Phio Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Business Update

MARLBOROUGH, Mass., Aug. 12, 2020 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL(TM)) therapeutic platform, today reported its financial results for the quarter ended June 30, 2020 and provided a business update.

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"The second quarter was an exciting period for our team as we presented during three major medical conferences new preclinical data from animal studies that validate the potential of our INTASYL RNAi technology as a cancer immunotherapy platform for innovative therapeutics. For example, we now have in vivo data showing the ability and safety of INTASYL technology to reprogram immune cells, such as T cells, in situ through intratumoral application, resulting in impressive anti-tumoral efficacy," said Dr. Gerrit Dispersyn, President and CEO of Phio.

"The recent data we presented from studies conducted with our lead asset, PH-762, our BRD4 targeting INTASYL compound, PH-894, as well as other pipeline products, support our advancement of these products into additional studies. We are currently planning to initiate clinical studies with PH-762 in 2021, and the required steps needed to initiate these clinical trials are underway. Due to the potential for delays related to the ongoing COVID-19 pandemic, we cannot provide more specific guidance as to exactly when the studies will be initiated."

Quarter in Review and Recent Corporate Updates

    --  Announced detailed data that provide support for the potential of
        PH-804, the Company's TIGIT targeting INTASYL compound, as an
        immuno-oncology therapeutic and a viable alternative to anti-TIGIT
        antibodies in a presentation at the American Association for Cancer
        Research (AACR) 2020 Virtual Annual Meeting II. These data provide
        insight around the mechanisms of action of the tumor growth suppression
        with PH-804.
    --  Presented new data at the American Society of Clinical Oncology (ASCO)
        2020 Virtual Scientific Program that show how intratumoral delivery of
        INTASYL compounds inhibited tumor growth by overcoming the
        immunosuppressive tumor microenvironment as shown by changes in T cell
        composition and activation. Therefore, the Company believes these
        pipeline programs show great promise in the treatment of solid tumors.
    --  Presented data at the American Society of Gene & Cell Therapy (ASGCT)
        2020 Annual Meeting that details how INTASYL compares favorably to other
        technologies for improving cells used in adoptive cell therapy (ACT) for
        the treatment of solid tumors, especially in cases where permanent gene
        modification is not required or is undesirable.
    --  Hosted a key opinion leader (KOL) call on intratumoral therapy with
        self-delivering RNAi that featured a presentation by Professor Caroline
        Robert, M.D., Ph.D., of the Gustave Roussy Institute, on the promising
        new avenues to treat melanoma patients. Her presentation included
        scientific and clinical rationale for intratumoral neoadjuvant therapy
        and the role that INTASYL technology can play in such therapeutic
        approaches.
    --  Announced ongoing preclinical work and planning that are underway that
        would support the planned initiation of clinical trials with PH-762 in
        2021, assuming no additional delays due the COVID-19 pandemic.
    --  Raised total net proceeds of $3.5 million through financing activities
        completed in April 2020.

Financial Results

Cash Position

At June 30, 2020, the Company had cash of $18.9 million as compared with $6.9 million at December 31, 2019. During the second quarter of 2020, the Company received net proceeds of $3.8 million from the exercise of outstanding warrants and raised $3.5 million in net proceeds through an equity offering completed in April. The Company expects its cash will be sufficient to fund currently planned operations for at least the next 12 months.

Research and Development Expenses

Research and development expenses were approximately $0.8 million for the quarter ended June 30, 2020, compared to approximately $1.1 million for the quarter ended June 30, 2019. The decrease is primarily due to a reduced use of an outside interim temporary labor consultant and a reduction in patent-related expenses as compared to the prior year period.

General and Administrative Expenses

General and administrative expenses were relatively steady at $0.9 million for the three-month periods ended June 30, 2020 and 2019.

Net Loss

Net loss was $1.7 million, or $0.34 per share, for the quarter ended June 30, 2020, compared with $2.0 million, or $4.62 per share, for the quarter ended June 30, 2019. The decrease in net loss was primarily attributable to a decrease in research and development expenses, as discussed above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of our capital raise activities as compared to the prior year period.

About Phio Pharmaceuticals Corp.

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (INTASYL(TM)) therapeutic platform. The Company's efforts are focused on silencing tumor-induced suppression of the immune system through its proprietary INTASYL platform with utility in immune cells and the tumor micro-environment. Our goal is to develop powerful INTASYL therapeutic compounds that can weaponize immune effector cells to overcome tumor immune escape, thereby providing patients a powerful new treatment option that goes beyond current treatment modalities. For additional information, visit the Company's website, www.phiopharma.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. These statements are based only on our current beliefs, expectations and assumptions regarding the impact to our business and operations by the recent coronavirus outbreak, results from our preclinical and clinical activities, the development of our product candidates, the ability to obtain future financing, the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, market and other conditions and those identified in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors" and in other filings the Company periodically makes with the SEC. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release, except as required by law.

Contact Phio Pharmaceuticals Corp.
ir@phiopharma.com

Investor Contact
Ashley R. Robinson
LifeSci Advisors
arr@lifesciadvisors.com


                                                                       
         
              PHIO PHARMACEUTICALS CORP.


                                                            
            
           CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


                                                        
            
           (Amounts in thousands, except share and per share data)


                                                                           
            
              (Unaudited)




                                                    Three Months Ended                                           
            
          Six Months Ended
                                               June 30,                                                                June 30,



                                                                  2020                                                 2019                                  2020                 2019




           Revenues                                        
            $                  
            -                           
        $               
           -       
     $     
           -       $
          21



           Operating expenses:



           Research and development                                                           779                                                     1,146                    1,997             2,235



           General and administrative                                                         890                                                       913                    2,028             1,991




           Total operating expenses                                                         1,669                                                     2,059                    4,025             4,226




           Operating loss                                                                 (1,669)                                                  (2,059)                 (4,025)          (4,205)



           Total other income (expense), net                                                  (3)                                                       24                        2                51




           Net loss                                                             $
            (1,672)                                           $
         (2,035)           $
        (4,023)    $
        (4,154)




           Net loss per share:



           Basic and diluted                                                     $
            (0.34)                                            $
         (4.62)            $
        (1.19)    $
        (10.23)




           Weighted average shares: basic and                                           4,966,047                                                   440,482                3,378,233           406,063
    diluted


                                                          
           
             PHIO PHARMACEUTICALS CORP.


                                                        
         
           CONDENSED CONSOLIDATED BALANCE SHEETS


                                                            
           
             (Amounts in thousands)


                                                                
         
                (Unaudited)




                                                                                             June 30,                  December
                                                                                                                          31,
                                                                                                                           2019
                                                                                                 2020




     
                ASSETS



     Current assets:



     Cash                                                                                                $
        18,864          $
         6,934



     Restricted cash                                                                                               50                    50



     Prepaid expenses and other current assets                                                                    640                   316




     Total current assets                                                                                      19,554                 7,300



     Right of use asset                                                                                           456                   511



     Property and equipment, net                                                                                  183                   210



     Other assets                                                                                                  18                    18




     Total assets                                                                                        $
        20,211          $
         8,039




     
                LIABILITIES AND STOCKHOLDERS' EQUITY



     Current liabilities:



     Accounts payable                                                                                       $
        481            $
         809



     Accrued expenses and other current liabilities                                                             1,301                   964



     Lease liability                                                                                              111                   107



     Total current liabilities                                                                                  1,893                 1,880



     Lease liability, net of current portion                                                                      354                   411



     Long-term debt                                                                                               231               
         -




     Total liabilities                                                                                          2,478                 2,291




     Total stockholders' equity                                                                                17,733                 5,748




     Total liabilities and stockholders' equity                                                          $
        20,211          $
         8,039

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SOURCE Phio Pharmaceuticals Corp.