Syndax Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Clinical and Business Update

WALTHAM, Mass., Nov. 2, 2020 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the third quarter ended September 30, 2020. In addition, the Company provided a clinical and business update.

"We continue to make exciting progress in the Phase 1 portion of the AUGMENT-101 trial of SNDX-5613, our highly selective, potent, oral menin inhibitor, in adult and pediatric patients with acute leukemias that harbor MLL-r and NPM1 genetic alterations," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We are highly encouraged by initial data from this study, which demonstrated clear clinical activity in this difficult to treat population of patients with genetically defined acute leukemias. We remain on track to present Phase 1 data from AUGMENT-101 and commence the Phase 2 portion in early 2021."

Dr. Morrison added, "In addition, following recent interactions with the FDA, we are excited to take the next step of initiating a pivotal trial for axatilimab, our anti-CSF-1R monoclonal antibody, in patients with cGVHD which we expect by the end of this year. We are encouraged by the clinical activity and overall safety we've seen in the ongoing trial, and firmly believe axatilimab has the potential to serve as an effective intervention for patients with cGVHD. We look forward to sharing updated results from the Phase 1 trial during an oral presentation at the ASH Annual Meeting in December."

Pipeline Updates

SNDX-5613

    --  In August 2020, the Company enacted the following enhancements to the
        Phase 1 portion of the AUGMENT-101 trial in patients with MLL-r and NPM1
        mutant acute leukemias: focusing enrollment exclusively on patients with
        mixed lineage leukemia rearranged (MLL-r) and nucleophosmin (NPM1)
        mutant acute leukemias; backfilling any dose escalation cohort up to a
        total of 12 patients if efficacy has been observed at that dose level;
        and expansion of enrollment to include pediatric patients over 30 days
        old. These enhancements were supported by initial clinical data, as well
        as insights from emerging data in the pediatric compassionate use
        setting. Enrollment in the amended Phase 1 portion remains ongoing, with
        a data presentation expected in early 2021. In early 2021, the Company
        also anticipates commencing the Phase 2 portion of AUGMENT-101, which it
        believes could serve as the basis for registration. SNDX-5613 was
        previously granted Orphan Drug Designation for the treatment of adult
        and pediatric acute myeloid leukemia by the U.S. Food and Drug
        Administration (FDA).

Axatilimab

    --  The Company today announced that following its End-of-Phase 1 meeting
        with the FDA, it has aligned on a regulatory path for axatilimab, its
        anti-CSF-1R monoclonal antibody, for the treatment of chronic graft
        versus host disease (cGVHD). The Company plans to commence a pivotal
        Phase 2 trial, AGAVE-201, to assess the safety and efficacy of different
        doses and schedules of axatilimab for the treatment of patients with
        cGVHD. The primary endpoint will assess objective response rate based on
        the 2014 NIH consensus criteria for GVHD with key secondary endpoints
        including duration of response and improvement in modified Lee Symptom
        Scale score. The Company expects to begin enrollment by year-end, with
        topline data anticipated in 2023.
    --  Enrollment remains ongoing in the Phase 2 portion of the Phase 1/2 trial
        evaluating axatilimab for the treatment of patients with cGVHD. In
        previously announced preliminary data from the Phase 1 portion of the
        trial, axatilimab demonstrated compelling clinical activity and a
        well-tolerated safety profile. The Company will present updated data
        from the Phase 1 portion in an oral presentation during the American
        Society of Hematology (ASH) Virtual Annual Meeting in December.
        Abstracts for the meeting, which will be held December 5-8, 2020, will
        be available on Thursday, November 5, 2020 at 9:00 a.m. ET.

Financial Update and Guidance

As of September 30, 2020, Syndax had cash, cash equivalents and short-term investments of $170.2 million and 44.4 million shares and share equivalents issued and outstanding which included 38.8 million shares of common stock and pre-funded warrants to purchase 5.6 million shares of common stock.

Third quarter 2020 research and development expenses increased to $14.4 million from $9.9 million for the prior year period. The increase was primarily due to increased clinical activity for SNDX-5613 and axatilimab and a $2.0 million milestone payable to UCB upon the achievement of a certain milestone.

General and administrative expenses for the third quarter 2020 increased to $5.8 million from $3.6 million for the prior year period. This increase was primarily due to employee related expenses including a one-time non-cash stock compensation expense.

For the three months ended September 30, 2020, Syndax reported a net loss attributable to common stockholders of $20.4 million or $0.46 per share compared to $12.8 million or $0.41 per share for the prior year period.

Financial Guidance

For the fourth quarter of 2020, research and development expenses are expected to be $15 to $20 million, and total operating expenses are expected to be $20 to $25 million.

Conference Call and Webcast

In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, November 2, 2020.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 7974533
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: https://edge.media-server.com/mmc/p/62ujymuo

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company's website, www.syndax.com.

About Syndax Pharmaceuticals, Inc.

Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company's pipeline includes SNDX-5613, a highly selective inhibitor of the Menin-MLL binding interaction, axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, and entinostat, a class I HDAC inhibitor. For more information, please visit www.syndax.com or follow the Company on Twitter and LinkedIn.

Syndax's Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, the potential use of our product candidates to treat various cancer indications, Syndax's expected fourth quarter research and development expenses, and expected total operating expenses. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


                                         
            
           SYNDAX PHARMACEUTICALS, INC.


                                                 
         
              (unaudited)


                                    
            
           CONDENSED CONSOLIDATED BALANCE SHEETS




                                                      
            
              September 30,    
     
     December 31,



                 (In thousands)                                                    2020                 2019



      Cash, cash equivalents and
       short-term investments                                                  $170,159              $59,775



     Total assets                                                             $179,309              $63,525



     Total liabilities                                                         $47,332              $31,925


      Total stockholders' equity
       (deficit)                                                               $131,977              $31,600




      Common stock outstanding                                               38,834,381           27,140,484


      Common stock and common
       stock equivalents*                                                    51,852,235           42,292,534





     *Common stock and common stock equivalents:


                       Common stock                                            38,834,381           27,140,484


                       Common stock
                        warrants
                        (pre-funded)                                            5,557,952            4,500,000



                       Common stock and pre-funded
                        stock warrants                                         44,392,333           31,640,484


                       Options to
                        purchase
                        common stock                                            6,770,660            6,057,011


                       Series 1 and 2
                        warrants                                                  689,242            4,595,039


                       Total common stock and common
                        stock equivalents                                      51,852,235           42,292,534


                                                                                 
          
               SYNDAX PHARMACEUTICALS, INC.


                                                                                      
            
                (unaudited)


                                                                       
              
           CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS




                                                     Three Months Ended September 30,                                Nine Months Ended September 30,



                   (In thousands, except share
                    and per share data)                                        2020                                                            2019          2020           2019




     License fee revenue                                                      $379                                                            $379        $1,138         $1,138



     Operating expenses:


                                     Research and
                                      development                              14,408                                                           9,923        34,913         33,492


                                     General and
                                      administrative                            5,824                                                           3,605        17,787         10,980


      Total operating expenses                                               20,232                                                          13,528        52,700         44,472



      Loss from operations                                                 (19,853)                                                       (13,149)     (51,562)      (43,334)


      Other (expense) income, net                                             (584)                                                            320       (1,173)         1,287



     Net loss                                                            $(20,437)                                                      $(12,829)    $(52,735)     $(42,047)

                                                                                                                                                                          ===



      Net loss attributable to
       common stockholders                                                $(20,437)                                                      $(12,829)    $(56,641)     $(42,047)

                                                                                                                                                                          ===




     Net loss per share attributable to common


                                     stockholders-
                                      -basic and
                                      diluted                                 $(0.46)                                                        $(0.41)      $(1.43)       $(1.40)






     Weighted-average number of common stock


                                    used to
                                      compute net
                                      loss per
                                      share
                                      attributable


                                     to common
                                      stockholders-
                                      -basic and
                                      diluted                              44,156,808                                                      31,630,639    39,714,490     30,103,338

Syndax Contacts

Investor Contact
Melissa Forst
Argot Partners
melissa@argotpartners.com
Tel 212.600.1902

Media Contact
Ted Held
ted.held@gcihealth.com
Tel 212.798.9842

SNDX-G

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SOURCE Syndax Pharmaceuticals, Inc.