Context Therapeutics Reports Second Quarter 2024 Operating and Financial Results

Rhea-AI Summary

Context Therapeutics (Nasdaq: CNTX) reported its Q2 2024 financial results and recent business highlights. Key points include:

• Acquisition of CT-95, a mesothelin x CD3 bispecific antibody
• Appointment of Dr. Claudio Dansky Ullmann as Chief Medical Officer
• Cash and cash equivalents of $101.5 million as of June 30, 2024
• FDA clearance for CTIM-76 IND, with first patient dosing expected in Q3 2024
• Closed a $100 million private placement in May 2024
• Net loss of $2.3 million for Q2 2024, compared to $5.0 million in Q2 2023
• Cash runway expected to fund operations into 2028

Positive

• Acquisition of CT-95, a potentially first-in-class mesothelin x CD3 bispecific antibody
• FDA clearance for CTIM-76 IND, with first patient dosing expected in Q3 2024
• Successful private placement raising $100 million in gross proceeds
• Strong cash position of $101.5 million as of June 30, 2024
• Reduced net loss of $2.3 million in Q2 2024 compared to $5.0 million in Q2 2023
• Extended cash runway expected to fund operations into 2028

Negative

• Decrease in R&D expenses from $3.5 million in Q2 2023 to $1.4 million in Q2 2024

Financial Analyst

Context Therapeutics' Q2 2024 results reveal a strong financial position with $101.5 million in cash, a significant increase from $14.4 million at the end of 2023. This boost is primarily due to a $100 million private placement in May 2024. The company's cash runway extends into 2028, providing ample resources for its clinical trials.

R&D expenses decreased from $3.5 million to $1.4 million year-over-year, mainly due to lower manufacturing and preclinical costs for CTIM-76. The net loss narrowed to $2.3 million from $5.0 million in Q2 2023, indicating improved financial efficiency. With a solid cash position and reduced losses, Context appears well-positioned to advance its pipeline without immediate financial pressure.

Oncology Research Analyst

Context Therapeutics is making significant strides in oncology with two promising bispecific antibodies. The acquisition of CT-95, a mesothelin x CD3 bispecific, adds a potentially first-in-class asset to their portfolio, complementing CTIM-76, their Claudin 6 x CD3 bispecific. Both targets, mesothelin and Claudin 6, are highly expressed in various solid tumors, making them attractive for targeted therapies.

The company's progress is evident with the FDA clearance of INDs for both assets. CTIM-76 is expected to dose its first patient in Q3 2024, while CT-95 is on track for Q1 2025. The appointment of Dr. Claudio Dansky Ullmann as CMO, with his expertise in oncology and T cell therapies, further strengthens the company's clinical development capabilities. These advancements position Context as a notable player in the competitive field of solid tumor immunotherapies.

Announced acquisition of CT-95, a mesothelin x CD3 bispecific antibody

Claudio Dansky Ullmann, M.D. named Chief Medical Officer

Cash and cash equivalents of $101.5 million as of June 30, 2024

PHILADELPHIA, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced its financial results for the second quarter ended June 30, 2024, and reported on recent business highlights.

“Context continues to build momentum, and we believe the Company is well positioned to have a successful year,” said Martin Lehr, CEO of Context. “Our team recently initiated our Phase 1 trial for CTIM-76, a Claudin 6 x CD3 bispecific antibody and looks forward to dosing our first patient in the third quarter. In addition, the recent acquisition of CT-95, a mesothelin x CD3 bispecific antibody, delivered Context a second potentially best-in-class clinical asset to complement CTIM-76.”

Mr. Lehr continued, “Additionally, we continue to strengthen our team and are pleased that Dr. Dansky Ullmann has joined our executive team as Chief Medical Officer. Dr. Dansky Ullmann brings deep expertise in oncology and T cell therapies and a proven track record of advancing programs through clinical development.”

Second Quarter 2024 and Recent Corporate Highlights

Pipeline Updates

• In July 2024, completed the acquisition of CT-95, a potentially first-in-class mesothelin x CD3 bispecific antibody that has received Investigational New Drug (“IND”) clearance from the U.S. Food and Drug Administration (“FDA”). We believe that CT-95 is on track for dosing the first patient in the Phase 1 trial in the first quarter of 2025.
• In May 2024, announced that the FDA cleared the Company’s IND for CTIM-76, a Claudin 6 x CD3 bispecific antibody. Dosing of the first patient in the CTIM-76 Phase 1 trial is expected to occur in the third quarter of 2024.

Corporate Updates

• In August 2024, announced the appointments of Dr. Claudio Dansky Ullmann as Chief Medical Officer and Ms. Karen Andreas as VP, Clinical Operations.
• In May 2024, closed a private placement that resulted in gross proceeds of approximately $100 million, before deducting placement agent fees and offering expenses.
• In April 2024, the Company participated in the 23rd Annual Needham Virtual Healthcare Conference.
  

Second Quarter 2024 Financial Results

• Cash and cash equivalents were $101.5 million at June 30, 2024, compared to $14.4 million at December 31, 2023.
• Research and development (“R&D”) expenses were $1.4 million for the second quarter 2024, as compared to $3.5 million for the same period in 2023. The decrease in R&D expenses was primarily driven by lower CTIM-76 contract manufacturing costs and preclinical costs, partially offset by an increase in clinical and regulatory costs as a result of preparing to initiate the CTIM-76 Phase 1 clinical trial. Personnel-related expenses also decreased, primarily due to lower headcount compared to the prior period.
• General and administrative expenses were $1.7 million for the second quarter 2024, as compared to $1.8 million for the same period in 2023. The decrease was primarily driven by decreased compensation and share-based compensation costs, as well as lower insurance expense, partially offset by an increase in professional fees.
• Other income, net was $0.8 million for the second 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 $2.3 million for the second quarter of 2024, as compared to $5.0 million for the same period in 2023.
  

2024 Cash Guidance
The Company expects that its cash and cash equivalents will be sufficient to fund the estimated duration of its CTIM-76 Phase 1 trial and the dose escalation portion of its CT-95 Phase 1 trial, as well as its operations into 2028.

About Context Therapeutics^®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors that is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics. Product candidates include CTIM-76, a Claudin 6 x CD3 bispecific antibody, and CT-95, a mesothelin 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 Statements
This 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 in the third quarter 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) having sufficient cash and cash equivalents to fund the estimated duration of our CTIM-76 Phase 1 trial and the dose escalation portion of our CT-95 Phase 1 trial, as well as our operations into 2028, (iv) the ability of the new officer appointment to support the Company and the advancement of its product candidates; (v) the potential benefits, characteristics, safety and side effect profile of CTIM-76 and CT-95, (vi) the ability of CTIM-76 and CT-95 to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (vii) the likelihood data will support future development of CTIM-76 and CT-95, and (viii) the likelihood of obtaining regulatory approval for CTIM-76 and CT-95. 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 June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
Operating Expenses
Research and development	$	1,384,553			$	3,460,937			$	3,357,762			$	7,995,613
General and administrative		1,703,996				1,831,431				3,554,288				3,963,303
Loss from operations		(3,088,549	)			(5,292,368	)			(6,912,050	)			(11,958,916	)
Other income		834,043				281,047				989,747				639,277
Net loss	$	(2,254,506	)		$	(5,011,321	)		$	(5,922,303	)		$	(11,319,639	)
Net loss per common share, basic and diluted	$	(0.04	)		$	(0.31	)		$	(0.17	)		$	(0.71	)
Weighted average shares outstanding, basic and diluted		54,958,635				15,966,053				35,462,344				15,966,053
Context Therapeutics Inc.
Condensed Balance Sheets Data
(Unaudited)
	June 30,				December 31,
		2024				2023
Cash and cash equivalents	$	101,536,832			$	14,449,827
Other assets		1,172,021				1,612,908
Total assets	$	102,708,853			$	16,062,735
Total liabilities	$	1,604,345			$	4,191,715
Total stockholders' equity		101,104,508				11,871,020
Total liabilities and stockholders' equity	$	102,708,853			$	16,062,735

Investor Relations Contact:
Jennifer Minai-Azary
Context Therapeutics
IR@contexttherapeutics.com

FAQ

What was Context Therapeutics' (CNTX) cash position at the end of Q2 2024?

Context Therapeutics reported cash and cash equivalents of $101.5 million as of June 30, 2024.

When does Context Therapeutics (CNTX) expect to dose the first patient in the CTIM-76 Phase 1 trial?

Context Therapeutics expects to dose the first patient in the CTIM-76 Phase 1 trial in the third quarter of 2024.

What was Context Therapeutics' (CNTX) net loss for Q2 2024?

Context Therapeutics reported a net loss of $2.3 million for the second quarter of 2024.

How long does Context Therapeutics (CNTX) expect its current cash to fund operations?

Context Therapeutics expects its current cash and cash equivalents to fund operations into 2028.

What new asset did Context Therapeutics (CNTX) acquire in July 2024?

In July 2024, Context Therapeutics completed the acquisition of CT-95, a potentially first-in-class mesothelin x CD3 bispecific antibody.