On May 12, 2020 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH; Nasdaq: IPHA) reported its revenue and cash position for the three-month period ended March 31, 2020 (Press release, Innate Pharma, MAY 12, 2020, View Source [SID1234557570]).

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"During this quarter, we have maintained momentum with our pipeline as well as ensuring business continuity despite this challenging and unprecedented time," said Mondher Mahjoubi, Chief Executive Officer, Innate Pharma. "As an agile company with potential molecules in our pipeline that could make an impact in the fight against COVID-19, we have initiated the FORCE Phase II trial evaluating avdoralimab in COVID-19 patients with severe pneumonia with the goal of helping improve their prognosis. Additionally, we look forward to sharing new efficacy data on the Phase Ib/II monalizumab and cetuximab combination in IO-pretreated head and neck patients at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. We are committed to executing across our pipeline programs and pursuing innovative therapies for high unmet patient populations."

First quarter of 2020 and recent pipeline highlights:

COVID-19 Impact:

As we navigate the COVID-19 pandemic, we are dedicated to supporting our patients, our employees and their families, and the communities where we live and work.

Currently, there is varying impact to our pipeline assets in relation to COVID-19, as outlined below. The COVID-19 pandemic could impair our ability to achieve our product development or commercialization objectives in the timeframes we had expected.

We are closely monitoring the rapidly evolving environment and will continue to provide relevant information on our COVID-19 web page as the situation evolves.

_________________________
iIncluding short term investments (€16.3 million) and non-current financial instruments (€33.9 million).

Lumoxiti, a first-in-Class marketed product in-licensed from AstraZeneca for the treatment of relapsed or refractory hairy cell leukemia:

In January, we announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for Lumoxiti.
In March 2020, the Biologics License Application for Lumoxiti was transitioned from AstraZeneca (LSE/STO/NYSE: AZN) to Innate. The transition is on track to be completed in 2020.
Due to the COVID-19 pandemic, widespread restrictions and social distancing measures have limited opportunities for in-person marketing of Lumoxiti to oncology healthcare professionals and access to physicians causing interruptions of treatments for patients. As a result, the rate of new Lumoxiti patients has slowed which is expected to impact 2020 sales.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

At the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Conference, new efficacy data will be presented from a Phase II expansion cohort of IO-pretreated patients.
· ASCO (Free ASCO Whitepaper) abstract (Abstract #6516, Poster#177), entitled "Combination of Monalizumab and Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Cancer Previously Treated with Platinum-based Chemotherapy and PD-(L)1 Inhibitors."
The advancement of monalizumab in combination with cetuximab to a Phase III trial in IO-pretreated patients suffering from recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) is expected in 2020.
A controlled, randomized, study will explore monalizumab, amongst other treatment arms, to investigate the potential efficacy versus standard of care against COVID-19 in cancer patients with mild symptoms. This study is sponsored by Centre Léon Bérard, Lyon.
Lacutamab (IPH4102, anti-KIR3DL2 antibody):

In January, the French and UK regulatory agencies agreed the lacutamab TELLOMAK trial could resume recruitment in Sézary syndrome and mycosis fungoides patients. In all other geographies, no new patients may be enrolled in the trial until a new Good Manufacturing Practice (GMP)-certified batch is available. Currently enrolled patients can continue treatment in the trial except in Italy.
· New batches of drug product have been successfully manufactured. A new clinical GMP-certified batch is on track to be available in the second half of 2020.
· The Company is progressing PTCL in alternative clinical development pathways and therefore, has taken the decision to stop the PTCL cohort in the TELLOMAK study.
Due to slower clinical trial recruitment as a result of the regulatory status of TELLOMAK, compounded by the COVID-19 pandemic, potential delays in clinical development timelines may occur. The Company will provide an update in due time.
Avdoralimab (IPH5401, anti-C5aR antibody):

The first patient was dosed in a randomized, double-blind, placebo-controlled, FORCE clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab, in COVID-19 patients with severe pneumonia.
· The Phase II trial is supported by an exploratory translational study, EXPLORE, which suggests that patients who progress towards severe COVID-19 disease exhibit an increase of the C5a/C5aR pathway.
A controlled, randomized, study will explore avdoralimab, amongst other treatment arms, to investigate the potential efficacy versus standard of care against COVID-19 in cancer patients with pneumonia. This study is sponsored by Centre Léon Bérard, Lyon.
IPH5201 (anti-CD39 antibody), partnered with AstraZeneca:

In February 2020, the multicenter, open-label, dose-escalation Phase I trial started, which is evaluating IPH5201 as monotherapy or in combination with durvalumab (anti-PD-L1) with or without oleclumab (anti-CD73) in advanced solid tumors.
· The Phase I clinical trial evaluating IPH5201 in adult patients with advanced solid tumors has reactivated, following a temporary pause due to the COVID-19 pandemic.
Post-period events:

Following the dosing of the first patient on March 9, 2020 in the IPH5201 Phase I clinical trial, AstraZeneca made a $5.0 million milestone payment in April to Innate Pharma. In May, Innate made a €2.7 million milestone payment to Orega Biotech SAS pursuant to Innate’s exclusive licensing agreement.
Financial results:

Cash, cash equivalents and financial assets of the Company amounted to €206.9 million as of March 31, 2020. At the same date, financial liabilities amounted to €19.3 million.

During the first quarter of the year 2020 notably:

A $15.0m (€13.4m) milestone payment was made to AstraZeneca in January 2020 following the submission by AstraZeneca of the Marketing Authorization Access relating to the commercialization of Lumoxiti in Europe.

A €5.8m adverse variance in the fair value of our financial instruments was booked, resulting from the impact of the COVID-19 crisis on the financial markets.
Revenues for the first three-months of 2020 amounted to €19.3 million (€13.9 million for the same period in 2019). For the three-month period ended March 31, 2020, revenue from collaboration and licensing agreements mainly results from the spreading of the initial payments received under our agreements with AstraZeneca.

On May 12, 2020 Sanofi reported the Phase 3 IKEMA clinical trial evaluating Sarclisa (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma (Press release, Sanofi, MAY 12, 2020, View Source [SID1234557569]). There were no new safety signals identified in this study.

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"When Sarclisa was added to standard-of-care treatment carfilzomib and dexamethasone in this phase 3 trial, results clearly demonstrated a significant reduction in risk of disease progression or death," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "This is the second positive phase 3 trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma."

Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.

About the Trial

The randomized, multi-center, open label Phase 3 IKEMA clinical trial enrolled 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries. All study participants received one to three prior anti-myeloma therapies. During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with carfilzomib twice weekly at the 20/56mg/m2 dose and dexamethasone at the standard dose for the duration of treatment. The primary endpoint of IKEMA is progression-free survival. Secondary endpoints include overall response rate, the rate of very good partial response or greater, minimal residual disease, complete response rate, overall survival and safety.

The use of Sarclisa in combination with carfilzomib and dexamethasone in relapsed multiple myeloma is investigational and has not been fully evaluated by any regulatory authority.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma cells. It is designed to work through many mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of multiple myeloma cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Sarclisa is approved in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa has also received positive CHMP opinion in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. A final decision on the Marketing Authorisation Application for Sarclisa in the E.U. is expected in the coming months. The safety and efficacy of Sarclisa has not been fully evaluated by any regulatory authority outside of the U.S., Switzerland, Canada and Australia.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments for people with multiple myeloma. It is also under investigation for the treatment of other blood cancer types (hematologic malignancies) and solid tumors.

For more information on Sarclisa clinical trials please visit www.clinicaltrials.gov.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy, with more than 138,000 new diagnoses of multiple myeloma worldwide yearly. Despite available treatments, multiple myeloma remains an incurable malignancy, and is associated with significant patient burden. Since multiple myeloma does not have a cure, most patients will relapse. Relapsed multiple myeloma is the term for when the cancer returns after treatment or a period of remission. Refractory multiple myeloma refers to when the cancer does not respond or no longer responds to therapy.

On May 12, 2020 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported that financial results for the first quarter ended March 31, 2020 (Press release, Ideaya Biosciences, MAY 12, 2020, View Source [SID1234557568]).

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"IDEAYA continues to advance development of IDE196 in our Phase 1/2 tissue-agnostic basket trial in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11). We are generally not experiencing substantial impact from the COVID-19 pandemic on our IDE196 clinical program. We have completed enrollment of patients in the metastatic uveal melanoma (MUM) Phase 1 monotherapy portion of the clinical trial and are continuing enrollment of GNAQ/11 patients with other solid tumors, such as cutaneous melanoma and colorectal cancer, in an ongoing Phase 2 portion of the clinical trial. We also remain on track for initiating a new cohort in this clinical trial to evaluate IDE196 in combination with binimetinib under a clinical trial collaboration and supply agreement with Pfizer," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.

IDEAYA is also advancing its MAT2A program for patients having tumors with MTAP deletion. The company has selected a lead compound MAT2A inhibitor, and remains on track to file an IND for a differentiated and potential best-in-class MAT2A inhibitor development candidate in the fourth quarter of 2020.

IDEAYA’s broad pipeline of synthetic lethality programs also includes Pol-theta for tumors with BRCA or other homologous recombination deficiency (HRD) mutations, Werner helicase (WRN) for tumors with high microsatellite instability (MSI), and PARG for tumors with BRCA2 mutations, impaired base excision repair, or replication stress signature. The company is also advancing early discovery efforts on multiple undisclosed synthetic lethality targets.

Key highlights for IDEAYA’s research and development programs include:

Clinical IDE196 Program

IDE196

Continued to execute on IDEAYA’s Phase 1/2 tissue-type agnostic basket trial, initiated in June 2019, to evaluate IDE196 in solid tumors harboring activating GNAQ/11 mutations, entitled "A phase 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions" (ClinicalTrials.gov Identifier: NCT03947385). As of May 1, 2020, unless otherwise noted:

Enrolled 56 patients in IDE196 monotherapy arm of Phase 1/2 clinical trial

Completed enrollment and ongoing evaluation of IDE196 in the MUM monotherapy arm, with aggregate enrollment of 51 patients in the Phase 1 dose escalation and tablet formulation studies

Ongoing enrollment into the Phase 2 expansion arm for IDE196 as a monotherapy in solid tumors other than MUM having GNAQ or GNA11 hotspot mutations, with aggregate Phase 1/2 enrollment of 5 cutaneous melanoma patients

Completed evaluation of the tablet formulation of IDE196 in MUM patients in a Phase 1 sub-study, with the pharmacokinetic profile of the tablet formulation comparable to the powder-in-capsule form of IDE196

Completed in-life portion of the ongoing 13-week GLP-compliant toxicology studies in two species, initiated in November 2019

Interim data from the monotherapy arm of the Phase 1/2 basket trial on track for fourth quarter of 2020

COVID-19 pandemic is not currently having a substantial impact, generally, on the ongoing IDE196 clinical program

GNAQ/11 patients enrolled in the ongoing Phase 1/2 clinical trial and sites affected by COVID-19 restrictions are adapting to logistical constraints on activities, such as travel and site visits

Patients are continuing on IDE196 therapy, which is an oral drug and is being shipped to and self-administered by patients at home

Patients are being monitored through a combination of telemedicine visits and local visits

Enrollment into the Phase 2 expansion arm for IDE196 as a monotherapy in non-MUM solid tumors having GNAQ or GNA11 hotspot mutations may be delayed by circumstances resulting from the COVID-19 pandemic. The specific impact is currently uncertain; two of four active U.S. sites for this arm of the clinical trial are continuing enrollment activities to non-MUM; the other two U.S. sites have suspended enrollment to non-MUM due to COVID-19.

Preparing and on track for initiation of combination arm of the IDE196 Phase 1/2 clinical trial in mid-2020 to evaluate safety and efficacy of IDE196 in combination with binimetinib, a MEK inhibitor, in patients having tumors with activating GNAQ or GNA11 hotspot mutations, including in metastatic uveal melanoma and other solid tumors

Established Joint Development Committee with Pfizer to facilitate collaboration for combination arm drug supply, trial initiation and ongoing development

Coordinating with clinical trial sites to prepare for combination arm initiation

Preparation for combination arm of the clinical trial not currently substantially impacted by COVID-19

Preclinical Synthetic Lethality Programs

MAT2A

Continuing preclinical development efforts of selected lead compound believed to favorably differentiate in vivo activity, physical properties and tolerability profile relative to published Agios compounds

On track to select a development candidate in the second quarter of 2020

Anticipate filing an IND for MAT2A inhibitor development candidate in fourth quarter of 2020

Pol Theta

Targeting designation of Pol-theta inhibitor development candidate in second half of 2020

PARG

Demonstrated in vivo proof of concept in a relevant animal model having a replication stress genetic signature

WRN

Targeting to demonstrate in vivo proof of concept in relevant animal models in 2020

Corporate Updates

IDEAYA anticipates that existing cash, cash equivalents, and short-term and long-term marketable securities of $90.9 million (as of March 31, 2020) will be sufficient to fund planned operations into the end of 2021 to early 2022.

Our updated corporate presentation is available on our website, in the Presentations section of our Investor Relations page. See: View Source

Financial Results

As of March 31, 2020, IDEAYA had cash, cash equivalents, and short-term and long-term marketable securities totaling $90.9 million. This compared to cash, cash equivalents and short-term marketable securities of $100.5 million at December 31, 2019. The decrease was primarily due to cash used in operations.

Research and development expenses for the three months ended March 31, 2020 totaled $9.0 million compared to $8.0 million for the same period in 2019. The increase was primarily due to an increase in fees to CROs and CMOs as well as fees to contractors related to support costs for our Phase 1/2 clinical trial to evaluate IDE196 in solid tumors and the advancement of our lead product candidates through preclinical studies.

General and administrative expenses for the three months ended March 31, 2020 totaled $3.5 million compared to $2.1 million for the same period in 2019. The increase was primarily due to an increase in payroll expenses, including salaries, benefits and stock-based compensation expense related to increased general and administrative headcount to support our growth as a public company, and an increase in director and officer insurance policy premiums as a public company.

The net loss for the three months ended March 31, 2020 was $12.0 million compared to $9.6 million for the same period in 2019. Total stock compensation expense for the three months ended March 31, 2020 was $0.8 million compared to $0.4 million for the same period in 2019.

On May 12, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it is presenting three oral presentations and two poster presentations at the 23rd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), taking place virtually from May 12-15, 2020 (Press release, Intellia Therapeutics, MAY 12, 2020, View Source [SID1234557567]). Intellia researchers are presenting new data in support of NTLA-5001, the company’s engineered cell therapy candidate for the treatment of acute myeloid leukemia (AML). Intellia is also providing an update on NTLA-2002, its newest development candidate for the treatment of hereditary angioedema (HAE).

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"At Intellia, we are applying our CRISPR/Cas9 technology to develop new processes that can produce enhanced engineered cell therapies to treat severe cancers, such as AML, that traditional approaches cannot address. Our proprietary platform provides a powerful tool to generate more potent TCR-directed cells, that can treat blood cancers initially and potentially solid tumors. The data being presented today validate Intellia’s approach of reducing AML tumor cell blasts, and our plans to enter the clinic with NTLA-5001 next year," said Intellia President and CEO John Leonard, M.D. "We are also pleased to present data that support our recently announced HAE development candidate, NTLA-2002, Intellia’s second systemic therapy employing our in vivo knockout approach and modular delivery platform."

Data Presentations on Intellia’s First Engineered Cell Therapy Development Candidate, NTLA-5001 for the Treatment of AML, and Proprietary Cell Engineering Process

NTLA-5001 is Intellia’s first engineered T cell receptor (TCR) T cell therapy development candidate, which targets the Wilms’ Tumor 1 (WT1) intracellular antigen for the treatment of AML. NTLA-5001 is being developed in collaboration with Chiara Bonini’s team at IRCCS Ospedale San Raffaele to treat AML patients regardless of the genetic subtype of a patient’s leukemia. AML is a cancer of the blood and bone marrow that is rapidly fatal without immediate treatment and is the most common type of acute leukemia in adults (Source: NIH SEER Cancer Stat Facts: Leukemia – AML).

Intellia’s proprietary process is a significant improvement over standard engineering processes commonly used to introduce nucleic acids into cells. Intellia’s process enabled multiple gene edits using CRISPR/Cas9, while maintaining cell products with high expansion potential and minimal undesirable chromosomal translocations. CRISPR/Cas9 was used to insert a WT1-directed TCR in locus, while eliminating the expression of the endogenous TCRs, with the goal of producing homogeneous T cell therapies like NTLA-5001.

Intellia’s novel approach with NTLA-5001 can overcome the challenges of standard T cell therapy, including risks of reduced specificity associated with mixed expression and mispairing of endogenous and transgenic TCRs (tgTCRs); graph-versus-host disease (GvHD) risks, which could lead to an attack on the patient’s healthy cells; and reduced efficacy tied to lower tgTCR expression per T cell. Intellia’s unprecedented process is expected to streamline cell engineering and manufacturing, yielding a homogenous product comprising WT1-targeted T cells with high anti-tumor activity. Data highlights from today’s presentation include the following:

Developed a sequential genome editing process in primary human T cells that lead to the knockout of three genes with up to >98% efficiency and no detectable target-to-target translocations. Applied sequential editing approach to achieve knockout of the endogenous TCR with up to >99% efficiency, along with insertion of the tgTCR targeting WT1 into 50-70% of the cells.
Improved T cell viability post-editing that resulted in a significant increase in T cell expansion relative to cells engineered by standard methods, and which is expected to shorten the time required for T cell manufacturing and to increase the yield of therapeutic cells.
Increased proportion of cells having a desirable early stem cell memory phenotype with improved reactivity against WT1-expressing tumor cell lines and higher long-term proliferative capacity, which may be associated with better persistence in patients.
Intellia’s cell engineering efforts are focused on its initial clinical investigation of NLTA-5001 on AML, while continuing preclinical studies exploring the potential for targeting WT1 in solid tumors. The company confirmed plans last week to submit an IND or IND-equivalent for NTLA-5001 for the treatment of AML in the first half of 2021.

The presentation titled, "Enhanced tgTCR T Cell Product Attributes Through Process Improvement of CRISPR/Cas9 Engineering," will be made today by Aaron Prodeus, Ph.D., senior scientist, Cell Therapy, and can be found here, on the Scientific Publications & Presentations page of Intellia’s website. These data were a follow-on to the study presented at Keystone Symposia’s Engineering the Genome Conference from this past February.

In Vivo Data Supports Intellia’s Novel TCR Candidate

A second presentation on engineered cell therapy progress, in collaboration with IRCCS Ospedale San Raffaele, showed in vivo data demonstrating the potential of TCR-edited T cells to effectively target WT1 tumor cells in AML. In addition to the previously disclosed results of effective in vitro recognition of primary AML tumor cells by edited WT1-specific cytotoxic T cells (CD8 T cells), new data indicate that the selected TCR also enables T helper cells (CD4 T cells) to react to WT1-expressing tumor cells, providing cytokine support. This distinguishes Intellia’s TCR from other therapeutic TCR candidates, which either exclusively activate toxic CD8 T cells or require the co-transfection of CD8 into CD4 T cells to render them functional.

Using a mouse model carrying disseminated human primary AML, researchers observed a significant therapeutic effect, including decreased AML tumor burden. In addition, no signs of GvHD were observed in mice treated with the WT1-specific T cells. The data show that tgTCR-engineered cells have targeted anti-cancer activity in a challenging model of systemic AML, demonstrating the therapeutic potential of Intellia’s engineered TCR T cell approach.

The presentation titled, "Exploiting CRISPR-Genome Editing and WT1-Specific T Cell Receptors to Redirect T Lymphocytes Against Acute Myeloid Leukemia," will be given today by Eliana Ruggiero, Ph.D., Experimental Hematology Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS Ospedale San Raffaele, Italy. Notably, ASGCT (Free ASGCT Whitepaper) meeting organizers selected this presentation as one of six to receive the ASGCT (Free ASGCT Whitepaper) Excellence in Research Award this year.

Continued Progress on Intellia’s Second In Vivo Development Candidate, NTLA-2002 for the Treatment of HAE

Intellia is presenting development data updates on its potential HAE therapy, NTLA-2002, which utilizes the company’s systemic in vivo knockout approach, including its proprietary lipid nanoparticle (LNP) system. HAE is a rare genetic disorder characterized by recurring and unpredictable severe swelling attacks in various parts of the body, and is significantly debilitating or even fatal in certain cases. NTLA-2002 aims to prevent unregulated production of bradykinin by knocking out the prekallikrein B1 (KLKB1) gene through a single course of treatment to ameliorate the frequency and intensity of these swelling attacks.

The KLKB1 gene knockout in an ongoing non-human primate (NHP) study resulted in a sustained 90% reduction in kallikrein activity, a level that translates to a therapeutically meaningful impact on HAE attack rates (Source: Banerji et al., NEJM, 2017). This kallikrein activity reduction was sustained for at least six months, demonstrating the same high level of efficacy and durability seen in earlier rodent studies.

The short talk titled, "CRISPR/Cas9-Mediated Gene Knockout of KLKB1 to Treat Hereditary Angioedema," will be given by Jessica Seitzer, director, Genomics, Intellia on Fri., May 15, 2020, when it will be made available here, on the Scientific Publications & Presentations page of Intellia’s website. The presented data include results from ongoing collaborations with researchers at Regeneron, and the program is subject to an option by Regeneron to enter into a Co/Co agreement, in which Intellia would remain the lead party. Intellia expects to submit an IND or IND-equivalent to initiate a Phase 1 trial for NTLA-2002 in the second half of 2021.

On May 12, 2020 VBL Therapeutics (Nasdaq: VBLT), reported that it has closed the previously announced registered direct offering of 6,349,208 ordinary shares of the Company, at a purchase price of $1.575 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, VBL Therapeutics, MAY 12, 2020, View Source [SID1234557562]). VBL has also issued to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 6,349,208 of VBL’s ordinary shares. The warrants have an exercise price of $1.45 per ordinary share, are immediately exercisable and will expire on November 11, 2020. The registered direct offering closed on May 11, 2020.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from this offering were approximately $10.0 million, before deducting the placement agent’s fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The ordinary shares (but not the warrants or the ordinary shares underlying the warrants) were offered by VBL pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222138) previously filed with the Securities and Exchange Commission (the "SEC") on December 18, 2017 and declared effective by the SEC on January 4, 2018. The offering of the ordinary shares was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the ordinary shares offered have been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ordinary shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ordinary shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

$8.1 Million Registered Direct Offering to Key Current Shareholders

VBL also announced today that it has entered into definitive agreements with two of the Company’s largest current shareholders (the "Second Offering") for the purchase and sale of 5,142,857 ordinary shares of the Company, at a purchase price of $1.575 per share, in a registered direct offering priced at-the-market under Nasdaq rules. VBL has also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 5,142,857 of VBL’s ordinary shares. The warrants have an exercise price of $1.45 per ordinary share, will be immediately exercisable and will expire on November 11, 2021.

This Second Offering enables the participating shareholders to maintain, or increase, their relative holdings at the Company, under the same terms of the offering that was concluded on May 11, 2020.

The Second Offering is expected to close on or about May 12, 2020, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the Second Offering.

The gross proceeds from the Second Offering are expected to be approximately $8.1 million, before deducting the placement agent’s fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The ordinary shares (but not the warrants or the ordinary shares underlying the warrants) to be issued in the Second Offering are being offered by VBL pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222138) previously filed with the Securities and Exchange Commission (the "SEC") on December 18, 2017 and declared effective by the SEC on January 4, 2018. The Second Offering of the ordinary shares will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the ordinary shares being offered in the Second Offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above are being offered in the Second Offering in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ordinary shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ordinary shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.