Successful End-of-Phase 2 meeting with FDA regarding AL102 for the treatment of desmoid tumors
Enrollment in the Phase 3 segment of RINGSIDE trial evaluating AL102 continuing globally as planned
Definitive merger agreement with Biosight, expected to close near end of Q3 2023
“We continue to make progress advancing our lead candidate AL102, which is being evaluated in the ongoing Phase 3 registration-enabling RINGSIDE for the treatment of desmoid tumors. We recently concluded an instructive and successful End-of-Phase-2 (EOP2) meeting with the
Second Quarter 2023 and Recent Business Highlights
- End-of-Phase 2 meeting with FDA regarding AL102 for desmoid tumors: Ayala confirmed that it is in agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE, evaluating AL102 in desmoid tumors. The FDA accepted the selection of the 1.2 mg once daily dose for Phase 3 and the completed and proposed clinical pharmacology plan. Enrollment in Phase 3 commenced in
November 2022 , and is continuing globally as planned, with target enrollment of 156 patients. The primary endpoint is progression free survival with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures. - Updated results from Phase 2 of RINGSIDE study presented at 2023
American Society of Clinical Oncology (ASCO) annual meeting: ASCO poster highlighted 50% partial response and 100% disease control rates in evaluable desmoid tumor patients treated with AL102 1.2 mg once daily (the selected Phase 3 dose) at a cut off date ofJanuary 3, 2023 . Tumor responses, volume and T2 signal reduction were observed earlier in the 1.2 mg once daily group, with deeper and sustained treatment responses. AL102 continues to be generally well tolerated and has a manageable safety profile. - Definitive merger agreement with Biosight: Ayala entered into a definitive agreement with
Biosight Ltd. , pursuant to which, Ayala will combine with Biosight in an all-stock transaction. Upon completion of the proposed merger, the combined company will operate under the nameAyala Pharmaceuticals, Inc. , and will continue to trade on the OTCQX under Ayala’s current ticker symbol (“ADXS”). The combined company will work to advance a portfolio of oncology assets, with a primary focus on Ayala’s AL102, and Biosight’s aspacytarabine (BST-236). The transaction is expected to close near the end of the third quarter of 2023, subject to regulatory and other conditions including approval of Biosight stockholders.
Upcoming Milestones
- ESMO poster presentations on AL102 and AL101: Updated results from Phase 2 of RINGSIDE evaluating AL102 in desmoid tumors and final results from the ACCURACY trial evaluating AL101 in patients with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) have been selected for presentation at the
European Society for Molecular Oncology (ESMO) Congress 2023, to be held inMadrid, Spain 20-24 October 2023 . - Data from Phase 1 trial of ADXS-504: ADXS-504 is being evaluated in a Phase 1 investigator-sponsored study at
Columbia University in patients with biochemically recurrent (early) prostate cancer. Readout of initial clinical and PSA data are expected in 2023. - Gain clarity on path for future development plan for AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC), expected in 2023.
Consolidated Financial Results for the Second Quarter Ended
Cash position On
Revenue Collaboration revenue was
R&D Expenses Research and development expenses were
G&A Expenses General and administrative expenses were
Net Loss The net loss for the three months ended
For further details on the Company’s financial results, including results for the six-month period ended
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Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this filing may be considered forward-looking statements that involve a number of risks and uncertainties, including statements regarding the future conduct of our studies and the potential efficacy and success of product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the conditions to the closing of the proposed transaction with Biosight are not satisfied, including the failure to timely or at all obtain the approval of the Biosight stockholders for the proposed transaction or the failure to timely or at all obtain any required regulatory clearances; uncertainties as to the timing of the consummation of the proposed transaction and the ability of each of Biosight and us to consummate the proposed transaction; the ability of Ayala and us to integrate our businesses successfully and to achieve anticipated synergies; the possibility that other anticipated benefits of the proposed transaction will not be realized, including without limitation, anticipated revenues, expenses, earnings and other financial results, and growth and expansion of the combined company’s operations, and the anticipated tax treatment of the combination; potential litigation relating to the proposed transaction that could be instituted against us, Biosight or our respective directors; possible disruptions from the proposed transaction that could harm our and/or Biosight’s respective businesses; the ability of us and Biosight to retain, attract and hire key personnel; potential adverse reactions or changes to relationships with customers, employees, suppliers or other parties resulting from the announcement or completion of the proposed transaction; potential business uncertainty, including changes to existing business relationships, during the pendency of the proposed transaction that could affect our or Biosight’s financial performance; certain restrictions during the pendency of the proposed transaction that may impact our or Biosight’s ability to pursue certain business opportunities or strategic transactions; the success and timing of clinical trials, including subject accrual, the ability to avoid and quickly resolve any clinical holds and the ability to obtain and maintain regulatory approval and/or reimbursement of product candidates for marketing; the ability to obtain the appropriate labeling of products under any regulatory approval; plans to develop and commercialize our products; our ability to continue as a going concern; our levels of available cash and our need to raise additional capital, including to support current and future planned clinical activities; the successful development and implementation of our sales and marketing campaigns; the size and growth of the potential markets for our product candidates and our ability to serve those markets; our ability to successfully compete in the potential markets for our product candidates, if commercialized; regulatory developments in
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) | |||||||
2023 | 2022 | ||||||
(Unaudited) | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 7,079 | $ | 2,408 | |||
Short-term restricted bank deposits | 106 | 110 | |||||
Trade receivables | - | 234 | |||||
Prepaid expenses and other current assets | 2,371 | 436 | |||||
Total current assets | 9,556 | 3,188 | |||||
LONG-TERM ASSETS: | |||||||
Deferred issuance costs | 1,953 | ||||||
Operating lease right of use asset | 1,390 | 1,462 | |||||
Intangible assets, net | 115 | - | |||||
Property and equipment, net | 882 | 960 | |||||
Other assets | $ | 208 | $ | 206 | |||
Total long-term assets | 2,595 | 4,581 | |||||
Total assets | $ | 12,151 | $ | 7,769 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY: | |||||||
CURRENT LIABILITIES: | |||||||
Trade payable | $ | 4,420 | $ | 4,080 | |||
Operating lease liabilities | 542 | 419 | |||||
Accrued expenses | 1,905 | 551 | |||||
Accrued payroll and employee benefits | 1,401 | 994 | |||||
Other accounts payable | 159 | 169 | |||||
Total current liabilities | 8,427 | 6,213 | |||||
LONG TERM LIABILITIES: | |||||||
Long-term warrant liability | 67 | - | |||||
Uncertain tax position | 1,648 | 1,323 | |||||
Long-term operating lease liabilities | 1,000 | 1,332 | |||||
Total long-term liabilities | $ | 2,715 | $ | 2,655 | |||
STOCKHOLDERS’ EQUITY: | |||||||
Common Stock of | $ | 5 | $ | 3 | |||
Additional paid-in capital* | 166,218 | 148,052 | |||||
Accumulated deficit | (165,214 | ) | (149,154 | ||||
Total stockholders’ equity | 1,009 | (1,099 | |||||
Total liabilities and stockholders’ equity | $ | 12,151 | $ | 7,769 |
See accompanying notes to unaudited condensed consolidated financial statements in Form 10Q.
* | Common Stock, additional paid-in capital and per share data have been retroactively adjusted for the impact of the merger, see note 1. 1 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except share & per share amounts) | ||||||||||||||
For the Three Months Ended | For the Six Months Ended | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Revenues from licensing agreement and others | $ | 9 | $ | 38 | $ | 13 | $ | 496 | ||||||
Cost of services | (9 | ) | (38 | ) | (13 | ) | (406 | ) | ||||||
Gross profit | — | — | — | 90 | ||||||||||
Operating expenses: | ||||||||||||||
Research and development | 5,723 | 5,580 | 12,988 | 13,083 | ||||||||||
General and administrative | 2,763 | 2,272 | 7,367 | 4,705 | ||||||||||
Operating loss | (8,486 | ) | (7,852 | ) | (20,355 | ) | (17,698 | ) | ||||||
Financial (loss) Income, net | (86 | ) | (42 | ) | 215 | 40 | ||||||||
Loss before income tax | (8,572 | ) | (7,894 | ) | (20,140 | ) | (17,658 | ) | ||||||
Taxes on income | (127 | ) | (214 | ) | 4,080 | (403 | ) | |||||||
Net loss | (8,699 | ) | (8,108 | ) | (16,060 | ) | (18,061 | ) | ||||||
Net Loss per share attributable to common stockholders, basic and diluted | $ | (1.82 | ) | $ | (2.83 | ) | $ | (3.51 | ) | $ | (6.30 | ) | ||
Weighted average common shares outstanding, basic and diluted* | 4,776,344 | 2,869,612 | 4,580,661 | 2,868,499 |
Source:
2023 GlobeNewswire, Inc., source