Oncolytics Biotech Announces 2017 Third Quarter Results

 

 
[08-November-2017]
 
 

CALGARY, and SAN DIEGO, CA, Nov. 8, 2017 /PRNewswire/ - Oncolytics Biotech Inc., a biotech company developing REOLYSIN®, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn 'cold' tumors 'hot', today announced its financial results and operational highlights for the quarter ended September 30, 2017.

"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) 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 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.

 

                                                          ONCOLYTICS BIOTECH INC.
                                           INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
                                                                (unaudited)


                                                                September 30,                    December 31,
                                                                                     2017                            2016
                                                                                        $                              $
                                                                                      ---                            ---

    Assets

    Current assets

    Cash and cash equivalents                                               14,033,644                      12,034,282

    Short-term investments                                                           -                      2,088,800

    Accounts receivable                                                         33,129                          54,406

    Prepaid expenses                                                           438,150                         260,841
    ----------------                                                           -------                         -------

    Total current assets                                                    14,504,923                      14,438,329
    --------------------                                                    ----------                      ----------


    Non-current assets

    Property and equipment                                                     343,307                         319,955
    ----------------------                                                     -------                         -------

    Total non-current assets                                                   343,307                         319,955
    ------------------------                                                   -------                         -------


    Total assets                                                            14,848,230                      14,758,284
    ============                                                            ==========                      ==========


    Liabilities And
     Shareholders' Equity

    Current Liabilities

    Accounts payable and
     accrued liabilities                                                     2,781,932                       4,068,664
    --------------------                                                     ---------                       ---------

    Total current liabilities                                                2,781,932                       4,068,664
    -------------------------                                                ---------                       ---------


    Shareholders' equity

    Share capital

                Authorized: unlimited

                Issued:

                September 30, 2017 - 140,671,722

                December 31, 2016 - 121,258,222                              270,899,669                     262,321,825

    Warrants                                                                 3,617,900                               -

    Contributed surplus                                                     26,887,579                      26,643,044

    Accumulated other
     comprehensive income                                                      361,726                         554,060

    Accumulated deficit                                                  (289,700,576)                  (278,829,309)
    -------------------                                                   ------------                    ------------

    Total shareholders' equity                                              12,066,298                      10,689,620
    --------------------------                                              ----------                      ----------

    Total liabilities and
     equity                                                                 14,848,230                      14,758,284
    =====================                                                   ==========                      ==========

 

 

                                                                        ONCOLYTICS BIOTECH INC.
                                                     INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
                                                                              (unaudited)


                                                   Three                                                              Three                     Nine                       Nine
                                                   Month                                                              Month                    Month                      Month
                                                  Period                                                              Period                   Period                     Period
                                                  Ending                                                              Ending                   Ending                     Ending
                                                 September                                                          September                September                  September
                                                                                           30, 2017                  30, 2016                 30, 2017                   30, 2016
                                                                                                  $                         $                        $                          $
                                                                                                ---                       ---                      ---                        ---

    Expenses

                     Research and development                                                             1,726,726                2,141,737                  6,913,470                   6,358,822

                     Operating                                                                            1,309,607                1,222,447                  4,054,450                   3,708,317
                     ---------                                                                            ---------                ---------                  ---------                   ---------

    Operating loss                                                                                    (3,036,333)             (3,364,184)              (10,967,920)               (10,067,139)

                     Interest                                                                                31,759                   31,691                     96,637                     136,849
                     --------                                                                                ------                   ------                     ------                     -------

    Loss before income taxes                                                                          (3,004,574)             (3,332,493)              (10,871,283)                (9,930,290)

                     Income tax expense                                                                         168                       19                         16                         333
                     ------------------                                                                         ---                      ---                        ---                         ---

    Net loss                                                                                          (3,004,406)             (3,332,474)              (10,871,267)                (9,929,957)

    Other comprehensive income items that may be

    reclassified to net loss


                     Translation adjustment                                                               (126,846)                  32,545                  (192,334)                  (268,341)
                     ----------------------                                                                --------                   ------                   --------                    --------


    Net comprehensive loss                                                                            (3,131,252)             (3,299,929)              (11,063,601)               (10,198,298)
    ======================                                                                             ==========               ==========                ===========                 ===========

    Basic and diluted loss per common share                                                                (0.02)                  (0.03)                    (0.08)                     (0.08)
    =======================================                                                                 =====                    =====                      =====                       =====

    Weighted average number of shares (basic and                                                      139,515,885              120,552,638                129,441,461                 119,455,440
    diluted)
    =======

 

 

                                                                                         ONCOLYTICS BIOTECH INC.
                                                                           INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
                                                                                               (unaudited)


                                                  Share Capital                Warrants                                   Contributed             Accumulated               Accumulated                 Total
                                                                                                                            Surplus                  Other                    Deficit
                                                                         $                      $                                                Comprehensive                                                           $
                                                                                                                                             $      Income                                        $

                                                                                                                                                                       $
                                                                                                                                                                     ---

    As at December 31, 2015                                    261,324,692                       -                                   26,277,966                    760,978               (263,689,330)             24,674,306

    Net loss and other comprehensive loss                                -                      -                                            -                 (268,341)                (9,929,957)           (10,198,298)

    Issued pursuant to "At the Market" Agreement                 1,339,378                       -                                            -                         -                          -              1,339,378

    Issued pursuant to incentive share award plan                   41,000                       -                                     (41,000)                         -                          -                      -

    Share issue costs                                            (486,842)                      -                                            -                         -                          -              (486,842)

    Share based compensation                                             -                      -                                      299,635                          -                          -                299,635
    ------------------------                                           ---                    ---                                      -------                        ---                        ---                -------

    As at September 30, 2016                                   262,218,228                       -                                   26,536,601                    492,637               (273,619,287)             15,628,179
    ========================                                   ===========                     ===                                   ==========                    =======                ============              ==========


                                                      Share                    Warrants                                   Contributed             Accumulated               Accumulated                 Total
                                                     Capital                                                                Surplus                  Other                    Deficit                                    $
                                                                         $                      $                                            $   Comprehensive                                    $
                                                                                                                                                    Income

                                                                                                                                                                       $
                                                                                                                                                                     ---

    As at December 31, 2016                                    262,321,825                       -                                   26,643,044                    554,060               (278,829,309)             10,689,620

    Net loss and other comprehensive loss                                -                      -                                            -                 (192,334)               (10,871,267)           (11,063,601)

    Issued pursuant to "At the Market" Agreement                 1,479,065                       -                                            -                         -                          -              1,479,065

    Issued pursuant to public offering                           7,893,600               3,617,900                                             -                         -                          -             11,511,500

    Issued pursuant to stock option plan                           536,949                       -                                    (193,509)                         -                          -                343,440

    Share issue costs                                          (1,331,770)                      -                                            -                         -                          -            (1,331,770)

    Share based compensation                                             -                      -                                      438,044                          -                          -                438,044
    ------------------------                                           ---                    ---                                      -------                        ---                        ---                -------

    As at September 30, 2017                                   270,899,669               3,617,900                                    26,887,579                    361,726               (289,700,576)             12,066,298
    ========================                                   ===========               =========                                    ==========                    =======                ============              ==========

 

 

                                                          ONCOLYTICS BIOTECH INC.
                                               INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
                                                                (unaudited)


                                               Three                                   Three                   Nine Month                   Nine Month
                                               Month                                   Month                     Period                       Period
                                               Period                                  Period                    Ending                       Ending
                                               Ending                                  Ending                  September                    September
                                             September                               September                   30, 2017                     30, 2016
                                                           30, 2017                   30, 2016                          $                            $
                                                                  $                          $
                                                                ---                        ---


    Operating Activities

    Net loss for the period                                          (3,004,406)                (3,332,474)                (10,871,267)                 (9,929,957)

                                 Amortization -property and
                                 equipment                                  20,591                      44,014                       70,315                      134,631

                                Share based compensation                   148,447                      98,369                      438,044                      299,635

                                Unrealized foreign exchange gain           (6,414)                   (49,400)                   (119,058)                   (152,019)

    Net change in non-cash
     working capital                                                   (331,590)                    216,611                  (1,186,142)                     978,847
    ----------------------                                              --------                     -------                   ----------                      -------

    Cash used in operating
     activities                                                      (3,173,372)                (3,022,880)                (11,668,108)                 (8,668,863)
    ----------------------                                            ----------                  ----------                  -----------                   ----------

    Investing Activities

    Acquisition of property and
     equipment                                                           (9,451)                    (4,851)                    (95,337)                    (10,553)

    Redemption (purchase) of
     short-term investments                                       -                          -                  2,088,800                      (27,823)
    ------------------------                                    ---                        ---                  ---------                       -------

    Cash (used in) provided by
     investing activities                                                (9,451)                    (4,851)                   1,993,463                     (38,376)
    --------------------------                                            ------                      ------                    ---------                      -------

    Financing Activities

    Proceeds from "At the
     Market" equity
     distribution agreement                                              733,171                     242,706                    1,292,698                      852,536

    Proceeds from public
     offering                                                     -                          -                 10,366,098                             -

    Proceeds from exercise of
     options                                                 48,090                           -                    343,440                             -
    -------------------------                                ------                         ---                    -------                           ---

    Cash provided by financing
     activities                                                          781,261                     242,706                   12,002,236                      852,536
    --------------------------                                           -------                     -------                   ----------                      -------

    (Decrease) increase in cash                                      (2,401,562)                (2,785,025)                   2,327,591                  (7,854,703)

    Cash and cash equivalents,
     beginning of period                                              16,676,298                  18,320,981                   12,034,282                   24,016,275

    Impact of foreign exchange
     on cash and cash
     equivalents                                                       (241,092)                     76,773                    (328,229)                   (548,843)
    --------------------------                                          --------                      ------                     --------                     --------

    Cash and cash equivalents,
     end of period                                                    14,033,644                  15,612,729                   14,033,644                   15,612,729
    ==========================                                        ==========                  ==========                   ==========                   ==========

 

To view the Company's Fiscal 2017 Third Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's annual filings, which will be available under the Company's profile at www.sedar.com and on Oncolytics' website at http://www.oncolyticsbiotech.com/investor-centre/financials/.

About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing REOLYSIN, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning 'cold' tumors 'hot' - through innate and adaptive immune responses to treat a variety of cancers. Oncolytics' clinical development program emphasizes three pillars: chemotherapy combinations to trigger selective tumor lysis; immuno-therapy combinations to produce adaptive immune responses; and immune modulator (IMiD) combinations to facilitate innate immune responses. Oncolytics is currently planning its first registration study in metastatic breast cancer, as well as studies in combination with checkpoint inhibitors and targeted and IMiD therapies in solid and hematological malignancies. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's belief as to the potential of REOLYSIN® as a cancer therapeutic; the Company's expectations as to the success of its research and development programs in 2017 and beyond, the Company's planned operations, the value of the additional patents and intellectual property; the Company's expectations related to the applications of the patented technology; the Company's expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

SOURCE Oncolytics Biotech Inc.

 
 
Company Codes: OtherOTC:ONCYF, Toronto:ONC
 

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