Context Therapeutics (CNTX) Reports Third Quarter Net Loss of $ 1.4 Million, Cash and Equivalents of $ 0.4 Million


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Context Therapeutics Inc. (Nasdaq: CNTX), a female oncology company that develops small molecule therapies and immunotherapy to transform care for breast and gynecologic cancers, today announced the financial results of the third quarter ended September 30, 2021 and highlighted the recent achievements of the company.

“This is a pivotal time for Context as we debuted on the Nasdaq and entered into a $ 31.25 million private placement agreement that extends our treasury track through 2024. We have also strengthened our management team with the addition of CFO Jennifer Minai-Azary and Director Legal Counsel Alex Levit, who was instrumental in bringing our company public, ”said Martin Lehr, CEO of Context Therapeutics. “In addition, the clinical evaluation of our flagship product candidate onapristone extended-release (ONA-XR) continues to progress, with three phase 2 clinical trials and one phase 1b / 2 clinical trial in breast, breast cancer. ovary and endometrium of hormonal origin which are currently recruiting patients. . We also recently entered into a research collaboration and licensing agreement with Integral Molecular for the development of a bispecific monoclonal antibody (BsMAb) anti-claudin 6 (CLDN6) for gynecological cancer immunotherapy. We look forward to the first data from several of the ONA-XR clinical trials in 2022, as we continue our work to demonstrate its potential to make a significant difference for patients with female hormonal cancers.

Third Quarter 2021 and Recent Company Highlights

Pipeline Updates

  • In November 2021, the preliminary results announced from the Window of Opportunity study evaluating ONA-XR in postmenopausal women with early PR + / HER2- breast cancer will be presented at the San Antonio Breast Cancer Symposium (SABCS) 2021 to be held. virtually and in San Antonio, Texas, December 7-10, 2021 (Abstract # 511).
  • In October 2021, announced with the Wisconsin Oncology Network that the first patient was treated in the phase 2 SMILE study evaluating ONA-XR in combination with fulvestrant in women with ER +, PR + metastatic breast cancer, HER2- which progressed on aromatase inhibitor and Combination therapy of CDK4 / 6 inhibitors. A trial design poster will be presented at SABCS (Abstract # 379), and preliminary data from this trial is expected in 2022.

Company Updates

  • In December 2021, announced that the Company had entered into definitive securities purchase agreements for a private placement with qualified investors of 5,000,000 common shares of Context Therapeutics as well as warrants to purchase 5,000,000 d common shares at a combined offering price of $ 6.25, which will generate gross proceeds for Context Therapeutics of approximately $ 31.25 million, before the deduction of offering offering fees.
  • In November 2021, announced the appointment of Jennifer Minai-Azary as Chief Financial Officer and the prior appointment, in April 2021, of Alex Levit as Chief Legal Officer.
  • In October 2021, completed an initial public offering (IPO) of common shares and raised gross proceeds of $ 28.75 million, before deducting subscription discounts, commissions and offering costs, through the sale of 5,750,000 shares, including shares sold as part of the underwriter’s full exercise of its option to purchase additional shares, at a public offer price of $ 5.00 l ‘action.
  • In August 2021, entered into a licensing agreement with Tyligand Bioscience, Ltd. (“Tyligand”) under which Tyligand has been granted the exclusive right and sole responsibility for the development and commercialization of ONA-XR in China, Hong Kong and Macau (the “” Territory “). Context is eligible to receive royalties on net sales of ONA-XR in the territory and retains the rights of the rest of the world to market ONA-XR.

Third Quarter Financial Highlights

  • Cash and cash equivalents were $ 0.4 million as at September 30, 2021, compared to $ 0.3 million as at December 31, 2020.
  • Research and development (R&D) expenses amounted to $ 0.7 million for the third quarter of 2021, compared to $ 0.5 million for the same period in 2020. The increase in R&D expenses is mainly due to the increase in preclinical and clinical costs related to our ONA-XR and CLDN6. programs.
  • General and administrative (G&A) expenses were $ 0.8 million for the third quarter of 2021, compared to $ 0.2 million for the same period in 2020. The increase in G&A expenses is mainly attributable to an increase in compensation expense due to an increase in our workforce and higher professional fees associated with preparing to operate as a public company.
  • Context reported a net loss of $ 1.4 million for the third quarter of 2021, compared to a net loss of $ 0.9 million for the same period in 2020.

Financial guidelines 2021

Context 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 through 2024.

About Context Therapeutics® Context Therapeutics Inc. (Nasdaq: CNTX), is a female oncology company that develops small molecule therapies and immunotherapy to transform care for breast and gynecologic cancers. The Company’s robust clinical program for lead candidate onapristone extended-release (ONA-XR) includes three Phase 2 clinical trials and one Phase 1b / 2 clinical trial in breast, ovarian and cancer. endometrium of hormonal origin, as well as two phase 0 pharmacodynamic trials with biomarkers in breast cancer. ONA-XR is a new, first-class small molecule in development as a complete antagonist of the progesterone receptor, a key uncontrolled mechanism in female cancers of hormonal origin. Context is headquartered in Philadelphia, Pennsylvania. For more information visit www.contexttherapeutics.com.

Forward-looking statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties for the safe harbor purposes of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this press release regarding management’s strategy, future operations, outlook, plans and objectives, including words such as “may”, “will”, “expect”, “anticipate”, “plan”, ” intend ”and similar expressions (as well as other words or phrases referring to future events, conditions or circumstances) are forward-looking statements. These include, but are not limited to, statements regarding (i) the results of our clinical trials, (ii) the potential benefits of product candidates, (iii) the expectations regarding the submission of data on our clinical trials during clinical trials. upcoming conferences, (iv) expectations regarding having preliminary data from one of our clinical trials in 2022, (v) probability data will support future development, (vi) the Company’s ability to finance its operations until 2024, (vii) the probability of the closing of the private placement, (viii) the probability of the future exercise of the warrants issued within the framework of the private placement; and other statements regarding future operations, financial performance, financial condition, prospects, objectives and other future events of the Company, and (vii) the likelihood of commercialization of ONA-XR in the Territory by Tyligand and the collection of royalties by the Company. The forward-looking statements contained in this press release involve substantial risks and uncertainties which 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 met or achieved. Other factors that could 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 United States Securities and Exchange Commission, including section titled “Risk Factors” contained therein. Unless otherwise provided by law, we disclaim any intention or obligation to update or revise forward-looking statements, which are only valid as of the date on which they were made, whether as a result of new information, future events or circumstances or otherwise.

Therapeutic Context Inc.
Condensed income statements
(Unaudited)
Three months ended September 30 Nine months ended September 30
2021 2020 2021 2020
Operating Expenses
Ongoing research and development acquired $ $ $ 3,087,832 $
Research and development 739,598 468 671 2,511,438 1,046,662
general and administrative 828,464 182,389 1,834,645 755,962
Operating loss (1,568,062 ) (651,060 ) (7 433 915 ) (1 802 624 )
Other income (expense), net 125 270 (225,177 ) 68 910 9 231 838
Net income (loss) $ (1,442,792 ) $ (876,237 ) $ (7 365 005 ) $ 7 429 214
Net earnings (loss) per common share, basic ($ 4.00 ) ($ 2.52 ) ($ 20.74) ) $ 4.04
Net earnings (loss) per common share, diluted ($ 4.00 ) ($ 2.52 ) ($ 20.74) ) ($ 3.35 )
Weighted average shares outstanding, basic 361,067 348,382 355,087 348 348
Weighted average of shares outstanding, diluted 361,067 348,382 355,087 2 337 027
Therapeutic Context Inc.
Condensed balance sheet data
(Unaudited)
September 30 The 31st of December,
2021 2020
Cash and cash equivalents $ 419,152 $ 341,037
other assets 1,840,152 126,303
Total assets $ 2,259,304 $ 467,340
Total responsibilities $ 4,408,614 $ 9,617,196
Total convertible preferred shares and redeemable common shares 21 064 623 7,771,223
Total shareholder deficit (23 213 933 ) (16 921 079 )
Total liabilities, convertible preferred shares, redeemable common shares and shareholders’ deficit $ 2,259,304 $ 467,340

Media contactGina Cestari6 Degrees917-797-7904gcestari@6degreespr.com

Investor Relations ContactYonker WoolEdison Grouplyonker@edisongroup.com

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Source: Context Therapeutics Inc.

Ann J. Cox