Annual financial results as of 31 December, 2021

On April 29, 2022 AB Science SA (Euronext-FR0010557264-AB) reported its revenues for the year 2021 and provides an update on its activities (Press release, AB Science, APR 29, 2022, View Source [SID1234613221]).

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CLINICAL DEVELOPMENT KEY EVENTS DURING THE YEAR 2021 AND SINCE DECEMBER 31, 2021

Authorization by Health Canada to file a New Drug Submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the Notice of Compliance with Conditions (NOC/c) policy AB Science announced that Health Canada has granted authorization to file a New Drug Submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the Notice of Compliance with Conditions (NOC/c) policy.

If granted, an NOC/c is authorization to market a drug with conditions. Such conditions will be discussed with Health Canada during the procedure. An assessment named Advance Consideration, performed by a Health Canada Adjudicating Committee, is necessary before being granted authorization to file under NOC/c policy. This assessment was made based on a pre-submission package sent by AB Science including, efficacy data of study AB10015, long-term survival data (75 months average follow-up from diagnosis) of study AB10015, and safety data. An estimated 3,000 Canadians are currently living with ALS. Each year approximately 1,000 Canadians die from ALS.

A similar number of Canadians are diagnosed with ALS each year. Publication of new long-term data showing that masitinib extended survival in amyotrophic lateral sclerosis by 25 months, provided that treatment starts early in disease course The survival analysis followed all patients originally randomized in study AB10015 for an average duration of 75 months from the date of diagnosis. In ALS patients with mild or moderate disease severity at baseline, it was seen that treatment with 4.5 mg/kg/day masitinib as an add-on to standard riluzole prolonged survival by 25 months relative to those treated with riluzole alone, with a 44% reduced risk of death. Patients with mild or moderate disease severity correspond closely to the patient cohort enrolled in confirmatory phase 3 study, AB19001. This new survival data has been published in in the peer-reviewed journal Therapeutic Advances in Neurological Disorders.Continuation of the development program in Covid-19 and recommendation without restriction of the Data and Safety Monitoring Board to continue study AB20001 for hospitalized moderate patients AB Science has initiated the continuation of a development program in the treatment of Covid-19, with on the one hand a non-clinical part, with the signing of an exclusive license agreement with the University of Chicago to carry out research on the prevention and treatment of humans infected with nidoviruses, coronaviruses and picornaviruses, and on the other hand the initiation of a second phase 2 study in the treatment of Covid-19. The Phase 2 study (AB21002) evaluates the antiviral efficacy of masitinib at 3 different dosages, administered as an add-on to best supportive care, with respect to placebo plus best supportive care.

The study is planned to recruit 78 patients (over 18 years of age with no upper age limit). The primary efficacy objective will be to demonstrate that masitinib can reduce the viral load of SARS-CoV-2 (the virus responsible for COVID-19) faster than a placebo control group, which will receive best supportive care. The population of study AB21002 therefore targets ambulatory (non-hospitalized) patients with mild disease or hospitalized patients without requirement for non-invasive ventilation (a score of 4 and 5 on the WHO clinical progression scale for COVID-19). 3 A second randomized (1:1), open-label, phase 2 study (AB20001) is ongoing and evaluates the safety and efficacy of masitinib plus isoquercetin in hospitalised patients with moderate COVID-19 (WHO 7-point ordinal scale level 4) or severe COVID-19 (level 5). The study is planned to recruit 200 patients (over 18 years of age with no upper age limit). The Data and Safety Monitoring Board (DSMB) recommended without restriction to continue the study in hospitalized patients with moderate oxygen requirements. In line with this recommendation, AB Science has made the decision to continue the study in moderate patients only. The study is therefore now planned to include 200 patients with score of 4 on the WHO clinical progression scale. Launch of a confirmatory Phase 3 study with masitinib in progressive forms of multiple sclerosis AB Science announced that it has been authorized by the French Medicine Agency, ANSM, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS). The study will enroll 800 patients from numerous study centers with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 and absence of T1 Gadolinium-enhancing brain lesions as measured by magnetic resonance imaging (MRI). The primary objective of the study will be to evaluate the effect of masitinib on time to confirmed disability progression, with progression defined as 1-point worsening when EDSS baseline score ≤5.5, or 0.5 if baseline score >5.5 from randomization to week 96. This confirmatory study follows successful completion of a first Phase 2B/3 study (AB07002) in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis. Results from that study were presented during the 8th Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) – European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Meeting (MSVirtual2020). The study met its primary analysis endpoint, demonstrating a statistically significant reduction in cumulative change on EDSS with masitinib 4.5 mg/kg/day (p=0.0256).

Positive results of Phase 3 clinical study with masitinib in Prostate Cancer Masitinib Phase 3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy met its predefined primary endpoint. The study results were presented at the American Urological Association (AUA) 2021 Annual Meeting, held on September 10-13, 2021. Validation by Health Authorities of a new risk management plan for masitinib In July 21, AB Science announced the resumption of patient enrollment in its ongoing studies. This resumption follows the decision in June 2021 to voluntarily suspend the inclusion of new patients in clinical studies with masitinib after the detection of a potential risk of ischemic heart disease with masitinib.

AB Science implemented a risk management plan to reinforce patient safety, which allowed the resumption of patient enrollment. Launch of a Phase 2 study with masitinib in patients with severe mast cell activation syndrome (MCAS) AB Science announced that its Phase 2 study with masitinib in patients with mast cell activation syndrome (MCAS) has been approved by the U.S. Food and Drug Administration (FDA). The study will enroll 60 patients from numerous study centers. The treatment objective in severe MCAS is to reduce symptoms (pruritus, flush, depression) and improve impaired quality-of-life. MCAS is a disease caused by inappropriate activation of mast cells, which can lead to mast cell mediator release symptoms with a severity ranging from mild to life-threatening. Because masitinib has been designed to be a potent inhibitor of mast cell activation (through its action against wild-type c-Kit, Lyn and Fyn tyrosine kinases), it is uniquely well-suited for the treatment of severe MCAS, unlike other c-Kit tyrosine kinase inhibitors that typically target specific c-Kit mutations that are associated with systemic mastocytosis. The study was also approved by the French agency in January 2022. 4 Launch of a Phase 1/2 study with AB8939 in acute myeloid leukemia AB Science announced that its clinical trial with AB8939 in adult patients with relapsed/refractory acute myeloid leukemia (AML) has been approved by Health Canada. AB8939 is a new generation synthetic microtubule destabilizer with the ability to overcome multidrug resistance and the potential for broad applicability as a potent anticancer drug.

The therapeutic potential of AB8939 has been demonstrated by preclinical results. In vivo data in a mouse model showed that AB8939, administered alone or in combination with Ara-C, increased survival compared to Ara-C alone. AB8939 was entirely discovered by the laboratories of AB Science, which retains full ownership of intellectual rights, and is an example of AB Science’s focus on innovative drug development focused on improving patients’ lives. CONSOLIDATED FINANCIAL INFORMATION FOR THE YEAR 2021 The operating loss as of 31 December 2021 corresponds to a loss of €13,808K, compared to a loss of €14,749K as of 31 December 2020, i.e. a decrease in the operating loss of €941K (6.4%).

-Operating income, exclusively made up of sales related to the operation of a veterinary medicine, was stable compared to 31 December 2020 and amounted to €1,607K.
-Operating expenses amounted to €15,415K as of 31 December 2021 compared to €16,332K as of 31 December 2020, a decrease of 5.6%.-Marketing expenses amounted to €493K as of 31 December 2021 compared to €781K as of 31 December 2020, a decrease of 36.9%.
-Administrative expenses increased by 35.48%, from €2,641K as of 31 December 2020 to €3,578K as of 31 December 2021. This increase is mainly due to the recognition of a provision relating to a penalty from the French Market Regulator of €1 million.
-Research and development expenses decreased by 12.5% compared to 31 December 2020 (€12,841K as of 31 December 2020 versus €11,233K as of 31 December 2021). This variation is explained by the end of a number of studies where masitinib is being developed, which has led to a decrease in clinical costs (clinical partners, hospitals, laboratories, etc.).

The financial result as of 31 December 2021 is a loss of €618K compared to a loss of €289K a year earlier. The loss of €618K is mainly due to the recognition of the discounting of conditional advances (representing a loss of €1,262K) and the change in fair value of financial liabilities (gain of €703K). These effects generate non-recurring and non-cash results. The net loss as of 31 December 2021 was €14,463K compared to €15,045K as of 31 December 2020. The following table summarizes the consolidated financial statements for the year 2021 prepared in accordance with IFRS, and comparative information with the year 2020OTHER CORPORATE INFORMATION FOR YEAR 2021 AND SINCE DECEMBER 31, 2021State-guaranteed loan (PGE) AB Science has obtained in March and April 2021 the agreement of Société Générale, Bpifrance and Banque Populaire for a total of 6 million euros in financing in the form of a state-guaranteed loan (PGE-prêt garanti par l’État), in the context of the COVID-19 pandemic. Each bank provided a loan of 2 million euros.

This loan is 90% guaranteed by the French State, with an initial maturity of 12 months and an extension option of up to five years, exercisable by AB Science. Agreement with historical shareholders and implementation of a joint strategy to increase the value of masitinib including financing for 12 to potentially 36 months and search for a licensing agreement AB Science announced that it has signed an agreement with historical shareholders to implement a joint strategy to increase the value of masitinib. Under this agreement, these historical shareholders, representing today 8.7% of the company’s share capital, undertake to act in concert with the founding shareholders of AB Science in order to: study strategies to optimize the value of masitinib, in particular in the context of a potential strategic alliance with one or several pharmaceutical company(ies) for the clinical development and commercialization of masitinib in one or more major indication(s), and/or in one or more major region(s); and study the opportunity of listing AB Science on a foreign market, in particular the NASDAQ (through an American Depository Receipts program).

The agreement will be implemented subject to the condition of obtaining a final exemption decision from the French Autorité des Marchés Financiers, free and clear of any appeal, confirming that there is no need for a public offer. This agreement also includes the signature of a firm financing option for an amount of €25 million over the next 12 months, at the initiative of AB Science. These financings will have to be carried out within the framework of the "private placement" or "capital increase reserved for categories of persons" resolutions that are currently in place. With this agreement, AB Science’s financial visibility is extended 6 beyond 24 months. This funding commitment may be increased by an additional 50 million euros, at the rate of 25 million euros per year from the first anniversary date, subject to a clause of absence of significantly unfavorable event.

Finally, this agreement includes a lock-up by certain minority shareholders on 1.8 million shares for a period of three years (or until the implementation of the value enhancement strategy if this occurs before the end of the three-year period). Financing of USD 8.5 million through the issuance of bonds with attached warrants AB Science reached an agreement with a historical investor on a financing of USD 8.5 million through the issuance of bonds convertible into new ordinary shares with attached warrants (OCABSA). 50,000 OCABSA will be issued, representing a nominal value of USD 8.5 million. It will reinforce the cash position of AB Science for the development of its clinical research program. 50,000 convertible bonds will be issued at their par value of USD 170,0 each (the "PV"), representing a total par value of USD 8.5 million. Decision of the Enforcement Committee of the French market regulator (AMF) following the investigation relating to the financial information and the market for AB Science shares, opened in September 2021 On March 24, 2022, the AMF Enforcement Committee ruled that there was no privileged information, neither at the time of the two capital increases carried out by AB Science on March 24 and 27, 2017, nor at the time Alain Moussy sold a part of his shares on March 31, 2017.

The AMF Enforcement Committee therefore completely exonerated Alain Moussy, prosecuted for insider trading, and found that AB Science had not failed to comply with its disclosure obligations at the time of these capital increases in March 2017. The AMF Enforcement Committee nevertheless considered that AB Science should have communicatedas early as April 7, 2017 the high probability of a negative opinion from the European Medicine Agency (EMA) on the marketing authorization application for masitinib for the treatment of mastocytosis and ordered AB Science to pay the sum of one million euros. In application of its internal procedures, AB Science had nevertheless put in place a deferral of privileged information from this date of April 7, 2017, considering that the delay in communication was in the interest of the Company and in line with industry practices of not communicating before the final vote of the CHMP, or else withdrawing the registration dossier, which AB Science had no intention to do.Given this difference in assessment concerning a technical point relating to one of the criteria for the deferred communication of privileged information, as well as the amount of penalty, AB Science has decided to appeal to the Paris Court of Appeal.

In accordance with Article R. 621-44 of the Monetary and Financial Code, this appeal must be lodged within two months of notification of the AMF Enforcement Committee’s decision, i.e. by 31 May 2022. Changes in the Board of Directors AB Science has announced the reorganization of its Board of Directors with the co-optation of four new independent directors, Cécile de Guillebon, replacing Nathalie Riez, Catherine Johnston-Roussillon, replacing Emmanuel Mourey, Guillemette Latscha, replacing Béatrice Bihr, and Renaud Sassi, replacing Jean-Pierre Kinet. Shareholders’ agreements expiring in 2021 Some agreements expire in 2021. All these agreements are described in chapter 8.5 of the annual financial report as of December 31, 2021. Other events Other securities transactions During the year 2021, 138, 000 stocks options and 1,921,845 share subscription warrants were granted. Other information Covid-19 pandemic 7 In 2021, the COVID-19 pandemic had a very limited impact on AB Science’s clinical development program, as this crisis occurred at a time when most of AB Science’s clinical studies were completed and confirmatory studies had not yet started. The integrity of the study data is not affected by the pandemic. No treatment interruptions or deaths due to COVID-19 have been observed. At the employee level, the activity of all employees was maintained in 2021.

Considerations arising from the Russia-Ukraine war Russia launched invasion of Ukraine in February 2022, which, alongside humanitarian concerns, may also have an impact on the health research ecosystem in the form of delays in the conduct of clinical trials. At the date of publication of the December 31, 2021 annual report, there were no significant delays or impacts on the studies monitored in Russia and Ukraine. PEA-PME eligibility AB Science confirms its eligibility for PEA-PME (a share savings plan aimed at providing finance to SMEs) in accordance with decree no. 2014-283 of 4 March 2014 taken for the application of article 70 of law no. 2013-1278 of 29 December 2013 of finance for 2014 fixing the eligibility of companies for PEA-PME, i.e. less than 5,000 employees on the one hand, an annual turnover of less than 1,500 million euros or a total balance sheet of less than 2,000 million euros, on the other hand.

Coherus BioSciences to Report First Quarter 2022 Financial Results on May 5th, 2022

On April 29, 2022 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that its first quarter 2022 financial results will be released after the close of the United States financial markets on Thursday, May 5th, 2022 (Press release, Coherus Biosciences, APR 29, 2022, View Source [SID1234613212]). Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call and webcast to discuss financial results and provide a general business update.

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After releasing first quarter 2022 financial results, the Company will post them on the Coherus website at View Source

Webcast: View Source

Please dial-in 15 minutes early to ensure a timely connection to the call. A replay of the webcast will be archived on the Coherus website for 30 days.

Quarterly Activities Report and 4C to 31 March 2022

On April 29, 2022 Avecho (ASX:AVE) reported its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 March 2022 (Press release, Phosphagenics, APR 29, 2022, View Source [SID1234613211]).

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Key highlights from this period include:

Completion of Phase II Clinical Trial examining its proprietary topical cannabidiol (CBD) gel for the management of pain associated with arthritis of the hand;
First licensing and supply agreement for the use of TPM in the US recreational cannabis space;
TGA feedback on Phase III CBD soft-gel program and completion of initial Phase III Clinical Trial design;
Avecho’s cash balance on 31 March was $3.265m.

Throughout the Quarter, the Company has remained heavily focused on advancing its CBD soft-gel product, whilst also pursuing large, untapped licensing opportunities in the US cannabis space.

Avecho CEO, Dr Paul Gavin, said:

"The data we have generated across our expanded cannabinoid program is beginning to pay dividends. Our deep biotechnology expertise and experience in non-cannabinoid drug development is seen as a major differentiator to medicinal cannabis companies for potential licensees. We are focused on expanding our business development activities with the aim of closing further deals in the various cannabinoid markets"

AbbVie Reports First-Quarter 2022 Financial Results

On April 29, 2022 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2022 (Press release, AbbVie, APR 29, 2022, View Source [SID1234613210]).

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"This year is off to a strong start. Our first quarter results highlight the diversity of our portfolio and include compelling performance from key growth drivers Skyrizi, Rinvoq, Aesthetics and Neuroscience," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Our momentum combined with ramping contributions from new products and new indications will drive accelerating revenue and EPS growth through the rest of the year."

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

1 Beginning in the first quarter 2022, AbbVie includes the impact of upfront and milestone payments related to collaborations, licensing agreements and other asset acquisitions in its reported non-GAAP financial measures.

First-Quarter Results

Worldwide net revenues were $13.538 billion, an increase of 4.1 percent on a GAAP basis, or 5.4 percent on an operational basis.

Global net revenues from the immunology portfolio were $6.141 billion, an increase of 6.9 percent on a reported basis, or 8.1 percent on an operational basis.
Global Humira net revenues of $4.736 billion decreased 2.7 percent on a reported basis, or 1.8 percent on an operational basis. U.S. Humira net revenues were $3.993 billion, an increase of 2.2 percent. Internationally, Humira net revenues were $743 million, a decrease of 22.6 percent on a reported basis, or 17.9 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $940 million, an increase of 63.7 percent on a reported basis, or 65.6 percent on an operational basis.
Global Rinvoq net revenues were $465 million, an increase of 53.6 percent on a reported basis, or 57.3 percent on an operational basis.
Global net revenues from the hematologic oncology portfolio were $1.646 billion, a decrease of 1.6 percent on a reported basis, or 0.6 percent on an operational basis.
Global Imbruvica net revenues were $1.173 billion, a decrease of 7.4 percent, with U.S. net revenues of $874 million and international profit sharing of $299 million.
Global Venclexta net revenues were $473 million, an increase of 16.9 percent on a reported basis, or 21.1 percent on an operational basis.
Global net revenues from the neuroscience portfolio were $1.488 billion, an increase of 19.2 percent on a reported basis, or 20.4 percent on an operational basis.
Global Botox Therapeutic net revenues were $614 million, an increase of 15.4 percent on a reported basis, or 16.6 percent on an operational basis.
Vraylar net revenues were $427 million, an increase of 23.4 percent.
Global Ubrelvy net revenues were $138 million.
Global net revenues from the aesthetics portfolio were $1.374 billion, an increase of 20.5 percent on a reported basis, or 22.5 percent on an operational basis.
Global Botox Cosmetic net revenues were $641 million, an increase of 34.4 percent on a reported basis, or 36.6 percent on an operational basis.
Global Juvederm net revenues were $410 million, an increase of 27.5 percent on a reported basis, or 30.9 percent on an operational basis.
On a GAAP basis, the gross margin ratio in the first quarter was 70.1 percent. The adjusted gross margin ratio was 84.5 percent.
On a GAAP basis, selling, general and administrative expense was 23.1 percent of net revenues. The adjusted SG&A expense was 21.1 percent of net revenues.
On a GAAP basis, research and development expense was 11.1 percent of net revenues. The adjusted R&D expense was 10.9 percent of net revenues.
Acquired IPR&D and milestones expense was 1.1 percent of net revenues.
On a GAAP basis, the operating margin in the first quarter was 34.8 percent. The adjusted operating margin was 51.4 percent, which includes an unfavorable 110 basis point impact from acquired IPR&D and milestones expense.
Net interest expense was $539 million.
On a GAAP basis, the tax rate in the quarter was 8.8 percent. The adjusted tax rate was 12.1 percent.
Diluted EPS in the first quarter was $2.51 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.16. These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib, 45 mg (induction dose) and 15 mg and 30 mg (maintenance dose)) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The approval is supported by data from two Phase 3 induction studies and one maintenance study. In these studies, significantly more patients treated with Rinvoq achieved the primary and all secondary endpoints compared to placebo. The safety of Rinvoq, including the 45 mg dose as induction therapy, in these studies was generally consistent with the known safety profile of Rinvoq, with no new important safety risks observed. This approval marks the first indication for Rinvoq in gastroenterology and represents Rinvoq’s fourth FDA approved indication.
AbbVie announced positive top-line results from the Phase 3 induction study U-EXCEL, which showed Rinvoq (45 mg, once daily) achieved both primary endpoints of clinical remission and endoscopic response, compared to placebo at week 12, as well as most key secondary endpoints in patients with moderate to severe Crohn’s disease (CD). The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. U-EXCEL is the second of two Phase 3 induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate to severe CD and full results will be presented at upcoming medical conferences and published in a peer-reviewed journal. Positive top-line results from the Phase 3 portion of the first induction study, U-EXCEED, were announced in December 2021 and the maintenance study for both clinical trials is ongoing.
AbbVie announced that the FDA extended the review period for Skyrizi (risankizumab) for the treatment of moderate to severe CD by three months to review additional data submitted by AbbVie, including information about the on-body injector. Currently approved indications for Skyrizi were not affected by this extension. Skyrizi is a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
AbbVie announced that it resolved all U.S. Humira (adalimumab) litigation with Alvotech. Under the terms of the resolution, AbbVie will grant Alvotech a non-exclusive license to its Humira-related patents in the U.S., which will begin on July 1, 2023. AbbVie will make no payments of any form to Alvotech, and Alvotech will pay royalties to AbbVie for licensing its Humira patents and acknowledges the validity and enforceability of the licensed patents. The resolution included dismissal of the patent and trade secret litigation between AbbVie and Alvotech.
At the Congress of European Crohn’s and Colitis Organization (ECCO), AbbVie shared 26 abstracts, including 16 oral and digital oral presentations, that reinforced AbbVie’s commitment to research that helps advance standards of care for inflammatory bowel disease (IBD) patients. Highlights included new post-hoc analyses from the pivotal Phase 3 Skyrizi program in CD as well as results from a post-hoc analysis of Phase 3 Rinvoq pivotal trials evaluating UC symptoms.
At the American Academy of Dermatology (AAD) Annual Meeting, AbbVie and Allergan Aesthetics presented new research that demonstrated their shared commitment to advancing science across a spectrum of dermatologic conditions and aesthetic indications. The research included new data on the efficacy, durability and safety of Rinvoq and Skyrizi as well as data from across the Allergan Aesthetics portfolio.
AbbVie and Genmab announced topline results from the first cohort of the EPCORE NHL-1 phase 1/2 clinical trial evaluating epcoritamab (DuoBody-CD3xCD20) in patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy. Results from this cohort demonstrated a confirmed overall response rate (ORR) of 63.1 percent with a 12-month median duration of response. Based on the topline results, the companies will engage global regulatory authorities and data from the clinical trial will be presented at a future medical meeting. Epcoritamab is being co-developed by AbbVie and Genmab.
At the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, AbbVie presented positive results from a Phase 2 trial evaluating navitoclax in combination with ruxolitinib in patients with myelofibrosis that previously had a suboptimal response or disease progression with ruxolitinib monotherapy. The study evaluated 34 patients and median overall survival was not reached for patients who had a ≥ 1 grade improvement in bone marrow fibrosis (BMF) or ≥ 20% variant allele frequency (VAF) reduction. Additionally, at the time of analysis with > 2 year follow up, the survival estimate was 100% in patients who had improvements in BMF or VAF.
AbbVie announced that it submitted a supplemental New Drug Application (sNDA) to the FDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder (MDD). The submission is based on clinical trial results that showed clinically and statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score in patients with MDD treated with Vraylar and an antidepressant. If approved, this milestone will be the fourth indication for Vraylar joining approvals for the treatment of adults with schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of depressive episodes associated with bipolar I disorder. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc.
AbbVie announced that the Phase 3 PROGRESS trial evaluating Qulipta (atogepant), an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the preventive treatment of chronic migraine in adults, met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo, for both the 60 mg once daily (QD) and 30 mg twice daily (BID) doses, across the 12-week treatment period. The study also demonstrated statistically significant improvement in all secondary endpoints and the overall safety profile of Qulipta was consistent with safety findings observed in previous studies with an episodic migraine population. Data from this study will support a submission to expand the use of Qulipta to include preventive treatment of chronic migraine in the U.S. and additional submissions globally.
At the American Academy of Neurology (AAN) Annual Meeting, AbbVie shared 30 abstracts demonstrating the breadth of its neuroscience portfolio. The abstracts highlighted AbbVie’s continued migraine treatment research across the spectrum of the disease, AbbVie’s commitment to patients with advanced Parkinson’s disease and new studies in spasticity and cervical dystonia.
AbbVie and Gedeon Richter Plc. (Richter) announced a new co-development and license agreement to research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. The collaboration is based on the results of preclinical research carried out by Richter and includes several new chemical entities selected for development. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as Vraylar.
AbbVie announced the successful completion of its acquisition of Syndesi Therapeutics SA. The acquisition gives AbbVie access to Syndesi’s portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118, which is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and MDD.
Allergan Aesthetics announced that the FDA approved Juvederm Volbella XC for improvement of infraorbital (undereye) hollows in adults over the age of 21. With this approval, Juvederm Volbella XC became the first and only dermal filler to receive FDA approval for the improvement of infraorbital hollows.
At the Aesthetic and Anti-aging Medicine World Congress (AMWC), Allergan Aesthetics presented research that demonstrated its commitment to the future of aesthetics with a forward-facing trends report. The meeting also marked Allergan Aesthetics’ entry into the emerging category of Hybrid Injectables with the launch of HArmonyCa with lidocaine across Europe. The dual-effect Hybrid Injectable contains two active ingredients, hyaluronic acid, a well-known ingredient found in facial fillers, and calcium hydroxyapatite (CaHA), which is known to help stimulate collagen production.
AbbVie announced positive results from the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with age-related blurry near vision (presbyopia). Additional details of this trial will be presented at future medical congresses and will serve as the basis for a sNDA submission for an optional twice-daily administration to the FDA in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, Vuity is the first and only eye drop to treat age-related blurry near vision in adults.
At the American Glaucoma Society (AGS) Annual Meeting and the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, AbbVie presented data from its leading portfolio of eye care treatments. Highlights included updated analyses that help further scientific understanding of Durysta (bimatoprost intracameral implant), a first-of-its-kind biodegradable implant to lower eye pressure for glaucoma patients; new data on the Xen Gel Stent, a surgical implant designed to lower high eye pressure approved for refractory glaucoma patients; and new data on Vuity 1.25%.
AbbVie and Scripps Research, an independent, non-profit biomedical research and drug discovery institute, announced a global collaboration to develop potential novel, direct-acting antiviral treatments for COVID-19.
Full-Year 2022 Outlook

AbbVie is updating its adjusted diluted EPS guidance range for the full-year 2022 from $14.00 – $14.20 to $13.92 – $14.12 which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2022. The company’s 2022 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2022, as both cannot be reliably forecasted.

OncoSec Appoints Dr. Robert Arch as President and Chief Executive Officer

On April 29, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer, reported the appointment of Robert H. Arch, Ph.D., as President and Chief Executive Officer (Press release, OncoSec Medical, APR 29, 2022, View Source [SID1234613209]).

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Dr. Arch was previously Head of Research at Elpiscience Biopharma, Ltd. from October 2019 to June 2021, and Head of the Liver Disease Department at China Novartis Institutes for BioMedical Research from February 2017 to October 2019. Robert’s leadership roles have been focused on shaping strong teams and building diversified R&D pipelines with innovative assets, from ideas to late-stage clinical development programs. His career over 28 years extends from academia to the pharmaceutical industry, including positions at Novartis, Takeda, GlaxoSmithKline, and Pfizer. Robert’s expertise in basic research and drug development includes chronic liver disease, cancer, immuno-oncology, respiratory disease, and inflammatory disorders.

"On behalf of the Board of Directors, we are excited to welcome Robert to OncoSec and confident he will bring a focus on long-term value creation," remarked Kevin Smith, Board member of OncoSec. "Robert is uniquely qualified based on his executive experience in leading cross-functional pipeline strategy, and building and leading discovery teams across multiple geographic regions throughout his career."

"I am grateful for the opportunity to join OncoSec and excited to advance TAVO and the intratumoral platform technology," said Dr. Robert Arch. "I am honored to lead our team in our mission to bring truly novel immunotherapies to patients."

Dr. Arch earned his Ph.D. in Germany at the University of Wuerzburg and the German Cancer Research Center (DKFZ), Heidelberg. After postdoctoral training at the DKFZ and the University of Chicago, he started his independent career as a faculty member in the Departments of Medicine and Pathology & Immunology at Washington University in Saint Louis. Robert is an author on more than 40 publications and book chapters, and he is co-inventor on several patents for clinical-stage assets.

Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

In connection with the hiring of Dr. Arch, the Compensation Committee of OncoSec’s Board of Directors granted to Dr. Arch non-qualified stock options to purchase 700,000 shares of OncoSec common stock as an inducement material to Dr. Arch entering into employment with OncoSec in accordance with Nasdaq Listing Rule 5635(c)(4), which grant shall be made outside of OncoSec’s 2011 Stock Incentive Plan. The stock options have an exercise price equal to the closing price of OncoSec’s common stock on May 2, 2022, and will vest quarterly commencing on the first completed calendar quarter after the date of grant, subject to the terms of grant. The vesting of shares of common stock underlying the non-qualified stock options are subject to Dr. Arch’s continuous service with OncoSec through each such vesting date.