Context Therapeutics Inc (NASDAQ:CNTX), a women’s oncology company, said it is in a pivotal period following its debut on Nasdaq and a recent private placement of its units that extends its cash runway into 2024.
Releasing third-quarter results, the company told investors it also strengthened its leadership team with the addition of chief financial officer Jennifer Minai-Azary and chief legal officer Alex Levit, who was instrumental in getting Context Therapeutics (NASDAQ:CNTX) listed.
“Additionally, the clinical evaluation of our lead product candidate Onapristone extended-release (ONA-XR) continues to progress, with three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian and endometrial cancers currently enrolling patients,” CEO Martin Lehr said in a statement.
“We also recently entered into a research collaboration and license agreement with Integral Molecular for the development of an anti-claudin 6 (CLDN6) bispecific monoclonal antibody (BsMAb) for gynecologic cancer immunotherapy.”
WATCH: Context Therapeutics on track to report initial data from its four women's cancer focused clinical trials in 2022
Context said it ended the three months to September 30, 2021, with cash and cash equivalents of $400,000, up from $300,000 on December 31, 2020.
For the quarter, research and development expenses increased to $700,000, from $500,000 in 3Q 2020, mostly due to increased preclinical and clinical costs related to its ONA-XR and CLDN6 programs. General and administrative expenses amounted to $800,000, up from $200,000 in the year-earlier period, driven by an increase in compensation expenses as a result of higher headcount and professions fees as it prepared to operate as a public company.
It reported a 3Q net loss of $1.4 million, from a net loss of $900,000 in 3Q 2020.
The company said it expects its cash and cash equivalents, including the net proceeds from its IPO and the expected proceeds from its private placement, to be sufficient to fund its operations until 2024.
In October, Context completed an initial public offering (IPO) of its common stocks, raising gross gross proceeds of $28.75 million, as it listed on Nasdaq. On December 2, 2021, it said it entered securities purchase agreements of 5 million common shares together with warrants to purchase an equal number of shares, to result in gross proceeds of $31.25 million.
Context said its pipeline updates include:
- In November 2021, announced preliminary results from the Window of Opportunity study assessing ONA-XR in postmenopausal women with PR+/HER2- early breast cancer will be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) taking place virtually and in San Antonio, Texas, from December 7-10, 2021 (Abstract # 511).
- In October 2021, announced with the Wisconsin Oncology Network that the first patient was dosed in the Phase 2 SMILE study assessing ONA-XR in combination with fulvestrant in women with ER+, PR+, HER2- metastatic breast cancer who have progressed on prior aromatase inhibitor and CDK4/6 inhibitor combination therapy. A trial design poster will be presented at SABCS (Abstract # 379), and preliminary data from this trial are anticipated in 2022.
- In August 2021, entered into a license agreement with Tyligand Bioscience, Ltd. whereby Tyligand was granted the exclusive right and sole responsibility for the development and commercialization of ONA-XR in China, Hong Kong, and Macau. Context is eligible to receive royalties on net sales of ONA-XR in the Territory and retains rest-of-world rights to commercialize ONA-XR.
“We look forward to early data from several of the ONA-XR clinical trials in 2022, as we continue our work to demonstrate its potential to make a meaningful difference for patients with hormone-driven women’s cancers,” Lehr concluded.
Context Therapeutics (NASDAQ:CNTX) is developing small molecule and immunotherapy treatments to transform care for breast and gynecological cancers.
Contact the author at stephen.gunnion@proactiveinvestors.com