On July 13, 2022 Orion Corporation reported that upgrades the full-year outlook for 2022, provided on 10 February 2022, both for the part regarding net sales and operating profit (Press release, Orion , JUL 13, 2022, View Source [SID1234616651]). Due to the collaboration agreement regarding ODM-208, announced at the same time with this release in a separate stock exchange release, and related significant upfront payment, Orion estimates net sales in 2022 to be clearly higher than in 2021. Operating profit is estimated to be clearly higher than in 2021. The upfront payment is USD 290 million of which approximately EUR 220 million is recognised in Orion’s 2022 net sales and operating profit.

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New full-year outlook, provided on 13 July 2022

Orion estimates that net sales in 2022 will be clearly higher than in 2021
(net sales in 2021 were EUR 1,041 million).

Operating profit is estimated to be clearly higher than in 2021.
(operating profit in 2021 was EUR 243 million).

Previous full-year outlook, provided on 10 February 2022

Orion estimates that net sales in 2022 will be at a similar level as in 2021
(net sales in 2021 were EUR 1,041 million).

Operating profit is estimated to be at a similar level as in 2021
(operating profit in 2021 was EUR 243 million).

On July 13, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published today in PLOS ONE show that the company’s Percepta Genomic Sequencing Classifier (GSC) is highly accurate in re-classifying lung cancer risk among patients with lung nodules whose bronchoscopy results are inconclusive (Press release, Veracyte, JUL 13, 2022, View Source [SID1234616650]). The authors also conclude that, based on findings from the large, multi-cohort study, use of the genomic test could enable a significant portion of patients to avoid unnecessary and invasive diagnostic procedures and offer the potential for earlier diagnosis.

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"Quickly and accurately determining whether lung nodules identified through screening or incidentally are benign or malignant is critical to improve patient outcomes, but is often challenging. Physicians frequently use bronchoscopy to evaluate potentially cancerous lung nodules because it is less invasive than surgery, however, many times this procedure produces inconclusive results, leaving physicians and patients without clear guidance about what to do next," said Bill Bulman, M.D., Veracyte’s medical director for lung cancer. "The findings from this study suggest that the Percepta GSC provides accurate, objective information that can help resolve this challenge."

Researchers evaluated the ability of the Percepta GSC to accurately classify risk of malignancy (ROM) in a blinded, independent set of 412 samples from lung nodule patients who were included in one of three, large study cohorts (AEGIS I/II and the Percepta Registry study). Each sample was classified pre-bronchoscopy as low, intermediate or high ROM and subsequently had a bronchoscopy result that was inconclusive.

Among patients with a pre-bronchoscopy intermediate ROM – which accounts for the largest group of lung nodules undergoing bronchoscopy – the Percepta GSC re-classified a total of 41% to either low or high risk. Patients in this cohort were re-classified to low risk with a 91% negative predictive value (NPV) or up-classified to high-risk with a 65% positive predictive value (PPV). Additionally, among pre-bronchoscopy low-risk nodules, the Percepta GSC down-classified 54.5% to very low risk with 100% sensitivity, indicating no false negatives, and a >99% NPV, and the test up-classified 27.3% of high-risk lesions to very-high risk with a specificity of 91.2% and 91.5% PPV. Across all pre-bronchoscopy risk groups, the Percepta GSC re-classified nearly 40% (39.1%) of patients into a different category of cancer risk.

The researchers also concluded that if the Percepta GSC results were used in this cohort of patients, 50% of those with low or intermediate pre-bronchoscopy ROM and benign lesions, as well as 29% of those with malignant lesions, who underwent additional invasive procedures could have avoided them.

"By accurately classifying lung nodules that have inconclusive bronchoscopy results, the Percepta GSC can help patients avoid unnecessary invasive procedures, and help ensure earlier diagnosis and more timely treatment for those at high risk of cancer," said Giulia C. Kennedy, Ph.D., Veracyte’s global chief scientific officer and chief medical officer.

The Percepta GSC stratifies the risk of primary lung cancer across all pre-bronchoscopy risk groups to guide patient management when bronchoscopy is inconclusive. Veracyte developed the second-generation genomic test using RNA whole-transcriptome sequencing and machine learning, and by leveraging novel "field of injury" science through which genomic changes associated with lung cancer can be found in the airways of current or former smokers. The Percepta GSC is performed utilizing a sample collected from a brushing of the patient’s main lung airway during a bronchoscopy. The test is covered by Medicare.

On July 13, 2022 Theratechnologies Inc. ("Theratechnologies" or "the Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has received a binding commitment with respect to a non-dilutive term loan with an affiliate of Marathon Asset Management for up to $100 million (Press release, Theratechnologies, JUL 13, 2022, View Source [SID1234616649]). All dollar amounts are expressed in U.S. dollars, unless otherwise stated.

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"Through this non-dilutive facility, we have gained a strong partner and supporter in Marathon Asset Management," said Paul Lévesque, President and Chief Executive Officer, Theratechnologies. "The term loan is a significant vote of confidence by a leading healthcare investor and serves to materially strengthen our ongoing execution capabilities. Our strategic priorities include the advancement of our clinical oncology pipeline, which is currently in a larger Phase 1b basket study, and the rapid growth of our existing marketed brands, EGRIFTA SV and Trogarzo. We are fortunate to have a strong commercial division with a refocused concentration on revenue growth in North America, our core market. We now have every element in place to ensure we can execute on our future plans and benefit from an extended cash runway," concluded Mr. Lévesque.

The facility is subject to the terms and conditions of a credit agreement. Highlights of the agreement are as follows:

Senior secured term loan of up to $100 million available across multiple tranches;
$40 million is expected to be funded on or before July 29, 2022 (Tranche 1);
$20 million to be made available through June 2023, subject to the satisfaction of defined milestones (Tranche 2);
$15 million to be made available through March 2024 subject to the satisfaction of defined milestones, (Tranche 3);
An additional $25 million will be available to Theratechnologies until December 2024 upon meeting certain defined milestones (Tranche 4);
The facility will have an initial term of five years (six years if Tranche 3 is drawn), provide for an interest-only period of 24 months (36 months if Tranche 3 is drawn prior to December 31, 2023), and bear interest at the Secured Overnight Financing Rate (SOFR) plus 9.50%, subject to a SOFR floor of 1.00%); and,
The Company has agreed to purchase $30 million of the principal amount of the Convertible Notes due June 2023, at a discount to par, in privately negotiated agreements with United States based noteholders, which are expected to close on or before July 29, 2022;
"We are strong believers in Theratechnologies’ portfolio of therapeutic assets, and we have been impressed with this management team’s commitment to addressing patients’ needs," said Evan Bedil, Head of Healthcare at Marathon. "We are pleased to offer this non-dilutive financing that will help fund the company’s growth well into the future."

Truist Securities acted as exclusive financial advisor to Theratechnologies on this transaction.

Covington & Burling LLP acted as external counsel to Marathon Asset Management LP on this transaction.

On July 13, 2022 Royalty Pharma plc (Nasdaq: RPRX) reported that it has agreed to acquire a royalty interest in TRELEGY ELLIPTA (Trelegy) from Theravance Biopharma, Inc. (Nasdaq: TBPH) and Innoviva, Inc. (Nasdaq: INVA) for $1.31 billion in cash up front and up to $300 million in additional payments contingent on the achievement of certain sales milestones (Press release, Royalty Pharma , JUL 13, 2022, View Source [SID1234616648]). The acquisition is expected to close within ten business days.

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Trelegy, marketed by GSK, is a combination of an inhaled corticosteroid (fluticasone furoate) and two bronchodilators (umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting ß2 adrenoreceptor agonist) in a single delivery device administered once-daily for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and the maintenance treatment of asthma in patients aged 18 years and older(2). Many moderate to severe COPD and asthma patients still experience symptoms and Trelegy has been shown to meaningfully improve lung function and quality of life, as well as reduce exacerbations. In 2021, Trelegy generated sales of $1.68 billion, an increase of 57% at constant exchange rates versus the prior year.

"We are excited to acquire this royalty from Theravance and Innoviva," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "Trelegy is the leading triple combination therapy for COPD and asthma and adds another important, rapidly growing blockbuster therapy to our royalty portfolio. Additionally, providing capital at scale positions Theravance and Innoviva to pursue important strategic initiatives. The transaction involves multiple parties with different motivations and goals and once again highlights how Royalty Pharma can facilitate complex transactions to create win-win solutions for its partners."

Transaction Terms

Royalty Pharma is acquiring from Theravance and Innoviva all of the equity interests in Theravance Respiratory Company, LLC, which is entitled to an upward tiering royalty of 6.5% to 10% on annual worldwide Trelegy sales, payable by GSK. Royalty Pharma will pay to Theravance 85% of the royalties in respect of ex-U.S. net sales after June 30, 2029 and 85% of the royalties in respect of U.S. net sales after December 31, 2030.

Royalty Pharma is also providing Theravance $25 million in upfront funding and a potential $15 million regulatory milestone to support the clinical development of ampreloxetine, an investigational once-daily norepinephrine reuptake inhibitor for the treatment of symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy. Neurogenic orthostatic hypotension is a rare disorder in which the autonomic system fails to regulate blood pressure properly, resulting in low blood pressure upon standing. In exchange, Royalty Pharma will receive a low- to mid-single digit royalty on worldwide sales of ampreloxetine.

Trelegy Financial Contribution

The purchase of royalties on Trelegy will further diversify Royalty Pharma’s portfolio with a premier, blockbuster therapy. Based on the current analyst consensus estimate, Royalty Pharma expects this transaction to add at least $200 million to Adjusted Cash Receipts(1) (non-GAAP) in 2025, resulting in enhanced long-term growth.

Royalty Pharma expects to fund this transaction with existing cash on the balance sheet and to maintain significant financial capacity to deploy capital in additional value-creating opportunities.

Advisors

Goodwin Procter, Jones Day and Maiwald acted as legal advisors to Royalty Pharma.

On July 13, 2022 Novimmune SA (LCB), is an antibody discovery and development company located in Geneva, Switzerland (Press release, Light Chain Bioscience, JUL 13, 2022, View Source [SID1234616646]). LCB reported that the first patient was dosed in the Phase 1, first-in-human trial of NI-1801 in patients with advanced, metastatic, or recurrent solid malignancies expressing mesothelin (MSLN) . NI-1801 is a human IgG1 bispecific antibody based on LCB’s , targeting MSLN and CD47. "NI-1801 is the second κλ body entering clinical evaluation. This represents an important milestone in the development of LCB’s pipeline of bispecific antibodies featuring a truly native human IgG structure," said Nicolas Fischer, Chief Executive Officer.

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The surface protein CD47 is an innate immune checkpoint that allows tumor cells to escape immune surveillance, thus acting as a don’t eat me signal. LCB’s bispecific antibody approach simultaneously targets CD47 and a tumor-specific antigen, here MSLN, to selectively block CD47 on MSLN-expressing malignant cells. "As CD47 is ubiquitous, measures need to be taken to limit the immune response to tumor cells. NI-1801 represents a promising novel treatment approach for several cancers with high medical need. We are excited to further investigate this in our Phase 1 study," said Dr. med. Anja Seckinger, Chief Medical Officer.

The LCB-1801-001 Phase 1 trial is a multi-center, open-label, dose escalation and expansion, first-in-human clinical trial that is expected to enroll approximately 40 patients with MSLN-expressing triple-negative breast, non-squamous non-small cell lung or ovarian cancer. The primary objectives of the dose escalation portion (Part A) are to assess the safety and tolerability of escalating doses of NI-1801, with the goal of establishing a maximum-tolerated dose (MTD) and non-tolerated toxic dose. The expansion part (Part B) will further evaluate the safety and efficacy of NI-1801 administered at or below the MTD in up to 20 additional patients to determine the recommended Phase 2 dose. Additional objectives include evaluation of preliminary efficacy, pharmacokinetics (PK), pharmacodynamics and potential predictive biomarkers.

NI-1801 induces antibody-dependent cellular phagocytosis (ADCP) and antibody-dependent cell-mediated cytotoxicity of a variety of MSLN-positive cancer cell lines in vitro. ADCP is negligible or unaffected by a CD47-sink effect mimicked by CD47-expressing red blood cells. NI-1801 does not induce in vitro hemagglutination or platelet aggregation. In multiple preclinical (xenograft) models, NI-1801 inhibits tumor growth in mice. NI-1801 was well tolerated and demonstrated favorable pharmacokinetics in multiple non-human primate studies.