Context Therapeutics® Reports Third Quarter 2022 Operating and Financial Results
November 09 2022 - 4:14PM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a women’s oncology company developing novel treatments for
breast and gynecologic cancers, today reported on recent and
upcoming business highlights and announced its financial results
for the third quarter ended September 30, 2022.
“We are pleased with the continued strengthening of onapristone
extended release’s (“ONA-XR”) clinical profile. The preliminary
Phase 2 findings for ONA-XR in combination with anastrozole in
progesterone receptor-positive (PR+) recurrent endometrial cancer
highlight a 4-month progression free survival (PFS) rate of 77.7%,
and favorable safety and tolerability, representing a meaningful
improvement over the single activity of either agent alone.
Additionally, we are pleased to announce that we initiated the
Phase 1b portion of our Phase 1b/2 ELONA breast cancer clinical
trial to evaluate ONA-XR in combination with elacestrant. These
achievements underscore our commitment to creating new standards of
care in the women’s oncology field,” said Martin Lehr, CEO of
Context Therapeutics.
“Looking ahead, we plan to complete enrollment of the Phase 2
PR+ recurrent endometrial cancer trial and evaluate a potential
registrational path. We will also continue to assess ONA-XR across
multiple ongoing clinical trials, including an initial Phase 2 data
readout in second- or third-line advanced or metastatic
ER+,PR+,HER2- breast cancer in December 2022,” Lehr added.
“Separately, we anticipate nominating a development candidate for
our Claudin 6 bispecific antibody program in December. Our expected
cash runway into Q1 2024 gives us the financial flexibility to
execute on the advancement of our pipeline targeting female
cancers.”
ONA-XR Clinical Update
- PR+ Endometrial Cancer: In an ongoing Phase 2
trial in collaboration with Jefferson Health investigating ONA-XR
50mg BID in combination with anastrozole 1mg QD in women with PR+
endometrial adenocarcinoma who have failed front-line therapy with
a platinum/taxane-based chemotherapy regimen, we note the following
as of September 30, 2022:
- The trial has enrolled 12 of 25 planned patients.
- The preliminary 4-month PFS rate was 77.7%, based on nine
evaluable patients.
- Three patients received treatment for greater than 12
months.
- Overall, seven patients remain in the trial.
- There have been no treatment-related serious adverse events
reported.
- PR+ Granulosa Cell Tumor (GCT) of Ovary: In an
ongoing Phase 2 basket trial in collaboration with Memorial Sloan
Kettering Cancer Center investigating ONA-XR 50mg BID as a single
agent or in combination with anastrozole 1 mg QD in women with PR+
recurrent gynecologic cancers, we note the following as of
September 30, 2022:
- Cohort 1, which treats patients with PR+ recurrent granulosa
cell tumors with ONA-XR as a single agent, completed accrual to
stage 1 and has shown a 12-month PFS rate of 20.1% and a Clinical
Benefit Rate (stable disease) of 35.7%. Two patients continued on
active treatment for greater than 18 months. One patient remains on
trial.
- Cohort 4, which treats patients with PR+ recurrent granulosa
cell tumors with ONA-XR in combination with anastrozole, enrolled
14 patients in stage 1 and will expand to stage 2 when greater than
or equal to one response is observed. Seven patients remain on
trial.
- There have been no treatment-related serious adverse events
reported.
- SMILE trial: Enrollment continues in an
ongoing Phase 2 trial in collaboration with Wisconsin Oncology
Network evaluating the combination of ONA-XR with fulvestrant in
patients with second- or third-line advanced or metastatic
ER+,PR+,HER2- breast cancer (the “SMILE” trial). Initial clinical
data are expected in December 2022.
- ELONA trial: In August 2022, Context entered
into a clinical trial and supply agreement with The Menarini Group
(“Menarini”) to evaluate the combination of ONA-XR with Menarini’s
oral selective estrogen degrader, elacestrant, in patients with
second- or third-line advanced or metastatic ER+,PR+,HER2- breast
cancer (the “ELONA” trial). We initiated the ELONA trial in
November 2022 and Phase 1b data is expected in Q4 2023.
The observations from the ongoing clinical trials noted above
are based on information available as of September 30, 2022. These
trials are still actively enrolling patients, and these preliminary
clinical findings may materially fluctuate on a month-to-month
basis as the trials progress and may not be representative of
results after all patients complete the respective trial and all
data is collected and analyzed. Further, this data is subject to
continuing audit and verification procedures that will not be
complete until the conclusion of the respective trial and therefore
the interim data is subject to change.
Claudin 6 Update
- Our Claudin 6 bispecific antibody program remains on track with
a development candidate nomination expected in December 2022.
- We anticipate an Investigational New Drug Application
submission for this program in Q1 2024.
Third Quarter 2022 Financial Results
- Cash Position: Cash, cash equivalents, and
restricted cash were $39.4 million at September 30, 2022, compared
to $49.7 million at December 31, 2021.
- R&D Expense: Research and development
(R&D) expenses were $2.1 million for third quarter 2022, as
compared to $0.7 million for the same period in 2021. The increase
in R&D expenses was primarily driven by increased ONA-XR
contract manufacturing and clinical costs and an increase in
salaries and related benefits due to a higher employee
headcount.
- G&A Expense: General and administrative
(G&A) expenses were $2.0 million for third quarter 2022, as
compared to $0.8 million for the same period in 2021. The increase
in G&A expenses was primarily driven by increased compensation
and share-based compensation due to a higher employee headcount and
changes to compensation arrangements, higher insurance costs, and
other costs associated with operating as a public company.
- Net Loss: Context reported a net loss of $3.9
million for third quarter 2022, as compared to $1.4 million for the
same period in 2021.
About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a
clinical-stage biopharmaceutical company committed to advancing
medicines for female cancers. The Company’s pipeline includes small
molecule and bispecific antibody drug candidates that target cancer
signaling pathways. Onapristone extended release (ONA-XR), a novel,
first-in-class potent and selective progesterone receptor
antagonist, is currently in three Phase 2 clinical trials and one
Phase 1/2 clinical trial in hormone-driven breast, ovarian,
and endometrial cancers. Context and The Menarini Group have also
entered a Clinical Trial Collaboration and Supply Agreement for a
Phase 1b/2 clinical proof-of-concept trial evaluating ONA-XR in
combination with Menarini’s oral selective estrogen receptor
degrader (SERD), elacestrant. Context is also developing a
selective Claudin 6 (CLDN6) x CD3 bispecific antibody for CLDN6
positive tumors, currently in preclinical development. Context is
headquartered in Philadelphia. For more information, please
visit www.contexttherapeutics.com or follow the Company
on Twitter and LinkedIn.
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) having sufficient cash to fund our
operations into the first quarter 2024, (ii) the expectation to
report initial clinical data for the SMILE trial in December 2022
and Phase 1b data for the ELONA trial in the fourth quarter of
2023, (iii) the expectation to select a development candidate for
our CLDN6xCD3 program in December 2022, (iv) the expectation to
have an IND submission for our CLDN6xCD3 bispecific in the first
quarter of 2024, (v) the results of our clinical trials, (vi) the
potential benefits of our product candidates, (vii) the likelihood
data will support future development, 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. |
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Condensed Statements of Operations |
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(Unaudited) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating Expenses: |
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Acquired in-process research and development |
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$ |
- |
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$ |
- |
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$ |
500,000 |
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$ |
3,087,832 |
|
Research and development |
|
|
2,077,566 |
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739,598 |
|
|
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4,946,304 |
|
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2,511,438 |
|
General and administrative |
|
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1,970,521 |
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828,464 |
|
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|
6,052,556 |
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|
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1,834,645 |
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Loss from operations |
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(4,048,087 |
) |
|
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(1,568,062 |
) |
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(11,498,860 |
) |
|
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(7,433,915 |
) |
Other income |
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|
193,777 |
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125,270 |
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|
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219,702 |
|
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|
68,910 |
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Net loss |
|
$ |
(3,854,310 |
) |
|
$ |
(1,442,792 |
) |
|
$ |
(11,279,158 |
) |
|
$ |
(7,365,005 |
) |
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Net loss per common share, basic and diluted |
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($0.24 |
) |
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($4.00 |
) |
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($0.71 |
) |
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($20.74 |
) |
Weighted average shares outstanding, basic and diluted |
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15,966,053 |
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|
|
361,067 |
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15,966,053 |
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355,087 |
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Context Therapeutics Inc. |
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Condensed Balance Sheets Data |
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(Unaudited) |
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September 30, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and restricted cash |
|
$ |
39,427,118 |
|
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$ |
49,685,586 |
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Other assets |
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2,655,903 |
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1,620,164 |
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Total assets |
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$ |
42,083,021 |
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$ |
51,305,750 |
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Total liabilities |
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$ |
4,011,511 |
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$ |
3,033,415 |
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Total stockholders' equity |
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38,071,510 |
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48,272,335 |
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Total liabilities and stockholders' equity |
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$ |
42,083,021 |
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$ |
51,305,750 |
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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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