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We are a clinical-stage pharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of solid tumors and other major diseases.
−Removed: Our investigational product, certepetide (LSTA1), is designed to activate a novel uptake pathway that allows co-administered or tethered (i.e., molecularly bound) anti-cancer drugs to target and penetrate solid tumors more effectively.
−Removed: Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, while normal tissues are expected to be unaffected.
−Removed: Certepetide has also been shown to modify the tumor microenvironment (“TME”) by reducing T-regulatory cells and augmenting cytotoxic T cells, thereby making tumors more susceptible to immunotherapies and inhibiting the metastatic cascade (i.e., the spread of cancer to other parts of the body).
+Added: Our investigational product, certepetide (formerly known as LSTA1 or CEND-1), is designed to activate a novel uptake pathway that allows co-administered or tethered (i.e., molecularly bound) anti-cancer drugs to target and penetrate solid tumors more effectively.
+Added: Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, while normal tissues are expected to remain unaffected.
+Added: Certepetide has also been shown to modify the tumor microenvironment (“TME”) by reducing T-regulatory cells and augmenting cytotoxic T cells, thereby making tumors more susceptible to immunotherapies while also inhibiting the metastatic cascade (i.e., the spread of cancer to other parts of the body).
We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics.
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This stroma often limits the efficacy of current chemotherapies for these cancers.
−Removed: Emerging immunotherapies, including but not limited to checkpoint inhibitors and adoptive cell therapies (e.g., chimeric antigen receptor T cells (CAR-Ts)), also face challenges in penetrating solid tumors.
−Removed: Many tumors also exhibit an immunosuppressive TME, which suppresses a patient's immune system and can thus limit the effectiveness of immunotherapies and/or contribute to metastases.
−Removed: These factors negatively impact the ability of many therapeutic agents to effectively treat these cancers.
−Removed: To address the tumor stroma’s role as a primary impediment to effective treatment, our approach is to activate the C-end rule (“CendR”), or CendR active transport mechanism, a naturally occurring transport system.
+Added: Emerging immunotherapies, including but not limited to checkpoint inhibitors and adoptive cell therapies (e.g., chimeric antigen receptor T cells (CAR-Ts)), also face challenges in effectively treating solid tumors.
+Added: Many tumors exhibit an immunosuppressive TME, which suppresses a patient's immune system and can thus limit the effectiveness of immunotherapies and/or contribute to metastases.
+Added: These factors, i.e., the combination of a dense stroma and an immunosuppressive TME, negatively impact the ability of many therapeutic agents to effectively treat these cancers.
+Added: To address the tumor stroma’s role as a key impediment to effective treatment, our approach is to activate the C-end rule (“CendR”), or CendR active transport mechanism, a naturally occurring transport system.
Our investigational drug, certepetide (a specific internalizing R-G-D or iRGD peptide), activates this transport system in a tumor-specific manner (Sugahara, Science, 2010).
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While it is possible to couple/tether or conjugate some anticancer drugs to certepetide, we believe that our initial approach of co-administration of certepetide with anti-cancer therapies is advantageous.
−Removed: Co-administration does not create a new chemical entity (“NCE”) with its attendant development and regulatory hurdles, thereby providing an anticipated faster-to-clinic and faster-to-market product opportunity for a range of co-administration therapies.
+Added: Co-administration does not create a new chemical entity (“NCE”) with its attendant development and regulatory hurdles, thereby providing an anticipated faster-to-clinic and faster-to-market product opportunity for a range of combination therapies.
That said, an attractive life-cycle management strategy for certepetide would be to molecularly bind it to a variety of anti-cancer agents (as an alternative to co-administration), thereby creating new NCEs with the potential for distinct patent protection, compositionally or otherwise.
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Certepetide’s cancer-targeted delivery may also enable emerging solid tumor treatment modalities to prove more effective.
+Added: For example, preliminary results of the combination of certepetide with immunotherapy and chemotherapy are promising.
Certepetide as a treatment for solid tumor cancers in combination with other anti-cancer agents
Certepetide is an investigational drug that actuates the CendR active transport mechanism.
−Removed: Certepetide has been shown to modify the TME, making it less immunosuppressive and thereby making the tumor more susceptible to attack by the immune system while also inhibiting the metastastic cascade.
+Added: Certepetide has been shown to modify the TME, making it less immunosuppressive and thereby making the tumor more susceptible to attack by the immune system while also inhibiting the metastatic cascade.
It targets tumor vasculature, endothelial cells, tumor cells and some intratumoral immunosuppressive cells by its selective affinity for alpha-v beta-3 and beta-5 integrins that are upregulated on these cells.
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Additional Out-licensing Opportunities
−Removed: Our intellectual property portfolio is comprised of notable programs available for out-licensing and/or partnering in order to augment or continue their clinical development.
+Added: Our intellectual property portfolio comprises notable programs available for out-licensing and/or partnering in order to augment or continue their clinical development.
Our current long-term strategy focuses on advancing our therapies through development with the ultimate objective of obtaining market authorizations and entering commercialization, either alone or with partners, to provide treatment options to patients suffering from life-threatening medical conditions.
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Results of Operations
−Removed: Three Months Ended June 30, 2024 Compared to Three Months Ended June 30, 2023
−Removed: The following table summarizes our results of operations for the three months ended June 30, 2024 and June 30, 2023 (in thousands):
−Removed: Three Months Ended June 30,
+Added: Three Months Ended September 30, 2024 Compared to Three Months Ended September 30, 2023
+Added: The following table summarizes our results of operations for the three months ended September 30, 2024 and September 30, 2023 (in thousands):
+Added: Three Months Ended September 30,
2024 2023 Change
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Net loss $ (4,930) $ (5,261) $ 331
−Removed: Overall, net losses were $5.0 million for the three months ended June 30, 2024, compared to $4.0 million for the three months ended June 30, 2023.
+Added: Overall, net losses were $4.9 million for the three months ended September 30, 2024, compared to $5.3 million for the three months ended September 30, 2023.
Operating Expenses
−Removed: For the three months ended June 30, 2024, operating expenses totaled $5.5 million, compared to $6.9 million for the three months ended June 30, 2023, representing a decrease of $1.4 million or 19.7%.
+Added: For the three months ended September 30, 2024, operating expenses totaled $5.3 million, compared to $6.0 million for the three months ended September 30, 2023, representing a decrease of $0.6 million or 10.5%.
Operating expenses are comprised of the following:
−Removed: • Research and development expenses were approximately $2.6 million for the three months ended June 30, 2024, compared to $3.2 million for the three months ended June 30, 2023, representing a decrease of $0.6 million or 17.7%.
−Removed: This was primarily due to a reduction in expenses associated with the Phase 2b ASCEND trial which completed enrollment in the prior year, lower spend on chemistry, manufacturing and control (“CMC”) related expenses and lower equity expense partially offset by an increase in expenses associated with our enrollment activities in the current year for our certepetide Phase 2a proof-of-concept Bolster trial.
−Removed: • General and administrative expenses were approximately $2.9 million for the three months ended June 30, 2024, compared to $3.7 million for the three months ended June 30, 2023, representing a decrease of $0.8 million or 21.3%.
−Removed: This was primarily due to one-off related severance costs in the prior year associated with the elimination of the Chief Business Officer position on May 1, 2023, a reduction in equity expense and a decrease in directors and officers insurance premiums in the current year.
+Added: • Research and development expenses were approximately $2.5 million for the three months ended September 30, 2024, compared to $3.4 million for the three months ended September 30, 2023, representing a decrease of $0.8 million or 24.8%.
+Added: This was primarily due to a reduction in clinical research organization (“CRO”) expenses associated with our Phase 2a proof-of-concept Bolster trial as a result of trial protocol modifications and lower equity expense.
+Added: In addition, there were start up expenses in the prior year related to our Glioblastoma Multiforme (“GBM”) study.
+Added: • General and administrative expenses were approximately $2.8 million for the three months ended September 30, 2024, compared to $2.6 million for the three months ended September 30, 2023, representing an increase of $0.2 million or 8.1%.
+Added: This was primarily due to higher consulting expenses.
Historically, to minimize our use of cash, we have used a variety of equity instruments to compensate employees, consultants and other service providers.
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Other Income (Expense)
−Removed: Total other income (expense) is comprised primarily of investment income from cash, cash equivalents and marketable securities for the three months ended June 30, 2024 and 2023.
−Removed: Six Months Ended June 30, 2024 Compared to Six Months Ended June 30, 2023
−Removed: The following table summarizes our results of operations for the six months ended June 30, 2024 and June 30, 2023:
−Removed: Six Months Ended June 30,
+Added: Total other income (expense) is comprised primarily of investment income from cash, cash equivalents and marketable securities for the three months ended September 30, 2024 and 2023 and an investment in Impilo which was fully expensed under the equity method of accounting within the current year period.
+Added: Nine Months Ended September 30, 2024 Compared to Nine Months Ended September 30, 2023
+Added: The following table summarizes our results of operations for the nine months ended September 30, 2024 and September 30, 2023:
+Added: Nine Months Ended September 30,
2024 2023 Change
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Net loss $ (15,375) $ (15,475) $ 100
−Removed: Overall, net losses were $10.4 million for the six months ended June 30, 2024, compared to $10.2 million for the six months ended June 30, 2023.
+Added: Overall, net losses were $15.4 million for the nine months ended September 30, 2024, compared to $15.5 million for the nine months ended September 30, 2023.
Operating Expenses
−Removed: For the six months ended June 30, 2024, operating expenses totaled $12.1 million compared to $13.7 million for the six months ended June 30, 2023, representing a decrease of 11.6%.
+Added: For the nine months ended September 30, 2024, operating expenses totaled $17.5 million compared to $19.7 million for the nine months ended September 30, 2023, representing a decrease of $2.2 million or 11.3%.
Operating expenses are comprised of the following:
−Removed: • Research and development expenses were approximately $5.8 million for the six months ended June 30, 2024, compared to $6.3 million for the six months ended June 30, 2023, representing a decrease of $0.5 million or 7.9%.
−Removed: This was primarily due to a reduction in expenses associated with the Phase 2b ASCEND trial which completed enrollment in the prior year, lower spend on chemistry, manufacturing and control (“CMC”) related expenses and lower equity expense partially offset by an increase in expenses associated with our enrollment activities in the current year for our certepetide Phase 2a proof-of-concept Bolster trial.
−Removed: • General and administrative expenses were approximately $6.3 million for the six months ended June 30, 2024, compared to $7.4 million for the six months ended June 30, 2023, representing a decrease of $1.1 million or 14.9%.
−Removed: This was primarily due to one-off related severance costs in the prior year associated with the elimination of the Chief Business Officer position on May 1, 2023, a reduction in equity expense, a decrease in directors and officers insurance premiums, and a reduction in spend on legal fees partially offset by one-off settlement related costs.
+Added: • Research and development expenses were approximately $8.4 million for the nine months ended September 30, 2024, compared to $9.7 million for the nine months ended September 30, 2023, representing a decrease of $1.3 million or 13.8%.
+Added: This was primarily due to a reduction in expenses associated with the Phase 2b ASCEND trial which completed enrollment in the prior year and lower equity expense.
+Added: In addition, there were start up expenses in the current year related to our FORTIFIDE study that were offset by start up expenses in the prior year for our GBM study.
+Added: • General and administrative expenses were approximately $9.1 million for the nine months ended September 30, 2024, compared to $10.0 million for the nine months ended September 30, 2023, representing a decrease of $0.9 million or 8.9%.
+Added: This was primarily due to one-off related severance costs in the prior year associated with the elimination of the Chief Business Officer position on May 1, 2023, a reduction in equity expense, a decrease in directors and officers insurance premiums, and a reduction in spend on legal fees partially offset by one-off settlement related costs and an increase in consulting expenses.
Historically, to minimize our use of cash, we have used a variety of equity instruments to compensate employees, consultants and other service providers.
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Other Income (Expense)
−Removed: Total other income (expense) is comprised primarily of investment income from cash, cash equivalents and marketable securities and losses on sales related to the sales of our New Jersey net operating losses (“NJ NOLs”) for the six months ended
−Removed: June 30, 2024 and 2023 and an investment in Impilo which was fully expensed under the equity method of accounting within the current year period.
+Added: Total other income (expense) is comprised primarily of investment income from cash, cash equivalents and marketable securities and losses on sales related to the sales of our New Jersey net operating losses (“NJ NOLs”) for the nine months ended
+Added: September 30, 2024 and 2023 and investments in Impilo which were fully expensed under the equity method of accounting within the current year period.
Income Tax Benefit
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Analysis of Liquidity and Capital Resources
−Removed: As of June 30, 2024, we had cash, cash equivalents and marketable securities of approximately $38.3 million, working capital of approximately $37.5 million, and stockholders’ equity of approximately $38.2 million.
−Removed: During the six months ended June 30, 2024, we met our immediate cash requirements through existing cash balances.
+Added: As of September 30, 2024, we had cash, cash equivalents and marketable securities of approximately $35.9 million, working capital of approximately $33.0 million, and stockholders’ equity of approximately $33.7 million.
+Added: During the nine months ended September 30, 2024, we met our immediate cash requirements through existing cash balances.
Additionally, we used equity and equity-linked instruments to pay for services and compensation.
Net cash (used in) or provided by, operating, investing and financing activities were as follows (in thousands):
−Removed: Six Months Ended June 30,
+Added: Nine Months Ended September 30,
Net cash used in operating activities $ (14,828) $ (15,963)
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Operating Activities
−Removed: Our cash used in operating activities during the six months ended June 30, 2024 was $12.3 million, which is comprised of (i) our net loss of $10.4 million, adjusted for non-cash expenses totaling $0.6 million (which includes adjustments for equity-based compensation, depreciation and amortization, loss from equity method investment, and amortization/accretion of marketable securities), and (ii) changes in operating assets and liabilities using approximately $2.5 million.
−Removed: Our cash used in operating activities during the six months ended June 30, 2023 was $12.4 million, which is comprised of (i) our net loss of $10.2 million, adjusted for non-cash expenses totaling $0.9 million (which includes adjustments for equity-based compensation, depreciation and amortization, a loss on disposal of fixed assets, and amortization/accretion of marketable securities) and (ii) changes in operating assets and liabilities using approximately $3.1 million.
+Added: Our cash used in operating activities during the nine months ended September 30, 2024 was $14.8 million, which is comprised of (i) our net loss of $15.4 million, adjusted for non-cash expenses totaling $0.9 million (which includes adjustments for equity-based compensation, depreciation and amortization, loss from equity method investment, and amortization/accretion of marketable securities), and (ii) changes in operating assets and liabilities using approximately $0.4 million.
+Added: Our cash used in operating activities during the nine months ended September 30, 2023 was $16.0 million, which is comprised of (i) our net loss of $15.5 million, adjusted for non-cash expenses totaling $1.0 million (which includes adjustments for equity-based compensation, depreciation and amortization, a loss on disposal of fixed assets, and amortization/accretion of marketable securities) and (ii) changes in operating assets and liabilities using approximately $1.5 million.
Investing Activities
−Removed: Our cash provided by investing activities during the six months ended June 30, 2024 totaled $18.1 million and was primarily due to net sales of marketable securities (net of purchases of marketable securities) partially offset by an investment of $0.1 million in Impilo.
−Removed: Our cash provided by investing activities during the six months ended June 30, 2023 totaled $3.6 million and was primarily due to net sales of marketable securities (net of purchases of marketable securities).
+Added: Our cash provided by investing activities during the nine months ended September 30, 2024 totaled $11.8 million and was primarily due to net sales of marketable securities (net of purchases of marketable securities) partially offset by an investment of $0.1 million in Impilo.
+Added: Our cash provided by investing activities during the nine months ended September 30, 2023 totaled $15.8 million and was primarily due to net sales of marketable securities (net of purchases of marketable securities).
Financing Activities
−Removed: Our cash used in financing activities during the six months ended June 30, 2024 totaled $0.1 million and consisted primarily of tax withholding-related payments on net share settlement equity awards to employees.
−Removed: Our cash provided by financing activities during the six months ended June 30, 2023 totaled $0.4 million and consisted of proceeds from the issuance of shares through our ATM Agreement of $0.3 million, option exercise proceeds of $0.2 million partially offset by tax withholding-related payments of $0.1 million on net share settlement equity awards to employees.
+Added: Our cash used in financing activities during the nine months ended September 30, 2024 totaled $0.1 million and consisted primarily of tax withholding-related payments on net share settlement equity awards to employees.
+Added: Our cash provided by financing activities during the nine months ended September 30, 2023 totaled $0.4 million and consisted of proceeds from the issuance of shares through our ATM Agreement of $0.3 million and option exercise proceeds of $0.2 million partially offset by tax withholding-related payments of $0.1 million on net share settlement equity awards to employees.
Liquidity and Capital Requirements Outlook
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As of the date of this filing and so long as our public float remains below $75.0 million, we are subject to limitations pursuant to General Instruction I.B.6 of Form S-3 (the “Baby Shelf Limitation”), which limits the amount we can offer to up to one-third of our public float during any trailing 12-month period.
−Removed: Subsequent to the filing of our Registration Statement on Form S-3 (File No.
−Removed: 333-279034) on May 1, 2024, the aggregate market value of our outstanding common stock held by non-affiliates was approximately $26.7 million.
−Removed: Pursuant to the Baby Shelf Limitation, since the aggregate market value of our outstanding common stock held by non-affiliates was below $75.0 million at the time of such S-3 filing, the aggregate amount of securities that we are permitted to offer and sell is now $8,915,094, which was equal to one-third of the aggregate market value of our common stock held by non-affiliates as of March 21, 2024.
+Added: Subsequent to the filing of a prospectus supplement to our Registration Statement on Form S-3 (File No.
+Added: 333-279034) relating to the at the market offering on August 21, 2024, the aggregate market value of our outstanding common stock held by non-affiliates was approximately $29.6 million.
+Added: Pursuant to the Baby Shelf Limitation, since the aggregate market value of our outstanding common stock held by non-affiliates was below $75.0 million at the time of such prospectus supplement filing, the aggregate amount of securities that we are permitted to offer and sell is now $9,855,890, which was equal to one-third of the aggregate market value of our common stock held by non-affiliates as of August 20, 2024.
If our public float exceeds $75.0 million on a future measurement date, the Company will no longer be subject to the Baby Shelf Limitation.
−Removed: There were no issuances of common stock under the ATM Agreement for the three and six months ended June 30, 2024.
+Added: There were no issuances of common stock under the ATM Agreement for the three and nine months ended September 30, 2024.
Since inception we have issued 64,394 shares of common stock under the ATM Agreement for net proceeds of $270,774.
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Critical Accounting Policies and Estimates
−Removed: There have been no material changes in our critical accounting policies and estimates during the three and six months ended June 30, 2024, compared to those reported in our 2023 Form 10-K.
+Added: There have been no material changes in our critical accounting policies and estimates during the three and nine months ended September 30, 2024, compared to those reported in our 2023 Form 10-K.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.