SYNDAX PHARMACEUTICALS, INC. (NASDAQ:SNDX) Files An 8-K Other Events
Item8.01
| Other Events. |
On May23, 2017, Syndax Pharmaceuticals, Inc. (the Company)
announced that it had commenced a public offering of $50,000,000
of its common stock, par value $0.0001 per share, in an
underwritten public offering (the Offering). A copy of the press
release is attached as Exhibit 99.1 hereto, the terms of which
are incorporated herein by reference.
In the prospectus supplement used in connection with the Offering
and filed with the Securities and Exchange Commission (SEC), the
Company provided the following disclosures as to recent clinical
developments:
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In May 2017, the Company announced that the ENCORE 601 non-small cell lung cancer (NSCLC) cohort enrolling patients with disease progression on or after PD-1 therapy has met the prespecified objective response threshold to advance into the second stage of the Phase 2 trial. The cohort of NSCLC patients with disease progression on or after PD-1 therapy will now re-open and enroll a total of 56 patients, and the Company expects to present initial results from this cohort in the fourth quarter of 2017. Completion of enrollment is anticipated in the first half of 2018. Later this quarter, the Company anticipates being able to determine whether to expand the cohort of NSCLC patients nave to PD-1 or PD-L1 therapy. |
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Also, in May 2017, the Company announced results from the melanoma cohort of the ongoing Phase 2 ENCORE 601 trial of entinostat in combination with KEYTRUDA (pembrolizumab), Mercks anti-PD-1 (programmed death receptor-1) therapy. The Company reported that the first cohort of 13 melanoma patients who had progressed on or after prior immune checkpoint inhibitor therapy in ENCORE 601 met the pre-specified objective response criteria to advance into the second stage of the trial, defined as a minimum of two patients demonstrating a confirmed or unconfirmed objective response. Data from the first cohort of patients indicate that four patients achieved an objective response by irRECIST criteria (three patients had a confirmed response; one patient had an unconfirmed response; 31% ORR, 95% CI: 961%). Of the four responders, two patients had stable disease and two patients had progressive disease as best response to their prior anti-PD-1 therapy prior to progressing, with a median duration on prior anti-PD-1 therapy of 4.9 months (range 2.7-12.5). Three patients remain on treatment, without progression, as of the data cutoff, one with a partial response, and two with stable disease. |
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During the fourth quarter of 2017, the Company expects to present correlative data from the biomarker assessments of melanoma patients enrolled in Stage 1 of the Phase 2 ENCORE 601 trial. The Company also expects to present results from Stage 2 of the Phase 2 melanoma and NSCLC cohorts of ENCORE 601 and from Stage 1 of the Phase 2 colorectal cohort of ENCORE 601 during the first half of 2018. |
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The Company anticipates presenting efficacy and safety data from the Phase 2 portion of the ENCORE 602 clinical trial during the second half of 2018. |
This Current Report shall not constitute an offer to sell, or the
solicitation of an offer to buy, nor shall there be any sale of
the Shares in any state or jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction. Any offer, if at all, will be made only by means of
a prospectus supplement and accompanying prospectus, which will
be a part of the Companys registration statement previously
declared effective by the SEC.
| Item9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit No. |
Description |
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| 99.1 | Press Release, dated May 23, 2017. |
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking
statements within the meaning of the Private Securities
Litigation Reform Act of 1995, including statements relating to
Syndaxs expectations regarding the completion, timing and size of
the proposed public offering. These statements are subject to
significant risks and uncertainties and actual results could
differ materially from those projected. Syndax cautions investors
not to place undue reliance on the forward-looking statements
contained in this release. These risks and uncertainties include,
without limitation, risks and uncertainties related to market
conditions and the satisfaction of customary closing conditions
related to the proposed public offering. There can be no
assurance that Syndax will be able to complete the proposed
public offering on the anticipated terms, or at all. Risks and
uncertainties relating to Syndax and its business can be found in
Syndaxs filings with the U.S. Securities and Exchange Commission,
including the Risk Factors sections contained therein, as well as
the risks identified in the registration statement and the
preliminary prospectus supplement relating to the offering. These
forward-looking statements are based on Syndaxs expectations and
assumptions as of the date of this press release. Except as
required by law, Syndax undertakes no duty or obligation to
update any forward-looking statements contained in this report as
a result of new information, future events or changes in Syndaxs
expectations.
About SYNDAX PHARMACEUTICALS, INC. (NASDAQ:SNDX)
Syndax Pharmaceuticals, Inc (Syndax) is a clinical stage biopharmaceutical company focused on developing a pipeline of combination therapies in multiple cancer indications. The Company’s product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from its Phase IIb clinical trial, ENCORE 301, is being evaluated in a Phase III clinical trial for advanced hormone receptor positive breast cancer. It is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to enhance the body’s immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase Ib/II clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma, with Genentech, Inc. for TNBC, and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. SYNDAX PHARMACEUTICALS, INC. (NASDAQ:SNDX) Recent Trading Information
SYNDAX PHARMACEUTICALS, INC. (NASDAQ:SNDX) closed its last trading session up +0.06 at 14.67 with 179,832 shares trading hands.
