On May 19, 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported its virtual participation in the 2022 H.C. Wainwright Global Investment Conference (Press release, CohBar, MAY 19, 2022, View Source [SID1234614922]).

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Dr. Joseph Sarret, CohBar’s Chief Executive Officer, will present a company overview available for on-demand listening starting Tuesday, May 24, 2022, at 7:00 a.m. Eastern Time. Interested parties can register for the conference and view the presentation here: www.hcwevents.com/globalconference.

The presentation can also be accessed on the Events & Presentations page of the Investors section of CohBar’s website at View Source An archived replay of the webcast will be available on CohBar’s website for at least 30 days after the event concludes.

On May 19, 2022 Physicians and scientists at the University of Minnesota reported that have opened a new solid tumor cancer clinical trial and have treated their first patient with HCW9218, an injectable, bifunctional immunotherapeutic, developed by HCW Biologics Inc (NASDAQ: HCWB) (Press release, HCW Biologics, MAY 19, 2022, View Source [SID1234614907]). This Phase I, first-in-human clinical trial is enrolling patients that have advanced solid tumors with progressive disease after prior chemotherapies.

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The trial is led by University of Minnesota oncologist Melissa Geller, MD, MS, Professor, and Division Director, Gynecologic Oncology, Department of Obstetrics, Gynecology and Women’s Health (OBGYN) in the Medical School and the Masonic Cancer Center’s Associate Director for Clinical Research, with collaboration from Jeffrey Miller, MD, Professor of Medicine in the Medical School’s Division of Hematology, Oncology and Transplantation and Deputy Director of the Masonic Cancer Center, and Manish Patel, DO, Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation and Director of the Developmental Therapeutics Clinic.

"Our team is very excited to bring this clinical trial to patients who have recurrent cancer," noted Dr. Geller. "With the ease of a subcutaneous injection, this innovative compound can stimulate the immune system while at the same time inhibiting proteins that cause immunosuppression. This unique combination will provide patients with cancer a novel immune-based therapy when previous treatments have failed."

The treatment, HCW9218 has an IL-15 component that activates the immune system (NK cells and T cells) and a second component that neutralizes TGF-beta, a common protein induced by tumors to suppress the immune system. As a result, this bifunctional fusion protein complex is designed to drive anti-tumor immune activity to attack cancer cells while simultaneously blocking unwanted immunosuppressive activities.

On May 19, 2022 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the fourth quarter and full year ended March 31, 2022 (Press release, Dr Reddy’s, MAY 19, 2022, View Source [SID1234614906]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

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Revenue Analysis [Q4 and full year FY22]

Global Generics (GG)

ØGG segment at Rs. 179.2 billion higher by 16% over FY21. This growth was driven by good performance across all our markets with strong growth in Emerging markets and India.

ØQ4 revenue at Rs. 46.1 billion, YoY growth of 19% and QoQ growth of 4%. The YoY & QoQ growth was driven by growth across all our markets, however the QoQ growth was partially impacted due to a decline in revenues in India.

North America

ØRevenues from North America Generics for the year at Rs. 74.9 billion, YoY growth of 6%. The growth was contributed by new launches and scale up of existing products, which was partially offset by price erosion.

ØRevenues for Q4 at Rs. 20.0 billion, YoY growth of 14% and QoQ growth of 7%. The YoY and QoQ growth were primarily on account of new product launches and volume traction in some of our products, partly offset by price erosion.

ØDuring this quarter, we launched 3 new products – Vasopressin Injection, Nicotine Lozenges Cherry Flavour (OTC) and Clobetasol Shampoo in Canada and for full year we have launched 17 products.

ØDuring the year, we filed 7 new Abbreviated New Drug Applications (ANDAs) with the US Food and Drug Administration (USFDA). As of 31st March 2022, cumulatively 90 generic filings are pending for approval with the USFDA (87 ANDAs and 3 NDAs under 505(b)(2) route). Out of the pending 87 ANDAs, 44 are Para IVs, and we believe 24 have ‘First to File’ status.

Europe

ØRevenues from Europe for the year at Rs. 16.6 billion. YoY growth of 8%, primarily on account of volume traction in base business and new product launches, which was partially offset by price erosion in some of our products.

ØRevenues for Q4 at Rs. 4.4 billion, YoY growth of 12% and QoQ growth of 10%. YoY and QoQ growth was primarily on account of new product launches, partly offset by price erosion in the base business.

India

ØRevenues from India for the year at Rs. 42 billion. Year-on-year growth of 26% was primarily attributable to an increase in both sales volume and price of our existing products, along with additional revenues from the launch of new products. The growth was also aided by covid product sales. During FY2022, we launched 20 new brands in India, including Sputnik-V vaccine for Covid-19.

ØRevenues for Q4 at Rs. 9.7 billion, YoY growth of 15% and QoQ decline of 6%. YoY growth primarily driven by volume traction in the base business, favorable price variance, new product launches, and non-core brand divestments while QoQ decline was majorly due to decline in volumes of some of our products.

Emerging Markets

ØRevenues from Emerging Markets for the year at Rs. 45.7 billion, growth of 30% YoY.

-Revenues from Russia for the year at Rs. 20.9 billion, YoY growth of 32%. This growth was driven by improved base business performance, launch of new products during the year and divestment of a few non-core brands.

-Revenues from other CIS countries and Romania for the year at Rs. 8.3 billion, YoY growth of 11%. Growth was on account of new product launches, partly offset by lower volumes.

-Revenues from Rest of World (RoW) territories for the year at Rs. 16.5 billion, YoY growth of 40%. Growth primarily on account of new launches, volume traction in key products and sale of Covid products, partially impacted by adverse price variance in certain markets.

ØRevenues for the quarter are Rs. 12 billion, YoY growth of 36%, QoQ growth of 4%.

-Revenues for Russia for Q4 at Rs. 6.9 billion, YoY growth of 70%, QoQ growth of 45%. The increase is majorly attributable to traction in volume of base business and income from divestment of a few non-core brands. However, the QoQ growth was partly impacted by adverse forex rates.

-Revenues from other CIS countries and Romania for the quarter are Rs. 2.3 billion, YoY growth of 20%, QoQ decline of 4%. YoY growth was primarily due to launch of new products and price benefits in some of our markets. The QoQ decline was on account of lower volume traction in some of our markets and adverse forex rates.

-Revenues from Rest of World (RoW) territories for Q4 are Rs. 2.9 billion, YoY decline of 1% and QoQ decline of 35%. The QoQ decline is primarily due to higher base of previous quarter which includes sale of covid related products, lower volumes in some of our products and adverse price variance in some of our markets, which was offset partially by new product launches.

Pharmaceutical Services and Active Ingredients (PSAI)

ØRevenues from PSAI at Rs. 30.7 billion. YoY decline of 4%. The decline was majorly on account of price erosion in some of our products.

ØRevenues for Q4 at Rs. 7.6 billion, YoY decline of 5% and QoQ growth of 4%. YoY decline was primarily due to lower volumes and price erosion while the QoQ growth was driven by new product sales.

ØDuring the year, we have filed 10 DMFs in the US, of which 3 DMFs were filed in Q4FY22.

Proprietary Products (PP) & Others

ØRevenues from PP & others for the year at Rs. 4.5 billion, YoY growth of 34%. The growth is attributable to recognition of a license fee associated with the sale of our U.S. and Canada territory rights for ELYXYB (celecoxib oral solution) 25 mg/ml, to BioDelivery Sciences International, Inc during Q2 FY22.

ØRevenues for Q4 at Rs. 693 million.

Income Statement Highlights:

ØGross profit margin for the year at 53.1%, a decrease of ~120 bps over previous year. The decrease was driven by pricing pressure in the North America & Europe, lower export benefits, and an increase in the inventory provisions. This was partially offset by productivity benefits. Gross profit margin for GG and PSAI business segments are at 57.6% and 22.2% respectively.

Gross profit margin for the Q4 at 52.9% (GG: 58.2%, PSAI: 18.4%). Gross margin declined by ~80 bps YoY and by ~90 bps QoQ. The decline was primarily due to price erosion, an increase in the inventory provisions, which was partly offset by income from divestment of non-core brands.

ØSelling, general & administrative (SG&A) expenses for FY22 at Rs. 62.1 billion, an increase of 14% on a YoY basis. This increase was primarily due to annual increments, investments in brands and digitalization, and royalty paid on sales. SG&A expenses for Q4 at Rs. 15.7 billion, YoY increase of 9% and QoQ increase of 2%. The increase is mainly due to provision made of Rs. 1.0 billion pertaining to litigation with Texas state, US. SG&A as a % to sales for the full year remained largely in line with FY21.

ØImpairment charge at Rs. 7.6 billion in FY22. This is majorly due to product impairment of PPC-06 (Tepilamide Fumarate Extended Release Tablets) of Rs. 4.3 billion on account of its decrease in market potential and impairment of Shreveport plant assets and Goodwill of Rs. 3.1 billion which were taken considering the triggers which occurred during the year.

ØResearch & development (R&D) expenses in FY22 at Rs. 17.5 billion. As % to Revenues – FY22: 8.2% | FY21: 8.7%. R&D expenses for Q4 at Rs. 4.3 billion, as % to revenues stood at 8.0%. Our focus continues on building a global pipeline of new products across our markets.

ØOther operating income for the year at Rs. 2.8 billion compared to Rs. 1 billion in FY21. The increase was on account of recognition of income towards sale of our rights relating to anti-cancer agent E7777 (denileukin diftitox) to Citius Pharmaceuticals in Q2 FY22. Other operating income in Q4 is Rs. 0.3 bn.

ØNet Finance income for the year at Rs. 2.1 billion compared to Rs. 1.7 billion in FY21. The increase is primarily on account of higher foreign exchange gain in current year as compared to FY21. Net finance income in Q4 is Rs. 0.9 billion.

ØProfit before Tax for the year at Rs. 32.3 billion, growth of 22%. Profit before Tax for Q4 is Rs. 2.5 bn.

ØProfit after Tax for the year at Rs. 23.6 billion and for Q4 at Rs. 0.9 billion. The effective tax rate for the year has been 27.0% as compared to 34.7% in FY21 and that for the quarter has been at 64.8% as compared to 41.2% in Q4 FY21. The ETR was higher on account of lower Profit before Tax, due to the impairment charge taken.

ØDiluted earnings per share for the year is Rs. 141.7. Diluted earnings per share for Q4 is Rs. 5.3.

Other Highlights:

ØEBITDA for FY22 at Rs. 51.4 billion and the EBITDA margin is 24.0%. EBITDA for Q4 FY22 is at 13.0 billion and the EBITDA margin in 23.9%.

ØCapital expenditure for FY22 is at Rs. 14.7 billion. Capital expenditure for Q4 FY22 is at Rs. 3.7 billion.

ØFree cash-flow for FY22 is at Rs. 11.6 billion and for Q4 it is at Rs. 4.8 billion.

ØNet cash surplus for the company is at Rs. 15.5 billion as on March 31, 2022. Consequently, net debt to equity ratio is (0.08).

ØThe Board has recommended payment of a dividend of Rs. 30/- per equity share of face value Rs. 5/- each (600% of face value) for the year ended March 31, 2022 subject to approval of members.

On May 19, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported that it will present for the first time proof-of-concept data from clinical trials with EO2401, its first-in-class off-the-shelf OncoMimics cancer immunotherapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago and virtually (Press release, Enterome, MAY 19, 2022, View Source [SID1234614902]).

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OncoMimics peptides – generating strong CD8+ T-cell responses derived from pre-existing memory cells

OncoMimics peptides are gut microbiome-derived peptides that closely mimic antigens expressed by tumor cells. In contrast to tumor antigens, however, OncoMimics peptides are recognized by the immune system as "non-self" and can generate a strong human cytotoxic CD8+ response steming from memory T cells, offering enormous potential to create a new class of cancer vaccines targeting solid and liquid tumors.

Enterome’s pioneering work on its OncoMimics pipeline leverages the fundamental understanding that the gut is the largest lymphoid organ in the body and is home to most of its memory T-cells. As a result, there is constant interaction and presentation of peptides and proteins secreted by gut bacteria to the body’s immune system, resulting in the formation of a pool of effector memory T cells protecting the human body against bacterial invasion. In the event that the bacterial antigens are mimics of tumor antigens, this process leads to the generation of circulating effector memory T cells with a preserved ability to recognize tumor antigens.

To-date, Enterome has generated a repertoire of OncoMimics peptides correlating to tumor antigens across a wide range of solid and liquid tumor types. From this, the Company is creating a pipeline of off-the-shelf cancer immunotherapies designed to act via the same novel mode of action. The first candidates include EO2401 (in clinical trials for glioblastoma and adrenal malignancies), EO2463 (in clinical development for liquid tumors) and EO4010 (in development for colorectal cancer, and targeted to enter clinical trials in 2023).

Enterome’s lead candidate EO2401 combines three OncoMimics peptides that closely mimic IL13Ra2, BIRC5 and FOXM1, all of which are known driver antigens present on aggressive solid tumors and generate strong human CD8+ responses. In addition, EO2401 contains a CD4 helper peptide UCP4.

At ASCO (Free ASCO Whitepaper), in the first two abstracts, Enterome will present, for the first time, clinical proof-of-concept data from Phase 1/2 clinical trials of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo), for the treatment of patients with first progression/recurrence of glioblastoma (the ROSALIE trial, EOGBM1-18) and for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma (the SPENCER trial, EOADR1-19).

In a third abstract, the Company will present the use of its second therapeutic vaccine program, EO2463 as monotherapy and in combination with lenalidomide and rituximab, for treatment of patients with indolent non-Hodgkin lymphoma (the SIDNEY trial, EONHL1-20). EO2463 combines four OncoMimics peptides that exhibit molecular mimicry with the B cell markers CD20, CD22, CD37, and CD268 (BAFF-receptor), respectively.

Jan Fagerberg, Chief Medical Officer of Enterome said, "As a proof-of-concept for the entire Mimicry platform, we have put in action a clinical development strategy for EO2401 that is designed to identify a clinical efficacy signal in various tumor types that have in common the same tumor antigens (IL13Ra2, BIRC5 and FOXM1). In both the ROSALIE and SPENCER trials, EO2401 in combination with checkpoint blockade generated strong systemic immune responses directed against human tumor antigens. We look forward to sharing these very promising clinical data at ASCO (Free ASCO Whitepaper) while continuing to progress these trials, with the aim of providing a more mature set of data at ESMO (Free ESMO Whitepaper), Europe’s leading medical oncology conference, later in the year."

Enterome’s Mimicry Platform

Enterome’s Mimicry drug discovery platform is based on its unique ability to decode the interaction between the gut microbiome and the immune system. The Mimicry platform uses best-in-class biocomputational tools and bioassays to identify novel therapeutics from its proprietary database of 21 million full-length gut microbiome peptides and proteins.

The Mimicry platform is highly productive and has already generated first-in-class small protein and peptide drug candidates targeting multiple therapeutic areas that modulate the immune system by closely mimicking the structure, effect or actions of specific human antigens, hormones or cytokines.

"We are thrilled to be able to present the first clinical data demonstrating the potential of our unique OncoMimics pipeline at ASCO (Free ASCO Whitepaper) this year. We are using our Mimicry platform to generate multiple pipelines of transformative drug candidates, targeting a broad range of therapeutic areas. Presently we are advancing two pipelines of distinct drug candidates – OncoMimics and EndoMimics – which have the potential to address cancer, inflammatory and autoimmune diseases," said Pierre Belichard, CEO of Enterome. "We believe that our unique platform has the potential to create effective new medicines that make a real difference to patients. Our corporate strategy is designed to advance the development of these new therapies as quickly and robustly as possible while generating significant value for our shareholders. Enterome’s future has never looked so exciting."

On May 19, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Jefferies 2022 Healthcare Conference on Wednesday, June 8, 2022, at 9:30 a.m. EDT (Press release, Bio-Techne, MAY 19, 2022, View Source [SID1234614901]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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