Syndax Pharmaceuticals Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Syndax Pharmaceuticals Inc. filed its 2023 annual report (10-K) detailing its financial and operational status, including various agreements and equity activities.</b>

AI Summary

Syndax Pharmaceuticals Inc (SNDX) filed a Annual Report (10-K) with the SEC on February 27, 2024. Syndax Pharmaceuticals Inc. filed its 2023 Form 10-K on February 27, 2024. The company is incorporated in Delaware and its fiscal year ends on December 31. Syndax Pharmaceuticals is in the Pharmaceutical Preparations industry (SIC 2834). The filing includes details on various agreements and offerings, including At-The-Market offerings, loan agreements, and license agreements. Key dates mentioned relate to stock offerings, loan agreements, and equity plans spanning from 2007 to 2023.

Why It Matters

For investors and stakeholders tracking Syndax Pharmaceuticals Inc, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Syndax's financial health, operational activities, and strategic partnerships for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed information on agreements, offerings, and key dates helps stakeholders understand the company's capital structure, financing activities, and potential future dilution or funding events.

Risk Assessment

Risk Level: medium — Syndax Pharmaceuticals Inc shows moderate risk based on this filing. The company is in the pharmaceutical industry, which is subject to significant regulatory oversight, lengthy development cycles, and high R&D costs, posing inherent risks to its financial performance and market position.

Analyst Insight

Investors should review the detailed risk factors and financial statements in the 10-K to understand the specific challenges and opportunities facing Syndax Pharmaceuticals in the competitive biopharmaceutical market.

Key Numbers

• 20231231 — Fiscal Year End (Fiscal year end date)
• 001-37708 — SEC File Number (SEC file number for the company)
• 2834 — SIC Code (Standard Industrial Classification code for Pharmaceutical Preparations)
• 781-419-1400 — Business Phone (Company's business phone number)

Key Players & Entities

• Syndax Pharmaceuticals Inc. (company) — Filer name
• 20231231 (date) — Conformed period of report
• 20240227 (date) — Filed as of date
• 0000950170-24-021253 (filing_id) — Accession number
• DE (state) — State of incorporation
• WALTHAM (city) — Business address city
• MA (state) — Business address state
• 02451 (zip_code) — Business address zip

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by governmental authorities, which can impact product development, manufacturing, marketing, and pricing.
• Financing Risks [high — financial]: The company may require significant additional capital to fund its operations and development programs, and there is no assurance that such financing will be available on acceptable terms.
• Clinical Trial Risks [high — operational]: The success of the company's product candidates depends on the outcome of clinical trials, which are inherently uncertain and may not demonstrate safety or efficacy.
• Competition [medium — market]: The company faces intense competition from other pharmaceutical and biotechnology companies, including those with greater resources and established market positions.

Key Dates

• 2024-02-27: 10-K Filing — Annual report filing for fiscal year 2023

Key Financial Figures

• $20.93 — 30, 2023 based on the closing price of $20.93 as reported on the Nasdaq Global Select

Filing Documents

• sndx-20231231.htm (10-K) — 2767KB
• sndx-ex4_3.htm (EX-4.3) — 29KB
• sndx-ex10_16.htm (EX-10.16) — 339KB
• sndx-ex10_20.htm (EX-10.20) — 27KB
• sndx-ex10_22.htm (EX-10.22) — 233KB
• sndx-ex10_23.htm (EX-10.23) — 27KB
• sndx-ex10_25.htm (EX-10.25) — 27KB
• sndx-ex10_27.htm (EX-10.27) — 27KB
• sndx-ex10_30.htm (EX-10.30) — 27KB
• sndx-ex10_31.htm (EX-10.31) — 14KB
• sndx-ex23_1.htm (EX-23.1) — 4KB
• sndx-ex31_1.htm (EX-31.1) — 14KB
• sndx-ex31_2.htm (EX-31.2) — 14KB
• sndx-ex32_1.htm (EX-32.1) — 14KB
• sndx-ex97.htm (EX-97) — 50KB
• img207175068_0.jpg (GRAPHIC) — 246KB
• img207175068_1.jpg (GRAPHIC) — 121KB
• img207175068_2.jpg (GRAPHIC) — 53KB
• img207175068_3.jpg (GRAPHIC) — 89KB
• img207175068_4.jpg (GRAPHIC) — 53KB
• 0000950170-24-021253.txt (&nbsp;) — 12576KB
• sndx-20231231.xsd (EX-101.SCH) — 1644KB
• sndx-20231231_htm.xml (XML) — 1577KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 22 Item 1B. Unresolved Staff Comments 56 Item 1C. Cybersecurity 56 Item 2.

Properties

Properties 57 Item 3.

Legal Proceedings

Legal Proceedings 57 Item 4. Mine Safety Disclosures 57 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuers Purchases of Equity Securities 58 Item 6. [Reserved] 60 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 61 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 71 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 72 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 72 Item 9A.

Controls and Procedures

Controls and Procedures 72 Item 9B. Other Information 74 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 75 PART III Item 10. Directors, Executive Officers and Corporate Governance 76 Item 11.

Executive Compensation

Executive Compensation 76 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 76 Item 13. Certain Relationships and Related Transactions, and Director Independence 76 Item 14. Principal Accountant Fees and Services 76 PART IV Item 15. Exhibit and Financial Statement Schedules 77 Item 16. Form 10-K Summary 81 i SPECIAL NOTE REGARDING FO RWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, or Annual Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are "forward-looking statements" for purposes of this Annual Report. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative or plural of those terms, and similar expressions.

Forward-looking statements include, but are not limited to, statements about

Forward-looking statements include, but are not limited to, statements about: our estimates regarding our expenses, future revenues, anticipated capital requirements and our needs for additional financing; the initiation, cost, timing, progress and results of our research and development activities, clinical trials and preclinical studies; our ability to replicate results in future clinical trials; our expectations regarding the potential safety, efficacy or clinical utility of our product candidates as well as the potential use of our product candidates to treat various cancer indications and fibrotic diseases; our ability to obtain and maintain regulatory approval for our product candidates and the timing or likelihood of regulatory filings and approvals for such candidates; our ability to maintain our licenses with UCB Biopharma Sprl, and Vitae Pharmaceuticals, Inc., a subsidiary of Allergan plc, which was acquired by AbbVie Inc.; the success of our collaboration with Incyte Corporation, or Incyte, to further develop and commercialize axatilimab; the potential milestone and royalty payments under certain of our license agreements; the implementation of our strategic plans for our business and development of our product candidates; the scope of protection we establish and maintain for intellectual property rights covering our product candidates and our technology; the market adoption of our product candidates by physicians and patients; developments relating to our competitors and our industry; and the impact of geo-political actions, including war or the perception that hostilities may be imminent (such as the ongoing war between Russia and Ukraine and the war in Israel), adverse global economic conditions, terrorism, public health crises or natural disasters on our operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations

B USINESS

Item 1. B USINESS Our Company We are a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Our two lead product candidates are revumenib, and axatilimab. We are developing revumenib, a potent, selective, small molecule inhibitor of the menin-MLL binding interaction for the treatment of KMT2A rearranged, or KMT2Ar, also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including acute lymphoblastic leukemia, or ALL, and acute myeloid leukemia, or AML, and necleophosmin 1, also known as NPM1, mutant AML. We are also exploring the use of revumenib as a treatment in solid tumors, specifically its activity in metastatic colorectal cancer. We are developing axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 receptor, or CSF-1R, in chronic graft-versus-host disease, or cGVHD, as well as idiopathic pulmonary fibrosis, or IPF. We plan to continue to leverage the technical and business expertise of our management team and scientific collaborators to license, acquire and develop additional therapeutics to expand our pipeline. Our Strategy We are developing revumenib for the treatment of acute leukemias and as a treatment for solid tumors, and axatilimab for use in cGVHD and other fibrotic-macrophage driven diseases, such as IPF, as single agents and in combination with approved drugs. Key elements of our strategy include: Develop and commercialize revumenib for the treatment of genetically defined leukemias. We believe that revumenib has the potential to treat at least two genetically defined acute leukemias: (i) KMT2Ar and (ii) mutations in NPM1, or mNPM1, AML. Our Phase 1/2 open-label AUGMENT-101 trial is nearing completion. The pivotal Phase 2 portion of the trial enrolled relapsed/refractory, or R/R, patients in three indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib in KMT2Ar ALL, KMT2Ar AML and mNPM1

View Full Filing

View this 10-K filing on SEC EDGAR