UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 7, 2020
SYNDAX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
001-37708 |
32-0162505 |
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(state or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
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Building D, Floor 3 35 Gatehouse Drive Waltham, Massachusetts |
02451 |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (781) 419-1400
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered or to be registered pursuant to Section 12(b) of the Act.
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Common Stock |
SNDX |
The Nasdaq Stock Market, LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☑
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☑
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Item 2.02. |
Results of Operations and Financial Condition. |
On May 7, 2020, Syndax Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2020. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
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Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit
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Description
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99.1 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SYNDAX PHARMACEUTICALS, INC. |
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By: |
/s/ Briggs W. Morrison, M.D. |
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Briggs W. Morrison, M.D. |
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Chief Executive Officer |
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Dated: May 7, 2020
Exhibit 99.1
Syndax Pharmaceuticals Reports First Quarter 2020 Financial Results and
Provides Clinical and Business Update
- Final OS analysis for Phase 3 E2112 trial in HR+, HER2- metastatic breast cancer
expected this quarter; potential NDA filing later this year -
- Preliminary Phase 1 results from AUGMENT-101 trial of menin inhibitor SNDX-5613
represent first clinical evidence that inhibition of the menin-MLL1 interaction can induce
response in patients with MLL-r acute leukemias -
- Recently completed a follow-on offering with net proceeds of $93.7M -
- Company to host conference call today at 4:30 p.m. ET -
WALTHAM, Mass., May 7, 2020 -- 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 first quarter ended March 31, 2020. In addition, the Company provided a clinical and business update.
“During the first quarter, we generated significant momentum that we believe will take us through what we expect will be a transformational year for Syndax, with key data readouts expected across the entirety of our portfolio,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “We continue to anticipate the final overall survival readout from E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer later this quarter, with a potential regulatory filing for entinostat in HR+ breast cancer by year end. Supported by the compelling overall survival benefit observed in the Phase 2b ENCORE 301 trial, we believe the combination of entinostat and exemestane has strong potential to serve as a much-needed option in a setting for which existing therapies are inadequate. While we await this final readout, we remain focused on preparations to establish ourselves as a fully integrated oncology company, with a potential launch expected in 2021.”
Dr. Morrison added, “Beyond entinostat, we were pleased to recently announce initial Phase 1 data from the AUGMENT-101 trial of SNDX-5613, our oral menin inhibitor, in adults with relapsed/refractory acute leukemias. These data provide the first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias. We believe that SNDX-5613 has great potential to serve as an effective intervention for both MLL-r acute leukemias and NPM1 mutant AML, and we look forward to presenting additional data from this trial in the fourth quarter of this year. With a strong balance sheet, which includes proceeds from our recent follow-on offering, we believe we are well positioned to execute on upcoming milestones.”
Pipeline Updates
Entinostat
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• |
Syndax continues to anticipate that the E2112 trial will reach 410 death events this quarter, which will trigger the final overall survival (OS) analysis. E2112 is the Company's NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer. A positive OS assessment would allow the Company to file for full regulatory approval in the U.S. |
SNDX-5613
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• |
Syndax recently announced initial clinical data from the Phase 1 portion of its ongoing open-label Phase 1/2 AUGMENT-101 trial of SNDX-5613, the Company's potent, highly selective oral menin inhibitor. Data presented serve as the first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with mixed lineage leukemia rearranged (MLL-r) acute leukemias. The presentation, which was featured at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I, also highlighted preclinical findings, including data recently published in Cancer Cell and Science magazine, supporting the potential of single-agent menin-MLL inhibition to serve as an effective intervention for both MLL-r acute leukemias and nucleophosmin (NPM1) mutant acute myeloid leukemia (AML). A copy of the presentation is available on Syndax's website under Publications, Menin-MLLR Inhibitors. |
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• |
The Company recently announced that SNDX-5613 was granted Orphan Drug Designation for the treatment of adult and pediatric AML by the FDA. |
Axatilimab
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• |
Data from the Phase 1 trials exploring axatilimab, both as a monotherapy and in combination with IMFINZI® (durvalumab) in patients with locally-advanced or metastatic solid tumors, were summarized in two oral presentations at the AACR Virtual Annual Meeting I. The data indicate that axatilimab is tolerated well in solid tumor patients, and provide evidence of its ability to deplete circulating pro-inflammatory monocytes. A recommended Phase 2 dose of axatilimab for the treatment of patients with solid tumors was determined as monotherapy and in combination with IMFINZI® (durvalumab). A copy of each presentation is available on Syndax's website under Publications, Axatilimab. |
Financial Update and Guidance
As of March 31, 2020, Syndax had cash, cash equivalents and short-term investments of $99.0 million and 36.1 million shares and share equivalents issued and outstanding which included 30.2 million shares of common stock and pre-funded warrants to purchase 5.8 million shares of common stock.
In May 2020, Syndax closed an underwritten public offering whereby the Company sold 5,555,556 shares of common stock at a price of $18.00 per share. The aggregate net proceeds received by the Company were $93.7 million, net of underwriting discounts and commissions and estimated offering expenses payable by the Company. The offering allows for an additional 833,333 shares to be issued pursuant to the underwriters’ exercise of their option to purchase additional shares of common stock.
In February 2020, Syndax issued 3,036,719 shares of its common stock and 1,338,287 pre-funded warrants to purchase common stock at $8.00 per share, representing a premium of 20% to the share price at market close on Thursday, January 30, 2020. As a result of the offering, Syndax received net proceeds of $34.9 million.
In February 2020, the Company entered into an agreement with Hercules Capital, Inc. (NYSE: HTGC) for a term loan of up to $30.0 million, consisting of an initial tranche of $20.0 million that was funded at the closing with the potential for a second tranche of $10.0 million subject to satisfaction of certain terms and conditions.
First quarter 2020 research and development expenses decreased to $9.6 million from $11.3 million for the prior year period. The first quarter decrease was primarily due to reduced CMC activities and a net decrease in clinical activities.
General and administrative expenses for the first quarter 2020 increased to $5.9 million from $3.9 million for the prior year period. The increase was primarily due to increased pre-commercialization expenses and increased employee related expenses.
For the three months ended March 31, 2020, Syndax reported a net loss attributable to common stockholders of $19.1 million or $0.56 per share compared to $14.3 million or $0.53 per share for the prior year period.
Financial Guidance
Today the Company provided operating expense guidance for the second quarter of 2020. Financial guidance for the second half of 2020 will be issued after the Company announces the result of the E2112 study. The Company expects operating expenses for the second quarter of 2020 to increase over the quarterly operating expenses reported for the first quarter of 2020. Research and development (R&D) expenses will increase, primarily due to increased development activities for SNDX-5613. Second quarter G&A expenses are expected to be similar to the first quarter G&A expenses. For the second quarter of 2020, R&D expenses are expected to be $12 to $14 million, and total operating expenses are expected to be $18 to $20 million. Given its cash operating expense guidance, the Company expects to end the second quarter of 2020 with approximately $175 million of cash, which provides the financial flexibility to take advantage of key development milestones.
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, Thursday, May 7, 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: 5579109
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: https://edge.media-server.com/mmc/p/pnyq8m58
For those unable to participate in the conference call or webcast, a replay will be available for 30 days 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 lead product candidate, entinostat, a once-weekly, oral, small molecule, class I HDAC inhibitor, is being tested in a Phase 3 combination trial with exemestane for treatment of advanced HR+, HER2- breast cancer and has been evaluated in combination with several approved PD-1/PD-(L)1 antagonists. The Company's pipeline also includes axatilimab (SNDX-6352), a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, and SNDX-5613, a highly selective inhibitor of the menin–MLL binding interaction. 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 second 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.
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SYNDAX PHARMACEUTICALS, INC. |
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(unaudited) |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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March 31, |
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December 31, |
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(In thousands) |
2020 |
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2019 |
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Cash, cash equivalents and short-term investments |
$ |
99,005 |
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$ |
59,775 |
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Total assets |
$ |
105,155 |
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$ |
63,525 |
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Total liabilities |
$ |
51,646 |
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$ |
31,925 |
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Total stockholders' equity (deficit) |
$ |
53,509 |
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$ |
31,600 |
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Common stock outstanding |
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27,140,484 |
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27,140,484 |
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Common stock and common stock equivalents* |
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47,571,966 |
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42,292,534 |
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*Common stock and common stock equivalents: |
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Common stock |
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30,240,838 |
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27,140,484 |
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Common stock warrants (pre-funded) |
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5,838,287 |
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4,500,000 |
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Common stock and pre-funded stock warrants |
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36,079,125 |
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31,640,484 |
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Options to purchase common stock |
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6,897,802 |
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6,057,011 |
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Series 1 and 2 warrants |
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4,595,039 |
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4,595,039 |
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Total common stock and common stock equivalents |
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47,571,966 |
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42,292,534 |
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SYNDAX PHARMACEUTICALS, INC. |
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(unaudited) |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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Three Months Ended March 31, |
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(In thousands, except share and per share data) |
2020 |
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2019 |
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License fee revenue |
$ |
379 |
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$ |
379 |
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Operating expenses: |
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Research and development |
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9,562 |
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11,279 |
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General and administrative |
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5,917 |
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3,911 |
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Total operating expenses |
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15,479 |
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15,190 |
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Loss from operations |
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(15,100 |
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(14,811 |
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Other (expense) income, net |
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(136 |
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509 |
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Net loss |
$ |
(15,236 |
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$ |
(14,302 |
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Net loss attributable to common stockholders |
$ |
(19,142 |
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$ |
(14,302 |
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Net loss per share attributable to common |
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stockholders--basic and diluted |
$ |
(0.56 |
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$ |
(0.53 |
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Weighted-average number of common stock |
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used to compute net loss per share attributable |
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to common stockholders--basic and diluted |
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34,328,640 |
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27,023,466 |
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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