VBL Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update

On March 14, 2023 VBL Therapeutics (Nasdaq: VBLT) (VBL), reported financial results for the fiscal year ended December 31, 2022, and provided a corporate update (Press release, VBL Therapeutics, MAR 14, 2023, View Source [SID1234628666]).

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"I am confident that the recently announced merger with Notable Labs Inc. provides the best path forward and will position the new enterprise to deliver both near and long-term value for shareholders of both companies and patients," said Prof. Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The successful closing of the sale of VBL’s manufacturing facility for $7.1 million has provided an influx of non-dilutive capital that can be employed by the combined entity to advance its pipeline. I am impressed by the management team at Notable, who have an excellent track record developing successful pharmaceuticals, and the vision to create a leading clinical stage oncology company utilizing Notable’s Predictive Precision Medicine Platform."

Recent Corporate Highlights

On February 23, 2023 VBL announced that it entered into a definitive merger agreement with Notable Labs Inc. (Notable). The combined company will focus on the advancement of Notable’s proprietary Predictive Precision Medicines Platform (PPMP) and therapeutic pipeline focused on cancer patients with high unmet medical needs.
Notable has applied its PPMP to selecting and developing two clinical-stage therapeutic candidates in acute myeloid leukemia (AML); Phase 2a results for lead asset Volasertib in adult AML in platform-predicted responding patients are expected in 3Q 2024.
Results from a new clinical validation study of Notable’s PPMP will be presented at a medical conference in the second quarter of 2023.
The combined company will be led by Notable’s current management team and will be headquartered in Foster City, California.
Upon closing of the merger, Notable stockholders are expected to own approximately 76% and VBL shareholders are expected to own approximately 24% of the combined company, each on a fully-diluted basis and subject to adjustment.
The combined company is expected to operate under the name Notable Labs, Ltd. with its shares listed on the Nasdaq Capital Market under the ticker symbol ‘NTBL.’
Concurrent with the execution of the merger agreement, a healthtech-focused investor syndicate, including existing Notable stockholders Builders VC, B Capital Group, Y Combinator, First Round Capital, and Founders Fund, entered into a definitive securities purchase agreement with Notable to invest $10.3 million in gross proceeds prior to the close of the proposed merger. After completion of the merger, the combined company is expected to have a cash runway into 2025.

On March 9, 2023, VBL closed the previously announced sale of the rights to its Modi’in manufacturing facility, along with certain tangible assets and equipment located therein for $7.1 million in cash.
Financial Results for the Full Year 2022

On December 31, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $21.1 million. In addition, in March 2023, VBL received $7.1 million in proceeds from the sale of VBL’s Modi’in manufacturing facility and certain related assets.
For the year ended December 31, 2022, VBL reported a net loss of $32.3 million, or ($0.42) per basic share, compared to a net loss of $29.9 million, or ($0.45) per basic share, in the comparable period in 2021.
Revenues for the year ended December 31, 2022 were $0.7 million, compared to $0.8 million for the year ended December 31, 2021, a decrease of $0.1 million. The decrease is due to the winding down of the revenue recognized from the terminated Nanocarrier license agreement.
For the year ended December 31, 2022, total operating expenses were approximately $33.4 million, consisting of $21.7 million in research and development expenses, net, and $11.8 million in general and administrative expenses. This compares with total operating expenses of $30.4 million in the year ended December 31, 2021, which was comprised of $22.7 million in research and development expenses, net, and $7.7 million in general and administrative expenses.

Theratechnologies to Present Preclinical Data at AACR Demonstrating Synergy Between TH1902 and Anti-PD-L1 Immunotherapy in Cold Tumor Model

On March 14, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that new data will be presented demonstrating the promise of its SORT1+ Technology platform of proprietary peptides, and of its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), in enabling targeted delivery of anticancer therapy (Press release, Theratechnologies, MAR 14, 2023, View Source [SID1234628665]).

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The new data, to be presented in three poster sessions at the 2023 annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held April 14-19 in Orlando, Fla., highlight a synergistic effect of sudocetaxel zendusortide in combination with programmed death-ligand 1 (PD-L1), checkpoint inhibitor therapy in a melanoma mouse model; high expression of the sortilin (SORT1) receptor in multiple tumor types compared to healthy tissues; and the rationale for using sudocetaxel zendusortide as a potential therapeutic approach in SORT1-positive triple-negative breast cancer (TNBC) and HER2-positive breast cancers.

"We are particularly encouraged by the potential synergistic activity of sudocetaxel zendusortide when combined with an anti-PD-L1 checkpoint inhibitor in a melanoma model," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. "Our new data continue to support the clinical development of sudocetaxel zendusortide as a single agent and in combination with other anticancer therapies. Together, the AACR (Free AACR Whitepaper) poster presentations provide fresh insights to guide our oncology program, and our efforts to bring advanced personalized therapies to patients with cancer."

Theratechnologies will present the following data on Tuesday April 18, 2023, from 9:00am-12:30pm Eastern Time (ET) at AACR (Free AACR Whitepaper) 2023:

Title: The peptide-drug conjugate sudocetaxel zendusortide (TH1902) potentiates anti-tumoral activity of the anti-PD-L1 checkpoint inhibitor and induces immune cell infiltration in a B16-F10 syngeneic melanoma model

Presenting Author: Michel Demeule, Ph.D., Theratechnologies
Session Category: Clinical Research Excluding Trials
Session Title: Molecular Targeted Therapies 2
Location: Poster Section 42
Poster Board Number: 24
Abstract Presentation Number: 4499
Title: Sudocetaxel zendusortide (TH1902), a peptide-drug conjugate for the treatment of sortilin-positive (SORT1+) TNBC and Her2-positive breast cancers

Presenting Author: Cyndia Charfi, Ph.D., Theratechnologies
Session Category: Clinical Research Excluding Trials
Session Title: Molecular Targeted Therapies 2
Location: Poster Section 42
Poster Board Number: 18
Abstract Presentation Number: 4493
Title: Differential expression of a novel transport receptor, SORT1 (sortilin), in cancer versus healthy tissues that can be utilized for targeted delivery of anti-cancer drugs

Presenting Author: Guylaine Roy, Ph.D., Theratechnologies
Session Category: Experimental and Molecular Therapeutics
Session Title: Identification of Molecular Targets 1
Location: Poster Section 17
Poster Board Number: 30
Abstract Presentation Number: 3942
About SORT1+ Technology and Sudocetaxel Zendusortide (TH1902)

Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

Sudocetaxel zendusortide (TH1902) is currently Theratechnologies’ lead investigational peptide drug conjugate candidate for the treatment of cancer derived from its SORT1+ Technology. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The FDA granted fast track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. TH1902 is currently being evaluated in a Phase 1 clinical trial, although patient recruitment was voluntarily paused on December 1, 2022. In alignment with this decision, the FDA placed the trial on partial clinical hold and the Company is currently preparing responses to their questions and planning a protocol amendment.

Tempest to Present New Translational and Preclinical Data at the 2023 AACR Annual Meeting

On March 14, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported that two abstracts have been accepted for poster presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 14-19, 2023 in Orlando, FL (Press release, Tempest Therapeutics, MAR 14, 2023, View Source [SID1234628664]). The presentations will highlight biomarker data from the Phase 1 trial of TPST-1120, an oral selective PPAR⍺ antagonist and preclinical data from TREX1 inhibitor, a tumor-selective STING pathway activator.

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Poster presentation details:

Title: Lipid and immune-based biomarkers associated with clinical response to TPST-1120: A small molecule antagonist of peroxisome-proliferator activated receptor-alpha

Session Category: Clinical Research Excluding Trials
Session Title: Biomarkers of Therapeutic Benefit 2
Session Date & Time: Monday, April 17, 2023 9:00 a.m. – 12:30 p.m. ET
Location: Poster Section 39
Abstract Number: 2130

Title: Generation of novel potent human TREX1 inhibitors facilitated by crystallography

Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 3
Session Date & Time: Monday, April 17, 2023 9:00 a.m. – 12:30 p.m. ET
Location: Poster Section 17
Abstract Number: 1636
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1 If approved by the FDA

Abstracts are available for viewing via the AACR (Free AACR Whitepaper) Online Itinerary Planner located here, View Source!/10828.

Synaffix Announces Expansion of ADC Collaboration with MacroGenics  

On March 14, 2023 Synaffix B.V. (Synaffix), a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, has reported the expansion of its license agreement with MacroGenics Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer (Press release, Synaffix, MAR 14, 2023, View Source [SID1234628663]).

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The expansion comes just a year after the original February 2022 deal, increasing the total potential consideration by up to $2.2 billion, plus tiered low to high single-digit royalties on potential net sales of any resulting products. MacroGenics currently has the option to pursue up to seven ADC programs under the expanded deal, which includes three programs from the original collaboration.

Under the original licensing agreement, MacroGenics gained access to Synaffix’s clinical stage GlycoConnect antibody conjugation technology, HydraSpace polar spacer technology, as well as select toxSYN linker-payloads (SYNtecan E, SYNeamicin D and SYNeamicin G), each designed to enable ADCs with best-in-class efficacy and tolerability. These may be combined with MacroGenics’ proprietary antibody and bispecific DART platform technologies to generate next-generation ADCs.

Sonnet BioTherapeutics to Present Clinical Data from the SB101 Study with SON-1010 at the AACR 2023 Annual Meeting

On March 14, 2023 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported that data from the company-sponsored SB101 multiple-dose clinical trial (NCT05352750) of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors will be presented in a poster session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, to be held April 14-19, in Orlando, Florida (Press release, Sonnet BioTherapeutics, MAR 14, 2023, View Source [SID1234628662]).

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Presentation details:

Title: Clinical development of a novel form of interleukin-12 with extended pharmacokinetics
Session Title: Phase I and First-in-Human Clinical Trials in Progress
Presentation Type: Poster
Session Date and Time: Tuesday April 18, 2023, 1:30 PM – 5:00 PM
Abstract Number: CT245
Location: Poster Section 46