Novus Therapeutics Reports Third Quarter 2017 Results

For the third quarter of 2017, Novus reported a net loss of $3.0 million, or $0.43 loss per share, compared to a net loss of $2.0 million, or $4.35 loss per share, for the same period in 2016.

 
[08-November-2017]
 
 

IRVINE, Calif., Nov. 8, 2017 /PRNewswire/ -- Novus Therapeutics (NASDAQ: NVUS), a development stage specialty pharmaceutical company focused on the development of products for disorders of the ear, nose, and throat (ENT), announced financial results for the quarter ended September 30, 2017.

For the third quarter of 2017, Novus reported a net loss of $3.0 million, or $0.43 loss per share, compared to a net loss of $2.0 million, or $4.35 loss per share, for the same period in 2016. For the nine months ended September 30, 2017, Novus reported a net loss of $11.0 million, or $2.25 loss per share, as compared to a net loss of $4.1 million, or $9.09 loss per share, for the first nine months of 2016. Novus ended the third quarter 2017 with $19.1 million in cash and cash equivalents.

Research and development (R&D) expenses were $517,000 during the third quarter of 2017 compared to $1.1 million for the same period in 2016. For the nine months ended September 30, 2017, R&D expenses were $1.5 million, compared to $2.3 million for the same period in 2016. The decrease in R&D expense for both periods is primarily due to decreased spending towards the OP-01 program, offset by wind-down costs incurred for legacy Tokai programs. We expect R&D expenses to increase in subsequent periods as we advance our OP-02 program.

General and administrative (G&A) expenses were $2.5 million for the third quarter of 2017 compared to $0.6 million for the third quarter of 2016. For the nine months ended September 30, 2017, G&A expenses were $9.5 million, compared to $1.3 million for the first nine months of 2016. The increase in G&A expense for both periods is primarily due to merger related expenses of $7.2M, plus legal costs associated with the legacy Tokai litigation and administrative costs associated with operating as a publicly traded company.

"We are continuing formulation development and clinical planning activities for our OP-02 program and we are expecting to begin our clinical trials in 2018," said Gregory J. Flesher, Chief Executive Officer of Novus Therapeutics. "As a potential first-in-class treatment option to both treat and prevent otitis media, OP-02 has the ability to dramatically improve the lives of millions of patients around the world."

About Novus Therapeutics

Novus Therapeutics is a development stage specialty pharmaceutical company focused on the development of products for disorders of the ear, nose, and throat (ENT). Novus has two technologies, each of which has the potential to be developed for multiple ENT indications. The company's lead product (OP-02) is a surfactant-based, combination drug product being developed as a potential first-in-class treatment option for patients at risk for or with otitis media ("OM") (middle ear inflammation and effusion with or without infection). Globally, OM affects more than 700 million adults and children every year. OM is a common disorder seen in pediatric practice, and in the United States is the most frequent reason children are prescribed antibiotics and undergo surgery. Novus also has a foam-based drug delivery technology (OP-01), which may be developed in the future to deliver drugs into the ear, nasal, and sinus cavities. For more information please visit novustherapeutics.com.

Forward-looking Statements

Any statements in this press release about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, the review of strategic alternatives and the outcome of such review and other statements containing the words "believes," "anticipates," "plans," "expects," "may," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, expectations regarding the timing for the commencement and completion of our clinical trials and our ability to accelerate the development of our drug candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the sufficiency of the company's cash resources; the ability to timely develop and manufacture clinical batches of our study drugs; the ability to obtain necessary approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product, any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, it will be successfully distributed and marketed. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts

The Trout Group
Gita Ogawa
Tel: (646) 378-2949
gogawa@troutgroup.com

Novus Therapeutics, Inc.
Investor Relations
Tel: (949) 238-8090
investors@novustherapeutics.com

 

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                                                                NOVUS THERAPEUTICS, INC.

                                                          CONDENSED CONSOLIDATED BALANCE SHEETS

                                                     (In thousands, except share and per share data)


                                                  September 30,                                      December 31,

                                                           2017                                               2016

                                                   (Unaudited)
                                                   ----------


                            ASSETS

    Current assets:

    Cash and cash equivalents                                                        $19,094                          $1,103

    Restricted cash                                                                        -                             14

    Prepaid expenses and other current
     assets                                                                            1,941                              33
                                                                                       -----                             ---

    Total current assets                                                              21,035                           1,150

    Property and equipment, net                                                           47                              31

    Restricted cash                                                                       70                               -

    Goodwill                                                                           1,867                               -

    Other assets                                                                           -                             15
                                                                                         ---                            ---

    Total assets                                                                     $23,019                          $1,196
                                                                                     =======                          ======

             LIABILITIES AND STOCKHOLDERS' EQUITY
                           (DEFICIT)

    Current liabilities:

    Accounts payable                                                                    $189                            $338

    Accrued severance                                                                    963                               -

    Accrued expenses and other liabilities                                             1,154                             113

    Convertible notes                                                                      -                          3,447
                                                                                         ---                          -----

    Total current liabilities                                                          2,306                           3,898

    Long-term liabilities                                                                 94                               -
                                                                                         ---                             ---

    Total liabilities                                                                  2,400                           3,898

    Commitments and contingencies

    Stockholders' equity (deficit):

    Preferred stock, $0.001 par value,
     5,000,000 shares authorized and none
     issued and outstanding at September
     30, 2017; preferred stock, $0.0026 par
     value, 6,565,540 shares authorized and
     452,706 shares issued and outstanding
     at December 31, 2016                                                                  -                             11

    Common stock, $0.001 par value,
     200,000,000 shares authorized and
     6,943,058 shares issued and
     outstanding at September 30, 2017;
     common stock, $0.0026 par value,
     9,207,060 shares authorized and 82,246
     shares issued and outstanding at
     December 31, 2016                                                                     7                               1

    Additional paid-in capital                                                        46,008                          11,385

    Receipts on account of Preferred A
     stock                                                                                 -                            291

    Accumulated deficit                                                             (25,396)                       (14,390)
                                                                                     -------                         -------

    Total stockholders' equity (deficit)                                              20,619                         (2,702)
                                                                                      ------                          ------

    Total liabilities and stockholders'
     equity (deficit)                                                                $23,019                          $1,196
                                                                                     =======                          ======

 

                                                                                       NOVUS THERAPEUTICS, INC.

                                                                CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

                                                                                              (Unaudited)

                                                                            (In thousands, except share and per share data)


                                   Three Months Ended                        Nine Months Ended

                                      September 30,                          September 30,
                                      -------------                          -------------

                                                 2017                          2016                                               2017         2016
                                                 ----                          ----                                               ----         ----

    Operating expenses

    Research and development                               $517                                                    $1,053                   $1,529       $2,335

    General and administrative                            2,448                                                       564                    9,487        1,326
                                                          -----                                                       ---                    -----        -----

    Total operating expenses                              2,965                                                     1,617                   11,016        3,661
                                                          -----                                                     -----                   ------        -----

    Loss from operations                                (2,965)                                                  (1,617)                (11,016)     (3,661)

    Other income (expense), net                             (5)                                                    (418)                      10        (479)
                                                            ---                                                      ----                      ---         ----

    Net loss and comprehensive
     loss                                              $(2,970)                                                 $(2,035)               $(11,006)    $(4,140)
                                                        =======                                                   =======                 ========      =======

    Net loss per share, basic and
     diluted                                            $(0.43)                                                  $(4.35)                 $(2.25)     $(9.09)
                                                         ======                                                    ======                   ======       ======

    Weighted-average common
     shares outstanding, basic and
     diluted                                          6,943,058                                                    81,339                3,845,258       79,026
                                                      =========                                                    ======                =========       ======

 

                                                   NOVUS THERAPEUTICS, INC.

                                       CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

                                                         (Unaudited)

                                                        (In thousands)


                                      Nine Months Ended

                                        September 30,
                                        -------------

                                                   2017                                2016
                                                   ----                                ----

    Operating activities

    Net loss                                                            $(11,006)               $(4,140)

    Adjustments to reconcile net loss
     to net cash used in operating
     activities:

    Depreciation and amortization                                              18                      16

    Stock-based compensation                                                  386                     142

    Loss on disposal of fixed assets                                           31                       -

    Fair value of debt in excess of
     proceeds                                                                   -                    517

    Changes in operating assets and
     liabilities:

    Prepaid expenses and other assets                                       (761)                     42

    Accounts payable and accrued
     expenses                                                               (998)                  (218)
                                                                             ----                    ----

    Net cash used in operating
     activities                                                          (12,330)                (3,641)

    Investing activities

    Cash received from merger
     transaction                                                           23,250                       -

    Proceeds from sale of equipment                                             8                       -

    Purchase of property and
     equipment                                                                  -                   (12)
                                                                              ---                    ---

    Net cash provided by (used in)
     investing activities                                                  23,258                    (12)

    Financing activities

    Proceeds from issuance of common
     stock, net                                                             4,000                       -

    Proceeds from exercise of
     warrants                                                               3,119                       -

    Proceeds from convertible loan                                              -                  2,930
                                                                              ---                  -----

    Net cash provided by financing
     activities                                                             7,119                   2,930
                                                                            -----                   -----

    Net increase (decrease) in cash,
     cash equivalents and restricted
     cash                                                                  18,047                   (723)

    Cash, cash equivalents and
     restricted cash at beginning of
     period                                                                 1,117                   3,095
                                                                            -----                   -----

    Cash, cash equivalents and
     restricted cash at end of period                                     $19,164                  $2,372
                                                                          =======                  ======

    Supplemental disclosure of cash
     flow information

    Noncash activities:

    Conversion of promissory notes
     and interest to common stock                                          $3,447             $         -
                                                                           ======           ===       ===

    Conversion of contingently
     issuable shares to common stock                                         $291             $         -
                                                                             ====           ===       ===

    Fair value of assets acquired and
     liabilities assumed in the
     merger:

    Fair value of assets acquired,
     excluding cash and restricted
     cash                                                                  $3,072

    Fair value of liabilities assumed                                     (2,947)
                                                                           ------

    Fair value of net assets acquired
     in the merger                                                           $125
                                                                             ====

 

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SOURCE Novus Therapeutics, Inc.

 
 
Company Codes: NASDAQ-SMALL:NVUS
 
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