On May 9, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended March 31, 2022 (Press release, ORIC Pharmaceuticals, MAY 9, 2022, View Source [SID1234613925]).

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"We continue to make steady progress in advancing our pipeline of novel oncology candidates," said Jacob M. Chacko, MD, chief executive officer, "We expect to report initial data from our three ongoing studies in the first half of 2023, which includes our Phase 1b single agent trials for ORIC-533, our orally bioavailable CD73 inhibitor, ORIC-114, our brain penetrant EGFR/HER2 inhibitor, and ORIC-944, our embryonic ectoderm development (EED) inhibitor."

First Quarter 2022 and Other Recent Highlights

Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2022, ORIC disclosed new preclinical data in three poster presentations and one oral presentation at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

ORIC-533: Oral Small Molecule CD73 Inhibitor

ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73 that has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule inhibitors of the adenosine pathway. In preclinical studies, ORIC-533 overcame immune suppression and triggered significant lysis and cell death of multiple myeloma cells in an assay comprised of autologous bone marrow microenvironment. A Phase 1b trial with ORIC-533 as a single agent in multiple myeloma is enrolling patients, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-114: EGFR/HER2 Inhibitor

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. In preclinical studies, ORIC-114 achieved tumor regressions in an EGFR exon 20 NSCLC model with superior efficacy relative to CLN-081 and demonstrated greater anti-tumor activity compared to mobocertinib (TAK-788) in an intracranial NSCLC model. A Phase 1b trial with ORIC-114 as a

single agent is enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows for patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-944: PRC2 Inhibitor

ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. A Phase 1b trial with ORIC-944 as a single agent is enrolling patients with metastatic prostate cancer, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

PLK4 Inhibitor Program

In March, the company announced a small molecule therapeutic program intended to address a mechanism of innate resistance found in a subset of breast cancers, specifically a synthetic lethal interaction of polo-like kinase 4 (PLK4) inhibition in tumors bearing a TRIM37 DNA amplification. ORIC discovered novel, potent, orally bioavailable small molecule inhibitors of PLK4 that are highly selective and achieved strong anti-tumor activity of TRIM37 high xenograft tumors, with corresponding pharmacodynamic effects and no body weight loss. The PLK4 inhibitor program is currently in lead optimization.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

•ORIC-533: Initial Phase 1b data in 1H 2023
•ORIC-114: Initial Phase 1b data in 1H 2023
•ORIC-944: Initial Phase 1b data in 1H 2023

First Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256.2 million as of March 31, 2022, which the company expects will fund its current operating plan into the second half of 2024.

R&D Expenses: Research and development (R&D) expenses were $16.8 million for the three months ended March 31, 2022, compared to $11.7 million for the same period in 2021, an increase of $5.1 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and our other product candidates of $4.6 million, offset by a decrease in ORIC-101 costs of $0.7 million due to the discontinuation of the program in the first quarter of 2022. Higher internal expenses related to higher personnel costs, including additional non-cash stock-based compensation of $0.5 million, also contributed to the increase in research and development expenses.

G&A Expenses: General and administrative (G&A) expenses were $6.4 million for the three months ended March 31, 2022, compared to $4.9 million for the same period in 2021, an increase of $1.6 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.7 million.

On May 9, 2022 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported pipeline and business highlights and financial results for the first quarter ended March 31, 2022 (Press release, Beam Therapeutics, MAY 9, 2022, View Source [SID1234613941]). In addition, as part of a long-term effort to better understand sickle cell disease (SCD), a genetic disease in which individuals carry two copies of the sickle cell mutation, and sickle cell trait, in which individuals carry only one copy of the mutation, Beam will fund and collaborate with the National Alliance of Sickle Cell Centers (NASCC) to initiate the AUNT (Achieving Understanding of the Natural History of Sickle Trait) Study, a natural history study of sickle cell trait.

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"Base editing has the potential to offer life-changing medicines for a broad range of diseases, and we are committed to better understanding the pathophysiology of the diseases in our pipeline, and their impacts on the lives of patients and their families," said John Evans, chief executive officer of Beam. "We are excited to be collaborating with the Globin Research Network for Data and Discovery (GRNDad) on the AUNT natural history study in people with sickle cell trait. We are on track and expect to commence SCD patient enrollment in our Phase 1/2 BEACON-101 clinical trial to evaluate the safety and efficacy of BEAM-101 in patients with SCD, as well as make our planned IND submission for BEAM-102, which is also in development for the treatment of SCD. Our immunology and liver-directed pipelines are also progressing, with plans for additional regulatory submissions, research studies and program nominations throughout the year, and we continue to build upon our delivery capabilities, including our novel LNP technology platform, potentially allowing us to expand the future reach of our programs. We believe the parallel advancement of these diverse programs creates a broad foundation for our future growth and is evidence of our commitment to developing new and better treatments for multiple patient populations and to unlocking the full potential of precision genetic medicine."

Pipeline Highlights & Anticipated Milestones
Ex Vivo HSC Programs

Beam continues to advance its BEAM-101 program for the treatment of SCD and expects to enroll the first patient in its Phase 1/2 clinical trial evaluating the safety and efficacy of BEAM-101 for the treatment of SCD, referred to as the BEACON-101 trial, in the second half of 2022.
Beam’s second SCD-focused program, BEAM-102, continues to progress and the company plans to submit an investigational new drug (IND) application for BEAM-102 for the treatment of SCD in the second half of 2022.
Ex Vivo T Cell Programs

Beam’s BEAM-201 program for the treatment of relapsed/refractory T cell acute lymphoblastic leukemia/T cell lymphoblastic lymphoma is progressing with submission of an IND application anticipated in the second half of 2022.
Beam continues to make progress towards its planned nomination of a second CAR-T development candidate in 2022.
In Vivo LNP Liver-targeting Programs

Beam plans to present updated preclinical data from its BEAM-301 program at the American Society of Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) meeting, demonstrating high and durable editing efficiency in a mouse model of glycogen storage disease 1a (GSDIa) out to 35 weeks. Beam plans to initiate IND-enabling studies in 2022 for BEAM-301, a liver-targeting LNP formulation of base editing reagents designed to correct the R83C mutation, the most common disease-causing mutation of GSDIa.
Also at ASGCT (Free ASGCT Whitepaper), Beam will present new preclinical data from its base editing program targeting the treatment of alpha-1 antitrypsin deficiency, highlighting optimizations made to the editor and the guide RNA that have led to two-fold increases in observed editing potency in mice, leading to potentially clinically relevant increases in circulating alpha-1 antitrypsin at doses below 1 mg/kg.
Beam continues to anticipate the nomination of a second liver-targeted development candidate in 2022.
Initiation of AUNT Natural History Study
SCD is a severe, inherited blood disorder that alters the structure and function of oxygen-carrying hemoglobin in red blood cells and is caused by a single point mutation in the beta globin gene. Carriers of the disease, or individuals with sickle cell trait, have only one copy of the sickle mutation and produce variable amounts of the abnormal sickle hemoglobin (25-45% of total hemoglobin). Despite the high prevalence of sickle cell trait (estimated to affect 300 million individuals worldwide), research to understand its full biology and clinical features has been limited.

Beam is developing two programs for SCD, BEAM-101 and BEAM-102. BEAM-101 is designed to raise fetal hemoglobin while lowering abnormal sickle hemoglobin to <40% of total, which is similar to levels seen in individuals with sickle cell trait. BEAM-102 is designed to replace the sickle mutation with a normal human variant of hemoglobin, HbG-Makassar, potentially reducing even further the abnormal sickle hemoglobin in patient cells. A better understanding of sickle cell trait, along with an in-depth understanding of SCD, will help better establish the relationship between levels of the abnormal sickle hemoglobin and long-term clinical outcomes.

The AUNT Study will create a first of its kind multi-center, prospective, longitudinal cohort of individuals with sickle trait, targeting a large enrollment of approximately 1,000 participants. This research is designed to establish an understanding of the hematologic and clinical phenotype of people with sickle cell trait, including blood rheology, potential complications, and genetic modifiers, in an effort to better understand the hematologic phenotype that is associated with good health and lack of organ dysfunction, as well as provide increased counseling to people with sickle cell trait.

Business Updates

Manmohan Singh, Ph.D., senior vice president, pharmaceutical sciences & delivery technologies, was appointed to the company’s executive leadership team. Dr. Singh joined Beam in 2018, bringing more than 24 years of drug discovery and development experience from Takeda Pharmaceuticals, Novartis and Chiron Corporation.
Anne Marie Woodland joined Beam as senior vice president, regulatory affairs, bringing more than 20 years of experience to Beam, previously serving in regulatory focused roles at Replimune, UniQure and BioVex.
Upcoming ASGCT (Free ASGCT Whitepaper) Presentation Details
Title: Single, systemic administration of BEAM-301 mitigates fasting hypoglycemia and restores metabolic function in a transgenic mouse model of glycogen storage disease type Ia
Date & Time: Monday, May 16, 2022, from 4:15-4:30 p.m. ET

Title: Optimized base editing reagents yield more potent genetic correction in a mouse model of alpha-1 antitrypsin deficiency (poster M-123)
Date & Time: Monday May 16, 2022, from 5:30-6:30 p.m. ET

Title: Efficient LNP delivery of mRNA in vivo and in vitro to T and NK cells (poster Tu-107)
Date & Time: Tuesday May 17, 2022, from 5:30-6:30 p.m. ET

First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $1.2 billion as of March 31, 2022, as compared to $965.6 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses were $65.4 million for the first quarter of 2022, compared to $190.1 million for the first quarter of 2021. R&D expenses for the first quarter of 2021 includes $155.0 million of expense related to in-process research and development acquired from Guide Therapeutics, Inc.
General & Administrative (G&A) Expenses: G&A expenses were $19.2 million for the first quarter of 2022, compared to $10.3 million for the first quarter of 2021.
Net Loss: Net loss was $69.2 million for the first quarter of 2022, or $1.01 per share, compared to $201.6 million for the first quarter of 2021, or $3.35 per share.

On May 9, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in cell-free, enzymatic DNA production, reported that it will report fiscal 2022 second quarter financial results after market close on Thursday, May 12, 2022 (Press release, Applied DNA Sciences, MAY 9, 2022, View Source;id=230827&p=2228311&I=1206939-c7Z3G6f3m8 [SID1234613957]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

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A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

On May 9, 2022 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the first quarter 2022 and provide a business update on Monday, May 16, 2022 (Press release, Protalix, MAY 9, 2022, View Source [SID1234613974]).

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Management will host a conference call with investors to discuss the financial results and provide an update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

The conference will be webcast live from the Company’s website and will be available via the following links:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On May 9, 2022 StromaCare reported a fundraising of €1,500,000 from Sham Innovation Santé (Advised by Turenne Groupe), Kréaxi, and Crédit Agricole Création (Press release, Stroma Care, MAY 9, 2022, View Source [SID1234640990]).

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Stromacare is developing a new therapy in oncology based on the immuno-modulation of the tumor stroma using a monoclonal antibody. The tumor stroma is a reaction of the tissue in which the tumor is growing, which inhibits the CD8 T cells and creates a physical barrier preventing access of immune system and therapeutic molecules to the tumor. An overexpressed protein is at the origin of this stromal barrier. Thanks to a specific antibody directed against this protein, we are able to reactivate CD8 T lymphocytes and modulate the stroma stiffness, allowing them to reach and act on the tumor and facilitate the action of other therapies. This new approach opens the way to considerable clinical developments, the stroma being common to all solid cancers.

The company leverages the results of proof of concept in animals carried out by the team led by Dr Ana Hennino, Laureate of the Béatrice Denys Foundation 2021, within INSERM-CRCL, the CNRS, the University of Lyon and the Leon Bérard Center. Her laboratory is internationally recognized for its work on the stroma and is considered as a pioneer in this field. It has been granted with several awards of excellence.

Stromacare has signed an exclusive worldwide license with Inserm Transfert covering a portfolio of three patent families and all the know-how developed.

Ana Hennino, co-founder and CSO announces: "We have shown that the use of this antibody is capable of significantly increasing the survival of animals with solid stromal cancer, alone and in combination with other therapies. Our purpose is now to go to the "First in Human" clinical phase in order to evaluate our product and offer an innovative therapy to cancer patients".

Pierre-Olivier Goineau, co-founder and CEO declares: "The work carried out by Ana is remarkable; it opens up truly innovative therapeutic perspectives in oncology. I would like to thank the funds and the business-angels who trusted us from this stage. Thanks to these new shareholders, this fundraising will be supplemented by "innovation" loans and will make it possible to develop the antibody and refine our regulatory preclinical plan as well as our clinical plan. »

Camille Darcissac (Turenne Groupe) states: "Laureate of our Béatrice Denys Foundation, we were quickly convinced by the relevance and robustness of the approach, targeting the tumor stroma, developed by Ana. The innovation brought by Stromacare is unique and bears considerable therapeutic promises for patients suffering from solid tumors. Combined with Pierre-Olivier’s extensive experience in biotech development, Stromacare has the necessary assets to conduct its preclinical development and prepare its clinical plan. »

Isabelle Bou Antoun (Chief Executive Officer of Kréaxi) adds: "Stromacare opens a promising new therapeutic avenue in the field of oncology, resulting from research work carried out within the Léon Bérard Center (CLB-Lyon). The quality and robustness of the science, supported by a very experienced team, convinced us to support this project with a major societal impact in the treatment of solid tumors".

Contact: [email protected] / www.stroma.care