1stOncology™: Cancer Intelligence Service – Page 6496 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ITI to present at the BIO CEO & Investor Conference 2022

On February 11, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy reported that the company will be presenting at the upcoming 2022 BIO CEO & Investor Conference being held at the Marriott Marquis in NYC on February 14-15 and virtually through the 17th (Press release, Immunomic Therapeutics, FEB 11, 2022, View Source [SID1234608012]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Bob Newman, ITI’s Chief Business Officer, will deliver a presentation titled, "Pioneering the Next Generation of Immunotherapies" discussing ITI’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). ITI’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

Hosted annually by the Biotechnology Innovation Organization (BIO) for over 20 years, the conference is focused on emerging public and private companies, offering a meeting place for institutional investors, industry analysts, and senior biotech executives. The conference draws biotech companies looking to make the connections needed to take their products to the next phase.

Presentation details are as follows:

Who: Bob Newman, Chief Business Officer of Immunomic Therapeutics, Inc.

What: Pioneering the Next Generation of Immunotherapies

Registered attendees may access the presentation here: https://bit.ly/3HIAh9b

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP1), an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

Nykode Therapeutics announces completion of patient enrollment in its Phase 2 trial of VB10.16 in combination with atezolizumab for the treatment of advanced cervical cancer

On February 11, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported the completion of patient enrollment in the Phase 2 study of VB10.16, Nykode’s lead cancer vaccine candidate, in combination with Roche’s checkpoint inhibitor atezolizumab for the treatment of advanced cervical cancer (Press release, Nykode Therapeutics, FEB 11, 2022, View Source [SID1234608011]). VB10.16 is a potentially first-in-class off-the-shelf therapeutic HPV16 cancer vaccine designed to induce strong HPV16 specific T cell responses for the treatment of HPV16-positive cancers.

"We are pleased to report the completion of patient enrollment in our ongoing Phase 2 trial of VB10.16, our wholly owned product candidate for the treatment of cervical cancer," said Michael Engsig, CEO of Nykode Therapeutics. "This is an important inflection point for Nykode as we advance our lead candidate through the clinic. After successfully enrolling 50 patients across trial sites in six countries, we look forward to reporting interim efficacy and safety data from the first patients in the first half of 2022. In parallel, we are exploring the possibility of evaluating VB10.16 in other HPV-driven cancers, including head and neck cancer."

VB C-02 is a multi-center, open-label Phase 2 trial of patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. Almost 20 European sites in six European countries were engaged in enrolling patients in the trial. Nykode has previously reported positive interim safety data from the trial.

Siri Torhaug, Chief Medical Officer of Nykode Therapeutics, commented: "Cervical cancer is a leading cause of death for women. It is an indication which continues to have a high unmet medical need with limited response to standard of care treatment in an advanced setting. We are very happy to have reached this important milestone for our lead cancer vaccine VB10.16 and look forward to continuing the development program. We are thankful for the patients, their families, the investigators and the trial site personnel who have made this trial possible."

Additional information about the Phase 2 trial is available at clinicaltrials.gov (NCT04405349).

Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2021 Financial Results and Provides Financial Expectations for Fiscal 2022

On February 11, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the fourth quarter and fiscal year ended December 31, 2021 and provided financial guidance for 2022 (Press release, Neurocrine Biosciences, FEB 11, 2022, View Source [SID1234608010]).

"As we exited last year with restored growth for INGREZZA, investments we are making this year will further accelerate our ability to help many more patients with tardive dyskinesia who remain undiagnosed and untreated. Additionally, we now have 12 clinical programs in mid-to-late-stage studies, many which will generate important data readouts over the next two years," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With a blockbuster product in INGREZZA, a novel and diverse pipeline, and a strong balance sheet, Neurocrine Biosciences is uniquely positioned to be a leading neuroscience-focused company."

Fourth Quarter and Fiscal 2021 INGREZZA Net Product Sales and Commercial Highlights:

INGREZZA fourth quarter and fiscal 2021 net product sales of $301 million and $1.1 billion, respectively
Fourth quarter 2021 INGREZZA net sales and total prescriptions grew 25% and 32%, respectively, vs. fourth quarter of 2020
Quarterly growth driven by record number of patients on therapy exiting 2021
Commercial expansion to better meet the needs of healthcare professionals across diverse sites of care on track for completion by the end of Q1 2022
Financial Highlights:

Fourth quarter 2021 GAAP net loss and loss per share of $7 million and $0.08, respectively, compared with fourth quarter 2020 GAAP net income and diluted earnings per share of $348 million and $3.58, respectively, primarily driven by a non-cash tax benefit of $296 million related to the release of substantially all of the Company’s valuation allowance against its deferred tax assets on December 31, 2020
Fourth quarter 2021 non-GAAP net income and diluted earnings per share of $4 million and $0.04, respectively, compared with $87 million and $0.89, respectively, for fourth quarter 2020
Differences in fourth quarter 2021 GAAP and non-GAAP financial results compared with fourth quarter 2020 driven by:
In-Process Research and Development (IPR&D) associated with a $100 million upfront fee paid to Sosei Heptares pursuant to our exclusive license agreement
Increased R&D expense in support of our expanded and advancing portfolio, including investment in in-licensed programs in epilepsy and psychiatry commencing at the end of 2019 and in mid-2020, respectively
Increased SG&A expense primarily due to increased investment in commercial initiatives including the launch of our INGREZZA direct-to-consumer advertising campaign, "TD Spotlight"
No cash payments for federal income tax were made in 2021 as the Company offset pre-tax income against previously benefited Federal net operating losses (NOLs)
At December 31, 2021, the Company had cash, cash equivalents and marketable securities of $1.3 billion
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Recent Events:

In December 2021, the Company completed a strategic partnership with Sosei Heptares to expand its clinical psychiatry pipeline. The $100 million upfront fee paid to Sosei Heptares pursuant to our exclusive license agreement was expensed as IPR&D in fiscal 2021.
In the fourth quarter of 2021, the Company announced positive top-line data from the Phase III KINECT-HD study evaluating the efficacy, safety and tolerability of valbenazine in 120 adult patients with chorea in Huntington disease, also known as Huntington chorea. The study met the primary endpoint of reduction in severity of chorea. The Company plans to submit a supplemental new drug application for valbenazine for the treatment of Huntington chorea with the FDA in the second half of 2022.
In February 2022, the Company entered into a lease agreement for a four-building campus facility to be constructed in San Diego, California, pursuant to which a 6-year option for the construction of a fifth building and an option to purchase the entire campus facility in the future were also secured. Upon completion of construction, the Company expects to utilize the campus facility as its new corporate headquarters, which will consist of office space and R&D laboratories. The Company expects to begin subleasing its existing leased facilities beginning in 2023.

Based upon Federal NOL’s and tax credits, the Company expects to make minimal cash payments for Federal income tax beginning in the fourth quarter of 2022.

Key: VMAT2 = Vesicular Monoamine Transporter 2; CaV = Calcium Channel, Voltage-Gated; CSWS = Epileptic Encephalopathy with Continuous Spike and Wave During Sleep; M4= M4 Muscarinic Receptor; CFR1 = Corticotropin-Releasing Factor Type 1; AMPA = Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid; GPR = Orphan G Protein Coupled Receptor; NaV1.6 = Sodium Channel, Voltage-Gated
Neurocrine Bioscience Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in East Asia;
** In-Licensed from Idorsia Pharmaceuticals; † In-Licensed from Sosei Group Corporation; ‡ Partnered with Takeda Pharmaceutical Company Limited; ∝ In-Licensed from Xenon Pharmaceuticals

Conference Call and Webcast Today at 8:00 AM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

BIO-TECHNE TO PRESENT AT THE 11th ANNUAL SVB LEERINK GLOBAL HEALTHCARE CONFERENCE

On February 11, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the 11th Annual SVB Leerink Global Healthcare Conference on Thursday, February 17, 2022, at 9:20 a.m. EST (Press release, Bio-Techne, FEB 11, 2022, View Source [SID1234608009]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

Ipsen presents strong full-year 2021 results and enters into exclusive negotiations to divest its Consumer Healthcare business

On February 11, 2022 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its financial results for FY 2021 and provides an update on the strategic review of its CHC business (Press release, Ipsen, FEB 11, 2022, View Source [SID1234608007]).

David Loew, Chief Executive Officer, commented:

"The strong results in 2021 are aligned with our strategic intent, with improving levels of commercial execution reflecting in excellent performances from every major brand. As the replenishment of our pipeline gathered pace, it was an exciting year for business development and our key clinical programs. Furthermore, sharpening our focus on Specialty Care, I am pleased that we have entered into exclusive negotiations to divest our Consumer Healthcare business.

We will continue to grow our business in 2022, and beyond, through our core and innovative brands as we manage the gradual erosion of Somatuline while in addition, supporting growth through external innovation. Based on our strategy and our improved execution, we are pleased to update our mid-term outlook, underpinning the strength of Ipsen’s growth story built on our culture and an unrelenting focus on patients."

Exclusive negotiations to divest the Consumer Healthcare business
Following the decision of its Board of Directors held on 10 February 2022, Ipsen has entered into exclusive negotiations with Mayoly Spindler for the divestment of its global CHC business. This is a major step forward in the Company’s execution of its strategic roadmap presented in December 2020 towards building a more-focused Ipsen, centring on Specialty Care.

The combination of Ipsen’s and Mayoly Spindler’s respective CHC businesses will create a global consumerhealthcare platform with a critical size and the capacity to support its growth. The consideration for Ipsen’s CHC business represents an enterprise value of €350m, including an earnout contingent payment of €50m.

The proposed transaction will be submitted to the relevant employee-representation bodies and is expected to close before the end of Q3 2022, subject to regulatory approvals and customary closing conditions.

Delivering on strategy
Ipsen delivered successfully on its first year of the implementation of its strategy: Focus. Together. For patients and society. The key Specialty Care brands grew across all geographies, and alongside its expanding footprint in 2021, Ipsen began to invest in, and prepare for, a number of future launches.

It was a strong year of advancement of key R&D programs in Oncology, Rare Disease and Neuroscience, enhanced by the completion of seven external-innovation agreements. Ipsen also initiated a global program to drive efficiencies across the entire cost base, which started to deliver savings in 2021.

Further accomplishments were made in the Company Social Responsibility agenda, across the pillars of Employees, Communities and Environment. Ipsen increased the proportion of female leaders, now representing 42% of the full Global Leadership Team. Ipsen also announced the halving of absolute greenhouse-gas emissions of facilities and fleet (Scopes 1 and 2) by 2030, and will work closely with partners to deliver science-based Scope 3 emissions reductions by 2030.

Those achievements were the result of Ipsen’s evolving culture, underpinned by the strengthening of the Executive Leadership Team and the establishment of an asset-centric model. These successes provide excellent platforms for a culture of high performance, improved execution and a better and faster decision-making process.

Comparison of 2021 performance to guidance
Ipsen exceeded its full-year 2021 guidance, upgraded in October 2021:

FY 2021 guidance FY 2021 actuals
Total-sales growth Greater than 11.0%3 12.3%6
Core operating margin Around 34% 35.2%

Full-year 2022 guidance
Ipsen has set its financial guidance for FY 2022, excluding any contribution from the CHC business4:

Total-sales growth greater than 2.0%, at constant currency. Based on the level of exchange rates in January 2022, Ipsen anticipates an additional favorable impact of 2% from currencies
Core operating margin greater than 35.0% of total sales, excluding any potential impact of incremental investments from future external-innovation transaction
This guidance incorporates expectations for Somatuline of further launches of generic lanreotide in other countries in the E.U., as well as increased competition in the U.S.

Update of mid-term 2020-24 outlook
Ipsen today updates its outlook for 2020-24 to exclude any contribution from the CHC business5 and based on the strong performance delivered in 2021:

Total-sales 2020-24 compound annual growth rate between +4% and +6%6 at constant currency and assuming risk-adjusted potential additional indications
Continued commitment to invest in R&D supported by SG&A efficiencies:
Reduced SG&A expenses as a percentage of total sales, driven by further focus and optimization
Higher R&D expenses as a percentage of total sales, driven by the external-innovation strategy
To support the external-innovation strategy, Ipsen anticipates cumulative remaining firepower of €3.5bn by 2024, including the divestment of the CHC business. The calculation is based on net debt at 2.0 x EBITDA.

Palovarotene
In January 2022, Ipsen announced the first regulatory approval for palovarotene worldwide with Health Canada approving SohonosTM (palovarotene capsules). Ipsen plans to make a resubmission for palovarotene in fibrodysplasia ossificans progressiva to the U.S. FDA in H1 2022 and to continue the review process with the European Medicines Agency after the ‘clock-stop’ period. Discussions are progressing with other regulatory authorities around the world.

Basis of preparation for reported Financial Statements including the CHC business as continuing operations. 5 Earnings per share.
At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
At CER, which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
Assuming presentation of the CHC business as discontinued operations starting in 2022 and comparing to the FY 2021 operating performance excluding the contribution of the CHC business (as presented in the section ‘Core Measures excluding contribution from CHC’ thereafter).
Assuming presentation of the CHC business as discontinued operations starting in 2022 and comparing to the FY 2020 operating performance, excluding the contribution from the CHC business (as presented in the section ‘Core Measures excluding contribution from the CHC business’ thereafter).
Prior outlook, outlined in December 2020, included a total-sales 2020-24 compound annual growth rate of 2% to 5% at CER.