Context Therapeutics Reports First Quarter 2024 Operating and Financial Results
08 Maio 2024 - 5:06PM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a biopharmaceutical company advancing medicines for solid
tumors, today announced its financial results for the first quarter
ended March 31, 2024, and reported on recent business highlights.
“We believe Context has had a great start to 2024 including
achieving significant regulatory goals, demonstrating robust
progress, and positioning us for future growth. The Company
successfully closed a private placement, generating approximately
$100 million in gross proceeds from leading institutional
investors, underscoring confidence from new and existing investors
in our vision and potential,” said Martin Lehr, CEO of Context.
“Additionally, we were excited to recently announce that the U.S.
Food and Drug Administration (“FDA”) granted clearance for our
Investigational New Drug (“IND”) application for CTIM-76, a
promising Claudin 6 (“CLDN6”) x CD3 T cell engaging bispecific
antibody, paving the way for the initiation of a Phase 1 dose
escalation and expansion clinical trial targeting CLDN6-positive
gynecologic and testicular cancers. We anticipate enrolling the
first patient in the dose escalation portion of this clinical trial
in mid-2024, marking a significant step forward in our mission to
address unmet medical needs and advance innovative treatments for
patients.”
First Quarter 2024 and Recent Corporate
Highlights
- In May 2024, Context announced a
private placement that resulted in gross proceeds of approximately
$100 million, before deducting placement agent fees and estimated
offering expenses.
- Also in May 2024, Context announced
that the FDA cleared its IND for CTIM-76, a CLDN6 x CD3 T cell
engaging bispecific antibody, submitted in March 2024. The IND
supports the initiation of a Phase 1 dose escalation and expansion
clinical trial of CTIM-76 in patients with CLDN6-positive
gynecologic and testicular cancers. The Company anticipates the
enrollment of the first patient in the dose escalation portion of
its clinical trial in mid-2024.
- In April 2024, the Company
participated in the 23rd Annual Needham Virtual Healthcare
Conference.
First Quarter 2024 Financial
Results
- Cash and cash equivalents were $10.1 million at March 31, 2024,
compared to $14.4 million at December 31, 2023.
- Research and development (“R&D”) expenses were $2.0 million
for the first quarter 2024, as compared to $4.5 million for the
same period in 2023. The decrease in R&D expenses was primarily
driven by lower onapristone extended release (“ONA-XR”) expenses,
mostly due to the Company’s decision in March 2023 to discontinue
the development of ONA-XR, as well as lower CTIM-76 contract
manufacturing costs and personnel-related expenses, partially
offset by an increase in preclinical, regulatory, and clinical
costs as a result of IND-enabling studies and preparing to initiate
the Company’s planned Phase 1 clinical trial.
- General and administrative expenses were $1.9 million for the
first quarter 2024, as compared to $2.1 million for the same period
in 2023. The decrease was primarily driven by decreases in
insurance and professional fees as well as lower compensation and
share-based compensation costs.
- Other income was $0.2 million for the first quarter 2024, as
compared to $0.4 million for the same period in 2023, primarily due
to lower interest income earned on cash and cash equivalent
balances.
- Context reported a net loss of $3.7 million for the first
quarter of 2024, as compared to $6.3 million for the same period in
2023.
2024 Cash GuidanceThe Company expects that the
net proceeds from the private placement, together with its cash and
cash equivalents at March 31, 2024, will be sufficient to fund its
operations into 2028.
About Context Therapeutics®Context Therapeutics
Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing
medicines for solid tumors. Context’s clinical stage product
candidate, CTIM-76, is a selective CLDN6 x CD3 bispecific antibody
for CLDN6-positive tumors. CLDN6 is a tight junction membrane
protein target expressed in multiple solid tumors, including
ovarian, endometrial, testicular, and lung, and absent from or
expressed at low levels in healthy adult tissues. 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
enroll the first patient in a Phase 1 clinical trial for CTIM-76 in
mid-2024, (ii) our expectation regarding the trial design,
treatment indications, and patient size of our Phase 1 CTIM-76
trial, (iii) our expectation that the proceeds from the private
placement extends our operations into 2028, (iv) the potential
benefits, characteristics, safety and side effect profile of
CTIM-76, (v) the ability of CTIM-76 to have benefits,
characteristics, manufacturability, and a side effect profile that
is differentiated and/or better than third party product
candidates, (vi) the likelihood data will support future
development of CTIM-76, and (vii) the likelihood of obtaining
regulatory approval for CTIM-76. 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) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2024 |
|
2023 |
|
|
|
|
|
Operating
Expenses |
|
|
|
|
Research and development |
|
|
1,973,209 |
|
|
|
4,534,676 |
|
General and administrative |
|
|
1,850,292 |
|
|
|
2,131,872 |
|
Loss from operations |
|
|
(3,823,501 |
) |
|
|
(6,666,548 |
) |
Other
income |
|
|
155,704 |
|
|
|
358,230 |
|
Net
loss |
|
$ |
(3,667,797 |
) |
|
$ |
(6,308,318 |
) |
|
|
|
|
|
Net loss per common share, basic and diluted |
|
($0.23 |
) |
|
($0.40 |
) |
Weighted average shares outstanding, basic and diluted |
|
|
15,966,053 |
|
|
|
15,966,053 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Context Therapeutics Inc. |
Condensed Balance Sheets Data |
(Unaudited) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2024 |
|
2023 |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
10,089,207 |
|
|
$ |
14,449,827 |
|
Other
assets |
|
|
962,445 |
|
|
|
1,612,908 |
|
Total assets |
|
$ |
11,051,652 |
|
|
$ |
16,062,735 |
|
|
|
|
|
|
Total
liabilities |
|
$ |
2,608,422 |
|
|
$ |
4,191,715 |
|
Total
stockholders' equity |
|
|
8,443,230 |
|
|
|
11,871,020 |
|
Total liabilities and stockholders' equity |
|
$ |
11,051,652 |
|
|
$ |
16,062,735 |
|
|
|
|
|
|
Media Contact:Gina Mangiaracina6
Degrees917-797-7904gmangiaracina@6degreespr.com
Investor Relations Contact:Jennifer
Minai-AzaryContext TherapeuticsIR@contexttherapeutics.com
Context Therapeutics (NASDAQ:CNTX)
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