On November 22, 2021 ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) reported that it has completed the previously announced acquisition of Novitium Pharma, a privately held, New Jersey-based pharmaceutical company with development, manufacturing, and commercialization capabilities (Press release, ANI Pharmaceuticals, NOV 22, 2021, View Source [SID1234595919]).

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"Today marks a major milestone for ANI and the many patients who rely on our high-quality, cost-effective medications. With the completion of this acquisition, we bring on board a world-class R&D engine in the generic and 505 (b)(2) sectors, and a highly-compliant U.S. based manufacturing facility, positioning us well for sustainable long-term growth. Novitium has continued to perform in-line or above our investment thesis since deal signing on March 9th with thirteen new product approvals, strong quarter-on-quarter EBITDA growth and a successful FDA GMP inspection completed in July 2021," stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

"ANI is thrilled to welcome the expertise and leadership of Novitium’s founders, Samy Shanmugam, Chad Gassert and Vijay Thorappadi, along with over 100 talented and dedicated employees, who have joined the ANI team. Our robust product pipeline includes several more CGT and 505 (b)(2) candidates and will be further expanded to maximize the value of our bolstered R&D engine," concluded Lalwani.

Samy Shanmugam, co-founder of Novitium and ANI’s new Head of Research & Development and Chief Operating Officer of New Jersey Operations added, "Today is an exciting day for all of our employees, as we combine the complementary strengths of our two platforms. We are energized by today’s events and look forward to strong contributions in driving the future success of an united ANI."

"ANI’s new capital structure, comprised of the recently completed $75 million equity raise and the closure of a new $300 million Term Loan-B, $40 million revolver and $25 million PIPE, gives the Company significant flexibility in supporting the integration of Novitium into ANI, ensuring a strong Purified CortrophinTM Gel commercial launch and will propel the next phase of growth for ANI," stated Stephen Carey, Senior Vice President and Chief Financial Officer of ANI.

Compelling Investment Thesis

Proven R&D Engine Fuels Sustainable Growth
Novitium has a strong pipeline with 20+ new product launches planned in the next 18 months, including products with U.S. Food and Drug Administration (FDA) Competitive Generic Therapy designation. Novitium received thirteen approvals since March 2021, several of which were limited competition launches. Novitium’s proven R&D leadership team of Samy Shanmugam, Chad Gassert and Vijay Thorapaddi will drive the combined company’s R&D engine.

Expands ANI’s R&D Pipeline Focused on Niche Opportunities
Novitium has expanded the 505 (b)(2) portfolio beyond the three initial 505(b)(2) candidates in Oncology and Hypertension. The combined company has also expanded dosage forms to include injectables and gels.

Enhances scale of CDMO Business & U.S. Based Manufacturing Capacity.
Novitium adds nine new customers to ANI’s growing CDMO business. Additionally, Novitium brings a U.S. based, state-of-the-art manufacturing facility enhancing manufacturing capabilities and CDMO opportunities.

Compelling Financial Profile
Immediately accretive to Adjusted non-GAAP earnings per share. The acquisition diversifies ANI’s revenue base by contributing to each of its reporting segments: Generics, Contract Manufacturing, Royalties/Other and, following the launch of Novitium’s 505(b)(2) pipeline products, the Brand segment.

The Transaction has satisfied customary closing conditions, and received approval from shareholders and relevant regulatory agencies, including clearance under the Hart-Scott Rodino Antitrust Improvements Act. As previously announced, the U.S. Federal Trade Commission (the FTC) has accepted the proposed consent order in connection with ANI’s definitive agreement to acquire Novitium Pharma. The divestitures required by the FTC of development rights to one generic drug and assets with respect to another generic drug are immaterial to the Company’s business and have been completed. The acceptance by the FTC satisfies all required antitrust clearances needed to be obtained for the acquisition.

Terms of the Transaction and Debt Re-Financing

Under the terms of the transaction, the Purchase Price is comprised of (i) a cash payment of $89.5 million and (ii) the issuance of 2,466,654 common shares of ANI equity. Novitium is also eligible to receive (i) $25 million in contingent payments upon the achievement of financial targets related to Generics products and filing of certain ANDAs and (ii) $21.5 million in contingent payments upon the achievement of financial targets from the 505(b)(2) products.

Commensurate with the completion of the transaction, ANI retired its existing Term Loan-A credit facility (including the repayment of $200.1 million of face value outstanding) and closed a new $300 million Term Loan-B and a $25 million PIPE investment with Ampersand Capital Partners. The new credit facility also includes a $40 million revolver that is un-drawn at this time. The new debt financing is secured by substantially all the assets of ANI and its subsidiaries.

Advisors

Bourne Partners, Truist Securities and Houlihan Lokey acted as financial advisors to ANI Pharmaceuticals. SVB Leerink acted as financial advisor to Novitium Pharma and its shareholders. Hughes Hubbard & Reed LLP were ANI’s legal advisors and Orrick, Herrington & Sutcliffe LLP acted as legal advisors to Novitium and its shareholders.

On November 22, 2021 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported an overview of its innovative pipeline with a focus on five mid- to late-stage assets with first-in-class and/or best-in-class potential at its R&D Update Call (Press release, Merck KGaA, NOV 22, 2021, View Source [SID1234595918]).

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"At Merck KGaA, Darmstadt, Germany we are working to translate our extensive expertise and deep knowledge in key tumors and neurological and immunological diseases with a goal to change treatment paradigms and improve patient outcomes," said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck KGaA, Darmstadt, Germany. "With evobrutinib, xevinapant, and berzosertib, we have the opportunity to be not only first-in-class, but potential game-changers in how we treat MS, head & neck cancer and small cell lung cancer going forward."

Advancing Assets with Transformational Potential

Evobrutinib (BTK inhibitor) – A pioneering development program with a new mechanism of action (MoA) for the treatment of patients with relapsing multiple sclerosis (RMS) that has the potential to change the standard of care.

Oral, central nervous system (CNS)-penetrant, covalent Bruton’s tyrosine kinase inhibitor (BTKi) in development for RMS.
MoA combines potent B-cell inhibition to target acute inflammation (associated with relapses) with a central effect on microglia that aims to reduce chronic inflammation (associated with disease progression).
Comprehensive Phase II clinical data support best-in-class potential.
Evobrutinib is the first BTKi to have completed enrollment of the Phase III clinical trial program for relapsing multiple sclerosis, with data readout expected in Q4 2023.
Xevinapant (IAP antagonist) – As a potent oral antagonist of Inhibitor of Apoptosis Proteins (IAP) and the only IAP antagonist in late-stage development, xevinapant builds on our market-leading expertise in squamous cell carcinoma of the head and neck (SCCHN), aimed at maximizing the chances of a cure in locally advanced disease setting.

Ongoing Phase III TrilynX study for previously untreated unresectable locally advanced (LA) SCCHN in combination with platinum-based chemoradiotherapy.
Second global Phase III study to be initiated in the first half of 2022 to evaluate xevinapant in patients with cisplatin-ineligible LA SCCHN.
5-year update of OS data from Phase II study anticipated in 2022.
First launch expected in 2025.
Berzosertib (ATR inhibitor) – The lead candidate in our DNA Damage Response (DDR) inhibitor portfolio and the first ATR inhibitor with positive randomized clinical trial in any tumor type, seeks to exploit the synergistic effect of combining ATR inhibition with topoisomerase I inhibitors

Multiple mid-stage clinical trials in small cell lung cancer (SCLC) build on positive Phase II study results, with the goal of establishing a new standard of care in second-line SCLC.
Study planned for indication expansion in ovarian cancer and potentially in refractory GI cancers.
M1231 (MUC1/EGFR bi-specific ADC) – The first bi-specific ADC (antibody-drug conjugate) from our pipeline that aims to optimize targeting of cancer cells and overcome remaining safety limitations of conventional ADCs.

M1231 delivers a cytotoxic payload to tumor cells expressing both MUC1 and EGFR and has a highly controlled drug-antibody ratio, which is anticipated to increase tumor specificity, selectivity, and efficacy.
Phase I clinical study to characterize the safety and preliminary activity is well underway, and efficacy expansions into late-stage non-small cell lung cancer and esophageal squamous cell carcinoma are expected to begin in 2022.
Enpatoran (TLR7/8 inhibitor) – Oral therapy that aims to overcome limitations of available lupus therapies by providing selective inhibition of lupus-relevant disease drivers, which may increase efficacy while preserving immunity against infections.

Highly specific potential first-in-class immune modulator blocking the activation of Toll-like receptor (TLR)7 and TLR8, known to be activated in lupus.
Initiation of Phase II studies in systemic lupus erythematosus (SLE) / cutaneous lupus erythematosus (CLE) in the first half of 2022.
Advancing the broader pipeline and portfolio

Merck KGaA, Darmstadt, Germany will initiate 11 new studies in 2022 across the early- and late-stage pipeline, including a Phase III confirmatory study with tepotinib in EGFRm MET amplification in NSCLC, five proof-of-concept studies including trials of M1774, an oral ATR inhibitor being evaluated as both a monotherapy and in combination with PARP inhibitors; the JAVELIN Bladder Medley umbrella study in the first-line urothelial carcinoma, combining avelumab with novel investigational agents including our anti-TIGIT M6223 and Nektar Therapeutics’ interleukin-15 (IL-15) receptor agonist, NKTR-255, in the maintenance setting; two first-in-human studies involving M9140, a next-generation ADC based on an internally developed linker-payload technology; and M1069, our dual adenosine receptor antagonist.

"Our rapidly progressing pipeline of in-house–discovered and partnered assets with first-in-class potential demonstrate the deep expertise and collaborative mindset of our R&D organization," said Joern-Peter Halle, Global Head of Research for the Healthcare business of Merck KGaA, Darmstadt, Germany. "We expect exciting new entries and substantial advances of our early- and late-stage pipeline in the next few years."

On November 22, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that new data from the ongoing Phase 1/2 GLORIA trial with NOX-A12 and radiotherapy in brain cancer (glioblastoma multiforme, GBM) were presented at the Society for Neuro-Oncology (SNO) Annual Meeting (Press release, NOXXON, NOV 22, 2021, View Source [SID1234595917]). The presentation was held by Frank A. Giordano, M.D., Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany, and lead investigator of the ongoing GLORIA study.

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The oral presentation, entitled "CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial", included results from 9 chemotherapy refractory (MGMT promoter unmethylated) patients participating in the proof-of-concept study on CXCL12 inhibition during and after radiotherapy of glioblastoma. Eight of 9 patients (89%) receiving NOX-A12 showed reductions in tumor size (2 patients with objective responses [>50% reduction] and 6 patients with stable disease [<50% reduction], while one patient progressed. These results compare favorably with historic patient outcomes from a matched cohort that received standard of care, where only 1 out of 13 patients (8%) showed a reduction in tumor size with an objective response and 12 patients’ tumors progressed.

Also, data from tissue analysis of a patient on NOX-A12 therapy shows [1] a significant reduction of the NOX-A12 target, CXCL12, on tumor blood vessels, [2] a significant decrease in tumor cell proliferation and [3] an increase in tumor infiltration of activated killer immune cells. Interestingly and very importantly, such benefits were observed across all available tumor tissue and not only in small subsections.

These benefits are strongly supportive of the dual mechanism of action of NOX-A12:
– inhibiting repair of blood vessels damaged by radiotherapy
– promoting of immune-response
This dual mechanism of action could prove transformational since this is not consistently observed in historical samples including patients treated with immune checkpoint inhibitors.

"The data presented by Dr. Giordano at the SNO meeting are a significant step forward in bringing NOX-A12 to glioblastoma patients. While a diagnosis of chemotherapy-resistant glioblastoma leads almost inevitably to systematic rapid progression of the disease, NOX-A12 combined with radiotherapy managed to achieve stable disease or an objective response in 8 out of the 9 patients. We very much look forward to presenting and explaining the transformational nature of these new data at our upcoming KOL event on Tuesday, November 23, when Dr. Giordano will also be available to answer questions," commented Aram Mangasarian, CEO of NOXXON.

Details of the Key Opinion Leader webinar are as follows:
Title: NOX-A12 and Radiotherapy combination: A Differentiated and Promising New Approach to Treating Brain Cancer
Presenter: Dr. Frank A. Giordano, Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany
Webinar time and date: November 23, 2021 at 02:00 p.m. CET (08:00 a.m. EST)
Registration: To register for the event, please click here

NOX-A12 acts via a unique mechanism of action, which was confirmed by the presented results: by removing the CXCL12 chemokine from the tumor blood vessels the revascularization of the irradiated tumor area is blocked and a significant increase in activated killer immune cell infiltration to the tumor can be seen.

More information about the GLORIA study can be found at ClinicalTrials.gov number NCT04121455.

Dr. Frank A. Giordano, is Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn, Germany. He is an expert in precision radiation therapy and intraoperative irradiation of malignant tumors and has received international recognition for his brain tumor research, including an award from the American Society of Radiation Oncology (ASTRO) and an honorary membership of the Spanish Society of Radiation Oncology (SEOR). Dr. Giordano received his medical degree from the University of Heidelberg, Germany, and did his post-doctoral training as a Peter Engelhorn fellow at the German Cancer Research Center (DKFZ). He received clinical training at the National Center for Tumor Diseases (NCT) Heidelberg and the University Medical Center Mannheim, where he served as acting chairman and director of the Department of Radiation Oncology before moving to Bonn. For many years, his research has focused on optimized radiation therapy of brain cancers to offer cancer patients personalized and even more effective treatment. As one of the few Else-Kröner-Fresenius Excellence Fellows, Dr. Giordano developed innovative therapy options that even found their way in clinical practice. He sees great potential in the combination of radiotherapy and immunomodulatory therapy.

On November 22, 2021 Lidds reported that (Press release, Lidds, NOV 22, 2021, View Source [SID1234595916])

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JANUARY – SEPTEMBER 2021

Net sales amounted to MSEK 1.2 (0.0)
Operating expenses amounted to MSEK -29,5 (-19,8)
Profit/loss before and after tax amounted to MSEK -28.4 (-19.8)
Earnings per share amounted to SEK -0.90 (-0.76)
Cash flow from operating activities amounted to MSEK -32.7 (-17.3)
Equity amounted to MSEK 57.4 (55.2) and the debt/equity ratio was 90% (88%)
JULY – SEPTEMBER 2021

Net sales amounted to MSEK 0.4 (0.0)
Operating expenses amounted to MSEK -8.2 (-6.6)
Profit/loss before and after tax amounted to MSEK -7.8 (-6.6)
Earnings per share amounted to SEK -0.26 (-0.23)
Cash flow from operating activities amounted to MSEK -9.2 (-5.2)
Equity amounted to MSEK 57.4 (55.2) and the debt/equity ratio was 90% (87%)
SIGNIFICANT EVENTS DURING THE THIRD QUARTER 2021

As part of the warrants-based incentive programme 2021/2024, a total of 146,000 warrants were subscribed to, by the CEO and key personnel at LIDDS. The remaining warrants are kept by LIDDS and will be offered to future key personnel in relation to employment.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

In October, the company announced that no further patients will be enrolled in its dose escalating Phase I study (NZ-DTX-001). The primary objective of the trial was to study safety of NanoZolid-docetaxel in solid tumors.
The data collected in the trial demonstrates safety and tolerability, an active and local drug release of docetaxel over an extended period of time and signs of clinical effect in injected tumors. LIDDS plan to communicate topline results during Q4 2021.
CEO Statement

The autumn has made its entrance in Sweden and when reflecting on the progress we have made during the third quarter of this year I feel pride.

We are making good progress in our projects and in October we communicated the closing of our NZ-DTX-001 study. The scope of the study was to investigate safety and tolerability of the NanoZolid-formulated cytotoxic drug docetaxel in patients with superficial tumours which also was accomplished. We are currently closing the study and preparing for next clinical step which will be communicated in 2021 together with the top-line results from the study. This program is clearly on strategy and a good example of the value LIDDS is generating given a safety profile of docetaxel that is severely limiting its application as a systemic drug. Local intratumorally administration will improve the safety and efficacy profile of docetaxel thus allowing targeting of new types of patients.

LIDDS has previously communicated the intent to initiate a clinical investigation of our first immunoncology drug which is a TLR9 agonist. I am personally very excited about this drug given the improved behaviour of it when formulated in our technology for local administration. Since I joined LIDDS we have performed preclinical studies where we have combined the TLR9 agonist with another substance and the data looks very promising. We even see signs of immune activity in non-treated tumours in our animal studies. Given the signs of abscopal effects when combining TLR9 we have decided to go into clinical development with a combination therapy rather than a monotherapy. This change means a delay in our clinical study but given the observed data we believe the combination will generate best value for all stakeholders. I can promise you that we will do our outmost to progress this program as promptly as possible. We are all excited and looking forward to the clinical data on this specific project!

The collaboration with Johnson & Johnson is progressing according to plan and we hope to be able to expand the cooperation in the future. In parallel, we are working on validating our phase III plans for Liproca Depot. As an important step, we submitted our phase III study protocol to the European Medicines Agency (EMA) for Scientific Advise (SA) on Sep 27.

We have set a direction for the company by defining what strategic areas to focus on to reach our key targets and our Vision 2026 which is to make "LIDDS the preferred solution and partner for elegant and optimal drug delivery – enabling better health!". We are a drug delivery company and will remain so by investing in our technology and our projects, and in our people and our partnerships. The unique value of LIDDS is to deliver drugs that are both safer and more efficacious by administration of NanoZolid-formulated depots delivering a controlled and sustained local release of drugs. We will present more details regarding our strategic focus early next year.

An important strategic focus area is to secure long-term financing of LIDDS to provide resources for a sustainable growth. We are currently continuing our preparations to make the move to Nasdaq Stockholm’s main list. This is part of the long-term perspective and something we work intensively on. As senior executives need to be in place in the company for at least a quarter before being listed on the main market this has taken longer time with the entrance of myself and of the new CFO. The ambition is to make the move in first half of 2022. The requirements that are added when listing on the main market represent an opportunity to increase the quality of our work, sharpen our value propositions and becoming a more mature company.

Given our vision, strategies and plans it is important to continue to grow the organization in an efficient and sustainable way. To be successful we need the best competences onboard. I am therefore very pleased that we have now the support of Johan Harmenberg. Johan has an excellent and relevant background as Chief Medical Officer in several oncology companies. With this background I am convinced that he will contribute very positively to our growth journey.

My colleagues and I are looking forward to the rest of 2021 and to 2022 where we expect to be able to present more details about our new strategic direction and about the progresses that we make in our projects. Progresses that ultimately will make a real difference to patients.

LIDDS AB (PLC) is required to disclose this information in accordance with the EU Market Abuse Regulation. The information was submitted through the agency of the aforementioned contact, for publication on November 22, 2021 at 16.45 CET.

On November 22, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported its participation in the following upcoming virtual investor conferences (Press release, Moderna Therapeutics, NOV 22, 2021, View Source [SID1234595915]):

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NASDAQ 45th Investor Conference on Wednesday, December 1st at 9:30 a.m. ET
Piper Sandler 33rd Annual Virtual Healthcare Conference on Wednesday, December 1st at 2:00 p.m. ET
A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of each webcast will be archived on Moderna’s website for at least 30 days following the presentation.