On May 20, 2022 Almac Discovery, the research driven drug discovery company and a member of the Almac Group, reported a new research collaboration with HitGen Inc. (SSE: 688222.SH), a world leader in the development and application of DNA-encoded library (DEL) technology for novel chemical equity (NCE) generation (Press release, Almac, MAY 20, 2022, View Source [SID1234614904]). The collaboration is focused on the identification of novel compounds against selected Deubiquitinating enzyme (DUB) targets of strategic interest to Almac.

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Almac Discovery has built an industry-leading platform to prosecute novel targets emerging from the DUB class of enzymes, an increasingly important target class for drug development, which is underpinned by high quality biological validation linking these targets to disease indications. Almac has utilised this platform to generate its own portfolio of drug discovery programmes, as well as to advance a number of DUB programmes of interest to pharmaceutical partners through a collaborative model.

In this collaboration, the companies will work together to identify novel chemical compounds against selected DUB targets. Almac will provide the targets, and HitGen will then screen their expansive library of over 1.2 trillion small molecules against these targets. Initial hits resulting from the screens will be further validated, and those that meet Almac Discovery’s selection criteria will be taken forward into discrete research and development programmes. The ultimate objective will be to generate highly potent and selective lead compounds that will allow the pharmacological validation of selected DUB targets in a number of different therapeutic modalities.

Professor Tim Harrison, Vice President of Drug Discovery at Almac Discovery, said: "We are delighted to have signed our latest research collaboration agreement with such an experienced and renowned leader in drug discovery chemistry research. The technology that HitGen has developed perfectly complements our expertise in DUB target chemistry and biology.

"We are excited at the possibility of utilizing DUBs to enable new approaches to disease modulation and look forward to working with HitGen to develop innovative treatments for diseases with high unmet medical need."

Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen, said: "As one of HitGen’s four core technology platforms, DEL is an efficient ‘engine’ to drive drug discovery with proven success. Over the past few years, we have worked with our partners to utilize this platform to generate nearly 500 licensed novel chemical structures for their research projects. We look forward to working with Almac Discovery to identify novel small molecule starting points from DNA-encoded libraries. We will work closely with Almac Discovery’s scientists to generate new lead compounds for their research programs to address unmet medical needs."

HitGen has built four core technology platforms including DNA-encoded library (DEL), molecular fragment and structure design (FBDD/SBDD), synthetic therapeutic oligonucleotide (STO) and targeted protein degradation (TPD). The DEL technology platform, centered around the design, synthesis and interrogation of over one trillion component libraries of DNA-encoded small molecules, is capable of providing services and products including DEL screening, customized DEL library, OpenDEL etc.

On May 19, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will present preclinical findings evaluating the characteristics and function of donor-derived allogeneic CAR T cells (Press release, Allogene, MAY 19, 2022, View Source [SID1234616277]). Data showed that cells from a diverse set of younger donors had improved characteristics and better in vitro anti-tumor activity compared to cells from older donors. The study also showed that cells from patients with certain cancers generally performed suboptimally based on functional assays and often could not be used to generate viable CAR T therapies. The findings will be presented during an oral session at the 2022 American Society of Gene and Cell Therapy Annual Meeting (ASGCT) (Free ASGCT Whitepaper) at 10:45am ET.

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"These results further support the benefits and characteristics of allogeneic CAR T cells produced from healthy donors and the potential for AlloCAR Ts to improve patient outcomes," said Rafael G. Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Allogene. "Cells derived from healthy, younger donors were more abundant, with greater fitness and cancer killing potential and have the potential to eliminate the risk of manufacturing failures seen with autologous CAR T therapies."

The study evaluated the characteristics and performance of CAR T cells derived from healthy donors aged 19 to 62, comparing the healthy donor cells to those derived from patients with cancer. Based on the analysis, CAR T cells produced from younger donors had stronger T cell phenotypes and better in vitro anti-tumor activity cytotoxicity compared to older donors. The expression of specific exhaustion and activation markers was also correlated with increased donor age and in vitro anti-tumor activity decreased with donor age. Regardless of age, the CAR T cells derived from healthy donors performed better and had a lower manufacturing failure rate compared to those derived from patients with cancer.

Creating allogeneic CAR T cells from healthy donors reduces product variability; reduces the risk of manufacturing failures; and enables treatment within days, eliminating the need for bridging chemotherapy. This study provides additional evidence that younger, healthy donors may improve product characteristics and potency compared to older donors.
Allogene currently has four clinical programs underway investigating the potential of AlloCAR T product candidates for the treatment of relapsed/refractory (R/R) large B cell lymphoma, RR multiple myeloma and advanced renal cell carcinoma.

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.