Context Therapeutics® Reports Third Quarter 2021 Operating and Financial Results
December 02 2021 - 4:01PM
Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology
company developing small molecule and immunotherapy treatments to
transform care for breast and gynecological cancers, today
announced financial results for the third quarter ended September
30, 2021, and highlighted recent corporate accomplishments.
“This is a pivotal time for Context, as we debuted on Nasdaq and
entered into a $31.25 million private placement agreement that
extends our cash runway into 2024. We also strengthened our
leadership team with the addition of Chief Financial Officer
Jennifer Minai-Azary and Chief Legal Officer Alex Levit, who was
instrumental in bringing our company public,” said Martin Lehr, CEO
of Context Therapeutics. “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. 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. 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.”
Third Quarter 2021 and Recent Corporate
Highlights
Pipeline Updates
- 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.
Corporate Updates
- In December 2021, announced that the Company entered into
definitive securities purchase agreements for a private placement
with accredited investors of 5,000,000 shares of common stock of
Context Therapeutics together with warrants to purchase 5,000,000
shares of common stock at a combined offering price of $6.25, which
will result in gross proceeds to Context Therapeutics of
approximately $31.25 million, before deducting placement offering
expenses.
- 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 stock and raised gross proceeds of $28.75 million, before
deducting underwriting discounts, commissions and offering
expenses, through the sale of 5,750,000 shares including shares
sold pursuant to the exercise in full by the underwriter of its
option to purchase additional shares, at a public offering price of
$5.00 per share.
- In August 2021, entered into a license agreement with Tyligand
Bioscience, Ltd. (“Tyligand”) whereby Tyligand was 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 rest of world rights to
commercialize ONA-XR.
Third Quarter Financial Highlights
- Cash and cash equivalents were $0.4 million at September 30,
2021 compared to $0.3 million at December 31, 2020.
- Research and development (R&D) expenses were $0.7 million
for the third quarter 2021, as compared to $0.5 million for the
same period in 2020. The increase in R&D expenses was
primarily driven by increased 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 2021, as compared to $0.2 million for the
same period in 2020. The increase in G&A expenses was primarily
driven by an increase in compensation expense as a result of an
increase in our headcount and higher professional fees related to
preparing to operate as a public company.
- Context reported a net loss of $1.4 million for the third
quarter of 2021, as compared to a net loss of $0.9 million for the
same period in 2020.
2021 Financial Guidance
Context expects that its cash and cash equivalents, including
the net proceeds from its IPO and expected proceeds from its
private placement, will be sufficient to fund its operations into
2024.
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 results of our clinical trials, (ii)
the potential benefits of the product candidates, (iii) the
expectation regarding presenting data about our clinical trials at
upcoming conferences, (iv) the expectation regarding having
preliminary data from one of our clinical trials in 2022, (v) the
likelihood data will support future development, (vi) the Company’s
ability to fund its operations into 2024, (vii) the likelihood of
the closing of the private placement, (viii) the likelihood of the
future exercise of the warrants issued in connection with the
private placement; and other statements regarding the Company's
future operations, financial performance, financial position,
prospects, objectives and other future events, and (vii) the
likelihood of commercialization of ONA-XR in the Territory by
Tyligand and the Company's receipt of royalties therefrom.
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.
|
Context Therapeutics Inc. |
Condensed Statements of Operations |
(Unaudited) |
|
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Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
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|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
Acquired in-process research and development |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
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 |
|
Loss from operations |
|
|
(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 income (loss) per common share, basic |
|
($4.00 |
) |
|
($2.52 |
) |
|
($20.74 |
) |
|
$4.04 |
|
Net income (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 shares outstanding, diluted |
|
|
361,067 |
|
|
|
348,382 |
|
|
|
355,087 |
|
|
|
2,337,027 |
|
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Context Therapeutics Inc. |
Condensed Balance Sheet Data |
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(Unaudited) |
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September 30, |
|
December 31, |
|
|
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|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
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Cash and cash equivalents |
|
$ |
419,152 |
|
|
$ |
341,037 |
|
|
|
|
|
Other assets |
|
|
1,840,152 |
|
|
|
126,303 |
|
|
|
|
|
Total assets |
|
$ |
2,259,304 |
|
|
$ |
467,340 |
|
|
|
|
|
|
|
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|
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Total liabilities |
|
$ |
4,408,614 |
|
|
$ |
9,617,196 |
|
|
|
|
|
Total convertible preferred stock and redeemable common stock |
|
|
21,064,623 |
|
|
|
7,771,223 |
|
|
|
|
|
Total stockholders' deficit |
|
|
(23,213,933 |
) |
|
|
(16,921,079 |
) |
|
|
|
|
Total liabilities, convertible preferred stock, redeemable common
stock and stockholders' deficit |
|
$ |
2,259,304 |
|
|
$ |
467,340 |
|
|
|
|
|
|
|
|
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Media ContactGina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations ContactLaine YonkerEdison
Grouplyonker@edisongroup.com
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