Context Therapeutics Reports Full Year 2022 Financial Results and Recent Pipeline Updates
22 Marzo 2023 - 3:08PM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a biopharmaceutical company developing novel treatments for
solid tumors, today announced financial results for the year ended
December 31, 2022. Additionally, the Company announced a portfolio
prioritization and capital allocation strategy that is expected to
extend its cash runway into late 2024. The resulting changes
include discontinuing the development of onapristone extended
release (ONA-XR) and focusing on the development of CTIM-76, its
Claudin 6 (CLDN6) bispecific antibody clinical candidate.
“Given the challenging market conditions for emerging companies,
the increasingly competitive landscape for breast cancer
treatments, and recent study findings, we have decided to
discontinue the development of ONA-XR,” said Martin Lehr, CEO of
Context. “We are shifting our development focus to our compelling
preclinical asset CTIM-76, a CLDN6 x CD3 bispecific antibody.
Additionally, we’re pleased that preclinical data regarding CTIM-76
will be presented at the upcoming American Association for Cancer
Research (AACR) Annual Meeting 2023 in April and look forward to
hosting an investor R&D webinar on the data following that
presentation.”
Context ended the fourth quarter of 2022 with approximately
$35.5 million in cash and cash equivalents. Based on its pipeline
prioritization and related expense reduction, the Company expects
to have sufficient financial resources to fund CTIM-76 beyond the
filing of its Investigational New Drug (IND) Application, which is
expected to occur in Q1 2024. The Company does not anticipate any
headcount reductions related to its portfolio prioritization.
CTIM-76 Program Overview
There is a large unmet need for targeted therapies to treat
solid tumors. CTIM-76 is a CLDN6 x CD3 bispecific antibody that
simultaneously binds to CLDN6 expressing cancer cells and CD3
expressing immune T cells. In this manner, CTIM-76 functions as an
immunotherapy that recruits a patient’s own immune system to attack
cancer cells. CLDN6 is a developmental gene that is required
for cell growth and that is silenced after birth. Some cancers,
including ovarian, lung, and testicular, reactivate this
developmental gene to promote cancer cell growth and survival.
Therefore, therapeutic inhibition of CLDN6 via CTIM-76
immunotherapy may restrict the growth of CLDN6-positive cancer
cells. Preclinical studies suggest the potential for convenient
dosing and scalable manufacturing to address the significant number
of patients who have CLDN6-positive disease.
ONA-XR Recent Study Findings
In the ongoing Phase 2 OATH trial evaluating ONA-XR in
combination with anastrozole, elevated liver function tests (LFT)
were identified in three patients, including in one patient who
discontinued treatment, although none of the elevated LFTs were
considered serious adverse events. The Company determined that
significant incremental program costs and delays were likely to be
required to analyze and potentially mitigate future LFT
abnormalities. Based upon the challenging market conditions for
emerging companies, the increasingly competitive landscape for
breast cancer treatments, recent study findings, and other factors,
the Company decided to cease development and explore strategic
options for ONA-XR. As a result, the Company will no longer
primarily focus on female cancers.
Strategy and Recent Pipeline Updates
- In March 2023, announced research regarding CTIM-76 will be
presented on Monday, April 17 at 9 a.m. ET at the AACR Annual
Meeting 2023, taking place April 14-19 in Orlando, FL. Details
about the presentations can be found here. Additionally
on April 17 at 4:30 p.m. ET, Context will host an investor R&D
webinar with the Company’s management team and AACR presenter to
discuss the presentation. To register for this event, please click
here.
- In January 2023, announced a
collaboration with Lonza, a global development and manufacturing
partner to the pharma, biotech, and nutrition industries, to
manufacture CTIM-76, Context’s clinical development candidate.
CTIM-76 is a CLDN6 x CD3 T-cell engaging bispecific antibody
targeting CLDN6-positive tumors.
- In November 2022, announced the
selection of CTIM-76 as the Company’s lead clinical development
candidate to target CLDN6-positive cancers, resulting from
Context’s research collaboration and licensing agreement
with Integral Molecular. IND-enabling studies have been
initiated and Context expects to submit an IND Application to
support human clinical trials for CTIM-76 in Q1 2024.
Full Year 2022 Financial Results
- Cash, cash equivalents, and restricted cash were $35.5 million
at December 31, 2022, compared to $49.7 million at December 31,
2021.
- Acquired in-process research and development expense was $0.5
million for 2022, as compared to $3.1 million for the same period
in 2021. The 2022 expense was due to a development milestone
achieved under our collaboration and license agreement with
Integral Molecular for the development of CTIM-76, while the 2021
expense reflects the fair value of consideration paid/equity issued
under that same agreement.
- Research and development (R&D) expenses were $7.1 million
for 2022, as compared to $3.8 million for the same period in 2021.
The increase in R&D expenses was primarily driven by higher
contract manufacturing costs and clinical trial costs related to
our ONA-XR program and increased preclinical costs for
CTIM-76.
- General and administrative (G&A) expenses were $7.8 million
for 2022, as compared to $3.6 million for the same period in 2021.
The increase in G&A expenses was primarily due to higher
employee compensation expense as a result of an increase in
headcount and changes to compensation arrangements, 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 $14.8 million for 2022, as
compared to $10.5 million for the same period in 2021.
2023 Cash GuidanceThe Company expects its cash
and cash equivalents will be sufficient to fund its operations into
late 2024.
About Context Therapeutics®Context Therapeutics
Inc. (Nasdaq: CNTX) is a biopharmaceutical company committed
to advancing medicines for solid tumors. Context is developing
CTIM-76, 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) the ability of the Company, its employees
and certain AACR presenters to participate in and present at
conferences and webinars, (ii) the expectation to have an IND
submission for CTIM-76 in the first quarter of 2024, (iii) having
sufficient cash to fund our current operations into late 2024, (iv)
the intention to cease development and explore strategic options
for ONA-XR, (v) the intention to no longer primarily focus on
female cancers, (vi) the expectation that there will be no
headcount reductions related to our portfolio prioritization, (vii)
the timing, enrollment and results of our clinical trials, (viii)
the potential benefits and side effect profile of our 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.
Context
Therapeutics Inc. |
Condensed
Statements of Operations |
(Unaudited) |
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
Operating
Expenses |
|
|
|
|
|
Acquired in-process research and development |
|
$ |
500,000 |
|
|
$ |
3,087,832 |
|
|
Research and development |
|
|
7,091,163 |
|
|
|
3,805,067 |
|
|
General and administrative |
|
|
7,790,040 |
|
|
|
3,632,920 |
|
|
Loss from operations |
|
|
(15,381,203 |
) |
|
|
(10,525,819 |
) |
|
Other income
(expense), net |
|
|
545,264 |
|
|
|
68,949 |
|
|
Net
loss |
|
$ |
(14,835,939 |
) |
|
$ |
(10,456,870 |
) |
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
|
($0.93 |
) |
|
|
($3.69 |
) |
|
Weighted average shares outstanding, basic and diluted |
|
|
15,966,053 |
|
|
|
2,833,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Context
Therapeutics Inc. |
Condensed Balance Sheets Data |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
December
31, |
|
December
31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
Cash, cash
equivalents and restricted cash |
|
$ |
35,497,445 |
|
|
$ |
49,685,586 |
|
|
Other
assets |
|
|
2,468,498 |
|
|
|
1,620,164 |
|
|
Total assets |
|
$ |
37,965,943 |
|
|
$ |
51,305,750 |
|
|
|
|
|
|
|
|
Total
liabilities |
|
$ |
3,207,577 |
|
|
$ |
3,033,415 |
|
|
Total
stockholders' equity |
|
|
34,758,366 |
|
|
|
48,272,335 |
|
|
Total liabilities and stockholders' equity |
|
$ |
37,965,943 |
|
|
$ |
51,305,750 |
|
|
|
|
|
|
|
|
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
Context Therapeutics (NASDAQ:CNTX)
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