Context Therapeutics Reports Third Quarter 2023 Operating and Financial Results
Context Therapeutics Reports Third Quarter 2023 Operating and Financial Results
CTIM-76 IND filing on track for late Q1 2024
CTIM-76 IND 申請有望在 2024 年第一季度末完成
Cash and cash equivalents of $21.7 million as of September 30, 2023
截至2023年9月30日，現金及現金等價物爲2170萬美元
Company expects its cash and cash equivalents will continue to fund operations into late 2024
公司預計，其現金及現金等價物將繼續爲運營提供資金，直至2024年底
PHILADELPHIA, Nov. 09, 2023 (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 third quarter ended September 30, 2023, and reported on recent and upcoming business highlights.
費城，2023年11月9日（GLOBE NEWSWIRE）——研發實體瘤藥物的生物製藥公司Context Therapeutics Inc.（“Context” 或 “公司”）（納斯達克股票代碼：CNTX）今天公佈了截至2023年9月30日的第三季度財務業績，並報告了最近和即將到來的業務亮點。
"During the third quarter of this year, Context continued to advance our lead clinical candidate, CTIM-76, a Claudin 6 ("CLDN6") x CD3 bispecific antibody, toward a first-in-human clinical study. Preclinical data presented at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting showed the broad therapeutic potential of CTIM-76 when targeting CLDN6-positive tumors and identified a potential first-in-human dose. The preclinical data supported CTIM-76's differentiated product profile, including its potential to address limitations of first-generation CLDN6-targeted clinical-stage therapies and the requirement of high CLDN6 expression and off-target toxicities," said Martin Lehr, CEO of Context. "We look forward to filing an Investigational New Drug Application ("IND") with the U.S. Food and Drug Administration late in the first quarter of 2024 for CTIM-76."
“在今年第三季度，Context繼續推動我們的主要臨床候選藥物——Claudin 6（“CLDN6”）x CD3雙特異性抗體 CTIM-76 進入人體首次臨床研究。在癌症免疫治療學會 (SITC) 第 38 屆年會上公佈的臨床前數據顯示，CTIM-76 在靶向 cldn6 陽性腫瘤時具有廣泛的治療潛力，並確定了潛在的首次人體劑量。臨床前數據支持了 CTIM-76 的差異化產品特徵，包括它有可能解決第一代 cldn6 靶向臨床階段療法的侷限性以及 CLDN6 高表達和脫靶毒性的要求，” Context 首席執行官馬丁·萊爾說。“我們期待在2024年第一季度末向美國食品藥品監督管理局提交針對CTIM-76 的在研新藥申請（“IND”）。”
Third Quarter 2023 and Recent Corporate Highlights
2023 年第三季度及最近的公司亮點
- In November 2023, announced encouraging preclinical data presented at the SITC 38th Annual Meeting that demonstrated CTIM-76 was well tolerated and induced dose-proportional tumor regressions in models of CLDN6-positive cancer. Benchmarking studies were conducted to compare CTIM-76 to clones of other CLDN6 clinical-stage compounds, including TORL-1-23 and AMG-794. In these studies, CTIM-76 was potent across a wide-range of CLDN6 expression profiles, whereas TORL-1-23 potency was limited to CLDN6-high expression. In addition, CTIM-76 demonstrated ten-fold higher potency than that of AMG-794 in in vitro cytotoxicity and cytokine activation assays.
- In August 2023, participated in the H.C. Wainwright Immune Cell Engager Virtual Conference.
- 2023 年 11 月，宣佈了在 SITC 第 38 屆年會上公佈的令人鼓舞的臨床前數據，這些數據表明 CTIM-76 具有良好的耐受性，並在 cldn6 陽性癌症模型中誘導了劑量成比例的腫瘤回歸。進行了基準研究，將 CTIM-76 與其他 CLDN6 臨床階段化合物的克隆進行比較，包括 TORL-1-23 和 AMG-794。在這些研究中，CTIM-76 在各種 CLDN6 表達譜中均有效，而 TORL-1-23 的效力僅限於 cldn6 高表達。此外，CTIM-76 的效力比 AMG-794 高十倍 體外 細胞毒性和細胞因子活化試驗。
- 2023 年 8 月，參加了 H.C. Wainwright 免疫細胞參與者虛擬會議。
Third Quarter 2023 Financial Results
2023 年第三季度 財務業績
- Cash and cash equivalents were $21.7 million at September 30, 2023, compared to $35.5 million at December 31, 2022.
- Research and development ("R&D") expenses were $4.5 million for the third quarter 2023, as compared to $2.1 million for the same period in 2022. The increase in R&D expenses was driven by higher CTIM-76 contract manufacturing costs and preclinical costs as a result of ongoing IND-enabling studies and activities. This increase was partially offset by a decrease in onapristone extended release ("ONA-XR") expenses, primarily due to the Company's decision in March 2023 to discontinue the development of ONA-XR and focus on the development of CTIM-76.
- General and administrative expenses were $1.7 million for the third quarter 2023, as compared to $2.0 million for the same period in 2022. The decrease was primarily driven by decreases in insurance expense, professional fees, compensation and share-based compensation costs.
- Other income was $0.3 million for the third quarter of 2023, as compared to $0.2 million for the same period in 2022, primarily due to higher interest income earned on cash and cash equivalent balances.
- Context reported a net loss of $5.9 million for the third quarter 2023, as compared to $3.9 million for the same period in 2022.
- 截至2023年9月30日，現金及現金等價物爲2170萬美元，而截至2022年12月31日爲3550萬美元。
- 2023年第三季度的研發（“研發”）支出爲450萬美元，而2022年同期爲210萬美元。研發費用的增加是由持續的支持 IND 的研究和活動導致的 CTIM-76 合同製造成本和臨床前成本增加所推動的。這一增長被onapristone延長髮行（“ONA-XR”）支出的減少部分抵消，這主要是由於該公司在2023年3月決定停止開發ONA-XR，專注於開發 CTIM-76。
- 2023年第三季度的一般和管理費用爲170萬美元，而2022年同期爲200萬美元。下降的主要原因是保險費用、專業費用、薪酬和基於股份的薪酬成本的減少。
- 2023年第三季度的其他收入爲30萬美元，而2022年同期爲20萬美元，這主要是由於現金和現金等價物餘額的利息收入增加。
- Context報告稱，2023年第三季度淨虧損590萬美元，而2022年同期爲390萬美元。
2023 Cash Guidance
The Company expects its cash and cash equivalents will be sufficient to fund its operations into late 2024.
2023 年現金指導
該公司預計，其現金和現金等價物將足以爲其2024年底的運營提供資金。
About Context Therapeutics
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. Context is developing CTIM-76, a selective CLDN6 x CD3 bispecific antibody for CLDN6-positive tumors, currently in preclinical development. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors, including ovarian, lung, and testicular, and absent from or expressed at low levels in healthy adult tissues. Context is headquartered in Philadelphia. For more information, please visit or follow the Company on Twitter and LinkedIn.
關於情境療法
Context Therapeutics Inc.（納斯達克股票代碼：CNTX）是一家開發實體瘤藥物的生物製藥公司。Context 正在開發 CTIM-76，這是一種針對 cldn6 陽性腫瘤的選擇性 CLDN6 x CD3 雙特異性抗體，目前正在臨床前開發中。CLDN6 是一種緊密連接的膜蛋白靶點，在包括卵巢、肺部和****在內的多種實體瘤中表達，在健康的成人組織中不存在或表達水平很低。Context 總部位於費城。欲了解更多信息，請在推特和領英上訪問或關注公司。
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 of filing an IND submission for CTIM-76 late in the first quarter of 2024, (ii) having sufficient cash and cash equivalents to fund our current operations into late 2024, (iii) the potential benefits, characteristics, and side effect profile of our product candidate, (iv) the ability of our product candidate to have benefits, characteristics, and a side effect profile that is differentiated and/or better than third party product candidates, (v) the likelihood data will support future development, and (vi) the likelihood of obtaining regulatory approval of our product candidate. 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.
前瞻性陳述
本新聞稿包含 “前瞻性陳述”，這些陳述涉及1995年《私人證券訴訟改革法》規定的安全港的重大風險和不確定性。除歷史事實陳述外，本新聞稿中包含的有關戰略、未來運營、前景、計劃和管理目標的任何陳述，包括 “可能”、“將”、“預期”、“預期”、“展望”、“展望”、“計劃”、“打算” 等詞語和類似表述（以及引用未來事件、條件或情況的其他詞語或表達）均爲前瞻性陳述。其中包括但不限於以下方面的聲明：(i) 我們預計在 2024 年第一季度末提交 CTIM-76 的 IND 申請；(ii) 有足夠的現金和現金等價物爲我們在 2024 年底之前的業務提供資金；(iii) 候選產品的潛在益處、特徵和副作用特徵；(iv) 我們的候選產品具有差異化和/或優於第三名的益處、特徵和副作用特徵的能力黨派候選產品，（v）可能性數據將支持未來開發，以及（vi）我們的候選產品獲得監管部門批准的可能性。本新聞稿中的前瞻性陳述涉及重大風險和不確定性，可能導致實際結果與前瞻性陳述所表達或暗示的結果存在重大差異，因此我們無法向您保證我們的計劃、意圖、預期或策略將得到實現或實現。我們向美國證券交易委員會提交的文件中討論了可能導致實際業績與本新聞稿中前瞻性陳述中表達或暗示的結果不同的其他因素，包括其中標題爲 “風險因素” 的部分。除非法律另有要求，否則我們不打算或沒有義務更新或修改任何前瞻性陳述，這些陳述僅代表其發表之日，無論是由於新信息、未來事件或情況還是其他原因。
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Context Therapeutics Inc. | ||||||||||||||||
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Condensed Statements of Operations | ||||||||||||||||
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(Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating Expenses | ||||||||||||||||
| Acquired in-process research and development | $ | - | $ | - | $ | - | $ | 500,000 | ||||||||
| Research and development | 4,485,223 | 2,077,566 | 12,480,836 | 4,946,304 | ||||||||||||
| General and administrative | 1,695,272 | 1,970,521 | 5,658,575 | 6,052,556 | ||||||||||||
| Loss from operations | (6,180,495 | ) | (4,048,087 | ) | (18,139,411 | ) | (11,498,860 | ) | ||||||||
| Other income | 305,809 | 193,777 | 945,086 | 219,702 | ||||||||||||
| Net loss | $ | (5,874,686 | ) | $ | (3,854,310 | ) | $ | (17,194,325 | ) | $ | (11,279,158 | ) | ||||
| Net loss per common share, basic and diluted | ($0.37 | ) | ($0.24 | ) | ($1.08 | ) | ($0.71 | ) | ||||||||
| Weighted average shares outstanding, basic and diluted | 15,966,053 | 15,966,053 | 15,966,053 | 15,966,053 | ||||||||||||
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Context Therapeutics Inc. | ||||||||||||||||
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Condensed Balance Sheets Data | ||||||||||||||||
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(Unaudited) | ||||||||||||||||
| September 30, | December 31, | |||||||||||||||
| 2023 | 2022 | |||||||||||||||
| Cash and cash equivalents | $ | 21,676,999 | $ | 35,497,445 | ||||||||||||
| Other assets | 1,311,624 | 2,468,498 | ||||||||||||||
| Total assets | $ | 22,988,623 | $ | 37,965,943 | ||||||||||||
| Total liabilities | $ | 4,603,768 | $ | 3,207,577 | ||||||||||||
| Total stockholders' equity | 18,384,855 | 34,758,366 | ||||||||||||||
| Total liabilities and stockholders' equity | $ | 22,988,623 | $ | 37,965,943 | ||||||||||||
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Context Therape | ||||||||||||||||
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簡明的運營報表 | ||||||||||||||||
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（未經審計） | ||||||||||||||||
| 截至9月30日的三個月 | 截至9月30日的九個月 | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| 運營費用 | ||||||||||||||||
| 收購了正在進行的研發 | $ | - | $ | - | $ | - | $ | 50 萬 | ||||||||
| 研究和開發 | 4,485,223 | 2,077,566 | 12,480,836 | 4,946,304 | ||||||||||||
| 一般和行政 | 1,695,272 | 1,970,521 | 5,658,575 | 6,052,556 | ||||||||||||
| 運營損失 | (6,180,495 | ) | (4,048,087 | ) | (18,139,411 | ) | (11,498,860 | ) | ||||||||
| 其他收入 | 305,809 | 193,777 | 945,086 | 219,702 | ||||||||||||
| 淨虧損 | $ | (5,874,686 | ) | $ | (3,854,310 | ) | $ | (17,194,325 | ) | $ | (11,279,158 | ) | ||||
| 每股普通股淨虧損，基本虧損和攤薄後 | (0.37 美元 | ) | (0.24 美元 | ) | (1.08 美元) | ) | （0.71 美元 | ) | ||||||||
| 基本和攤薄後已發行股票的加權平均值 | 15,966,053 | 15,966,053 | 15,966,053 | 15,966,053 | ||||||||||||
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Context Therape | ||||||||||||||||
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簡明資產負債表數據 | ||||||||||||||||
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（未經審計） | ||||||||||||||||
| 9月30日 | 十二月三十一日 | |||||||||||||||
| 2023 | 2022 | |||||||||||||||
| 現金和現金等價物 | $ | 21,676,999 | $ | 35,497,445 | ||||||||||||
| 其他資產 | 1,311,624 | 2,468,498 | ||||||||||||||
| 總資產 | $ | 22,988,623 | $ | 37,965,943 | ||||||||||||
| 負債總額 | $ | 4,603,768 | $ | 3,207,577 | ||||||||||||
| 股東權益總額 | 18,384,855 | 34,758366 | ||||||||||||||
| 負債和股東權益總額 | $ | 22,988,623 | $ | 37,965,943 | ||||||||||||
Media Contact:
Gina Cestari
6 Degrees
917-797-7904
gcestari@6degreespr.com
媒體聯繫人：
吉娜·塞斯塔裏
6 度
917-797-7904
gcestari@6degreespr.com
Investor Relations Contact:
Jennifer Minai-Azary
Context Therapeutics
IR@contexttherapeutics.com
投資者關係聯繫人：
詹妮弗·米奈-阿扎裏
情境療法
IR@contexttherapeutics.com
譯文內容由第三人軟體翻譯。