Context Therapeutics Reports Third Quarter 2024 Operating and Financial Results
November 06 2024 - 4:06PM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a biopharmaceutical company advancing T cell engagers for
solid tumors, today announced its financial results for the third
quarter ended September 30, 2024, and reported on recent and
upcoming business highlights.
“Context executed on its strategy to build a pipeline of T cell
engaging bispecific antibodies through its acquisitions of CT-95, a
Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3
bispecific antibody,” said Martin Lehr, CEO of Context. “We
continue to activate additional sites for our Phase 1 trial for
CTIM-76, a Claudin 6 x CD3 bispecific antibody, and expect to dose
our first patient by the end of this year. We also expect to
advance CT-95 into the clinic soon and expect to enroll our first
patient in our CT-95 Phase 1 study in the first quarter of
2025.”
Mr. Lehr continued, “Additionally, the expansion of our Board of
Directors is exemplary of the transformation Context has made this
year. Dr. Karen Smith and Dr. Luke Walker each bring a diversified
skillset and we are excited to leverage their wealth of operational
experience as we navigate the next stages of growth.”
Third Quarter 2024 and Recent Corporate
Highlights
Pipeline Updates
- In September 2024, announced an exclusive worldwide license
agreement with BioAtla, Inc. to develop and commercialize CT-202, a
Nectin-4 x CD3 bispecific antibody. Context expects to file an
Investigational New Drug (“IND”) application for CT-202 in
mid-2026.
- In July 2024, completed the acquisition of CT-95, a potentially
first-in-class Mesothelin x CD3 bispecific antibody that has
received IND clearance from the U.S. Food and Drug Administration.
The Company believes that CT-95 is on track for dosing the first
patient in the Phase 1 trial in the first quarter of 2025.
Corporate Updates
- In November 2024, the Company will participate in the
Guggenheim Global Healthcare Conference, the UBS Global Healthcare
Conference, and the Stifel 2024 Healthcare Conference. A live
webcast of each presentation will be available on the News and
Events section of the Company’s website
at https://ir.contexttherapeutics.com/.
- In November 2024, Context will present a poster titled
“Determination of First In Human Dose of the T Cell-redirecting
Bispecific Antibody CTIM-76 Targeting Claudin 6” at the
Society for Immunotherapy of Cancer’s (SITC) 39th Annual
Meeting.
- In September 2024, announced the appointments of Dr. Karen
Smith and Dr. Luke Walker to Context’s Board of Directors.
- In August 2024, announced the appointments of Dr. Claudio
Dansky Ullmann as Chief Medical Officer and Ms. Karen Andreas as
VP, Clinical Operations.
Third Quarter 2024 Financial
Results
- Cash and cash equivalents were $84.8 million at September 30,
2024, compared to $14.4 million at December 31, 2023.
- Research and development (“R&D”) expenses were $16.8
million for the third quarter of 2024, as compared to $4.5 million
for the same period in 2023. The increase in R&D expenses was
primarily driven by higher in-process research and development
charges of $14.75 million related to the acquisitions of CT-95 and
CT-202 in the third quarter 2024. This increase was partially
offset by lower CTIM-76 expense of $2.8 million, which was mainly
the result of lower contract manufacturing costs and preclinical
costs.
- General and administrative expenses were $1.9 million for the
third quarter 2024, as compared to $1.7 million for the same period
in 2023. The increase was primarily driven by an increase in
professional fees for legal services incurred.
- Other income, net was $1.2 million for the third quarter 2024,
as compared to $0.3 million for the same period in 2023, primarily
due to higher interest income earned on cash and cash equivalent
balances.
- Context reported a net loss of $17.5 million for the third
quarter of 2024, as compared to $5.9 million for the same period in
2023.
2024 Cash GuidanceThe Company expects that its
cash and cash equivalents will be sufficient to fund the estimated
duration of the dose escalation portions of its CTIM-76 and CT-95
Phase 1 trials, the estimated expenses through IND filing for
CT-202, as well as its operations into 2027.
About Context Therapeutics®Context Therapeutics
Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T
cell engaging (“TCE”) bispecific antibodies for solid tumors.
Context is building an innovative portfolio of TCE bispecific
therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific
antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and
CT-202, a Nectin-4 x CD3 bispecific antibody. Context is
headquartered in Philadelphia. For more information, please
visit www.contexttherapeutics.com or follow the Company
on X (formerly 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,” “look forward,” “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) our expectation to
dose the first patient in the Phase 1 clinical trial for CTIM-76 by
the end of 2024, (ii) our expectation to dose the first patient in
the Phase 1 clinical trial for CT-95 in the first quarter of 2025,
(iii) our expectation to file an IND for CT-202 in mid-2026, (iv)
having sufficient cash and cash equivalents to fund the estimated
duration of the dose escalation portions of our CTIM-76 and CT-95
Phase 1 trials, the estimated expenses through IND filing for
CT-202, as well as our operations into 2027, (v) the ability of the
Company and its employees to participate in and present at
conferences, (vi) the potential benefits, characteristics, safety
and side effect profile of our product candidates, (vii) the
likelihood data will support future development of our product
candidates, and (viii) the ability of the Company to build its
portfolio. 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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2024 |
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2023 |
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2024 |
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2023 |
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Operating Expenses |
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Research and development |
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$ |
16,825,198 |
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$ |
4,485,223 |
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$ |
20,182,960 |
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$ |
12,480,836 |
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General and administrative |
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1,876,230 |
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1,695,272 |
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5,430,518 |
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5,658,575 |
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Loss from operations |
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(18,701,428 |
) |
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(6,180,495 |
) |
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(25,613,478 |
) |
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(18,139,411 |
) |
Other (expense) income, net |
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1,241,535 |
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305,809 |
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2,231,282 |
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945,086 |
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Net loss |
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$ |
(17,459,893 |
) |
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$ |
(5,874,686 |
) |
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$ |
(23,382,196 |
) |
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$ |
(17,194,325 |
) |
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Net loss per common share, basic and diluted |
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$ |
(0.22 |
) |
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$ |
(0.37 |
) |
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$ |
(0.46 |
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$ |
(1.08 |
) |
Weighted average shares outstanding, basic and diluted |
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80,481,053 |
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15,966,053 |
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50,578,115 |
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15,966,053 |
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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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2024 |
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2023 |
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Cash and cash equivalents |
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$ |
84,801,556 |
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$ |
14,449,827 |
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Other assets |
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1,528,293 |
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1,612,908 |
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Total assets |
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$ |
86,329,849 |
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$ |
16,062,735 |
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Total liabilities |
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$ |
2,472,232 |
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$ |
4,191,715 |
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Total stockholders' equity |
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83,857,617 |
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11,871,020 |
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Total liabilities and stockholders' equity |
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$ |
86,329,849 |
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$ |
16,062,735 |
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Investor Relations Contact:Jennifer
Minai-AzaryContext TherapeuticsIR@contexttherapeutics.com
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