On February 10, 2023 Ayala Pharmaceuticals, Inc. (f/k/a Advaxis Inc.) (the "Company," "New Ayala," "we," "us" or "our") (OTCQX: ADXS), a clinical-stage oncology company, reported financial results for the fiscal year ended October 31, 2022 (Press release, Ayala Pharmaceuticals, FEB 10, 2023, View Source [SID1234627053]).

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Management Commentary

"We were pleased to close our previously announced merger in January 2023," said Kenneth A. Berlin, President and Chief Executive Officer of the Company. "Our immediate priorities include executing on Part B of the ongoing registration-enabling RINGSIDE study evaluating AL102 in desmoid tumors. We believe that AL102 has best in class potential and, if approved, may have important clinical advantages including safety, convenient once daily dosing and lower pill burden. For AL101, we expect to gain clarity this year on the development path in recurrent/metastatic adenoid cystic carcinoma (R/M ACC). We also continue to make progress on the development of ADXS-504 for the treatment of early prostate cancer. The dose escalation part of the investigator-sponsored trial at Columbia University has been completed and we are now enrolling patients in an expansion cohort."

Fiscal Year 2022 and Recent Business Highlights:

In October 2022, the Company, which was then known as Advaxis, Inc., entered into a definitive agreement to merge with the entity now known as Old Ayala, Inc. (which prior to the merger was named Ayala Pharmaceuticals, Inc.) The merged company is focused primarily on the development and commercialization AL102 for the treatment of desmoid tumors. The merger closed on January 19, 2023, at which time the Company changed its name to Ayala Pharmaceuticals, Inc.
Announced positive interim data from Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors: Data showed that AL102 had efficacy across all cohorts, with early responses that deepened over time. AL102 was well tolerated at all three dosing regimens with no dose-limiting toxicities and no Grade 4/5 adverse events. The data were featured in an oral presentation at ESMO (Free ESMO Whitepaper) 2022 and in a poster at the CTOS 2022 annual meeting.
Initiated Part B (Phase 3 segment) of the RINGSIDE study in desmoid tumors: Part B of RINGSIDE is a double-blind placebo-controlled study enrolling up to 156 patients with progressive desmoid disease, randomized between AL102 or placebo. The primary endpoint is progression free survival with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
Fast Track designation granted for AL102: The U.S. FDA granted Fast Track designation for AL102 for the treatment of progressing desmoid tumors. The designation holds important advantages that may expedite the development and regulatory review of AL102.
Presented data on AL101 in adenoid cystic carcinoma (ACC) at 2022 ASCO (Free ASCO Whitepaper) annual meeting: In a poster at ASCO (Free ASCO Whitepaper), an update was provided on the ACCURACY study, the only prospective study conducted to date in ACC patients carrying Notch-activating mutations. An overall disease control rate of 66.7% was observed. The median PFS in each of the 4mg and 6mg dose AL101 cohorts was 3.7 months and 6.7 months, respectively, among the patients who had a partial response.
Continued progress with Phase 1 clinical trial of ADXS-504 for early prostate cancer: Dose escalation has been completed and enrollment at second dose level is being expanded at Columbia University. Four out of six patients treated are still on study and PSA values are being followed up. ADXS-504 has been well tolerated with no serious adverse events reported.
New Ayala’s Consolidated Financial Results for the Fiscal Year Ended October 31, 2022

Cash position On October 31, 2022, the consolidated cash and cash equivalents position was $25.2 million.

Revenues: Revenues for the fiscal year 2022 were $250,000, compared with $3.2 million for the fiscal year 2021.

R&D expenses: Research and development expenses for fiscal year 2022 were $7.6 million, compared with $10.6 million for fiscal year 2021.

G&A expenses: General and administrative expenses for fiscal year 2021 were $8.9 million, compared to $11.5 million for fiscal year 2021.

Net loss: The net loss for the fiscal year ended October 31, 2022 was approximately $14.4 million or ($8.46) per share based on approximately 1.8 million weighted average shares outstanding. This compares with a net loss for fiscal year 2021 of approximately $17.9 million or ($11.07) per share based on approximately 1.6 million weighted average shares outstanding.

The above financial results, as well as the financial tables included in this press release, reflect the financial performance of the Company, then known as Advaxis Inc., prior to completion of the merger and do not include any contribution from Old Ayala.

For further details on the Company’s financial results, refer to our Annual report on Form 10-K for the twelve months ended October 31, 2022, filed with the Securities and Exchange Commission. Old Ayala will report consolidated financial results for the full year ended December 31, 2022 (a period completed prior to the merger) on or about March 31, 2023.

On February 10, 2023 Alligator Bioscience AB, reported that Strong final quarter concludes a successful 2022 (Press release, Alligator Bioscience, FEB 10, 2023, View Source [SID1234627050]).

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"We have made excellent progress in the clinic throughout the year which culminated with the outstanding Phase 2 interim results from our lead asset mitazalimab in the OPTIMIZE-1 trial. The encouraging 52% ORR from our study strongly indicates contribution of mitazalimab to the known activity of FOLFIRINOX chemotherapy backbone, with a manageable safety profile. An objective response indicates clinically meaningful reduction in the tumor burden, and a long duration of response can positively influence patient’s survival. With the continued enrolment for the remainder of the trial, the ongoing treatment and follow up we are now looking forward to announcing interim data on the longevity of response and survival in mid-2023 and we are confident that we will be able to initiate discussions with regulators in the US and Europe in H2 2023 on potentially accelerating the asset’s development and its route to market.We continue to strengthen and expand our existing partnerships and collaborations. Our co-development of ALG.APV-527 with Aptevo continues advancing towards the initiation of a Phase 1 study in the US, and we have initiated a second bispecific project in our research collaboration with Orion. Finally, our out-licensed asset AC101 (HLX22) has received IND approval for a second Phase 2 study in gastric cancer in China. We are very well placed for 2023 and looking ahead to what we expect will be a busy and productive year."

Søren Bregenholt, CEO Alligator Bioscience AB
BUSINESS UPDATE
Clinical Pipeline:
Mitazalimab

Alligator presented a poster at the SITC (Free SITC Whitepaper) Annual Meeting in November outlining Phase 1 dose escalation data showing mitazalimab induces strong immune responses in patients with advanced stage solid tumors, further strengthening the CD40 agonist’s proof of mechanism and potential in solid tumors.
In December, additional data from this Phase 1 study was published in the peer-reviewed journal Investigational New Drugs which confirmed mitazalimab’s manageable safety profile and favorable pharmacokinetic profile, further supporting ongoing and future mitazalimab trials.
ATOR-1017

Alligator presented a poster at the SITC (Free SITC Whitepaper) Annual Meeting in November highlighting new results from the Phase 1 first-in-human clinical trial of ATOR-1017, showing it to be safe and well tolerated at doses up to 900 mg with an excellent clinical profile as a potential best-in-class asset. These data warrant further development of ATOR-1017 in combination with other therapeutic approaches in solid tumors and Alligator is now seeking a partner to support this.
ALG.APV-527

On September 19, Alligator and Aptevo Therapeutics announced that the US Food and Drug Administration (FDA) had issued a "may proceed" notification for the ALG.APV-527 investigational new drug application (IND) allowing the companies to begin preparations for a multi-center Phase 1 trial in the US.
In November, Alligator and Aptevo Therapeutics announced the publication of a peer-reviewed article in Molecular Cancer Therapeutics highlighting preclinical data demonstrating a positive safety and anti-tumor profile in both in vitro and in vivo studies for ALG.APV-527.
AC101 (HLX22)

In November, Alligator announced that Shanghai Henlius Biotech, Inc. received investigational new drug (IND) approval from China’s National Medical Products Administration (NMPA) for a Phase 2 clinical trial of AC101 (HLX22) in combination with anti-PD-1 antibody serplulimab, trastuzumab and chemotherapy in gastric cancer.
Neo-X-Prime

In November, Alligator announced the publication of a peer-reviewed article in the Journal for ImmunoTherapy of Cancer highlighting how bispecific Neo-X-Prime antibodies targeting CD40 and tumor-associated antigens (TAA) represent a promising novel treatment modality with the potential to meet key needs in immuno-oncology.

Significant events after the end of the period:
Research Collaboration and License Agreement with Orion Corporation

In early January, Alligator and Orion announced the initiation of the second project of their collaboration to develop a bispecific antibody with potential applications in solid tumors.
Mitazalimab

On January 2, Alligator announced positive interim results from the OPTIMIZE-1 Phase 1b/2 trial in pancreatic cancer, with efficacy analysis showing mitazalimab combined with mFOLFIRINOX resulted in a 52 % Objective Response Rate.
The data confirm the safety of mitazalimab combined with mFOLFIRINOX as previously reported.
Alligator plans to discuss these strong results with regulators in H2 2023 once the interim PFS data are reported, to explore potential accelerated development and approval pathway in the US and Europe.

Outlook into 2023
Alligator continues to advance its clinical pipeline with an additional interim data readout from the ongoing Phase 2 OPTIMIZE-1 study planned for mid-2023. This readout will include efficacy evaluation with Progression Free Survival (PFS) data. Furthermore, preparatory work for OPTIMIZE-2, a second Phase 2 clinical study with mitazalimab, is ongoing and we expect to receive an IND clearance from the regulators in H1 2023. Looking into the second half of 2023, we aim to enter discussions with the FDA on the best regulatory path for mitazalimab in combination with mFOLFIRINOX in first-line pancreatic cancer with ORR and PFS as the basis for discussions.

FINANCIAL SUMMARY FOR Q4 2022 AND FULL YEAR 2022
The financial summaries for the quarterly periods ending December 31st, 2022 and December 31st, 2021 are presented below.

All amounts in MSEK,
unless specified October – December 2022 October – December 2021
Net Sales 20.1 5.2
Operating profit/loss -52.6 -36.9
Profit/loss for the period -53.3 -36.8
Earnings per share (SEK)
before and after dilution -0.24 -0.41*
Cash Flow -49.8 198.8
Cash & Cash Equivalents 97.3 278.1

The financial summaries for the full year ending December 31st, 2022 and December 31st, 2021 are presented below.

All amounts in MSEK,
unless specified January – December 2022 January – December 2021
Net Sales 35.7 12.9
Operating profit/loss -192.8 -141.6
Profit/loss for the period -193.4 -141.7
Earnings per share (SEK)
before and after dilution -0.88 -1.58*
Cash Flow -180.9 174.7
Cash & Cash Equivalents 97.3 278.1
*) Previous periods have been adjusted, see Note 8, page 21 in the attached report.

The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a conference call today at 2:00 p.m. CET / 8:00 a.m. ET for investors, analysts and media, where CEO Søren Bregenholt and CFO Marie Svensson will present and comment on the Q4 interim report, which will be followed by a Q&A chat session. The call will be held in English.

The livestream call can be accessed through Alligator’s website, LinkedIn or Youtube.

The information was submitted for publication, through the agency of the contact person set out below, at 08:00 a.m. CET on February 10, 2023.

On February 10, 2023 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in NASH and viral diseases, reported that Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos, will present at the virtual SVB Securities Global Biopharma Conference on Wednesday, February 15, 2023 at 5:00 p.m. ET (Press release, Aligos Therapeutics, FEB 10, 2023, View Source [SID1234627048]).

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SVB Leerink Virtual Healthcare Conference Information:

Date: Wednesday, February 15th, 2023
Time: 5:00 to 5:30 p.m. Eastern Time
Presenter: Lawrence Blatt, Ph.D., MBA, CEO of Aligos
Webcast: View Source

A replay of the session will be available following the conference for 90 days through the Aligos investor section of the website: View Source

On Jun 7, 2022 Vittoria Biotherapeutics reported it spun out of a University of Pennsylvania research lab is emerging from stealth mode with nearly $10 million from a seed funding round (Company Pipeline, viTToria biotherapeutics, FEB 10, 2023, View Source [SID1234627036]).

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Vittoria Biotherapeutics’ mission is to overcome current limitations of chimeric antigen receptor (CAR) T-cell therapeutics by using its unique cell engineering and gene editing technologies to create new therapies that address unmet clinical needs.

The technology the company is attempting to commercialize was developed by Dr. Marco Ruella, a hematologist from Italy who came to the United States 10 years ago to study under Penn CAR T-cell pioneers Dr. Carl June and Saar Gill.

Ruella, Vittoria’s scientific founder, is an assistant professor of medicine at the Center for Cellular Immunotherapies at Penn’s Perelman School of Medicine. He is also scientific director of the lymphoma program at the Hospital of the University of Pennsylvania.

Ruella said he got the idea to start a company about a year ago to further develop his method of augmenting CAR T-cell therapy with gene editing.

"I was very confident with my science, but not comfortable at all about what my next steps should be," Ruella said.

Gill, co-director of cell therapy and transplantation at Penn, co-founded two local cell and gene therapy companies: Carisma Therapeutics and Interius Biotherapeutics. He recommended Ruella talk with Bruce Peacock, a longtime life sciences industry entrepreneur and investor who was CEO at Adolor and Orthovita, held senior positions at Centocor and Cephalon, and is an investor and director at Carisma and Interius.

"Marco could see what he had and realized he needed a company to translate what he had accomplished into a meaningful therapy," Peacock said.

Peacock knew just the person to lead such a startup.

Prior to the company’s sale, Peacock was a major investor and board member at Invisible Sentinel, a Philadelphia life sciences company that had developed DNA contamination detection tools for the food, beer and wine industries. He knew its CEO, Nicholas Siciliano, was looking for his next challenge after Invisible Sentinel, where Siciliano is still a consultant, was acquired by bioMerieux of France for $75 million in 2019.

The trio — Ruella, Peacock and Siciliano — ended up co-founding the company, with Siciliano taking the CEO role and Peacock serving as board chairman.

"We fell in love with Marco and the science," Siciliano said. "The stars aligned."

On February 9, 2023 The University of California, San Francisco ("UCSF") and Foundery, a biotechnology venture studio focused on translating immunology discoveries into drug candidates, reported the signing of a five-year master agreement to collaborate on the translation of scientific discoveries in immunology by UCSF scientists into drug development candidates to treat diseases caused by immune system dysfunction (Press release, Foundery Biosciences, FEB 9, 2023, View Source [SID1234656473]). The partnership is designed to support UCSF investigator research and create opportunities to develop and commercialize immunotherapeutics. Selected researchers will have access to Foundery’s preclinical drug discovery infrastructure.

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The master agreement is structured to enable UCSF researchers to propose candidate drug targets or compelling biology relevant to the identification, prevention, treatment or amelioration of human diseases with underlying immune dysfunction. Foundery’s team of highly experienced and accomplished scientists subsequently conduct translational research on prioritized candidate targets in Foundery’s internal laboratories. If the research results in a candidate molecule or platform with therapeutic potential, Foundery aims to transition the preclinical candidate either directly via sale to biopharmaceutical partners or through the creation of a financing syndicate with later-stage venture capital funds to further develop the program. The master agreement is designed to enhance collaboration and develop impactful therapeutics between UCSF, participating scientists, and Foundery.

"UCSF has launched a series of innovation advancement programs under our Innovation Ventures department, including grants, technology management, entrepreneurship guidance, and external partnerships, to address what the pharmaceutical industry refers to as the ‘therapeutic valley of death," said Peter Kotsonis, PhD, Interim Vice Chancellor of UCSF Innovation Ventures. "A solution to this problem has been challenging because researchers working in academic institutions often cannot easily access resources and expertise needed to advance their scientific discoveries beyond novel, largely untested concepts. UCSF’s programs are designed to support the institution’s research community with the intent of advancing their discoveries from concept to commercial therapies where the patients who will benefit most from new medicines can access them."

"UCSF’s newest strategic partnership with Foundery is very exciting," said Amy Gryshuk, PhD, Associate Director, Strategic Alliances, UCSF Innovation Ventures. "This aims to remove translational barriers for innovative UCSF investigators and provide them with the ability to translate their cutting-edge research into first-in-class immunotherapies."

Foundery is the latest drug-development endeavor established by Max Krummel, PhD, Chair of the UCSF Bakar ImmunoX Initiative, a program to facilitate sharing of technology and findings across fields, disciplines, and geographies. Dr. Krummel previously discovered, patented, and developed anti-CTLA-4 checkpoint blockade therapies as a graduate student and subsequently founded Pionyr Immunotherapeutics ("Pionyr") in 2016 to develop "Myeloid Tuning" approaches. He is joined by former Pionyr colleagues, Michel Streuli, PhD, and Venkataraman Sriram, PhD, Foundery’s Chief Executive Officer and Chief Scientific Officer, respectively, who helped advance three myeloid tuning programs from target concepts to IND-ready assets prior to Pionyr’s $1.5B acquisition by Gilead in 2020. Both Dr. Streuli and Dr. Sriram were also involved in the early development of an anti-PD1 antibody, now known as the blockbuster drug pembrolizumab (Keytruda).

"Foundery’s strategy is to partner both scientifically and financially with top-tier scientists in immunology to evaluate their discoveries for translational potential into future first- or best-in-class therapeutics," said Dr. Krummel. "Basic research scientists do not always have the time, resources or inclination to conduct translational research in their own laboratories. Our goal is to efficiently and expertly fill that gap. We are looking forward to a highly productive relationship with UCSF and to develop similar relationships with other major life science research institutions."

The Foundery team will operate laboratories at 350 Parnassus Avenue in San Francisco. The selected location provides unprecedented proximity to UCSF-based investigators and allows them to tap into Foundery’s seasoned preclinical drug discovery and development team and access proprietary platforms, assays, industry-qualified reagents, and top-tier CROs. Together, Foundery and UCSF will extend novel and untapped fundamental biological observations, create proof-of-concept data, and generate pharma-ready development candidate packages to more efficiently validate and translate early drug concepts into transformative therapies for immune-based diseases.

"We are not only scientific partners but investment partners as well," said Dr. Streuli. "UCSF and partnering scientists become de facto limited partners in the fund that is supporting the translational research. They receive financial rewards if our work on their programs is successful and also benefit from the overall success of Foundery’s portfolio. We believe that this arrangement is highly beneficial to all parties."