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Ayala Announces Merger With Advaxis

Ayala Holds KOL Event On AL102 and Desmoid Tumors

Lowering AYLA To Market Perform

Robert LeBoyer

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Healthcare

Biotechnology

Ayala Pharmaceuticals Inc.

Summary.&nbsp; Ayala held a KOL webcast to discus AL102, its gamma secretase inhibitor in development to treat desmoid tumors.&nbsp; The presentations described the clinical aspects of desmoid tumors, current treatments, and data from AL102 clinical trials.&nbsp; After reviewing the RINGSIDE Phase 2/3 Part A dose-finding data, we continue to believe AL102 has potential to succeed in the placebo-controlled Part B portion.&nbsp; We continue to rate the stock Market Perform due to the time to the study completion and capital requirements to continue funding operations.
 Clinical Review.&nbsp;&nbsp;The RINGSIDE Phase 2/3 trial was designed in two parts. &nbsp;Part A tested three regimens in 36 patients at different doses and administration schedules to determine safety, tumor volume at 16 weeks, and select the dose for Part B.&nbsp; The results of Part A were announced in September 2022, with patients continuing in an open label extension phase.&nbsp; Part B is the larger, placebo-controlled part using the dose selected from Part A.
The presentation included an analysis of nirogasestat, a gamma secretase inhibitor from SpringWorks Therapeutics (SWTX, $28.72, Not Rated).&nbsp; Data from its Phase 3 DeFi (Desmoid/Fibromatosis) trial presented in September 2022 was also reviewed.&nbsp; Due to the differences in the stages and trial designs, it is too early to make efficacy comparisons.

 
Figure 1.&nbsp; Design of the RINGSIDE Phase 2/3 Trial.&nbsp; Part A has been completed, Part B has begun enrolling patients.
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/ringsidedesignB.jpg" style="width: 557px;height: 247px" /> 
 
Source: Ayala Pharmaceuticals, Inc. 
 

 
Data Review from RINGSIDE Part A.&nbsp; A detailed presentation of the data from the RINGSIDE Part A showed evaluations from the original 16 week assessment and at intervals of 12 weeks.&nbsp; Out of 12 patients with MRI results 28 weeks after treatment, 4 out of the 12 showed partial responses, with an improvement in tumor volume responses over time.&nbsp; Additional data from an open-label extension study is expected to be announced during 2023.&nbsp; We continue to believe that the data support moving into Part B.&#8212;&#8212;&#8212;- page break &#8212;&#8212;&#8212;-
Figure 2.&nbsp; Part A Tumor Volume and RECIST data.
 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/partArecist.jpg" style="width: 553px;height: 268px" /> 
 
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/mriafterfollowup.jpg" style="width: 557px;height: 302px" /> 
 
Source:&nbsp; Ayala Pharmaceuticals, Inc.

 
RINGSIDE Part B Has Begun.&nbsp;&nbsp;Part B has begun patient enrollment, with treatment expected to begin in 4Q22.&nbsp; This part of the study has a target enrollment of 156 patients, randomized 1:1 into treatment and placebo groups.&nbsp; Due to the rarity of desmoid tumors, we expect the trial to take about 2 years to fully enroll. 
 
 Conclusion:&nbsp;&nbsp;We continue to believe the RINGSIDE Part A data justified moving to the placebo-controlled portion of the study.&nbsp; We have concerns about funding, as Ayala ended 2Q22 with $20.1 million in cash.&nbsp; Based on year-to-date loss of $18.2 million and our estimated losses for the remainder of FY2022, we believe the company needs to raise capital to fund the trials in FY2023.&nbsp; With 14.8 million shares outstanding, we see the dilution required for sufficient funding as prohibitive.

Ayala Pharmaceuticals Inc. (AYLA)

Ayala Holds KOL Event On AL102 and Desmoid Tumors

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Dropping Coverage (AYLA)

Ayala Announces Merger With Advaxis (AYLA)

Ayala Holds KOL Event On AL102 and Desmoid Tumors (AYLA)

Lowering AYLA To Market Perform (AYLA)

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