte upon closing of the transaction in the fourth quarter of 2017.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $1.7 million for the quarter ended September 30, 2017, compared to $3.3 million for the quarter ended September 30, 2016. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the period.
R&D Expenses: Research and development expenses were $41.0 million for the quarter ended September 30, 2017, compared to $30.3 million for the quarter ended September 30, 2016. This increase was primarily due to the initiation of the MGA012 Phase 1 study and continued enrollment in multiple ongoing clinical trials.
G&A Expenses: General and administrative expenses were $8.4 million for the quarter ended September 30, 2017, compared to $7.2 million for the quarter ended September 30, 2016. This increase was primarily due to increased professional fees, including consulting expenses, and increased employee compensation and benefit expense to support our overall growth.
Net Loss: Net loss was $47.0 million for the quarter ended September 30, 2017, compared to net loss of $33.8 million for the quarter ended September 30, 2016.
Shares Outstanding: Shares outstanding as of September 30, 2017 were 36,807,112.
Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended September 30, 2017 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (+1) (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 5477659.

The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On November 8, 2017 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and financial results for the quarter ended September 30, 2017 (Press release, MacroGenics, NOV 8, 2017, View Source [SID1234521800]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We continue to be encouraged by data we’ve seen across multiple product candidates in our diverse pipeline. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting later this week, we will have five posters relating to our various PD-1-based programs, including MGA012 (anti-PD-1) and our two PD-1-based DART molecules," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Also, in addition to the Phase 1 flotetuzumab data presented recently at the European Society for Medical Oncology Annual Congress (ESMO) (Free ESMO Whitepaper), we look forward to having two posters and an oral presentation with updated clinical data, at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December. Finally, we are thrilled to work with our new collaboration partner, Incyte, to expand the current development efforts for MGA012 and accelerate our own efforts to investigate combinations of MGA012 with multiple molecules in MacroGenics’ portfolio."

Key Pipeline Highlights
Flotetuzumab. Enrollment of the Phase 1 dose expansion study of flotetuzumab, a bispecific DART molecule that recognizes both CD123 and CD3, is ongoing in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Recent highlights include:
•
In September, MacroGenics presented clinical data from its ongoing Phase 1 study of flotetuzumab in an oral session at ESMO (Free ESMO Whitepaper). Flotetuzumab demonstrated acceptable tolerability in the dose escalation portion of the study with encouraging initial anti-leukemic activity observed in AML patients. As of the data cut-off date of August 1, of the 14 response-evaluable patients treated at the threshold dose, six (43%) experienced an objective response. This included four (28%) patients who achieved a CR/CRi, with one patient who had a molecular CR.
•
MacroGenics will present updated clinical data in an oral presentation at ASH (Free ASH Whitepaper) in December 2017.
PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which are designed to enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are:
•
MGA012. Enrollment in the dose escalation portion of the Phase 1 study of this anti-PD-1 antibody has been completed and the data have been accepted for poster presentation at the upcoming SITC (Free SITC Whitepaper) meeting. MGA012 is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the Phase 1 study. In October 2017, MacroGenics entered into an exclusive global collaboration and license agreement with Incyte Corporation for MGA012, in which Incyte obtained exclusive worldwide rights for the development and commercialization of MGA012. MacroGenics retains the right to pursue its core strategy to develop its pipeline assets in combination with MGA012. The Company plans to initiate the first study of MGA012 in combination with another internal program by year end 2017.

•
MGD013. MacroGenics is developing MGD013, a DART molecule, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company is enrolling the dose escalation portion of the Phase 1 study and will present a preclinical data poster as well as a Trials-in-Progress poster describing the Phase 1 study at SITC (Free SITC Whitepaper).
•
MGD019. MacroGenics continues to advance a preclinical bispecific DART molecule that provides co-blockade of PD-1 and CTLA-4, resulting in enhanced T-cell activation. The Company is conducting activities to support the potential submission of an Investigational New Drug (IND) application for MGD019 in 2018 and will present a preclinical data poster at SITC (Free SITC Whitepaper).

B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:
•
Enoblituzumab: The Company and collaborators continue to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include a combination study with an anti-PD-1 antibody and a neoadjuvant prostate cancer study.
•
MGD009: This DART molecule targets B7-H3 and CD3 and is being evaluated in a Phase 1 study across multiple solid tumor types. The Company continues to explore the dose and schedule for MGD009 administration.
•
MGC018: The Company is conducting activities to support the potential submission of an IND application for this anti-B7-H3 antibody drug conjugate in 2018.
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:
•
Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics believes it is on track to complete and announce the results of an interim futility analysis by year-end 2017 or early 2018 and to complete enrollment of this study by late 2018.
•
Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. MacroGenics expects to complete enrollment of two 30 patient expansion cohorts in 2017 and present clinical data during the first half of 2018.
Additional DART Clinical Programs. Other DART molecules being led by MacroGenics in Phase 1 clinical development include MGD007 (gpA33 x CD3) for colorectal cancer and MGD014 (HIV x CD3) for HIV. Updates on these programs include:
•
MGD007. MacroGenics continues to recruit patients with colorectal cancer in a Phase 1 study and is evaluating various expansion cohorts to define a recommended dose and schedule.
•
MGD014. MacroGenics’ IND submission for MGD014 was cleared by FDA and the Company anticipates that a first patient will be dosed in early 2018.
Corporate Update

•
Incyte Collaboration. In October 2017, MacroGenics and Incyte Corporation entered into an exclusive global collaboration and license agreement for MGA012. Under this agreement, MacroGenics will receive an upfront payment of $150 million and could receive up to $750 million in potential development, regulatory and commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte. The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions.
•
GMP Manufacturing. Construction progress on MacroGenics’ GMP manufacturing suite remains on track. The Company anticipates that the 5 x 2,000 liter single-use bioreactor facility will be operational in 2018. As part of the MGA012 collaboration with Incyte, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012.
Third Quarter 2017 Financial Results
•
Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2017, were $203.6 million, compared to $285.0 million as of December 31, 2016. MacroGenics anticipates receipt of the $150 million upfront payment from Incyte upon closing of the transaction in the fourth quarter of 2017.
•
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $1.7 million for the quarter ended September 30, 2017, compared to $3.3 million for the quarter ended September 30, 2016. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the period.
•
R&D Expenses: Research and development expenses were $41.0 million for the quarter ended September 30, 2017, compared to $30.3 million for the quarter ended September 30, 2016. This increase was primarily due to the initiation of the MGA012 Phase 1 study and continued enrollment in multiple ongoing clinical trials.
•
G&A Expenses: General and administrative expenses were $8.4 million for the quarter ended September 30, 2017, compared to $7.2 million for the quarter ended September 30, 2016. This increase was primarily due to increased professional fees, including consulting expenses, and increased employee compensation and benefit expense to support our overall growth.
•
Net Loss: Net loss was $47.0 million for the quarter ended September 30, 2017, compared to net loss of $33.8 million for the quarter ended September 30, 2016.
•
Shares Outstanding: Shares outstanding as of September 30, 2017 were 36,807,112.

On November 8, 2017 Medtronic plc (NYSE:MDT) reported its preliminary revenue for its second quarter of fiscal year 2018, which ended October 27, 2017. The company announced preliminary second quarter worldwide revenue of approximately $7.050 billion, a decrease of 4 percent as reported, with the decline driven by the company’s divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses to Cardinal Health that occurred at the beginning of the quarter. Second quarter revenue increased 3 percent on a comparable, constant currency basis, which adjusts for the divestiture and a $35 million positive impact from foreign currency (Press release, Medtronic, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315619 [SID1234521801]). Excluding the impact of Hurricane Maria, second quarter revenue growth would have been 4 percent on a comparable, constant currency basis.

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The company announced that the impact of Hurricane Maria was approximately $55 to $65 million to its second quarter revenue and is expected to be approximately $0.03 to its second quarter non-GAAP earnings per share (EPS). The company was able to limit the financial impact versus its original expectations provided on October 6th due to the performance and resilience of its employees driving a faster-than-anticipated recovery of its operations in Puerto Rico. As expected, the majority of the impact was to its Minimally Invasive and Restorative Therapies Groups in the United States.

On September 20th, Hurricane Maria devastated the island of Puerto Rico and incapacitated Medtronic’s four manufacturing plants. Within two weeks, on October 2nd the company had substantially repaired its four Puerto Rico manufacturing facilities and restarted limited production, with production reaching 50 to 60 percent capacity by October 9th, and ramping to near pre-hurricane capacity by October 18th.

Medtronic’s primary focus has been to support the well-being of its more than 5,000 direct and contract employees on the island and restore its operations to full productivity. The company has and continues to provide critical supplies for its people in Puerto Rico, including water, food, temporary housing, medical care, counseling services, child care, laundry facilities, and power generators.

Despite ongoing island infrastructure challenges, the company is now fully prepared for sustained operations on the island. Medtronic took several actions to restore its manufacturing operations, including implementing on-site and redundant power generator systems; alternate technologies for telecommunication and data connectivity; access to critical suppliers and production materials; and shipping, transportation, and logistics capabilities. As a result, the company was able to minimize the impact of the hurricane on both its supply to customers as well as the company’s second quarter financial results.

"The creativity, dedication, and persistence of our employees – both on and off the island – in dealing with the aftermath of Hurricane Maria was simply incredible. In particular, our employees in Puerto Rico made countless selfless contributions, despite extensive impact to their personal lives, coming to work every day to ensure customers and patients worldwide received our products," said Omar Ishrak, Medtronic chairman and chief executive officer. "Through the efforts of our team, along with help from the local government and the U.S. FDA, we were able to achieve extraordinary results with our Puerto Rico operations over the month of October, well exceeding our initial expectations. I am extremely proud of our passionate employees whose tireless dedication was critical in restoring our operations."

Second Quarter EPS Guidance

Excluding the impact of Hurricane Maria, Medtronic today reiterated its expectation that second quarter adjusted EPS would be flat to slightly up on a comparable, constant currency basis from the prior year comparable EPS of $1.04. The company expects a one cent positive impact to adjusted EPS from foreign currency. Adjusted EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings.

Webcast Information

Medtronic will report financial results for the second quarter of fiscal year 2018 and provide an outlook for its fiscal year on Tuesday, November 21, 2017. This is one week earlier than the preliminary date previously provided by the company. A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at View Source Medtronic will host a webcast at 7:00 a.m. CST to discuss its financial results. The webcast can be accessed at View Source on November 21, 2017. Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal 2018 third and fourth quarter financial results on Tuesday, February 20, 2018, and Thursday, May 24, 2018, respectively. Confirmation and additional details will be provided closer to the specific quarterly earnings release date.

Non-GAAP Schedule

To view the Preliminary FY18 Second Quarter Non-GAAP Reconciliation schedule, click here. The document can also be accessed by visiting newsroom.medtronic.com.

On November 8, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported its financial results and operational highlights for the quarter ended September 30, 2017 (Press release, Oncolytics Biotech, NOV 8, 2017, View Source [SID1234521802]).

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"Towards the end of the third quarter we made a very important announcement regarding feedback from the FDA following our End-of-Phase 2 meeting. The favorable meeting resulted in the support of our proposed target patient population of hormone receptor positive, HER2 receptor negative metastatic breast cancer patients for our registration study," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "With this support and guidance outlining a single, four hundred patient study, we have prepared to file for breakthrough designation which we expect to do very soon, prepared for communications with the European regulators, conducted preliminary preparations to file for a special protocol assessment, or SPA, and advanced our business development activities. We expect to be able to announce the results of these filings and communications with the European regulators over the next several months as we continue to prepare the company to relist its shares on NASDAQ in 2018."

Selected Highlights from Q2 and through the end of July 2017

Clinical Updates

· Announced a favorable End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (mBC) patients. The agency’s guidance proposed a single, 400 patient registration study to support a future Biologics License Application submission in the U.S.
· Presented mBC data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress, that demonstrated a doubling of overall survival benefit for patients with HR double-positive, HER2-negative breast cancer – a major genetic subgroup – when treated with REOLYSIN/paclitaxel combination treatment versus paclitaxel alone.
· Announced the first patient treated in our phase 1b MUK Eleven collaborative study with Myeloma UK and Celgene, studying REOLYSIN in combination with Celgene immunomodulatory drugs (IMiDs), Revlimid or Imnovid as a rescue treatment in relapsing myeloma patients.
· Presented the largest ever safety database for an oncolytic virus at the ESMO (Free ESMO Whitepaper) 2017 Congress, that demonstrated REOLYSIN is safe and well tolerated when administered in combination with chemotherapy.
Corporate Updates

· Appointed Deborah Brown to the Board of Directors, to expand the Board’s experience with product launches, market expansion, regulatory affairs, research and development and business development.
Anticipated Milestones

• First quarter 2018: Results from regulatory filings
• First half of 2018: Update on our exploration of strategic and regional alliances
NASDAQ
Preliminary MUK eleven data
• Mid-2018: Initiate phase 3 registration study in mBC
Q3 2017 Financial Results

· At September 30, 2017, the Company reported $14.0 million in cash and cash equivalents. Cash runway expected to the end of 2018.
· As at November 7, 2017, the Company had an unlimited number of authorized common shares with 140,700,722 common shares issued and outstanding, 7,448,327 options outstanding (with exercise prices ranging between $0.26 and $6.72 and expiry dates ranging from 2017 to 2027), 16,445,000 warrants outstanding (with a $0.95 strike price expiring in June 2022) and 2,428,039 RSU’s and PSU’s outstanding.

On November 8, 2017 OncoSec Medical Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported positive updated long-term follow-up data from its Phase 2 OMS I-102 combination study of ImmunoPulse IL-12 and pembrolizumab in patients unlikely to respond to anti-PD-1 therapy (Press release, OncoSec Medical, NOV 8, 2017, View Source [SID1234521755]). The updated data will be presented in an oral poster presentation (P524) by Dr. Alain Alagzi at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD on November 10th, 2017 at 12:45 p.m. EST.

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The updated clinical and correlative immune-focused biomarker data demonstrated a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response and median PFS not yet reached. Building upon previously reported data of a best overall response rate (BORR) of 50% (41% complete response [CR] rate), the updated data further demonstrate that the combination of these therapies can prime a coordinated innate and adaptive immune response, and strongly suggests a synergistic relationship with anti-PD-1. The latest findings further demonstrate that this combination approach can reshape the tumor microenvironment, yielding a robust intratumoral and systemic anti-tumor response converting "cold" tumors to "hot," potentially improving clinical outcomes in patients predicted to not respond to anti-PD-1 therapy.

"Overall, the Phase 2 trial results, including progression free survival beyond two years in multiple patients, duration of response, best overall response rate, and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of ImmunoPulse IL-12 plus pembrolizumab as a viable treatment option for patients diagnosed with metastatic melanoma," said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

Dan O’Connor, CEO of OncoSec noted: "The robust PFS benefit and tolerability observed with ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating efficacy in a predicted PD-1 non-responder population and shows that the combination represents a potentially important addition to the treatment landscape for metastatic melanoma patients who have progressed or are progressing on anti-PD-1 therapy."

The full abstract is available and can be viewed on the STIC website at www.sitcancer.org. The poster is available in the Publications section of OncoSec’s website.

Analyst Event in National Harbor, MD

OncoSec will host an analyst and investor event with clinical investigators on Friday, November 10, 2017 at 7:00 a.m. EST in National Harbor, MD during the 2017 Society of Immunotherapy for Cancer Annual Meeting. The event will include a presentation and discussion of updated clinical data for the company’s ImmunoPulse IL-12 program, highlighting the global, registration-directed PISCES/KEYNOTE-695 trial. The event will be held in-person and via live webcast.

Investors and analysts are invited to listen to a live audio webcast of the presentation. To access the audio broadcast, please dial (877) 731-1960 and enter the conference ID number 4938639. To join via webcast, please use the following link: View Source An archived version of the presentation will be available for 90 days on the "Investors" section of OncoSec’s website: View Source

For those interested in attending this event in person, please contact [email protected]. Please RSVP in advance as seating is limited.

Peer-Reviewed Publication

The findings published in Immunotherapy provide an overview of OncoSec’s preclinical and Phase 1 clinical data demonstrating that ImmunoPulse IL-12 plus electroporation is safe and well-tolerated by patients. Many patients do not respond to anti-PD-1 therapies alone, representing a significant unmet medical need. ImmunoPulse IL-12 has shown to increase intratumoral lymphocyte infiltration, pro-inflammatory cytokines and TH1 immune responses, potentially boosting the activity of PD-1 antibodies without significant systemic toxicity.

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About the SITC (Free SITC Whitepaper) Annual Meeting

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC (Free SITC Whitepaper) has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 32nd SITC (Free SITC Whitepaper) Annual Meeting & Associated Programs will take place November 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to View Source

About PISCES/KEYNOTE-695

PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).