On May 11, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from its phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 11, 2022, View Source [SID1234614178]). The study did not meet its co-primary endpoint of progression-free survival. At this first analysis, the other co-primary endpoint of overall survival (OS) was immature, and the study will continue until the next planned analysis. A numerical improvement was observed in both co-primary endpoints. Data suggest that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab. Further analyses of these results are ongoing and data will be presented at an upcoming medical meeting.

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"While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our tiragolumab programme as they emerge."

The tiragolumab programme continues to explore advances in multiple clinical trials to build on Tecentriq, expand into earlier stages of disease, and seeks to provide new treatment options in advanced and difficult-to-treat cancers with high unmet medical need.

About the SKYSCRAPER-01 study
SKYSCRAPER-01 is a global phase III, randomised double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic non-small cell lung cancer. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity. Co-primary endpoints are overall survival and progression-free survival.

About tiragolumab
Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer.1 Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq (atezolizumab).2 The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.1

About Tecentriq (atezolizumab)
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma. Tecentriq is also approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted therapies and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as subcutaneous injection to hopefully provide a faster and more convenient option for cancer patients.

On May 11, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the first quarter ended April 2, 2022 (Press release, Perrigo Company, MAY 11, 2022, View Source,-RAISES-GUIDANCE [SID1234614222]). All comparisons are against the prior year fiscal first quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "We delivered another quarter of very strong organic net sales growth as consumer demand driven sales again strengthened sequentially. The categories in which we compete are growing and remain on-trend, and the products in our portfolio that were most disrupted by the pandemic, including cough/cold, have rebounded. The strong performance of our U.S. infant formula business, which benefited from innovation and availability while a competitor experienced quality issues, was also notable."

Kessler continued, "First quarter earnings were in-line with our expectations, despite significant and increasing cost headwinds and a significantly strengthening U.S. dollar. We now expect full year 2022 cost headwinds to increase by approximately $125 million versus prior year as compared to our original expectation of an increase of $80 million. While price increases and procurement actions are expected to offset inflation for the full year, adverse foreign exchange rate movements and to a lesser extent business disruption in Ukraine and Russia are likely to remain. With the addition of HRA Pharma and higher expectations for organic net sales growth, we expect to more than offset these headwinds and have raised our net sales and adjusted EPS guidance for the year."

Kessler concluded, "With our consumer self-care transformation complete, our focus going forward will be to ‘Optimize and Accelerate’ through gross margin enhancement via supply chain reinvention, pricing actions and portfolio consolidation, the successful integration of HRA and by continually improving our organization and culture. The path ahead is clear and we remain on track to deliver significant profitable growth over the next few years."

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

First Quarter 2022 Perrigo Results from Continuing Operations

Perrigo net sales for the first quarter were $1.1 billion, an increase of $65 million, or 6.4%. Organic net sales grew 9.7%.

Net sales were driven by 1) higher incidences of cough/cold and flu-like illnesses globally, leading to an increase of $49 million in cough/cold sales that benefited the Upper Respiratory and Pain and Sleep Aids categories, 2) strong growth in U.S. Nutrition stemming from store brand infant formula share gains and a competitor recall, 3) the addition of $33 million in contract manufacturing sales to the divested RX business, 4) higher net sales in the CSCI Skincare and Personal Hygiene category, and 5) increased pricing across both Consumer Self-Care segments. These drivers also benefited from new product sales and e-commerce growth. These increases were partially offset by 1) lower net sales in the global Healthy Lifestyle and CSCI VMS categories, 2) unfavorable currency exchange rate movements of $34 million, and lower sales in Ukraine and Russia.

First quarter reported operating income was $22 million in 2022, compared to $51 million in 2021. Adjusted operating income decreased $32 million, or 26.8%, to $87 million in 2022 driven by 1) $34 million in cost headwinds, including cost of goods sold inflation, carry over of unfavorable plant absorption in 2021 and increased freight expenses, 2) higher customer service claims related to unfulfilled customer orders due to unusual ordering patterns during the quarter in CSCA, 3) higher planned advertising and promotion investments to support brand growth, 4) lower profitability in contract manufacturing sales to the divested RX business compared to the prior year, and 5) the impact from lower sales in Ukraine and Russia. These factors were partially offset by higher gross profit flow-through resulting from higher volumes and pricing.

Reported net loss was $1.3 million, or $0.01 per diluted share, compared to reported net income of $2.8 million, or $0.02 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, first quarter 2022 adjusted net income was $45 million, or $0.33 per diluted share, compared to $67 million, or $0.50 per diluted share, last year. Currency-neutral EPS for the quarter was $0.37, including a $0.02 per share negative impact from the war in Ukraine.

First Quarter 2022 Business Segment Results from Continuing Operations

Consumer Self-Care Americas Segment

CSCA first quarter net sales of $710 million increased $70 million, or 10.9%. Primary category drivers are provided below.

Upper Respiratory
Net sales of $153 million increased 28.8% due primarily to higher incidences of cough/cold and flu-like illnesses that led to strong demand for cough/cold products, particularly store brand liquid-based cough/cold offerings, and demand for oral allergy products.

Digestive Health
Net sales of $119 million increased 0.2% as growth in e-commerce was offset by temporary packaging constraints on a specific product, which is expected to alleviate during the second half of 2022, and lower category consumption of proton pump inhibitors compared to the prior year.

Pain & Sleep-Aids
Net sales of $103 million increased 8.2% due primarily to strong demand for children’s analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, partially offset by higher demand for certain premium dosage forms where the Company today does not provide a store brand offering.

Nutrition
Net sales of $127 million increased 38.0% due primarily to strong growth in U.S. store brand infant formula stemming from share gains and a competitor recall, new product launches within infant formula and continued growth in the oral electrolytes business.

Oral Care
Net sales of $70 million decreased 6.1% due primarily to delayed receipt of products manufactured outside the U.S., leading to unfulfilled customer orders.

Healthy Lifestyle
Net sales of $68 million decreased 11.1% due primarily to the discontinuation of diabetes products and lower category consumption and share of certain smoking cessation products.

Skincare & Personal Hygiene
Net sales of $49 million decreased 12.3% due primarily to service challenges related to the now divested Scaraway(R) brand and discontinued product in non-strategic category segments.

Vitamins, Minerals, and Supplements ("VMS") and Other
Net sales of $21 million increased 132.6% due primarily to contract manufacturing sales to the divested RX business.

Reported operating income was $79 million in the quarter compared to $96 million in 2021. Adjusted operating income decreased $23 million to $87 million driven primarily by 1) cost headwinds, including cost of goods sold inflation, carry over of unfavorable plant absorption in 2021 and increased freight expenses, 2) higher customer service claims related to unfulfilled customer orders due to unusual ordering patterns during the quarter in CSCA, and 3) lower profitability in contract manufacturing sales to the divested RX business compared to the prior year. These factors were partially offset by higher gross profit flow-through resulting from net sales growth and lower operating expenses.

Consumer Self-Care International Segment

CSCI net sales of $365 million decreased $5 million, or 1.4%, including a negative impact of 9.1 percentage points from unfavorable currency exchange rate movements. Organic net sales growth was a strong 7.7%. Primary category drivers are provided below.

Skincare & Personal Hygiene
Net sales of $102 million decreased 4.8%, or an increase of 4.9% excluding the impact of currency, driven primarily by increased net sales of the anti-parasite brand Paranix, due to the easing of COVID-19-related restrictions, and strong performances and new product launches in the ACO and Sebamed skincare lines.

Upper Respiratory
Net sales of $61 million increased 43.1%, or 56.6% excluding the impact of currency, as the higher incidences of cough/cold and flu-like illnesses led to strong demand for cough/cold products, including Bronchonolo, Coldrex, Phytosun, Physiomer and U.K. store brands. New products also contributed to growth in the quarter.

VMS
Net sales of $48 million decreased 18.8%, or 10.5% excluding the impact of currency, due primarily to lower category consumption and the lingering impact from the third quarter 2021 recall of certain batches of Davitamon and Abtei.

Pain & Sleep-Aids
Net sales of $52 million increased 5.5%, or 13.5% excluding the impact of currency, due primarily to an increase in U.K. store brand consumption and higher demand for Solpadeine, a paracetamol-based analgesics product.

Healthy Lifestyle
Net sales of $43 million decreased 15.1%, or 7.6% excluding the impact of currency, due primarily to lower net sales in the XLS Medical weight management franchise stemming from lower category consumption and timing of NiQuitin smoking cessation product sales to customers.

Oral Care
Net sales of $24 million decreased 4.3% or an increase of 5.5% excluding the impact of currency, due primarily to customer restocking following supply constraints in the prior year.

Digestive Health and Other
Net sales of $35 million decreased 3.6%, or an increase of 3.1% excluding the impact of currency, due primarily to higher sales of distribution brands.

Reported operating income was $16 million in the quarter compared to $17 million in the prior year quarter. Adjusted operating income decreased $7 million, or 12.1%, to $53 million as higher gross profit flow-through resulting from net sales growth was more than offset by higher planned advertising & promotion investments to support brand growth and unfavorable currency exchange rate movements. Excluding the impact of currency, adjusted operating income was flat compared to the prior year quarter.

Updated Fiscal 2022 Outlook

Based on current foreign exchange rates, the Company is raising its fiscal 2022 growth range outlook from 3.5%-4.5% to 8.5%-9.5% versus the prior fiscal year, primarily due to the acquisition of HRA, which closed on April 29, 2022. The Company is also raising its fiscal 2022 organic growth range outlook from 7%-8% to 8%-9%.

The Company is raising its adjusted diluted EPS range from $2.10-$2.30 to $2.30-$2.40, reflecting approximately $0.35 from the HRA acquisition, partially offset by approximately $0.10 from additional unfavorable exchange rate movements, $0.05 from stopping distribution of product to Russia, and approximately $0.05 in higher interest expense from refinancing.

The Company continues to expect first half margin compression and second half margin expansion and an adjusted effective tax rate of approximately 23%. Cash flow from operations as a percentage of adjusted net income is now expected to be above the Company’s original range of 95%-105%.

The Company cannot reconcile its expected adjusted diluted earnings per share to diluted earnings per share under "Fiscal 2022 Outlook" without unreasonable effort because certain items that impact net income and other reconciling metrics are out of the Company’s control and/or cannot be reasonably predicted at this time.

On May 11, 2022 Neutron Therapeutics, a targeted radiation therapy company developing a comprehensive solution for Boron Neutron Capture Therapy (BNCT), and Cosylab, the world’s leading provider of control systems for the planet’s most complex machines, reported that Neutron Therapeutics’ nuBeam BNCT System, using Cosylab’s OncologyOne software, has reached a significant milestone in its clinical commissioning at Helsinki University Hospital – first simulated patient treatment (Press release, Neutron Therapeutics, MAY 11, 2022, View Source [SID1234614240]).

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BNCT is a targeted radiation cancer therapy in which neutron beams destroy only boron compound-bearing tumors without destroying neighboring normal tissue. BNCT has the potential to deliver highly effective and cell-localized radiation therapy to treat tumors with minimal impact on the patient’s quality of life compared to other radiation, chemotherapy or biological treatment modalities currently in use.

Neutron Therapeutics Inc. and the Helsinki University Hospital are collaborating to launch the first European hospital-based BNCT facility. Cosylab is a proven partner with over two decades of experience solving complex software challenges in radiation therapy.

Johanna Mattson, Senior Medical Director at the Helsinki University Hospital Comprehensive Cancer Center, commented: "Providing BNCT with the most sophisticated accelerator-based device will enable Finnish clinicians to treat patients with some of the most obstinate cancers and remain globally at the forefront of oncology. We are working hand in hand with our industry partners, Neutron Therapeutics and Cosylab, to bring the full clinical potential of BNCT to patients in Helsinki as soon as 2023."

Neutron Therapeutics’ nuBeam is a high-throughput, compact accelerator-based neutron source suitable for clinical settings. nuBeam replaces legacy nuclear reactors. It has the highest neutron flux of all currently available BNCT systems and is the only device producing an IAEA-compliant BNCT beam for the safe and effective clinical use of neutrons. During the commissioning process, the Helsinki nuBeam device has demonstrated both robustness and reliable operation, validating the Neutron Therapeutics technology as the best choice for a high-throughput BNCT clinic with stringent safety requirements.

"We are extremely excited that our collaboration with Helsinki University Hospital has demonstrated nuBeam’s excellent reliability in the clinical environment. We are committed to achieving the initiation of clinical trials in the first half of 2023 at our first European nuBeam installation. Our close partnership with Cosylab has enabled rapid progress towards this goal and positions Neutron Therapeutics to maximize the potential of BNCT and its beneficial impact on patients," said Dr. Elizabeth Reczek, CEO of Neutron Therapeutics.

The first simulated patient treatment at the Helsinki nuBeam installation was achieved using Cosylab’s OncologyOne software, the only solution on the market that covers all the needs of a radiation therapy device. It has already proven itself in other forefront radiation therapy modalities such as proton therapy and brings to the nuBeam system a software solution for radiation therapy that is much more readily upgradable and integrable than custom-built software while guaranteeing the shortest time-to-clinical-use.

"We are thrilled by the first-beam success and proud we could help Neutron Therapeutics stay on schedule with the commissioning of their nuBeam in Helsinki. Our OncologyOne suite of software products is designed from the ground up to empower our customers to bring their radiation therapy innovations into clinical practice in the shortest possible time and full working order, stated Dr. Mark Pleško, CEO of Cosylab.

Finland has been a European hotspot of BNCT trials since 1992. With the ongoing clinical verification and validation testing of the nuBeam system at the Helsinki University Hospital, patients who have inoperable, locally recurrent head, neck, and other cancers incurable with conventional radiation therapy are now much closer to reaping benefits from boron neutron capture therapy.

On May 11, 2022 Vaccitech plc (NASDAQ: VACC) reported its financial results for the first quarter ended March 31, 2022, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, MAY 11, 2022, View Source [SID1234614262]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases, autoimmunity, and cancer .

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"We’ve already made solid progress across the Company this year and are excited to share our plans to advance our recently acquired SNAPvax platform into the clinic in multiple disease indications including HPV cancer and celiac disease," said Bill Enright, Vaccitech’s CEO. "These are devastating diseases where we believe this novel platform provides a unique opportunity for potential cures. In addition, we expect to announce efficacy data in our chronic infectious disease programs in both HBV and HPV later this year. Finally, the royalty and milestone payments that we have begun to receive related to the sales of AstraZeneca’s SARS CoV2 vaccine will contribute non-dilutive capital to these efforts."

First Quarter 2022 and Recent Corporate Developments

·On April 6, 2022, the Company announced the notification of the commencement of royalty payments relating to commercial sales of Vaxzevria. The Company’s share of milestone and royalty payments received by OUI from AstraZeneca in the first quarter of 2022 amounted to $15.0 million.

·In April, the Company launched a program in HPV-associated cancer utilizing the SNAPvax platform and moved forward with an immunotherapeutic designed to induce regulatory T cells in patients with celiac disease. IND applications are expected to be filed for both programs during the first quarter of 2023.

·On April 29, 2022, the Company received scientific advice from the EMA defining a licensure pathway for the candidate MERS vaccine, VTP-500, which allows the Company to estimate expenses of the development pathway more accurately.

Upcoming Milestones

·In the second quarter of 2022, the Company expects to present additional Phase 1b/2a interim efficacy data on VTP-300 in patients with chronic HBV infection at the European Association for the Study of the Liver (EASL) International Liver Congress on June 22 to 26, 2022, which is also expected to be followed by full efficacy data in the second half of this year.

·In the third quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer.

·In the fourth quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1b/2 clinical trial of VTP-200, a potential non-invasive treatment for low grade HPV-related cervical lesions.

First Quarter 2022 Financial Highlights:

·Cash position: As of March 31, 2022, cash and cash equivalents were $200.6 million, compared to $214.1 million as of December 31, 2021. The decrease in cash was primarily due to $6.6 million of net cash being used in operating activities and a $5.6 million negative effect of exchange rates on cash and cash equivalents.

·Research and development expenses: Research and development expenses were $10.7 million in the first quarter of 2022 compared to $4.6 million in the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on the development of VTP-200, VTP-300, VTP-850 and VTP-600 and an increase in R&D personnel-related costs.

·General and administrative expenses: General and administrative expenses were $3.7 million in the first quarter of 2022 compared to $1.8 million in the comparable period of the prior year. The first quarter of 2022 includes $4.3 million of personnel expenses, including a share-based payment charge of $3.1 million, and a $5.3 million unrealized foreign exchange gain on revaluation of Company’s cash balances. Net of this gain, the increase in general and administrative expenses between the periods was mainly attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the period, and higher insurance costs associated with operating as a public company.

·Net Income: For the first quarter of 2022, the Company generated a net income of $2.6 million, or $0.07 per share on both basic and fully diluted bases, compared to a net loss of $15.4 million, or $1.90 per share on both basic and fully diluted bases, for the comparable period of the prior year.

On May 11, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology, reported the Company will submit an amended Investigational New Drug Application (IND) for its first oncology cell therapy candidate Procel directly to the FDA in the second half of 2022 (Press release, Kiromic, MAY 11, 2022, View Source [SID1234614223]).

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Over the course of the last ten months, the Company has developed a solid plan to address the previously outlined chemistry, manufacturing, and control (CMC) issues cited in the FDA’s July 2021 letter regarding the clinical hold on the Company’s INDs. Based on the unanimous advice from independent regulatory experts, the Company has determined that it is not necessary to proceed with the previously contemplated Type A meeting with the FDA to further address the CMC issues and instead will move forward with a submission of an amended IND for Procel directly to the FDA during the second half of this year.

The Company also announces ongoing progress toward the implementation of a current good manufacturing practice (cGMP) mammalian master cell bank (mMCB), which will provide a GMP-grade retroviral vector for gamma delta T (GDT) cell engineering. A cGMP mammalian master cell bank is a significant step forward in the Company’s clinical pathway and would address a key issue identified by the FDA in the clinical hold letter.

"We are very pleased to share these significant regulatory updates, reflecting the progress we have been making as a Company. In addition, progress toward establishing the master cell bank will enable us to create the GMP-grade retroviral vector for gamma delta cell engineering – a cornerstone of our clinical program" stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "These achievements demonstrate our team’s execution efforts toward our goal of beginning the activation of the clinical trial for our first oncology cell therapy candidate Procel by the end of the fourth quarter of 2022."