Context Therapeutics® Reports First Quarter 2022 Operating and Financial Results
May 11 2022 - 4:01PM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a women’s oncology company developing small molecule and
immunotherapy treatments for breast and gynecological
cancers, today announced financial results for the first
quarter ended March 31, 2022, and highlighted recent corporate
accomplishments.
“During the first quarter, Context laid a strong foundation upon
which to build. Encouraging data was presented from two pipeline
programs, including in vivo combination and
immunomodulation data evaluating onapristone extended release
(ONA-XR), the company’s lead clinical program, at the Association
for Cancer Research (AACR) Annual Meeting 2022. The preclinical
data for ONA-XR highlight the breadth of its potential as a highly
promising combination agent with standard-of-care therapies, as
well as with emerging therapies for hormone positive tumors such as
immune checkpoint inhibitors and inhibitors of the AURKA/STAT3
oncogenic axis. Additionally at AACR, two poster presentations for
our Claudin 6 x CD3 (“CLDN6xCD3”) bispecific antibody program
highlighted the program’s selectivity and potency. We also
announced that an abstract on the results of the monotherapy
portion of our ongoing Phase 2 trial of ONA-XR in granulosa cell
tumors of the ovary was accepted for oral presentation at the
upcoming 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting,” said Martin Lehr, CEO of Context Therapeutics. “Looking
ahead, 2022 looks to be a pivotal year for Context. We anticipate
reporting preliminary data of ONA-XR from ongoing Phase 2 trials in
breast, ovarian, and endometrial cancers later this year. The
Company will also select a development candidate for our CLDN6xCD3
program by year-end. We are excited by the potential of our
pipeline to make a difference in the treatment of female
cancers.”
First Quarter 2022 and Recent Corporate
Highlights
Pipeline Updates
- In May 2022, announced an abstract on the results of the
monotherapy portion of an ongoing Phase 2 trial of ONA-XR in
granulosa cell tumors of the ovary was accepted for oral
presentation at the 2022 ASCO Annual Meeting taking place June 3-7,
2022, at the McCormick Place Convention Center in Chicago, IL.
- In April 2022, announced encouraging preclinical data from two
pipeline programs presented at the AACR Annual Meeting 2022. The
presentations included in vivo combination and immunomodulation
data evaluating ONA-XR, as well as the first data from the
Company’s CLDN6xCD3 bispecific program, including antibody
optimization, binding properties, and T-cell dependent
cytotoxicity.
- Enrollment continues in three Phase 2 clinical trials and one
Phase 1b/2 clinical trial of ONA-XR including first line (1L) ER+,
PR+, HER2- metastatic breast cancer (MBC), second or third line
(2L/3L) ER+, PR+, HER2- MBC, PR+ granulosa cell tumor of the ovary,
and PR+ recurrent endometrial cancer. Context expects to report
preliminary data from the PR+ recurrent endometrial cancer trial in
mid-2022 and preliminary data from its other three currently
ongoing clinical trials in the second half of 2022.
Corporate Updates
- In April 2022, participated in the Canaccord Genuity's (CG)
2022 Horizons in Oncology Virtual Conference.
- Also in April 2022, participated in the 21st Annual Needham
Virtual Healthcare Conference.
- Additionally in April 2022, hosted a R&D webinar with the
Company’s management team and clinical trial investigators to
discuss the preclinical data presented at AACR. The webinar can be
viewed here:
https://ir.contexttherapeutics.com/events/event-details/context-rd-webinar.
First Quarter Financial Results
- Cash, cash equivalents, and restricted cash were $45.7 million
at March 31, 2022, compared to $49.7 million at December 31,
2021.
- Research and development (R&D) expenses were $1.4 million
for first quarter 2022, as compared to $0.4 million for the same
period in 2021. The increase in R&D expenses was primarily
driven by increased contract manufacturing and clinical costs
related to ONA-XR, higher preclinical costs for CLDN6, and an
increase in salaries and related benefits due to a higher employee
headcount.
- General and administrative (G&A) expenses were $2.1 million
for first quarter 2022, as compared to $0.4 million for the same
period in 2021. The increase in G&A expenses was primarily
driven by increased salaries and related benefits due to a higher
employee headcount, 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 $3.4 million for first quarter
2022, as compared to $0.9 million for the same period in 2021.
2022 Financial GuidanceContext expects that its
cash and cash equivalents will be sufficient to fund its operations
into 2024.
About Context
Therapeutics®Context Therapeutics Inc.
(Nasdaq: CNTX), is a women’s oncology company developing small
molecule and immunotherapy treatments to transform care for breast
and gynecological cancers. The Company’s robust clinical program
for lead candidate onapristone extended release (ONA-XR) comprises
three Phase 2 clinical trials and one Phase 1b/2 clinical trial in
hormone-driven breast, ovarian, and endometrial cancer. ONA-XR is a
novel, first-in-class small molecule under development as a potent
and specific antagonist of the progesterone receptor, a key
unchecked mechanism in hormone-driven women’s cancers. Context is
headquartered in Philadelphia, PA. For more information, visit
www.contexttherapeutics.com.
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 expectation to report preliminary data
from our currently ongoing clinical trials in mid-2022 and in the
second half of 2022, (ii) the expectation to select a development
candidate for our CLDN6xCD3 program in 2022, (iii) having
sufficient cash to fund our operations into 2024, (iv) the results
of our clinical trials, (v) the potential benefits of the product
candidates, (vi) the likelihood data will support future
development, and (vii) 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) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
Operating
Expenses |
|
|
|
|
Research and development |
|
$ |
1,351,495 |
|
|
$ |
438,739 |
|
General and administrative |
|
|
2,091,467 |
|
|
|
401,579 |
|
Loss from operations |
|
|
(3,442,962 |
) |
|
|
(840,318 |
) |
Other income
(expense), net |
|
|
4,625 |
|
|
|
(51,731 |
) |
Net
loss |
|
$ |
(3,438,337 |
) |
|
$ |
(892,049 |
) |
|
|
|
|
|
Net loss per
common share, basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(2.55 |
) |
Weighted
average shares outstanding, basic and diluted |
|
|
15,966,053 |
|
|
|
349,235 |
|
|
|
|
|
|
|
|
|
|
|
Context Therapeutics Inc. |
Condensed Balance Sheets Data |
(Unaudited) |
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
Cash, cash
equivalents and restricted cash |
|
$ |
45,728,235 |
|
|
$ |
49,685,586 |
|
Other
assets |
|
|
1,304,577 |
|
|
|
1,620,164 |
|
Total assets |
|
$ |
47,032,812 |
|
|
$ |
51,305,750 |
|
|
|
|
|
|
Total
liabilities |
|
$ |
1,638,326 |
|
|
$ |
3,033,415 |
|
Total
stockholders' equity |
|
|
45,394,486 |
|
|
|
48,272,335 |
|
Total liabilities and stockholders' equity |
|
$ |
47,032,812 |
|
|
$ |
51,305,750 |
|
|
|
|
|
|
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
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