CONTEXT THERAPEUTICS INC. | --- | --- | |-----------------------------|-------| | | | | Accelerated filer | ☐ | | | | | Smaller reporting company | ☒ | | Emerging growth company | ☒ | _________________________ For the quarterly period ended September 30, 2023 Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to f ...

For the quarterly period ended June 30, 2023 Commission file number: 001-40654 | --- | --- | --- | |------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------| | Delaware | (Exact name of registrant as specified in its charter) ___________________________________ | 86-3738787 | | (State of other jurisdiction of incorporation or organization) | (I.R.S. | Emplo ...

Commission file number: 001-40654 For the quarterly period ended March 31, 2023 Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý No o Indicate by check mark whether the registrant is a shell company (as define ...

Part I [Business](index=10&type=section&id=Item%201.%20Business) Context Therapeutics, a biopharmaceutical company, strategically shifted focus to its preclinical CTIM-76 program, extending its cash runway - On **March 22, 2023**, the company announced a strategic portfolio prioritization, discontinuing the development of **ONA-XR** to focus resources on its preclinical program, **CTIM-76**[42](index=42&type=chunk)[344](index=344&type=chunk) - The decision to cease **ONA-XR** development was influenced by a **competitive breast cancer treatment landscape**, **challenging market conditions**, and the identification of **elevated liver function tests (LFTs)** in three patients in a Phase 2 trial[42](index=42&type=chunk)[43](index=43&type=chunk)[345](index=345&type=chunk) - The company's lead program is now **CTIM-76**, an anti-Claudin 6 (CLDN6) x anti-CD3 bispecific antibody designed to target solid tumors An Investigational New Drug (IND) application is expected to be filed in **Q1 2024**[41](index=41&type=chunk)[47](index=47&type=chunk)[343](index=343&type=chunk) - Preclinical data indicates **CTIM-76** has high selectivity for **CLDN6** over the highly similar **CLDN9** (**>1000x**), which is a key development challenge and a potential competitive advantage[59](index=59&type=chunk)[67](index=67&type=chunk) - The company relies on **third parties** for manufacturing and has agreements with **Lonza** for the development and manufacture of **CTIM-76**[78](index=78&type=chunk)[80](index=80&type=chunk) - As of **March 1, 2023**, the company had **nine full-time employees** and **one consultant** serving as an executive officer[127](index=127&type=chunk)[185](index=185&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a history of losses, capital dependence, reliance on its lead candidate, and operational and market challenges - The company has a **history of losses**, has **never been profitable**, and will require **substantial additional capital** to fund its research, development, and commercialization efforts[136](index=136&type=chunk)[139](index=139&type=chunk) - The business is highly dependent on the successful development and commercialization of **CTIM-76**, which is in the **early stages of development** and has **not yet entered clinical trials**[153](index=153&type=chunk) - The decision to discontinue **ONA-XR** development carries risks, including the **inability to consummate a strategic transaction** for the asset, which could be **time-consuming and distracting** to management[177](index=177&type=chunk)[178](index=178&type=chunk) - The company relies **heavily on third parties**, such as CROs and contract manufacturers (e.g., **Lonza**), for clinical trials and manufacturing **Failure by these parties to perform** could **significantly harm the business**[210](index=210&type=chunk)[219](index=219&type=chunk) - On **January 24, 2023**, the company received a notice from Nasdaq for **non-compliance with the minimum $1.00 bid price requirement**, which could lead to **delisting** if not resolved[301](index=301&type=chunk) - The company is exposed to risks from the financial services industry, highlighted by the recent failure of **Silicon Valley Bank**, which could **impair access to funding** and affect counterparties[198](index=198&type=chunk)[200](index=200&type=chunk) [Unresolved Staff Comments](index=61&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) None [Properties](index=61&type=section&id=Item%202.%20Properties) The company's corporate headquarters are located in Philadelphia, Pennsylvania, where it leases approximately 3,500 square feet of office space A sublease for this space expires in July 2023, and a new direct lease for the same space will commence on August 1, 2023, and expire on August 31, 2024 - The company leases approximately **3,500 square feet** of office space in Philadelphia, PA A new direct lease for this space begins **August 1, 2023**, and expires **August 31, 2024**, with a **one-year renewal option**[330](index=330&type=chunk) [Legal Proceedings](index=61&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=62&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on The Nasdaq Stock Market under the symbol "CNTX" As of March 17, 2023, there were 15,966,053 shares outstanding held by 56 holders of record The company has never paid cash dividends and does not anticipate paying any in the near future - The company's common stock has traded on The Nasdaq Stock Market under the symbol "CNTX" since its IPO on **October 20, 2021**[335](index=335&type=chunk) - As of March 17, 2023, there were **15,966,053 shares** of common stock outstanding held by **56 holders of record**[336](index=336&type=chunk) - The company has **not paid and does not anticipate paying cash dividends** in the foreseeable future, intending to **retain earnings for business development**[337](index=337&type=chunk) [Reserved]](index=62&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=63&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $14.8 million in 2022 due to increased operating expenses, with $35.5 million cash expected to fund operations into late 2024 Comparison of Results of Operations (2022 vs. 2021) | | Year ended December 31, | | | | |---|---:|---:|---:|---:| | | **2022** | **2021** | **$ Change** | **% Change** | | **Operating Expenses:** | | | | | | Acquired in-process R&D | $500,000 | $3,087,832 | $(2,587,832) | (84)% | | Research and development | $7,091,163 | $3,805,067 | $3,286,096 | 86% | | General and administrative | $7,790,040 | $3,632,920 | $4,157,120 | 114% | | **Loss from operations** | **$(15,381,203)** | **$(10,525,819)** | **$(4,855,384)** | **46%** | | **Net loss** | **$(14,835,939)** | **$(10,456,870)** | **$(4,379,069)** | **42%** | - Research and development expenses increased by **$3.3 million (86%)** in 2022, primarily due to a **$2.4 million** increase in **ONA-XR** costs (contract manufacturing and clinical trials) and a **$0.3 million** increase in **CTIM-76** IND-enabling study costs[366](index=366&type=chunk) - General and administrative expenses increased by **$4.2 million (114%)** in 2022, driven by higher compensation (**$2.0 million**), insurance costs (**$1.2 million**), and other public company operating costs (**$1.0 million**)[367](index=367&type=chunk) - As of December 31, 2022, the company had **$35.5 million** in cash and cash equivalents and an accumulated deficit of **$44.1 million**[350](index=350&type=chunk)[371](index=371&type=chunk) - The company expects its current cash and cash equivalents to be sufficient to fund operations **into late 2024**, following its strategic decision to discontinue the **ONA-XR** program[345](index=345&type=chunk)[350](index=350&type=chunk)[372](index=372&type=chunk) - Net cash used in operating activities was **$13.5 million** in 2022, compared to **$8.8 million** in 2021, reflecting increased operational spending on product development[377](index=377&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=73&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required as the company qualifies as a smaller reporting company [Financial Statements and Supplementary Data](index=74&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section provides audited financial statements for 2022 and 2021, including key financial data and notes on accounting policies and subsequent events Consolidated Balance Sheet Data (as of December 31) | | 2022 | 2021 | |---|---:|---:| | Cash and cash equivalents | $35,497,445 | $49,635,197 | | Total assets | $37,965,943 | $51,305,750 | | Total liabilities | $3,207,577 | $3,033,415 | | Accumulated deficit | $(44,090,379) | $(29,254,440) | | Total stockholders' equity | $34,758,366 | $48,272,335 | Consolidated Statement of Operations Data (for the year ended December 31) | | 2022 | 2021 | |---|---:|---:| | Research and development | $7,091,163 | $3,805,067 | | General and administrative | $7,790,040 | $3,632,920 | | Loss from operations | $(15,381,203) | $(10,525,819) | | Net loss | $(14,835,939) | $(10,456,870) | | Net loss per share, basic and diluted | $(0.93) | $(3.69) | - A subsequent event note discloses that on **March 22, 2023**, the company announced a portfolio prioritization to discontinue development of **ONA-XR** and focus on **CTIM-76**[513](index=513&type=chunk) - The company has a full valuation allowance against its net deferred tax assets of **$9.2 million** as of December 31, 2022, as it is not more likely than not that they will be realized[506](index=506&type=chunk) - In **March 2023**, the company **amended its license agreement** with **Integral Molecular** for **CTIM-76**, modifying certain milestone payment terms[495](index=495&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosures](index=96&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosures) None [Controls and Procedures](index=96&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of December 31, 2022 Management also assessed internal control over financial reporting and concluded it was effective As an emerging growth company, an attestation report from the independent registered public accounting firm on internal controls is not required - Management concluded that as of December 31, 2022, the company's disclosure controls and procedures were **effective**[517](index=517&type=chunk) - Management concluded that as of December 31, 2022, the company's internal control over financial reporting was **effective** based on the **COSO 2013 framework**[519](index=519&type=chunk) - The annual report does not include an auditor's attestation report on internal control over financial reporting, as permitted for emerging growth companies under the **JOBS Act**[520](index=520&type=chunk) [Other Information](index=97&type=section&id=Item%209B.%20Other%20Information) This section discloses two material events from March 2023 On March 20, the company amended its license agreement with Integral Molecular, modifying milestone payment terms On March 21, in connection with discontinuing the ONA-XR program, the company mutually terminated its Clinical Trial Collaboration and Supply Agreement with Menarini Group - On **March 20, 2023**, the company **amended its license agreement** with **Integral Molecular**, removing a second milestone payment and reallocating its value to a third milestone payment[522](index=522&type=chunk) - On **March 21, 2023**, the company **mutually terminated its Clinical Trial Collaboration and Supply Agreement** with **Menarini Group** related to the **ONA-XR** program[523](index=523&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=97&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) Not applicable Part III [Directors, Executive Officers and Corporate Governance](index=98&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information required for this item will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders [Executive Compensation](index=98&type=section&id=Item%2011.%20Executive%20Compensation) Information required for this item will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=98&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information required for this item will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders [Certain Relationships and Related Transactions, and Director Independence](index=98&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information required for this item will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders [Principal Accountant Fees and Services](index=98&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information required for this item will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders Part IV [Exhibits and Financial Statement Schedules](index=99&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the exhibits filed with or furnished as part of the Annual Report Key exhibits include the company's charter and bylaws, various material contracts such as license and collaboration agreements with Integral Molecular, Tyligand Bioscience, and Lonza, employment agreements, and certifications from the CEO and CFO [Form 10-K Summary](index=102&type=section&id=Item%2016.%20Form%2010-K%20Summary) Not applicable

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________ FORM 10-Q ___________________________________ (Mark one) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ______________. Commission file number: 001-40654 CONTEXT THERAPEUTICS ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________ FORM 10-Q ___________________________________ (Mark one) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ______________. Commission file number: 001-40654 CONTEXT THERAPEUTICS INC. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________ FORM 10-Q ___________________________________ (Mark one) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ______________. Commission file number: 001-40654 CONTEXT THERAPEUTICS INC ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-04321 CONTEXT THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 86-3738787 (State of other jurisdiction of incorporation or organization) (I.R.S. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________ FORM 10-Q ___________________________________ (Mark one) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ______________. Commission file number: 001-40654 CONTEXT THERAPEUTICS ...