Context Therapeutics® Reports Full Year 2021 Operating and Financial Results
March 23 2022 - 4:01PM
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 financial results for the year ended
December 31, 2021, and highlighted recent corporate
accomplishments.
“Context has bolstered our corporate, financial, and scientific
efforts over the past two quarters. We’ve grown our R&D and
operations teams, reported positive data on lead product candidate
onapristone extended release (“ONA-XR”) in early breast cancer, and
closed on a $31.25M private placement, which combined with our IPO,
extends our cash runway into 2024,” said Martin Lehr, CEO of
Context Therapeutics. “We’ve set our sights on another exciting
year as we work to realize the potential of our pipeline to advance
treatments for women’s cancers. We’re looking forward to
preliminary data from several of the ONA-XR Phase 2 clinical trials
in 2022 and announcing our Claudin 6 x CD3 bispecific antibody
clinical candidate for ovarian and endometrial cancers.”
Fourth Quarter 2021 and Recent Corporate
Highlights
Pipeline Updates
- In March 2022, announced the acceptance of five abstracts that
highlight new preclinical data on ONA-XR and Claudin 6 (CLDN6)
programs that will be presented at the American Association for
Cancer Research Annual Meeting (AACR) 2022, taking place April 8-13
in New Orleans, LA. Details about the presentations can be found
here. On Wednesday, April 13, 2022, at 11 a.m. ET, Context will
host an investor R&D webinar with the Company’s management team
and AACR presenters to discuss the results from these
presentations. Following the formal presentation, the Context team,
along with AACR presenters, will be available for questions. To
register for this event, please click here:
https://edisongroup.zoom.us/webinar/register/WN_AczVH-d_QMy5qcT_enL3ww
- Additionally in 2022, the Company anticipates selecting a
candidate to support IND-enabling studies for its second clinical
program, an anti-CD3 x anti-CLDN6 antigen bispecific monoclonal
antibody (bsAb) intended to redirect T-cell-mediated lysis toward
malignant cells expressing CLDN6.
- In December 2021, announced data from a window-of-opportunity
clinical trial of ONA-XR in postmenopausal patients with
progesterone receptor positive (PR+) early breast cancer that
demonstrated ONA-XR significantly increased suppression of tumor
cell proliferation. The data was presented during the 2021 San
Antonio Breast Cancer Symposium.
- Enrollment continues in three Phase 2 clinical trials and one
Phase 1b/2 clinical trial of ONA-XR including first line (1L) ER+,
PR+, HER2- metastatic breast cancer (MBC), second or third line
(2L/3L) ER+, PR+, HER2- MBC, PR+ granulosa cell tumor of the ovary,
and PR+ recurrent endometrial cancer. Context expects to report
preliminary data from the 1L ER+, PR+, HER2- MBC and PR+ recurrent
endometrial cancer clinical trials in mid-2022 and preliminary data
from the 2L/3L ER+, PR+, HER2- MBC, and PR+ granulosa cell tumor of
the ovary clinical trials in the second half of 2022.
Corporate Updates
- In March 2022, participated in the Sachs 15th Annual European
Life Sciences CEO Forum.
- In January 2022, announced the appointments of Christopher Beck
as SVP of Operations and Mark Fletcher, Ph.D., as VP of
R&D.
- Also in January 2022, participated on the “Women’s Health:
Progress and Innovation Continue to Drive Increased Investor
Interest” panel at Biotech Showcase™ 2022.
- In December 2021, announced that the Company closed its 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, which resulted in gross proceeds to Context
of approximately $31.25 million, before deducting offering
expenses.
Full Year 2021 Financial Results
- Cash, cash equivalents, and restricted cash were $49.7 million
at December 31, 2021, compared to $0.3 million at December 31,
2020.
- Acquired in-process research and development expense was $3.1
million for 2021 which reflects the fair value of consideration
paid/issued under a collaboration and license agreement for the
development of CLDN6.
- Research and development (R&D) expenses were $3.8 million
for 2021, as compared to $1.6 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 $3.6 million
for 2021, as compared to $0.9 million for the same period in 2020.
The increase in G&A expenses was primarily driven by increased
costs related to employee compensation, as well as higher insurance
and professional fees to support ongoing business operations and
compliance obligations associated with being a publicly traded
company.
- Context reported a net loss of $10.5 million for 2021, as
compared to net income of $6.6 million for the same period in
2020.
2022 Financial GuidanceContext expects that its
cash and cash equivalents 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. 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 StatementsThis 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 expectation to report preliminary data
from our trials, including in mid-2022 and in the second half of
2022, (ii) the expectation to select a candidate to support
IND-enabling studies for our CLDN6 program in 2022, (iii) having
sufficient cash to fund our operations into 2024, (iv) the results
of our clinical trials, (v) the potential benefits of the product
candidates, (vi) the likelihood data will support future
development, (vii) the ability of the Company and its employees to
participate in and present at conferences, and (viii) 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.
Context
Therapeutics Inc. |
|
Condensed
Statements of Operations |
|
(Unaudited) |
|
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Year Ended December 31, |
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
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Operating
Expenses |
|
|
|
|
|
|
Acquired in-process research and development |
|
$ |
3,087,832 |
|
|
$ |
- |
|
|
|
Research and development |
|
|
3,805,067 |
|
|
|
1,641,501 |
|
|
|
General and administrative |
|
|
3,632,920 |
|
|
|
930,667 |
|
|
|
Loss from operations |
|
|
(10,525,819 |
) |
|
|
(2,572,168 |
) |
|
|
Other income
(expense), net |
|
|
68,949 |
|
|
|
9,216,633 |
|
|
|
Net (loss)
income |
|
$ |
(10,456,870 |
) |
|
$ |
6,644,465 |
|
|
|
|
|
|
|
|
|
|
Net (loss) income per common share, basic |
|
($3.69 |
) |
|
$3.07 |
|
|
|
Net (loss) income per common share, diluted |
|
($3.69 |
) |
|
($3.96 |
) |
|
|
Weighted average shares outstanding, basic |
|
|
2,833,674 |
|
|
|
348,368 |
|
|
|
Weighted average shares outstanding, diluted |
|
|
2,833,674 |
|
|
|
2,054,875 |
|
|
|
|
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|
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Context
Therapeutics Inc. |
|
Condensed Balance Sheets Data |
|
|
(Unaudited) |
|
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|
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|
|
|
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|
December
31, |
|
December
31, |
|
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2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
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Cash, cash
equivalents and restricted cash |
|
$ |
49,685,586 |
|
|
$ |
341,037 |
|
|
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Other
assets |
|
|
1,620,164 |
|
|
|
126,303 |
|
|
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Total assets |
|
$ |
51,305,750 |
|
|
$ |
467,340 |
|
|
|
|
|
|
|
|
|
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Total
liabilities |
|
$ |
3,033,415 |
|
|
$ |
9,617,196 |
|
|
|
Total
convertible preferred stock and redeemable common stock |
|
|
- |
|
|
|
7,771,223 |
|
|
|
Total
stockholders' equity (deficit) |
|
|
48,272,335 |
|
|
|
(16,921,079 |
) |
|
|
Total liabilities, convertible preferred stock, redeemable common
stock and stockholders' equity (deficit) |
|
$ |
51,305,750 |
|
|
$ |
467,340 |
|
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Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
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