Context Therapeutics® Amends Cash Guidance, Extends Runway into Q1 2024
September 27 2022 - 7:30AM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a women’s oncology company developing novel treatments for
breast and gynecological cancers, today announced updated cash
guidance to extend its runway into Q1 2024.
The company plans to defer noncritical R&D activities,
reduce future overhead and infrastructure expenditures, and
prioritize its onapristone extended release (ONA-XR) ELONA Phase
1b/2 clinical trial and Claudin 6 (CLDN6) program.
“Context has been fortunate to collaborate with two tremendous
organizations – The Menarini Group and Integral Molecular. We
believe these collaborations have broadened the therapeutic
potential for ONA-XR through the ELONA trial and accelerated the
development of a new treatment modality to address CLDN6 positive
tumors,” said Martin Lehr, CEO of Context Therapeutics. “In light
of the challenging current investment climate for biotechnology, we
are streamlining the organization’s resources with the intent to
take the Company through the execution of the Phase 1b portion of
the ELONA trial and the advancement of our CLDN6xCD3 bispecific
antibody program to an Investigational New Drug Application
(IND).”
The ELONA Phase 1b/2 clinical trial is evaluating ONA-XR, an
oral progesterone receptor (PR) antagonist, in combination with
Menarini’s elacestrant in estrogen receptor positive (ER+), PR+,
HER2- metastatic breast cancer (mBCa) patients who have previously
been treated with a CDK4/6 inhibitor. An IND amendment filed
specifically for this trial was submitted to the U.S. Food and Drug
Administration in September 2022. The Company remains on track to
initiate the ELONA clinical trial in Q4 2022 and to report Phase 1b
data in Q4 2023. Context retains worldwide rights for ONA-XR, other
than the rights it out-licensed for Greater China.
Context anticipates the nomination of a CLDN6xCD3 bispecific
monoclonal antibody (BsMAb) development candidate from the
organization’s research collaboration with Integral Molecular in Q4
2022. An IND submission is planned in Q1 2024. Context retains
worldwide rights to certain CLDN6 antibody patents in the field of
bispecific antibodies.
In addition, Context will continue to provide access to ONA-XR
through the Company’s ongoing Investigator-Sponsored Trials (ISTs)
and anticipates sharing preliminary data from its Phase 2 clinical
trials in granulosa cell tumors and endometrial cancer in November
2022, and from its Phase 2 clinical trial in breast cancer in
December 2022.
“We’re fortunate to have ISTs that can continue to explore the
potential of ONA-XR while we focus on derisking and moving our
near-term priority programs forward,” said Lehr. “We’re thinking
long-term; Context is committed to improving the lives of women
with cancer and we believe that these thoughtful and future-focused
changes best position us to be nimble during the current market
challenges. We continue to concentrate on fully realizing the value
of our collaborations and pipeline.”
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 preliminary data from certain of our currently ongoing
clinical trials in November and December 2022, (iii) the
expectation to select a development candidate for our CLDN6xCD3
program in the fourth quarter of 2022, (iv) the expectation to
initiate the combination study of ONA-XR and elacestrant in the
fourth quarter of 2022 and to report Phase 1b data in the fourth
quarter of 2023, (v) the intent to streamline the organization’s
resources to take the Company through the execution of the Phase 1b
portion of the ELONA trial and the advancement of our CLDN6xCD3
bispecific program to an IND, (vi) the expectation to have an IND
submission for our CLDN6xCD3 bispecific in the first quarter of
2024, (vii) the results of our clinical trials, (viii) the
potential benefits of the product candidates, (ix) the likelihood
data will support future development, and (x) 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.
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
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