# EDGAR Filing Document

**Accession Number:** 0001842952
**File Stem:** 0001628280-26-022931
**Filing Date:** 2026-4
**Character Count:** 11191
**Document Hash:** fc10e2d70d6b2dd48161f1c5767f5668
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628280-26-022931.hdr.sgml**: 20260402

**ACCESSION NUMBER**: 0001628280-26-022931

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20260402

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260402

**DATE AS OF CHANGE**: 20260402

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Context Therapeutics Inc.
- **CENTRAL INDEX KEY:** 0001842952
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 863738787
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40654
- **FILM NUMBER:** 26830641

**BUSINESS ADDRESS:**
- **STREET 1:** 2001 MARKET STREET
- **STREET 2:** SUITE 3915 UNIT #15
- **CITY:** PHILADELPHIA
- **STATE:** PA
- **ZIP:** 19103
- **BUSINESS PHONE:** 267-225-7416

**MAIL ADDRESS:**
- **STREET 1:** 2001 MARKET STREET
- **STREET 2:** SUITE 3915 UNIT #15
- **CITY:** PHILADELPHIA
- **STATE:** PA
- **ZIP:** 19103

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Context Therapeutics LLC
- **DATE OF NAME CHANGE:** 20210128

?xml version='1.0' encoding='ASCII'? cntx-20260402

**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): April 2, 2026**

**Context Therapeutics Inc.**

**(Exact name of registrant as specified in its charter)**

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-40654** | **86-3738787** |
| **(State of other jurisdiction of incorporation)** | **(Commission File Number)** | **(I.R.S. Employer Identification No.)** |

---

**2001 Market Street, Suite 3915, Unit #15**

**Philadelphia, Pennsylvania 19103**

**(Address of principal executive offices including zip code)**

**(267) 225-7416**

**(Registrant's telephone number, including area code)**

**Not Applicable**

**(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:

☐ &nbsp;&nbsp;&nbsp;&nbsp; Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ &nbsp;&nbsp;&nbsp;&nbsp; Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ &nbsp;&nbsp;&nbsp;&nbsp; Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐&nbsp;&nbsp;&nbsp;&nbsp; Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading <br>Symbol** | **Name of exchange<br>on which registered** |
| **Common Stock** | **CNTX** | **The Nasdaq Stock Market** |
| **$0.001 par value per share** |  |  |

---

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 7.01. Regulation FD Disclosure.**

On April 2, 2026, Context Therapeutics Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to CTIM-76, the Company's investigational Claudin 6 x CD3 T cell engaging bispecific antibody, for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

The information in this Item 7.01, and Exhibit 99.1 attached hereto, are being furnished and shall not be deemed "filed" for the 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 in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

**Item 8.01. Other Events.**

On April 2, 2026, the Company issued a press release announcing that the FDA has granted Fast Track designation to CTIM-76, the Company's investigational Claudin 6 x CD3 T cell engaging bispecific antibody, for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies.

**Item 9.01. Financial Statements and Exhibits.**

(d) **Exhibits**

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | <u>[Press Release issued by Context Therapeutics Inc., dated April 2, 2026](a04022026fasttrackdesignat.htm)</u> |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |

---

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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.

---

| | | |
|:---|:---|:---|
| Dated: April 2, 2026 | **Context Therapeutics Inc.** | **Context Therapeutics Inc.** |
|  | By: | /s/ Martin A. Lehr |
|  |  | Name: Martin A. Lehr |
|  |  | Title: Chief Executive Officer |

---

## Exhibit 99.1

Exhibit 99.1

![image_0.jpg](image_0.jpg)

**Context Therapeutics Announces CTIM-76 Receives FDA Fast Track Designation for the Treatment of Platinum-Resistant Ovarian Cancer**

*Fast Track Designation highlights potential of CTIM-76 to address unmet need for patients with PROC*

*CTIM-76 Phase 1a trial ongoing, with interim data expected in June 2026*

**PHILADELPHIA, PA— April 2, 2026** —Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody, for the treatment of platinum-resistant ovarian cancer ("PROC") in patients that have received all standard of care therapies.

Context is currently evaluating CTIM-76 in a Phase 1 clinical trial designed to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability and pharmacokinetics, as well as anti-tumor activity by overall response rate, duration of response and disease control rate.

"We are pleased to receive Fast Track Designation for CTIM-76, which underscores its potential to improve the lives of patients with platinum-resistant ovarian cancer," said Karen Chagin, M.D., Chief Medical Officer of Context. "This designation is an important step forward in our goal to quickly and efficiently advance CTIM-76 through clinical development and we look forward to sharing interim data for this program in June 2026."

The FDA's Fast Track Designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need.

**About CTIM-76**

CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. More information about the CTIM-76 clinical trial (NCT06515613) can be found on https://clinicaltrials.gov/.

**About Context Therapeutics**<sup>®</sup>

Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors. Context's goal is to build an innovative portfolio of TCE

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Exhibit 99.1

bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 TCE, CT-95, a Mesothelin x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia. For more information, please visit <u>www.contexttherapeutics.com</u> or follow the Company on <u>X</u> (formerly Twitter) and <u>LinkedIn</u>.

**Forward-looking Statements**<br>This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as "may," "will," "expect," "anticipate," "look forward," "plan," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the Company's expectation to provide Phase 1a interim data for CTIM-76 in June 2026, (ii) the potential benefits, characteristics, safety and side effect profile of the Company's product candidates, (iii) the likelihood data will support future development, and (iv) the likelihood of obtaining regulatory approval of the Company's product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and the Company therefore cannot assure the reader that its plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as otherwise required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

**Investor Relations Contact:**<br>Jennifer Minai-Azary

Chief Financial Officer

Context Therapeutics<br>IR@contexttherapeutics.com <br>

<br>