CNTX Context Therapeutics Inc.

2.11
-0.17  -7%
Previous Close 2.28
Open 2.27
52 Week Low 1.8299
52 Week High 10.87
Market Cap $23,133,968
Shares 10,963,966
Float 10,005,708
Enterprise Value $23,403,635
Volume 405,151
Av. Daily Volume 4,642,570
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Upcoming Catalysts

Drug Stage Catalyst Date
Onapristone (ONA-XR) and Anastrozole
Endometrial Cancer
Phase 2
Phase 2
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Onapristone (ONA-XR)
Ovarian cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Onapristone (ONA-XR) and Fulvestrant (The SMILE Study)
Breast Cancer - 2nd-line
Phase 2
Phase 2
Phase 2 trial dosing commenced October 27, 2021.
Onapristone (ONA-XR) - (ONAWA)
Breast Cancer
Phase 1
Phase 1
Early Phase 1 data demonstrated that the treatment decreased proliferation in tumors with high PR+ at baseline in early breast cancer, noted November 9, 2021.
FEMARA (Letrozole) IBRANCE (Palbociclib) and Onapristone (ONA-XR)
Breast cancer - first line
Phase 2
Phase 2
Phase 2 trial to be initiated mid-2021.

Latest News

  1. PHILADELPHIA, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. ("Context" or the "Company") (NASDAQ:CNTX), a women's oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced the appointments of Christopher Beck as SVP of Operations and Mark Fletcher, Ph.D., as VP of R&D. Context also announced the planned retirement of its current Head of CMC, Bill Rencher, Ph.D., who will move into an advisory role with the Company.

    "Context is in a pivotal phase of growth and change as we near key inflection points with our pipeline, bolstered by our recent private placement and initial public offering. As part of Context's leadership, Mr. Beck and Dr. Fletcher will help guide…

    PHILADELPHIA, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. ("Context" or the "Company") (NASDAQ:CNTX), a women's oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced the appointments of Christopher Beck as SVP of Operations and Mark Fletcher, Ph.D., as VP of R&D. Context also announced the planned retirement of its current Head of CMC, Bill Rencher, Ph.D., who will move into an advisory role with the Company.

    "Context is in a pivotal phase of growth and change as we near key inflection points with our pipeline, bolstered by our recent private placement and initial public offering. As part of Context's leadership, Mr. Beck and Dr. Fletcher will help guide Context's R&D operations, leveraging their proven knowledge, capabilities, and leadership skills to help Context achieve its product development objectives. We celebrate Dr. Rencher's distinguished pharmaceutical career and wish him well on his much deserved retirement," said Martin Lehr, CEO of Context Therapeutics. "As we start 2022, we're pleased with the strong team we've assembled to advance our lead product candidate onapristone extended release (ONA-XR) in breast, ovarian, and endometrial cancers, as well as our preclinical anti-claudin 6 bispecific antibody."

    Mr. Beck joins Context from Galera Therapeutics, where he served as VP of Program Management. Prior to Galera, Mr. Beck spent nearly a decade at Shire where he served in roles of increasing responsiblity and created the company's first global project management and resource capacity planning capability. Throughout his career, Mr. Beck also held management positions at Merck and AstraZeneca, among others. He holds a B.S. in Information Technology from Drexel University and a M.B.A. from Penn State University.

    "I'm delighted to join the Context team at this significant point in the Company's evolution," said Mr. Beck. "I look forward to leading Context's operational efforts to help it deliver on the important work to advance medicines for women's cancers."

    Prior to joining Context, Dr. Fletcher was VP of Product Development at Pharmaceutical Associates, Inc. where he led development, analytical, and regulatory activity. In prior roles, he served as Head of Non-Injectable R&D for Hikma Pharmaceutical U.S. Operations, CSO at Douglas Pharmaceuticals, and VP of Technical Operations and Regulatory Affairs at PBM Pharmaceuticals. Dr. Fletcher also held senior positions at Endo Health Solutions (Qualitest) and Ligand Pharmaceuticals, among others. He holds a B.S. in Pharmacy and a M.S and Ph.D. in Industrial Pharmacy from University of Maryland.

    "There exists a significant unmet need for more effective treatments for women's hormone-driven cancers," said Dr. Fletcher. "I look forward to collaborating with our internal and external development partners as we continue to progress the evaluation of ONA-XR's potential benefit in the treatment of these cancers."

    About Context Therapeutics®

    Context Therapeutics Inc. (NASDAQ:CNTX), is a women's oncology company developing small molecule and immunotherapy treatments to transform care for breast and gynecological cancers. The Company's robust clinical program for lead candidate onapristone extended release (ONA-XR) comprises three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian, and endometrial cancer, as well as two Phase 0 biomarker pharmacodynamic trials in breast cancer. ONA-XR is a novel, first-in-class small molecule under development as a potent and specific antagonist of the progesterone receptor, a key unchecked mechanism in hormone-driven women's cancers. Context is headquartered in Philadelphia, PA. For more information, visit www.contexttherapeutics.com.

    Forward-looking Statements

    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," "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 results of our clinical trials, (ii) the potential benefits of the product candidates, (iii) the likelihood data will support future development, (iv) the potential for our employees and consultants to perform services as anticipated, and (v) the likelihood of obtaining regulatory approval of our 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 we, therefore cannot assure you that our 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 our filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as otherwise required by law, we disclaim 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.

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    Investor Relations Contact:

    Laine Yonker

    Edison Group



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  2. PHILADELPHIA, Jan. 5, 2022 /PRNewswire/ -- Integral Molecular, the leader in discovering antibodies against multipass membrane proteins, has entered into an agreement to leverage Alloy Therapeutics' transgenic humanized ATX-Gx mice as an added strategy to rapidly isolate fully human monoclonal antibodies using Integral Molecular's MPS Antibody Discovery platform. ATX-Gx is a suite of immunologically robust transgenic mice that produce antibodies with fully human sequences. Lacking non-human sequences that can trigger severe immune side-effects, the resulting antibodies have high developability.

    Integral Molecular's MPS platform is optimized for discovering MAbs against structurally complex membrane proteins, a valuable group of therapeutic targets. With a 95% success rate in delivering antibodies targeting complex membrane proteins, MPS successes include antibodies recently licensed to Context Therapeutics (NASDAQ:CNTX) and AstraZeneca (NASDAQ:AZN). Alloy's ATX-Gx mice complement Integral Molecular's proprietary humanized chicken antibody technology (hCAT) now allowing partners to choose their preferred method to isolate fully humanized antibodies.

    "We look forward to working with Integral Molecular as a Certified Service Provider to make our antibody discovery platform available to more drug discovery teams," said Heather Schwoebel, Alloy Therapeutics' Chief Operating Officer and Head of Business Development. "By harnessing Integral's technologies, we have already seen exceptional immune responses to difficult targets, such as GPCRs, in the Alloy mice."

    Partners interested in antibody discovery should contact Integral Molecular.

    About Integral Molecular

    Integral Molecular (integralmolecular.com) is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

    About Alloy Therapeutics

    Alloy Therapeutics (alloytx.com) is a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community of partners, Alloy democratizes access to tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics. The company facilitates affordable, non-exclusive access to the entire drug discovery community from academic scientists, small and medium biotech, to the largest biopharma. Alloy's lead offering, the ATX-Gx™ platform, is a human therapeutic antibody discovery platform consisting of a growing suite of proprietary transgenic mice strains. Alloy is headquartered in Boston, MA with labs in Cambridge, UK; Basel, CH; San Francisco, CA; and Athens, GA. 

    Press Contact:

    Integral Molecular, Inc.

    Soma Banik, PhD, Director of Communications

    215-966-6061



    www.integralmolecular.com

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    SOURCE Integral Molecular

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  3. PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. ("Context" or the "Company") (NASDAQ:CNTX), a women's oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced that Chief Executive Officer Martin Lehr will participate virtually in two investor conferences in January 2022.

    Details of the events are as follows:

    • Biotech Showcase™ 2022: The company's presentation will be available for on-demand viewing during the conference which will take place January 10-12, 2022. Additionally, Mr. Lehr will participate on the "Women's Health: Progress and Innovation Continue to Drive Increased Investor Interest" panel taking place on January 12, 2022, at 8:00 a.m…

    PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. ("Context" or the "Company") (NASDAQ:CNTX), a women's oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced that Chief Executive Officer Martin Lehr will participate virtually in two investor conferences in January 2022.

    Details of the events are as follows:

    • Biotech Showcase™ 2022: The company's presentation will be available for on-demand viewing during the conference which will take place January 10-12, 2022. Additionally, Mr. Lehr will participate on the "Women's Health: Progress and Innovation Continue to Drive Increased Investor Interest" panel taking place on January 12, 2022, at 8:00 a.m. PST. Details about the event can be found here: https://informaconnect.com/biotech-showcase/agenda/4/
    • Edison Group Open House: Global Healthcare 2022: The company's presentation will be available for on-demand viewing during the conference which will take place January 25-27, 2022. Context will also participate in one-on-one meetings during the conference. To register for meetings with the Context team, please visit this link. Additionally, a replay of the company's video presentation will be available on the Events page of the Investor Relations section of Context's website, www.contexttherapeutics.com, for approximately 30 days after the meeting.

    About Context Therapeutics®

    Context Therapeutics Inc. (NASDAQ:CNTX), is a women's oncology company developing small molecule and immunotherapy treatments to transform care for breast and gynecological cancers. The Company's robust clinical program for lead candidate onapristone extended release (ONA-XR) comprises three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian, and endometrial cancer, as well as two Phase 0 biomarker pharmacodynamic trials in breast cancer. ONA-XR is a novel, first-in-class small molecule under development as a potent and specific antagonist of the progesterone receptor, a key unchecked mechanism in hormone-driven women's cancers. Context is headquartered in Philadelphia, PA. For more information, visit www.contexttherapeutics.com.

    Forward-looking Statements

    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," "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 results of our clinical trials, (ii) the potential benefits of the product candidates, (iii) the likelihood data will support future development, (iv) the ability of the Company and its employees to participate in and present at conferences, and (v) the likelihood of obtaining regulatory approval of our 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 we, therefore cannot assure you that our 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 our filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as otherwise required by law, we disclaim 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.

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    Investor Relations Contact:

    Laine Yonker

    Edison Group



    Primary Logo

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  4. Data demonstrated ONA-XR decreased proliferation in tumors with high PR+ at baseline in early breast cancer

    Two additional metastatic breast cancer clinical trials in progress also presented

    PHILADELPHIA, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (NASDAQ:CNTX), a women's oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced that data from the window-of-opportunity clinical trial of onapristone extended release (ONA-XR) in postmenopausal patients with progesterone receptor positive (PR+) early breast cancer demonstrated ONA-XR significantly increased suppression of tumor cell proliferation. The data were presented today during the 2021 San Antonio Breast…

    Data demonstrated ONA-XR decreased proliferation in tumors with high PR+ at baseline in early breast cancer

    Two additional metastatic breast cancer clinical trials in progress also presented

    PHILADELPHIA, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (NASDAQ:CNTX), a women's oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, today announced that data from the window-of-opportunity clinical trial of onapristone extended release (ONA-XR) in postmenopausal patients with progesterone receptor positive (PR+) early breast cancer demonstrated ONA-XR significantly increased suppression of tumor cell proliferation. The data were presented today during the 2021 San Antonio Breast Cancer Symposium (SABCS).

    The Phase 0 open-label, single-arm, multicenter ONAWA (SOLTI-1802) trial conducted by Spanish cancer research group SOLTI, enrolled 10 patients with ER+/PR+/HER2- negative tumors and levels of the cell proliferation marker "Ki67" above 10% to evaluate ONA-XR by the rate of Complete Cell Cycle Arrest (CCCR) determined by Ki-67 (≤2.7%) when administered for three weeks prior to surgery (Abstract #511). Secondary endpoints of the trial included safety and correlating biological activity with immunohistochemistry (IHC) of tumor expression (ER, PR, Ser294-PgR, CD24, CD44, ALDH1, Ki-67), estradiol, and progesterone blood levels, and gene expression profile (NanoString nCounter® Breast 360TM panel). While no patients achieved a CCCR, tumor Ki-67 expression decreased in six patients, remained stable in one patient, and increased in three patients. Mean percentage decrease of Ki67 for tumors with baseline PR expression ≥90% (N=4) and <90% (N=6) was -25.23% and 2.54%, respectively, indicating a trend towards enhance response for patients with high levels of PR expression at baseline. In addition, a shift towards more endocrine-sensitive disease was detected, implying an increased chance of the tumor responding to anti-estrogen therapy when used in combination with ONA-XR. Six patients reported adverse events (AEs), of which most were grade 1 or 2 including post-procedural pain, dry mouth, and an increase of gamma-glutamyl transferase (GGT). One patient experienced Grade 3 reversible GGT and aspartate aminotransferase (AST).

    "The data from the ONAWA trial signal the potential of ONA-XR to help inhibit tumor proliferation and shift tumors to a more endocrine treatment-sensitive phenotype during treatment prior to surgery in postmenopausal women with operable breast cancer and improve overall prognosis for these patients," said co-principal investigator Meritxell Bellet, M.D., Ph.D., medical oncologist at Vall d'Hebron University Hospital in Barcelona and an executive board member of SOLTI. "These results support further evaluation of ONA-XR in the treatment of early breast cancer."

    "ONA-XR is being evaluated in four investigator-sponsored clinical trials in hormone-driven breast, ovarian and endometrial cancers. This readout is the first for the novel PR antagonist, and the results are encouraging early evidence of the potential of ONA-XR to offer a new therapeutic option for hormone-dependent cancers," said Martin Lehr, CEO of Context Therapeutics. "We look forward to data updates from three other ONA-XR trials in 2022."

    The design of two additional clinical trials evaluating ONA-XR in metastatic breast cancer (MBC) were also presented in trials-in-progress posters during SABCS: The SMILE Study, a Phase 2 trial evaluating ONA-XR in combination with fulvestrant for patients with ER+ and HER2- metastatic breast cancer after progression on endocrine therapy and CDK4/6 inhibitors that is being conducted in collaboration with the Wisconsin Oncology Network (Abstract #311); and Memorial Sloan Kettering Cancer Center's Phase 1b trial designed to define the safety, tolerability and recommended Phase 2 dose of ONA-XR in combination with letrozole and palbociclib, in addition to investigating the circulating tumor DNA-guided response of this triplet therapy regimen in high-risk patients (Abstract #1538).

    About Onapristone Extended Release

    ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently being evaluated in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in PR+ breast, ovarian and endometrial cancers, as well as in two Phase 0 biomarker pharmacodynamic trials in breast cancer. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.

    About Context Therapeutics®

    Context Therapeutics Inc. (NASDAQ:CNTX), is a women's oncology company developing small molecule and immunotherapy treatments to transform care for breast and gynecological cancers. The Company's robust clinical program for lead candidate onapristone extended release (ONA-XR) comprises three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian and endometrial cancer, as well as two Phase 0 biomarker pharmacodynamic trials in breast cancer. ONA-XR is a novel, first-in-class small molecule under development as a potent and specific antagonist of the progesterone receptor, a key unchecked mechanism in hormone-driven women's cancers. Context is headquartered in Philadelphia, PA. For more information, visit www.contexttherapeutics.com.

    Forward-looking Statements

    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," "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 results of our clinical trials, (ii) the potential benefits of the product candidates, (iii) the likelihood data will support future development, and (iv) the likelihood of obtaining regulatory approval of our 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 we, therefore cannot assure you that our 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 our filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as otherwise required by law, we disclaim 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.

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    Investor Relations Contact:

    Laine Yonker

    Edison Group



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  5. PHILADELPHIA, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (NASDAQ:CNTX) ("Context Therapeutics" or the "Company"), a women's oncology company developing small molecule and immunotherapy treatments to transform care for breast and gynecological cancers, today announced that it has closed its previously announced private placement for the sale of 5,000,000 shares of common stock of Context Therapeutics together with warrants to purchase 5,000,000 shares of common stock ("Warrants"), which resulted in gross proceeds to Context Therapeutics of approximately $31.25 million, before deducting offering expenses (the "Offering"). Each share of common stock and accompanying Warrant were sold at a combined offering price of $6.25. The…

    PHILADELPHIA, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (NASDAQ:CNTX) ("Context Therapeutics" or the "Company"), a women's oncology company developing small molecule and immunotherapy treatments to transform care for breast and gynecological cancers, today announced that it has closed its previously announced private placement for the sale of 5,000,000 shares of common stock of Context Therapeutics together with warrants to purchase 5,000,000 shares of common stock ("Warrants"), which resulted in gross proceeds to Context Therapeutics of approximately $31.25 million, before deducting offering expenses (the "Offering"). Each share of common stock and accompanying Warrant were sold at a combined offering price of $6.25. The Warrants have a five and one-half year term and an exercise price of $6.25 per share.

    ThinkEquity acted as sole placement agent for the Offering.

    The securities offered and sold by Context Therapeutics in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from such registration requirements. Context Therapeutics has agreed to file a registration statement with the SEC covering the resale of the shares of common stock and the shares of common stock underlying the Warrants to be issued in the private placement. Any resale of Context Therapeutics' shares of common stock under such resale registration statement will be made only by means of a prospectus.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities 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. The securities were not registered under the Securities Act or any state securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state laws.

    About Context Therapeutics

    Context Therapeutics Inc. (NASDAQ:CNTX), is a women's oncology company developing small molecule and immunotherapy treatments to transform care for breast and gynecological cancers. The Company's robust clinical program for lead candidate onapristone extended release (ONA-XR) comprises three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian and endometrial cancer, as well as two Phase 0 biomarker pharmacodynamic trials in breast cancer. ONA-XR is a novel, first-in-class small molecule under development as a complete antagonist of the progesterone receptor, a key unchecked mechanism in hormone-driven women's cancers. Context is headquartered in Philadelphia, PA. For more information, visit www.contexttherapeutics.com.

    Forward-Looking Statements

    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," "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 likelihood of the future exercise of the Warrants issued in connection with the Offering, (ii) the likelihood data will support future development, (iii) the potential benefits of the product candidates, and (iv) the likelihood of obtaining regulatory approval of our 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 we, therefore cannot assure you that our 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 our filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as otherwise required by law, we disclaim 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.

    For further information, please contact:

    Media Contact:

    Gina Cestari

    6 Degrees

    917-797-7904

    Investor Relations Contact:

    Laine Yonker

    Edison Group



    Primary Logo

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