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Cellect Biotechnology Ltd. (APOP)

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  • Cellect Bio's ApoGraft Therapy Is Safe, Tolerable In GvHD Study
    Benzinga

    Cellect Bio's ApoGraft Therapy Is Safe, Tolerable In GvHD Study

    Cellect Biotechnology Ltd (NASDAQ: APOP) has announced data from the Phase 1/2 study in Israel evaluating ApoGraft technology for Graft versus Host Disease (GvHD), a severe complication of allogeneic hematopoietic stem cell transplantation (HSCT). All eleven patients enrolled for the trial were transplanted using the ApoGraft product and were engrafted on time. The primary objective, safety, and tolerability of ApoGraft administered to patients with hemato-oncology disorders was met, and no procedure-related adverse events were reported during the study. ApoGraft functionally selects cells to improve the safety and efficacy of regenerative medicine and cell therapies. Last month, the company announced a reverse merger agreement with a privately held Quoin Pharmaceuticals. The new entity will be listed on NASDAQ under the symbol 'QNRX.' Price Action: APOP shares are down 6.69% at $2.37 on the last check Monday. See more from BenzingaClick here for options trades from BenzingaOvid Therapeutics Stops Gaboxadol Development Citing Limited Efficacy In Rare Neurological ConditionsHumanigen's Lenzilumab Shows Encouraging Response Rate In Blood Cancer Study© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Cellect Biotechnology Reports Top Line Data from Phase 1/2 Clinical Trial
    GlobeNewswire

    Cellect Biotechnology Reports Top Line Data from Phase 1/2 Clinical Trial

    Results Support Ongoing Clinical Development of ApoGraft in U.S.Tel Aviv, Israel, April 19, 2021 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (NASDAQ: "APOP"), a developer of innovative technology that enables the functional selection of stem cells, today announced positive data from the Company's open label Phase 1/2 clinical trial of its ApoGraft™ technology in Israel. All eleven patients enrolled for the trial were transplanted using the ApoGraft product and were engrafted in a timely manner. The primary objective, safety and tolerability of ApoGraft administered to patients with hemato-oncology disorders, was met and there were no procedure related adverse events (AEs) reported during the course of the study. As previously announced last month, following the anticipated closing of the merger with Quoin Pharmaceuticals, the development of the ApoGraft technology is expected to be pursued by San-Diego based EnCellX, led by Adi Mohanty. “The data validates earlier results and supports the ongoing development of our products,” commented Dr. Shai Yarkoni, Chief Executive Officer. “I remain committed and believe that the human data from this study will expedite the clinical development of the ApoGraft.” About Cellect Biotechnology Ltd. Cellect Biotechnology (APOP) has developed a breakthrough technology for the selection of stem cells from any given tissue that aims to improve a variety of cell-based therapies. The Company's technology is expected to provide researchers, clinicians and pharmaceutical companies with the tools to rapidly isolate specific cells in quantity and quality, allowing cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment. Forward Looking Statements This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; or maintain its current operations; uncertainties involving any strategic transaction the Company may decide to enter into as the result of its current efforts to explore new strategic alternatives; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company's periodic filings with the SEC. ContactCellect Biotechnology Ltd.Eyal Leibovitz, Chief Financial Officerwww.cellect.co+972-9-974-1444Or EVC Group LLC Michael Polyviou(732) 933-2754mpolyviou@evcgroup.com

  • Cellect Biotechnology Reports Fourth Quarter and Full Year 2020 Financial and Operating Results
    GlobeNewswire

    Cellect Biotechnology Reports Fourth Quarter and Full Year 2020 Financial and Operating Results

    TEL AVIV, Israel, March 29, 2021 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (NASDAQ: “APOP”), a developer of innovative technology that enables the functional selection of stem cells, today reported financial and operating results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update. On March 24, the Company announced a strategic merger agreement with privately held Quoin Pharmaceuticals, a U.S. based specialty pharmaceutical company focused on rare and orphan diseases. Under the terms of the merger agreement, Quoin has secured $25 million in committed funding from a highly regarded, institutional healthcare investor. Current Cellect shareholders will retain approximately 25% of the combined shares before investment. The merger is expected to close by the end of the second quarter of 2021. Cellect has also signed an agreement to sell its wholly-owned subsidiary company, Cellect Biotherapeutics, to EnCellX, Inc. - a newly founded biotechnology company based in San-Diego, CA. - to continue the development of Cellect’s products. Recent Clinical Highlights Due to the COVID-19 pandemic and the Company decision to shift attention and resources to the U.S. Phase I clinical trial, which is expected to enroll the first patient soon, the Company has elected to close the Phase 1/2 clinical trial being performed in Israel earlier than expected, since recruitment of the 12th and final patient was not assured in a timely manner.To date, Data from the open label Israel Phase 1/2 clinical trial supports the Company’s optimism as it extends its clinical program to the U.S. The Company expects to publish the top line results of the Israel trial in Q2. “Concurrent with our plans to seek strategic alternatives to maximize shareholder value, we also remained focus on advancing our clinical interests in the U.S.,” commented Dr. Shai Yarkoni, Chief Executive Officer. “We have signed a compelling business proposition with Quoin and a privately-held U.S. biotechnology company that allows our current shareholders to benefit from Quoin’s promising technology and the fruits of continued progress of our clinical programs as they reach critical inflections points through the issuance of contingent value rights to our shareholders in connection with the sale of Cellect Biotherapeutics.” Fourth Quarter and Full Year 2020 Financial Results: Research and development (R&D) expenses for the fourth quarter and for the full year of 2020 were $0.53 million and $1.83 million respectively, compared to $0.80 million in the fourth quarter of 2019 and $3.77 million for the full year of 2019. The decrease in R&D expenses for the full year of 2020 as compared to the full year of 2019 resulted from the reduction in our research and development activities, as we decreased the number of our employees engaged in research and related activities.General and administrative (G&A) expenses for the fourth quarter and for the full year of 2020 were $0.67 million and $2.52 million respectively, compared to $0.74 million in the fourth quarter of 2019 and $3.18 million for the full year of 2019. The decrease in G&A expenses for the full year of 2020 as compared to the full year of 2019 resulted from the reduction in the company activities resulting from a decrease in the number of employees.Finance expenses for the fourth quarter of 2020 were $0.38 million, and financial expenses were $1.27 million for the full year of 2020, compared to finance expenses of $0.35 million in the fourth quarter of 2019 and financial income of $1.72 million for the full year of 2019, respectively. The financial expenses in the full year of 2020 as compared to the financial income in the full year of 2019 is primarily due to the change in the fair value of the listed warrants granted in our U.S. initial public offering in 2016 and of the unregistered warrants granted in our registered direct offerings in 2019.Total Comprehensive loss for the fourth quarter and for the full year of 2020 was $1.58 million and $5.62 million respectively, or $0.004 per share for the fourth quarter and $0.015 per share for the full year of 2020, respectively, compared to $1.89 million, or $0.008 per share, in the fourth quarter of 2019 and $5.23 million, or $0.025 per share, for the full year of 2019. * For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2020 (U.S. $1 = NIS 3.215). About Cellect Biotechnology Ltd. Cellect Biotechnology (APOP) has developed a breakthrough technology for the selection of stem cells from any given tissue that aims to improve a variety of cell-based therapies. The Company’s technology is expected to provide researchers, clinicians and pharmaceutical companies with the tools to rapidly isolate specific cells in quantity and quality, allowing cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company’s current clinical trial is aimed at bone marrow transplantations in cancer treatment. Forward Looking Statements This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company’s history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company’s ability to continue as a going concern; or maintain its current operations; uncertainties involving any strategic transaction the Company may decide to enter into as the result of its current efforts to explore new strategic alternatives; uncertainties of cash flows and inability to meet working capital needs; the Company’s ability to obtain regulatory approvals; the Company’s ability to obtain favorable pre-clinical and clinical trial results; the Company’s technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company’s clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company’s ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company’s industry; unforeseen scientific difficulties may develop with the Company’s technology; and the Company’s ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC. ContactCellect Biotechnology Ltd.Eyal Leibovitz, Chief Financial Officerwww.cellect.co+972-9-974-1444 Or EVC Group LLCMichael Polyviou(732) 933-2754mpolyviou@evcgroup.com Cellect Biotechnology LtdConsolidated Statement of Operation Convenience translation Twelve months ended Twelve months ended Three months ended December 31, December 31, December 31, 2020 2020 2019 2020 2019 Unaudited Audited Audited Unaudited Unaudited U.S. dollars NIS (In thousands, except share and per share data) Research and development expenses 1,830 5,883 12,122 1,693 2,571 General and administrative expenses 2,523 8,111 10,210 2,167 2,378 Operating loss 4,353 13,994 22,332 3,860 4,949 Financial expenses (income) due to warrants exercisable into ADS 846 2,721 (7,022) 4 998 Other financial expenses (income), net 424 1,362 1,498 1,224 129 Total comprehensive loss 5,623 18,077 16,808 5,088 6,076 Loss per share: Basic and diluted loss per share 0.015 0.049 0.079 0.013 0.027 Weighted average number of shares outstanding used to compute basic and diluted loss per share 368,078,786 368,078,786 212,642,505 390,949,079 224,087,799 Cellect Biotechnology LtdConsolidated Balance Sheet Data Convenience translation December 31, December 31, December 31, 2020 2020 2019 Unaudited Audited Audited U.S. dollars NIS ASSETS (In thousands, except share and per share data) CURRENT ASSETS: Cash and cash equivalents 5,277 16,964 18,106 Other receivables 88 284 469 5,365 17,248 18,575 NON-CURRENT ASSETS: Restricted cash 100 322 328 Right of use - Assets under operating lease 219 705 1,035 Other long-term assets 22 72 94 Property, plant and equipment, net 384 1,232 1,288 725 2,331 2,745 6,090 19,579 21,320 LIABILITIES ANDSHAREHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables 121 389 158 Leases liabilities 115 369 396 Other payables 693 2,228 3,080 929 2,986 3,634 NON-CURRENT LIABILITIES: Warrants to ADS 380 1,222 2,172 Leases liabilities 122 391 677 502 1,613 2,849 EQUITY: Ordinary shares of no par value: Authorized: 500,000,000 shares at December 31, 2019 and December 31 2020; Issued and outstanding: 224,087,799*) and 390,949,079*) shares as of December 31, 2019 and December 31, 2020, respectively. - - - Additional Paid In Capital 39,452 126,838 108,598 Share-based payments 5,135 16,508 16,528 Treasury shares (2,932) (9,425) (9,425)Accumulated deficit (36,996) (118,941) (100,864) 4,659 14,980 14,837 6,090 19,579 21,320 *)Net of 2,641,693 treasury shares of the Company held by the Company. Cellect Biotechnology LtdConsolidated Cash Flow Data Convenience translation Twelve months ended Twelve months ended Three months ended December 31, December 31, December 31, 2020 2020 2019 2020 2019 Unaudited Audited Audited Unaudited Unaudited U.S. dollars NIS (In thousands) Cash flows from operating activities: Total comprehensive loss (5,623) (18,077) (16,808) (5,088) (6,076) Adjustments to reconcile net loss to net cash used in operating activities: Exchange rate difference (412) (1,326) 1,036 (1,115) (50)Loss (gain) from revaluation of financial assets presented at fair value through profit and loss - - - - (8)Depreciation of Right of use - Assets under operating lease 115 369 433 97 (24)Depreciation 109 350 373 94 88 Finance expenses 27 88 128 40 128 Issuance expenses - - 1,621 - 1,621 Changes in fair value of traded and non traded warrants to ADS 847 2,722 (8,643) 4 708 Share-based payment 229 738 2,708 262 807 Decrease (increase) in other receivables 65 207 385 417 239 Increase (decrease) in other payables (193) (621) (1,663) 528 192 Interest received 20 64 93 8 168 Net cash used in operating activities (4,816) (15,486) (20,337) (4,753) (2,207) Cash flows from investing activities: Restricted deposit, net 2 6 9 7 9 Proceeds received from the sale of fixed assets 11 35 6 - 6 (Purchase) Sales of marketable securities measured at fair value through profit and loss - - - - - Purchase of property, plant and equipment (103) (329) (123) (170) (3)Net cash provided by investing activities (90) (288) (108) (163) 12 Cash flows from financing activities: Exercise of warrants and stock options into shares 1,435 4,615 - - - Repayment on account of lease liabilities (137) (441) (522) (117) (101)Issue of share capital and warrants, net of issue costs 2,860 9,194 22,393 - (1,330)Net cash provided (used) by financing activities 4,158 13,368 21,871 (117) (1,431)Exchange differences on balances of cash and cash equivalents 393 1,264 (1,129) 1,108 (117)Increase (decrease) in cash and cash equivalents (355) (1,142) 297 (3,925) (3,743)Balance of cash and cash equivalents at the beginning of the period 5,632 18,106 17,809 20,889 21,849 Balance of cash and cash equivalents at the end of the period 5,277 16,964 18,106 16,964 18,106