Bedminster, New Jersey, United States - January 05, 2023 - Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced that the United States Food and Drug Administration (US FDA) has granted Orphan Drug Designation for JBI-802 for the treatment of small cell lung cancer (SCLC) and acute myeloid leukemia (AML).

JBI-802 is a dual epigenetic modulator engineered in a single pharmacophore to achieve optimal inhibition of the transcriptional regulator CoREST, which regulates the development of cellular lineages responsible for neuroendocrine tumors like SCLC and hematopoietic tumors like AML.

This unique profile has shown synergistic anti-tumor activity and it is expected to overcome tolerability limitations of first-generation, single target epigenetic modulators.

“JBI-802 is the lead product candidate from our TIBEO (Therapeutic Index and Brain Exposure Optimization) Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved target product profile compared to existing agents. The Orphan Drug Designations (ODD) were supported by several relevant preclinical models. In SCLC, JBI-802 showed unique activity not just in normal neuroendocrine models but also in the ‘variant’ models driven by MYC amplification. This data also supports the ongoing Ph I/II clinical trial in neuroendocrine tumor patients. In AML the activity was uniquely seen in models of erythroleukemia, a subset of leukemia, with a unique erythroid phenotype and a very high unmet need based on its aggressive nature and limited therapy. This designation and emerging clinical data from the ongoing fist-in-human JBI-802 study will now underpin expansion of our clinical activities in thrombocythemia, leukemia and other erythroid tumors like MPN”, said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc

The US FDA’s Office of Orphan Products Development (OOPD) grants orphan designation status to a drug that is intended to treat a rare disease or condition that affects fewer than 200,000 persons in the United States.

About JBI-802

JBI-802 is an oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone inhibitors and has a favorable safety profile with no significant safety concerns or accumulation. It is being clinically evaluated in multiple neuroendocrine tumors including SCLC, with a goal to expand in to hematological cancers such as acute myelogenous leukemia, essential thrombocythemia, and other myeloproliferative cancers. Positive clinical data was recently reported for bomedemstat, a LSD1 only inhibitor, in essential thrombocythemia, thereby establishing a pivotal role of epigenetic modulators in hematological malignancies.

About Jubilant Therapeutics Inc.

Jubilant Therapeutics Inc. is a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to address unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Its advanced structure based discovery engine, TIBEO (Therapeutic Index and Brain Exposure Optimization), has been validated through successful partnerships including with Blueprint Medicines for a brain penetrant EGFR Exon-20 program. The Company’s pipeline, consists of a first in class dual epigenetic modifier, JBI-802, currently in a Phase I/II clinical trial in multiple tumors, a novel brain-penetrant modulator of PRMT5 for which an IND has been accepted, brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Bedminster, New Jersey and guided by globally renowned scientific advisors.

For more: www.jubilanttx.com, Twitter @JubilantTx, LinkedIn

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Katie Larch / Robert Flamm, Ph.D.
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Bedminster, New Jersey, USA – November 02, 2022 – Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to serve genetically defined patients suffering from cancer and autoimmune diseases, today announced that Syed Kazmi, Chief Executive Officer, will be making a business update presentation and meeting with institutional investors at the following conferences in November 2022:

About Jubilant Therapeutics Inc.
Jubilant Therapeutics Inc. is a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to address unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Its advanced structure based discovery engine, TIBEO (Therapeutic Index and Brain Exposure Optimization), has been validated through successful partnerships including with Blueprint Medicines.   The Company’s pipeline, consists of a first-in-class dual epigenetic modifier, JBI-802, currently in a Phase I/II clinical trial to treat solid tumors, a novel brain-penetrant modulator of PRMT5 for which an IND has been accepted, brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Bedminster, New Jersey and guided by globally renowned scientific advisors. For more: www.jubilanttx.com, Twitter @JubilantTx, LinkedIn

Media Contact
Robert Flamm, Ph.D. / Katie Larch 
rflamm@burnsmc.com / klarch@burnsmc.com

IR Contact
Monique Kosse
Monique@lifesciadvisors.com

The Board of Jubilant Pharmova Limited met today to approve financial result for the quarter ended September 30, 2022.

Commenting on Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Pharmova Limited said:

“During the quarter, the Company reported significant improvement in revenues sequentially due to strong performance in Specialty Pharmaceuticals, CDMO Sterile Injectables and CRDMO, which was offset by lower revenues in the Generics segment. On a YoY basis, however, the revenues were marginally lower as performance of the CDMO Steriles business normalized due to tapering of COVID deals and weaker performance in Generics segment.

In Specialty Pharmaceuticals, Radiopharmaceuticals business reported increase in revenues YoY driven by higher volumes with normalization in demand as pandemic eased-off. Our Allergy Business continued to grow with higher volumes. In CDMO sterile injectables, revenues normalised YoY due to tapering of one-off COVID-related revenues in the corresponding quarter. There was however sizeable improvement sequentially due to higher volumes. Generics business revenues impacted YoY with pricing headwinds and Import Alert related challenges. Management begins implementation of strategic reorganization, cost optimization and re-prioritization of geography-mix in generic business.

In CRDMO, our Drug Discovery Services continues to maintain momentum from strong order book and our API revenues stood higher on volume growth and is poised to gain further from the asset upgradation program at Nanjangud plant.

During the quarter, we refinanced our existing US$200m bonds and US$150m term loan with a 5-year US$350m term loan facility at favorable terms with lower interest costs. This enables us to optimize our finance costs. We incurred foreclosure charges in the refinancing transaction, which we expect to recover over the tenor of the new USD 350m facility.”

Q2’FY23 Highlights

Consolidated financials

• Revenues were at Rs 1,600 Crore vs. Rs 1,657 Crore in Q2'FY22 and Rs 1,452 Crore in Q1’FY23.
  • The higher volumes in Radiopharma, Allergy and CMO Sterile injectables, API and steady growth in Drug Discovery Services led to sequential revenue growth
• Reported EBITDA was at Rs 232 Crore vs. Rs 344 Crore in Q2'FY22 and Rs 204 Crore in Q1’FY23.
• Finance cost was at Rs 42 Crore vs. Rs 35 Crore in Q2'FY22 and Rs 40 Crore in Q1’FY23.
• Exceptional cost of Rs 57 Crore included Rs 48 Crore of foreclosure charges related to bond repayment and balance due to write-off of capitalized debt origination costs. We expect savings from lower interest rates pursuant to the refinancing will enable recovery of this cost over the tenor of the new facility
• Reported PAT was at Rs 5 Crore as compared with Rs 143 Crore in Q2'FY22 and Rs 47 Crore in Q1’FY23.
• Normalised PAT was at Rs 62 Crore as compared with Rs 143 Crore in Q2'FY22 and Rs 47 Crore in Q1’FY23.
• EPS was at Rs 0.34 vs. Rs 8.97 in Q2'FY22 and Rs 2.96 in Q1’FY23. Normalised EPS was Rs 3.88 vs. Rs 8.97 in Q2’FY22 and Rs 2.96 in Q1’FY23
• Capital expenditure for the quarter was Rs 128 Crore

Specialty Pharmaceuticals

• Revenues were at Rs 814 Crore vs. Rs 651 Crore in Q2'FY22 and Rs 722 Crore in Q1’FY23.
• EBITDA was at Rs 198 Crore vs. Rs 130 Crore in Q2’FY22 and Rs 117 Crore in Q1’FY23 with a margin of 24.4% vs. 19.9% in Q2’FY22 and 16.2% in Q1’FY23

a) Radiopharma

• Radiopharma revenues were at 658 Crore vs. 529 Crore in Q2’FY22 and Rs 592 Crore in Q1’FY23
  • Radiopharmaceuticals witnessed improvement in revenues YoY and QoQ driven by higher volumes. Higher sequential revenues were als
  • on account of customer order rescheduling in Q1’FY23
  • Radiopharmacies business witnessed growth due t
  • higher volumes resulting from recovery in demand as the pandemic’s impact waned. Turnaround plan working well as reflected by volumes at pre-COVID levels and lower losses
  • USFDA audit in the Montreal Radiopharma plant successfully completed with zero observation in early October 2022

b) Allergy Immunotherapy

• Allergy Immunotherapy revenues were at Rs 156 Crore vs. Rs 122 Crore in Q2’FY22 and Rs 130 Crores in Q1’FY23.
  • The healthy revenue growth was driven by volume growth, price increase and geographic expansion

CDMO Sterile Injectables

• CDMO Sterile Injectables’ revenues were at Rs 299 Crore vs. Rs 409 Crore in Q2'FY22 and Rs 263 Crore in Q1’FY23
• EBITDA was at Rs 71 Crore vs. Rs 203 Crore in Q2'FY22 and Rs 132 Crore in Q1’FY23.
• Reported EBITDA margin was 23.8% in Q2’FY23, in-line with our expectations of normalized CDMO-Sterile injectable business
• Reported EBITDA declined YoY due to substantially higher base of COVID related business.
  • In Q2’FY23, we witnessed about Rs 22 Crs of COVID deals, vs. about Rs 162 Crs in Q2’FY22 and about Rs 70 Crs in Q1’FY23
  • QoQ variation in margin in Q1’FY23 and Q2’FY23 is due to plant shutdown (twice in a year) and COVID deals

Generics

• Generics revenues were at Rs 161 Crore vs. Rs 333 Crore in Q2'FY22 and Rs 178 Crore in Q1’FY23.
• Reported EBITDA was at Rs (82) Crore vs. Rs (42) Crore in Q2'FY22 and Rs (74) Crore in Q1’FY23
• Revenues and profitability lowered vs. Q2’FY22 due to pricing pressure in the US generics market, lower volumes resulting from Roorkee Import Alert and lower Remdesivir sales.
• We have responded to the US FDA with a CAPA plan post audit of the Roorkee plant that resulted in six observations.
• To put the business on path of sustainable growth and profitability, we have kicked off a large scale business transformation focused on
  • Strategic re-organization of the generics business
  • Generics wide cost optimization (direct and indirect)
  • Re-prioritising geography-mix to accelerate growth in branded markets such as India
• We have identified and are in process of executing annualized cost opportunities worth around Rs 100 Crore across direct and indirect spend. These will be implemented by Q4’FY23, while we work on identifying additional cost savings opportunity.

CRDMO

• Revenues were at Rs 320 Crore vs. Rs 258 Crore in Q2'FY22 and Rs 280 Crore in Q1’FY23
• EBITDA was at Rs 68 Crore vs. Rs 69 Crore in Q2’FY22 and Rs 46 Crore in Q1’FY23 with a margin of 21.3% vs. 26.6% in Q2’FY22 and 16.3% in Q1’FY23
• Drug Discovery Services revenues were at Rs 150 Crore vs. Rs 108 Crore in Q2’FY22 led by robust volume growth YoY.
  • Strong demand from target clients for integrated drug discovery services, functional chemistry and DMPK. However, we register market is adopting more selective approach in launching new projects
  • Strong incremental order flow supported by the Greater Noida facility that was commissioned in Sep 2021.
  • Sequentially revenue higher, in-line with historical trends of Q2 being a stronger quarter
  • The commissioning and validation of the greater Noida DMPK in-vitro facility to enable comprehensive service capability from the site
• API revenues were at Rs 170 Crore vs. Rs 150 Crore in Q2’FY22 due to higher volumes and price. Sequentially, revenues were flat with expectation of growth from H2FY23.

Proprietary Novel Drugs

H1'FY23 Financial Highlights

• Revenues were Rs 3,051 Crore versus Rs 3,292 Crore in H1'FY22.
• Reported EBITDA at Rs 436 Crore vs. Rs 723 Crore in H1'FY22.
  • In H1’FY23, we witnessed COVID related deals of Rs 70 Crore vs. Rs 380 Crore in H1’FY22
• Finance costs at Rs 82 Crore vs. Rs 69 Crore in H1'FY22. Higher finance cost vs. H1’FY22 was due to increase in interest rates
• Exceptional cost of Rs 57 Crore included Rs 48 Crore of foreclosure charges related to bond repayment and balance due to write-off of capitalized debt origination costs. We expect savings from lower interest rates pursuant to the refinancing will enable recovery of this cost over the tenor of the new facility
• Reported PAT was at Rs 52 Crore as compared with Rs 303 Crore in H1’FY22
• Normalised PAT was at Rs 108 Crore as compared with Rs 303 Crore in H1’FY22
• EPS was at Rs 3.30 vs. Rs 19.06 in H1'FY22. Normalised EPS was Rs 6.81 vs. Rs 19.06 in H1’FY22
• Capital expenditure for H1’FY23 was Rs 226 Crore

Specialty Pharmaceuticals

• Revenues were Rs 1,536 Crore vs. Rs 1,282 Crore in H1'FY22.
• EBITDA at Rs 316 Crore vs. Rs 205 Crore in H1’FY22 with a margin of 20.6% vs. 16.0% in H1’FY22
• Radiopharma revenue at 1,250 Crore vs. 1,047 Crore in H1’FY22
  • Radiopharmaceuticals business witnessed improvement in sales driven by normalization in demand as the pandemic’s impact eased off.
  • Ruby-Fill installations in the US are gradually gaining momentum with encouraging installations trend
  • Radiopharmacies business witnessed growth due to higher volumes resulting from recovery in demand as the pandemic’s impact waned. Turnaround plan is working well reflected by volumes at pre-COVID levels and lower losses.
  • USFDA audit in the Montreal Radiopharma plant successfully completed with zero observation in early October 2022.
• Allergy Immunotherapy revenue at Rs 286 Crore vs. Rs 236 Crore in H1’FY22. Segment reported healthy revenue and EBITDA growth as volumes remain robust at higher than pre-COVID levels

CDMO Sterile Injectables

• CDMO Sterile Injectables’ revenue at Rs 562 Crore vs. Rs 782 Crore in H1'FY22.
• Revenue and profitability lower vs. H1’FY22 as business witnessed higher COVID related business during the previous quarter.
• Segmental EBITDA at Rs 203 Crore vs. Rs 418 Crore in H1'FY22
• In H1’FY22, we witnessed COVID related deals of about Rs 382 Crore vs. about Rs 93 Crore in H1’FY23

Generics

• Generics revenue at Rs 340 Crore vs. Rs 765 Crore in H1'FY22.
• Reported EBITDA was at Rs (155) Crore vs. Rs 11 Crore in H1’FY23
• Revenues and profitability lowered vs. Q2’FY22 due to pricing pressure in the US generics market, lower volumes resulting from Roorkee Import Alert and lower Remdesivir sales.
• We have responded to the US FDA with a CAPA plan post audit of the Roorkee plant that resulted in six observations.
• To put the business on path of sustainable growth and profitability, we have kicked off a large scale business transformation focused on
  • Strategic re-organization of the generics business
  • Generics wide cost optimization (direct and indirect)
  • Re-prioritising geography-mix to accelerate growth in branded markets such as India
• We have identified and are in process of executing annualized cost opportunities worth around Rs 100 Crore across direct and indirect spend. These will be implemented by Q4’FY23, while we work on identifying additional cost savings opportunity.

CRDMO

• Revenue at Rs 600 Crore vs. Rs 451 Crore in H1'FY22
• EBITDA at Rs 114 Crore vs. Rs 122 Crore in H1’FY22 with a margin of 19.0% vs. 27.1% in H1’FY22
• Drug Discovery Services (DDS) revenue at Rs 268 Crore vs. Rs 196 Crore in H1’FY22 as robust volume growth drove YoY revenue increase.
  • Higher demand from Biotech companies for integrated services, functional chemistry and DMPK.
  • Increase in the volume of the Chemistry services supported by the Greater Noida facility that was commissioned in Sept 2021.
  • Strong capex plan underway in view of robust demand conditions in the Integrated services, Chemistry and DMPK business
• CDMO – API revenue at Rs 332 Crore vs. Rs 256 Crore in H1’FY22 due to higher volumes.

Debt Profile

• Net Debt (constant currency) at Rs 2,204 Crore as on September 30, 2022 vs Rs 1,951 Crore as on June 30, 2022
• Average blended interest rate for H1’FY23 was at 4.81% vs 4.62% in H1’FY22

Key Business Priorities

Presented by Shri. Anurag Singh Thakur, Hon. Union Minister for Information & Broadcasting and Minister for Youth Affairs & Sports, Government of India

Noida, September 15, 2022: The Schwab Foundation for Social Entrepreneurship, the sister organisation of the World Economic Forum and the Jubilant Bhartia Foundation of Jubilant Bhartia group today conferred Aniket Doegar of Haqdarshak Empowerment Solutions with the prestigious 'Social Entrepreneur of the Year Award - India 2022'. The award was presented by Shri. Anurag Singh Thakur, Union Minister for Information & Broadcasting and Minister of Youth Affairs & Sports Government of India, at a grand ceremony in the presence of eminent personalities.

Congratulating the winner and finalists and lauding the work of social entrepreneurs, Shri. Anurag Singh Thakur, Union Minister for Information & Broadcasting and Minister for Youth Affairs & Sports Government of India, said, “In a world driven by uncertainties, geo-political upheavals, the role of social entrepreneurs is increasingly becoming critical to nation building. It is imperative to know investments in environment, sustainability and governance will play a crucial role in not only meeting our shared goal of 5 trillion dollar economy, but also sustainable development goals by 2030 and achieving net zero emissions by 2070.” He further added, “Social Entrepreneurs put their innovative ideas to action, build a team, align beneficiaries and stake-holders, raise necessary funds and drive the organisations with their passion and energy towards solving critical issues, be it reduction of poverty, education of children, empowerment of women, climate change mitigation, healthcare etc.”

The SEOY India Award 2022 winner, Aniket Doegar of Haqdarshak Empowerment Solutions is solving the information and access gap between citizens and the government’s welfare schemes at the last mile, through its tech-enabled intervention. Present in 24 states in India it has trained over 22,800 agents and provided benefits worth Rs 4,000 crore for over 20 lakh families and 35,000 micro businesses.

Ms. Hilde Schwab, Co-Founder and Chairperson, Schwab Foundation for Social Entrepreneurship, and Professor Klaus Schwab, Founder & Executive Chairman of World Economic Forum and Co-Founder of the Schwab Foundation for Social Entrepreneurship applauded the work of the social entrepreneurs and congratulated the winner & finalists. They shared, “Over these last challenging years, we have seen such depth of civic action, entrepreneurialism and innovation in India. Social entrepreneurs are the driving force behind innovations that improve the quality of life of individuals not only in India but around the world. Their role in creating a just, inclusive and sustainable COVID-19 response and recovery is pertinent. The Schwab Foundation for Social Entrepreneurship has been proud to partner with Jubilant Bhartia Foundation in recognising the exceptional work of Indian social entrepreneurs in alleviating environmental and social problems over the past 13 years. This year’s winner and finalists of the Social Entrepreneur of the Year India Award represent the ethos of social innovation and entrepreneurship.”

Congratulating the winner and the finalists, Mr. Shyam S Bhartia, Chairman and Founder and Mr. Hari S Bhartia, Chairman & Co-Founder, Jubilant Bhartia Group and Founder Directors of Jubilant Bhartia Foundation, shared, "The last two and a half years of the COVID-19 pandemic have showcased social entrepreneurs across the world as a different breed of individuals, going beyond the realm of possibility and serving humanity with all their might. Their creativity, resilience, commitment, potential and reach have been simply outstanding. Today we are proud to celebrate and felicitate all our finalists as extraordinary individuals with remarkable achievements and contributions towards society. We are proud of our 13 years of unique and rewarding partnership with the Schwab Foundation for Social Entrepreneurship. Through our partnership, we have been able to give the social entrepreneurs in India a global platform to showcase their work, scale-up their initiatives and cross-learn from an enriching alliance of similar high-spirited individuals from across the world."

Aniket Doegar, Haqdarshak Empowerment Solutions on winning the SEOY Award India 2022, shared, “I want to thank all our Haqdarshaks on-ground. This award will go a long way in supporting us as a young tech company. A big thanks to the Jubilant Bhartia Foundation and the Schwab Foundation for Social Entrepreneurship. With this recognition we hope to achieve our goal of reaching 100 million citizens.”

The winner of SEOY Award India, Aniket Doegar will join the world’s largest and the first inter-sectoral community of social innovators in the world affiliated with the Schwab Foundation for Social Entrepreneurship.

The other finalists for SEOY Award India 2022 were Osama Manzar from Digital Empowerment Foundation (DEF), Ajaita Shah from Frontier Markets, Wilma Rodrigues from Saahas Zero Waste and Meera Shenoy from Youth4jobs. The winner and finalists of SEOY Award India will also get an opportunity to apply for the Hindustan Times Fellowship for the Stanford Seed Transformation program.

This year the SEOY Award – India celebrates its 13th year. Over the last decade it has established itself as one of the most respectable awards for social entrepreneurs in India. In 2010, the Schwab Foundation for Social Entrepreneurship and Jubilant Bhartia Foundation came together to promote social innovation in India through the Social Entrepreneur of the Year (SEOY) Award – India and has since recognised and supported the growing field of social innovation in India.

This year's jury members for the SEOY Award India included Shobhana Bhartia, Chairperson & Editorial Director, HT Media Ltd; Hilde Schwab, Chairperson & Co-Founder, Schwab Foundation for Social Entrepreneurship; T V Narendran, CEO & Managing Director, Tata Steel Limited;  Sudha Pillai, Former Member Secretary, Planning Commission, Government of India; Aashti Bhartia, Non-Executive Director, Jubilant FoodWorks Limited; P R Ganapathy, Regional Director, Stanford Seed, India; Pranshu Singhal, Founder - Karo Sambhav, Winner SEOY 2021.

About the winner:

Haqdarshak Empowerment Solutions was formed with the objective to address the information and access gap related to the various government schemes at the last mile. The heart of all Haqdarshak’s innovative methods lies in their app-based technology platform. Haqdarshak digitizes information on schemes in 11 simple vernacular regional languages makes it available to intended beneficiaries through it’s various B2C channels and an agent-led model. All its products and services are available in 24 states of India. Over the last six years they have unlocked benefits worth Rs 1788 crore for over 16 lakh families.

To achieve their objective, Haqdarshak uses a two-pronged approach- i.e. by creating awareness about the applicable schemes for citizens and by training rural entrepreneurs in using their app and providing application support for the citizens. The entrepreneurs trained by Haqdarshak are local agents, who screen the family/citizen to determine the eligible welfare schemes applicable to them. They also have a proprietary ‘scheme eligibility engine’ that can identify entitled schemes based on the profile information provided by the beneficiaries. Haqdarshaks or the field agents track the applications and follow up with the government offices till the benefits are received by the citizens. Haqdarshaks earn a stipend during an initial program funded by philanthropic or corporate sponsors and are gradually able to earn a sustainable livelihood by using the app and charging a small fee to citizens. Haqdarshak has also built a similar platform to support the 63.5 million micro businesses in India, who form the backbone of the MSME sector. It has developed a curated list of schemes and documentation requirements for MSMEs along with a dedicated web & mobile platform too. Entrepreneurs can access the schemes’ information including benefits, application process and documentation required to apply, and check their eligibility. It has reached more than 20,000 micro-businesses in the last 12 months.

Note to the Editors:

The Schwab Foundation for Social Entrepreneurship was co-founded by Professor Klaus Schwab, Founder and Executive Chairman, World Economic Forum, and Hilde Schwab, Co-Founder and Chairperson, Schwab Foundation for Social Entrepreneurship. For over twenty years, the Schwab Foundation has supported the world’s leading social innovators to create a more just, equitable, and sustainable world. The Schwab Foundation provides unparalleled platforms at the regional and global, to highlight and advance leading models of sustainable social innovation.
Learn more at www.schwabfound.org

Follow on:
Twitter: https://twitter.com/schwabfound;
Facebook: https://www.facebook.com/schwabfound/
LinkedIn: https://www.linkedin.com/company/schwab-foundation-for-social-entrepreneurship

 Jubilant Bhartia Foundation (JBF), established in 2007, is the not-for-profit organisation of the Jubilant Bhartia Group. It focuses on conceptualising and implementing the Corporate Social Responsibility initiatives (CSR) for the Group. The Jubilant Bhartia Foundation’s activities include various community development work, healthcare programs, cultural and sports events, environmental preservation initiatives, vocational training, women empowerment, educational activities, and promotion of Social Entrepreneurship.
Learn more at www.jubilantbhartiafoundation.com

Follow on:
Twitter: https://twitter.com/indiaseoy
Facebook: https://www.facebook.com/IndiaSEOY
LinkedIn: https://in.linkedin.com/company/jubilantbhartiafoundation

For media queries, please contact:
Vivek Prakash
Jubilant Bhartia Foundation;
Ph: +91 120 436 1804/ 1811;
E-mail: vivek.prakash@jubl.com

Philadelphia, September 07, 2022 - Researchers in the laboratory of Yulia Nefedova, M.D., Ph.D., at The Wistar Institute and collaborators at the Jubilant Therapeutics Inc. have uncovered a novel mechanism by which protein arginine deiminase 4 (PAD4) in neutrophils promotes cancer progression. The paper also found that inhibition of this function of PAD4 reduces primary tumor growth and metastasis and enhances checkpoint inhibitor treatments. Jubilant Therapeutics Inc. is developing a novel small molecule PAD4 inhibitor that directly targets this mechanism. The findings appear in Cancer Research, a journal of the American Association for Cancer Research.

“Development of metastases remains a leading cause of death from cancer. Tumor-associated neutrophils have long been implicated in cancer progression. Understanding the mechanisms by which these cells promote tumor growth and metastatic spread is critically important for the development of new treatments,” shares Yulia Nefedova, M.D., Ph.D., associate professor, Immunology, Microenvironment & Metastasis Program, Ellen and Ronald Caplan Cancer Center of The Wistar Institute.

This research revealed the importance of PAD4 protein in the migration of neutrophils, specialized white blood cells that serve as the first line of immune defense in the body, directly impacting both primary tumor growth and secondary malignant tumor spread. Both genetic deletion of PAD4 and pharmacological inhibition of PAD4 using Jubilant Therapeutic Inc’s novel inhibitor dramatically down-regulated chemokine CXCR2, reduced immune suppressive polymorphonuclear myeloid derived suppressor cells (PMN-MDSCs) at tumor and metastatic sites, activated T cells, and synergized with immune checkpoint blockade.

All results point to a potent anti-tumor effect of PAD4 inhibition to target PMN-MDSCs in the tumor microenvironment. This finding is being further investigated in Wistar’s Nefedova laboratory.

“These results highlight the potential of PAD4 inhibition as a novel treatment approach for cancer in addition to the previously established role of this pathway in autoimmune diseases," said Luca Rastelli, Ph.D., Chief Scientific Officer, Jubilant Therapeutics Inc. "We are developing several highly selective oral, small molecule PAD4 inhibitors, with the goal of bringing this novel mechanism to the clinic as potential therapeutics for tumor metastasis in colorectal and pancreatic cancers, patients with liver metastasis as well as for both acute and chronic autoimmune/inflammatory diseases.”

These findings were only made possible through the supportive collaboration between Wistar, a Philadelphia based nonprofit biomedical research institute, and Jubilant Therapeutics Inc., a clinical-stage precision therapy company developing new therapies to treat oncology and autoimmune disease. 

“Only working together, we are able to efficiently translate our fundamental research discoveries into clinical realities,” states Heather Steinman, Ph.D., MBA, The Wistar Institute vice president for Business Development & executive director of Technology Transfer.

Co-authors: Hui Deng, Cindy Lin, Laura Garcia-Gerique, Shuyu Fu, Zachary Cruz, Erin Bonner Matthew Rosenwasser, Sridharan Rajagopal, M. Naveen Sadhu, Chandru Gajendran, Mohd Zainuddin, Ramachandraiah Gosu, Dhanalakshmi Sivanandhan, Miriam A. Shelef, Brian Nam, Dan T. Vogl, and Dmitry I. Gabrilovich.

Publication Information: Regulation of tumor progression by PAD4-mediated neutrophil migration and its targeting with a novel selective inhibitor JBI-589. Cancer Research, 2022. Online publication.

About:

The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the United States, Wistar has held the prestigious Cancer Center designation from the National Cancer Institute since 1972. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. Wistar’s Business Development Team is dedicated to advancing Wistar Science and Technology Development through creative partnerships. wistar.org.

Jubilant Therapeutics Inc. is a clinical stage precision therapeutics company advancing potent and selective small molecule modulators to address unmet medical needs in oncology and autoimmune diseases. Its advanced discovery engine integrates structure-based design and computational algorithms to discover and develop novel, precision therapeutics against both first-in-class and validated but intractable targets in genetically defined patient populations. The Company’s advanced pipeline consists of a first in class dual epigenetic modifier, JBI-802, currently in a Phase I/II clinical trial to treat solid tumors, a novel brain-penetrant modulator of PRMT5 for which an IND has been accepted, a brain penetrant PDL1 inhibitor, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Bedminster, New Jersey and guided by globally renowned key opinion leaders and scientific advisory board members. For more: www.jubilanttx.com Twitter @JubilantTx, LinkedIn

Contact – The Wistar Institute

Darien Sutton
(215) 898-3988
dsutton@wistar.org

Contact – Jubilant Therapeutics Inc.

PR Contact
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Bedminster, New Jersey, USA – August 03, 2022 – Jubilant Therapeutics Inc., a biopharmaceutical Company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (US FDA) clearance of the Investigational New Drug application (IND) for JBI-778, an oral, brain penetrant and selective protein arginine methyl transferase 5 (PRMT5) inhibitor, for the treatment of solid tumors with brain metastases and primary brain tumors including high-grade glioma.

The Phase I/II trial is an open-label, two-part dose escalation and expansion study designed to define the safety profile, pharmacokinetics, optimal dosing and preliminary activity of JBI-778. The study population in the dose escalation phase will include patients with stable brain metastasis whose disease has failed prior standard therapy. Expansion cohorts will include patients with active brain metastases and high-grade gliomas.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, “JBI-778 will be our second, highly selective oral drug candidate to enter clinical development following JBI-802. These two programs, along with several others partnered or in preclinical development, highlight Jubilant Therapeutics’ proven discovery engine and structure-based drug discovery expertise.”

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, “JBI-778 was engineered by our drug discovery team to be a PRMT5 substrate-competitive and brain penetrant drug candidate to address primary brain tumors and brain metastases which currently have limited treatment options. The incidence of brain metastasis is increasing due to improved therapies, increased imaging of neurologically asymptomatic patients and patients living longer. Our team has developed a unique capability to optimize brain penetration for precision oncology therapeutics. In addition to JBI-778, we are also advancing an oral brain penetrant PDL1 inhibitor, JBI 2174, which is on the IND-track to potentially treat primary CNS cancers among others.”

About JBI-778

JBI-778 is a potent and selective brain penetrant inhibitor of protein arginine methyl transferase 5 (PRMT5), which is overexpressed in many cancers. JBI-778 is in development for the treatment of patients with advanced cancer with brain metastasis, and patients with high-grade glioma all of whom have limited treatment options. It has a unique mechanism of action compared to existing PRMT5 inhibitors by being substrate-competitive and S-adenosylmethoinine (SAM) cooperative, combined with a high brain exposure that enables targeting of both primary brain tumors and CNS metastasis. The substrate competitive profile appears to provide enhanced selectivity in the biological system by not interfering with the functions of SAM and shows a good tolerability profile in toxicological studies.

The Board of Jubilant Pharmova Limited met today to approve financial results for the quarter ended June 30, 2022.
Commenting on Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Pharmova Limited said:
“During the quarter, the Company reported YoY improvement in sales in Specialty Pharmaceuticals and CRDMO, which was offset by CDMO Sterile Injectables and Generics segments.
In Specialty Pharmaceuticals, the Radiopharmaceuticals segment reported higher sales and profitability on account of recovery from COVID-19 impact, while Radiopharmacies business witnessed higher sales on account of recovery from pandemic and launch of new products. Our Allergy Business continues to perform strongly and witnessed healthy growth YoY. In the CDMO sterile injectables segment, revenue stood lower YoY as in Q1’FY22 the business realized higher revenue from COVID-19 related contracts as compared to this quarter. Generics segment’s performance was impacted by pricing pressure in the US market and Import Alert related challenges, which resulted in lower performance as compared to Q1’FY22.
In CRDMO, while our Drug Discovery Services segment continued to report robust growth led by higher volumes and stable pricing, the CDMO-API segment reported lower revenue as the Nanjangud plant is undergoing asset replacement and plant upgradation, which contributed to lower volumes.
We are glad to share that the API demerger has become effective with April 1, 2022 as the appointed date. This demerger will enable to create synergies between CRO & CDMO businesses and help in supporting our customers for their needs from early stage of research to commercialization of active ingredients, and will provide competitive edge to this business.
We would like to inform that for better understanding of performance and outlook of our various businesses, the Company has reorganized the reporting segments from Q1’FY23 onwards and the details are covered in this quarter’s investor materials.”

Q1’FY23 Highlights

Consolidated financials

• Revenue was at Rs 1,452 Crore vs. Rs 1,635 Crore in Q1'FY22 and Rs 1,528 Crore in Q4’FY22
• Reported EBITDA at Rs 204 Crore versus Rs 379 Crore in Q1'FY22 and Rs 244 Crore in Q4’FY22
  • In Q1’FY23, we witnessed COVID related deals of Rs 70 Crore vs. Rs 220 Crore in Q1’FY22 and Rs 11 Crore in Q4’FY22
  • In Q1’FY23, we witnessed nil sales of Remdesivir vs Rs 133 Crore in Q1’FY22 and Rs 4 Crore in Q4’FY22
• Finance costs at Rs 40 Crore vs. Rs 35 Crore in Q1'FY22 and Rs 40 Crore in Q4’FY22 . Higher finance cost vs. Q1’FY22 was due to increase in interest rates
• PAT was at Rs 47 Crore as compared with Rs 161 Crore in Q1'FY22 and Rs 59 Crore in Q4’FY22
• EPS is Rs 2.96 versus Rs 10.09 in Q1'FY22 and Rs 3.74 in Q4’FY22
• Capital expenditure for the quarter was Rs 98 Crore

Specialty Pharmaceuticals

• Revenue at Rs 722 Crore vs. Rs 632 Crore in Q1'FY22 and Rs 695 Crore in Q4’FY22. Over 90% of the revenues are from the North America region
• EBITDA at Rs 117 Crore vs. Rs 75 Crore in Q1’FY22 and Rs 149 Crore in Q4’FY22 with a margin of 16.2% vs. 11.9% in Q1’FY22 and 21.5% in Q4’FY22

a) Radiopharma

• Radiopharma revenue at 592 Crore vs. 518 Crore in Q1’FY22 and Rs 566 Crore in Q4’FY22
  • Radiopharmaceuticals business witnessed improvement in sales driven by recovery from easing of COVID-19 pandemic. Sequentially sales lower due to some customer order scheduling in previous quarter
    • Ruby-Fill installations shows encouraging trend, sales increased both on a YoY and sequential basis in Q1’FY23
  • Radiopharmacies business witnessed growth YoY and sequentially due to higher volumes led by recovery from COVID-19 and launch of new products. Turnaround plan is working well reflected by volumes at pre-COVID levels and lower losses

b) Allergy Immunotherapy

• Allergy immunotherapy revenue at 130 Crore vs. 114 Crore in Q1’FY22
  • Allergy Immunotherapy reported healthy revenue growth YoY. Business continues to operate at volumes higher than pre-COVID levels.

CDMO Sterile Injectables

• CDMO Sterile Injectables’ revenue at Rs 263 Crore vs. Rs 373 Crore in Q1'FY22 and Rs 288 Crore in Q4’FY22. Over 85% of the sales come from North America with balance from Europe and Japan
  • Revenue and profitability lower vs. Q1’FY22 as business witnessed higher COVID related business during the previous quarter.
  • In Q1’FY23, we witnessed COVID related deals of Rs 70 Crore vs. Rs 220 Crore in Q1’FY22 and Rs 11 Crore in Q4’FY22
  • Sequentially revenue lower due to shutdown in Q4’FY22 and some stabilization issues in Q1’FY23 that led to lower volumes during the quarter
• egment’s EBITDA at Rs 132 Crore vs. Rs 216 Crore in Q1'FY22

CRDMO

• Revenue at Rs 280 Crore vs. Rs 193 Crore in Q1'FY22 and Rs 318 Crore in Q4’FY22
• EBITDA at Rs 46 Crore vs. Rs 53 Crore in Q1’FY22 and Rs 73 Crore in Q4’FY22 with a margin of 16.3% vs. 27.7% in Q1’FY22 and 23% in Q4’FY22
• Drug Discovery Services revenue at 118 Crore vs. 88 Crore in Q1’FY22 as robust volume growth drove YoY revenue increase.
  • Higher demand from Biotech companies for integrated services, functional chemistry and DMPK.
  • Chemistry Volume increase supported by the Greater Noida facility that was commissioned in Sep 2021.
  • Sequentially revenue lower in-line with historical trends of Q4 being a stronger quarter
  • Strong capex plan underway in view of robust demand conditions in the Integrated , Chemistry and DMPK business
• CDMO – API revenue at Rs 162 Crore vs. Rs 102 Crore in Q1’FY22 due to higher volumes. Sequentially revenue lower as there was a shutdown in one of the plants at the facility as part of the ongoing asset replacement programs for plant upgradation.

Generics

• Generics revenue at Rs 178 Crore vs. Rs 432 Crore in Q1'FY22 and Rs 221 Crore in Q4’FY22
• Revenue and profitability lower vs. Q1’FY22 due to:
  • Pricing pressure in the US market. During the quarter the business witnessed sharp fall in sartan prices that impacted performance
  • Lower volumes due to import alert at Roorkee plant
  • Lower Remdesivir sales due to fewer hospitalisations. In Q1’FY23, we witnessed nil sales of Remdesivir vs Rs 133 Crore in Q1’FY22 and Rs 4 Crore in Q4’FY22
• US FDA audited the Roorkee facility and has issued six observations. Company will submit action plan on same and will engage with US FDA
• Health Canada inspected Roorkee site in early June and gave compliance rating.
• In July 2022, the USFDA announced removal of Olanzapine, Spironolactone, and Valsartan from the list of excepted products w.r.t the Roorkee Import Alert post its review of the product supply situation and company’s compliance status
• Generics EBITDA at –ve Rs 74 Crore vs. Rs 53 Crore in Q1’FY22 and -ve Rs 24 Crore in Q4’FY22

Proprietary Novel Drugs

Debt Profile

• Net Debt (constant currency) at Rs 1,951 Crore as on June 30, 2022 vs Rs 1,951 Crore as on March 31, 2022
• Average blended interest rate for Q1’FY23 at 4.84% from 4.56% in FY22

Key Business Priorities

Business Outlook

Speciality Pharmceuticals: In radiopharma, we continue to build a long term pipeline of diagnostic and therapeutic radiopharmaceuticals and are executing a turnaround plan of radiopharmacies, which is showing encouraging results. I131 MIBG clinical trials underway with launch expected in FY25. Medium-long term outlook remains robust. Allergy business well placed to grow strongly with healthy margins over the medium term
CDMO Sterile Injectables: We expect the business to operate at normal healthy pre-COVID levels for next 2-3 years before new capacity comes upstream and drive volumes

CRDMO: The Drug Discovery Services business will continue to grow especially with commissioning of the State of the art Greater Noida facility. DMPK expansion at the Greater Noida is underway. We are committing further investments towards capex in this business as we have high capacity utilizations amid strong demand climate. CDMO-API business is planning asset replacement programs in H1’FY23 for plant upgradation and capacity expansion with volumes expected to normalize in H2’FY23

Generics: Company hopeful of early resolution of the regulatory issue at the site and post that expect performance to improve led by new launches. In the meantime, emphasis is on shifting of production to CMOs and focus on Non-US strategic markets

Proprietary Novel Drugs: Phase I/II trial underway for our lead program – LSD1/HDAC6 inhibitor in patients with solid tumors. IND filing in Q2 FY23 for 2nd program – brain penetrant PRMT5 inhibitor – has been approved by FDA. Jubilant Therapeutics is now a clinical stage biotech with higher value creation opportunities driven by emerging data from first-in-human studies and additional IND filings.

Investments and Growth: We are accelerating capacity expansions to create new capabilities in our businesses. We expect to incur capex of around Rs 700-750 Crore in FY23 primarily towards expansion in CMO business and enhancement of CRDS capabilities and capacities. In addition, we expect product development expenditure of Rs 250-300 Crore. In view of the strong demand from our customers, we have approved further expansion of the Greater Noida facility, which will deliver both Chemistry and DMPK services

Earnings Call details

The company will host earnings call at 5.00 PM IST on Aug 02, 2022

Participants can dial-in on the numbers below
Primary Number: + 91 22 6280 1141 / + 91 22 7115 8042
Toll Free Numbers:
USA: 1 866 746 2133
UK: 0 808 101 1573
Singapore: 800 101 2045
Hong Kong: 800 964 448

Replay: Aug 02 to Aug 09, 2022
Dial-in: +91 22 7194 5757 / +91 22 6663 5757
Playback ID: 65703

Income Statement – Q1 FY23

Jubilant Pharmova wholly owned subsidiary Jubilant Pharma Limited, through one of its wholly owned subsidiaries, Jubilant HollisterStier General Partnership, (JHS) a leading Canada-based pharmaceutical contract manufacturer, announced today that the Government of Quebec, through its agent Investissement Quebec, is granting a loan of CAD 25 million, which includes a forgivable portion of CAD 6.3 million to fund the CAD 100 Mn capacity expansion at the CMO Montreal facility. The loan disbursement is subject to final agreement to be signed between the two parties.

This investment aims to modernize and augment the drug production capacity by over 100% at the Montreal, Canada facility. As part of this initiative, Jubilant HollisterStier will acquire new specialized equipment and equip the plant with a single-use sterile preparation room to maximize the filling process linked to the production of liquid sterile products.

The Minister of Economy and Innovation and Minister responsible for Regional Economic Development, Mr. Pierre Fitzgibbon, made the announcement today.

"This modernization project shows the effervescence that is being created in Montreal in the life sciences. To have a more efficient health network, we must increase our health autonomy. The pandemic has shown us how important it is to strengthen our supply chains, and that is exactly what we are doing today. said Mr Pierre Fitzgibbon.

Christian Dubé, Minister of Health and Social Services said, "Quebec has a strong industrial fabric in life sciences, and the modernization of Jubilant HollisterStier's facilities will further consolidate this key sector. This project will also generate contract development and manufacturing activities for other Quebec biopharmaceutical companies. With the new Québec Life Sciences Strategy, we want to create even more synergies like this between our companies to meet the major health challenges."

Speaking on the announcement, Mr Pramod Yadav, CEO, Jubilant Pharma Limited said, "Jubilant HollisterStier is excited to be chosen as a part of the eco-system being developed by Canada to make it self-dependent for its future needs of vaccines and treatments in case of a pandemic. This funding will enable our continued effort to expand our capabilities in Canada and create more jobs."

"This new agreement is a testament to the contributions of our organization during the current pandemic and public health emergencies over the past two decades. Jubilant HollisterStier's expansion will target large Pharmaceuticals and Biotech companies parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit).," shared Mr Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier.

Bedminster, New Jersey, USA – June 1, 2022 – Jubilant Therapeutics Inc. a clinical stage precision therapeutics Company advancing small molecule therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced data to be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The data report on the pharmacokinetic and in vitro and in vivo anti-cancer properties of JBI-2174, the Company’s lead oral, brain penetrant PD-L1 inhibitor, which is in IND-enabling studies for the treatment for solid tumors. The poster will be presented by Luca Rastelli, Ph.D., Company’s Chief Scientific Officer, during the Developmental Therapeutics—Immunotherapy session at 8:00 a.m. CDT on June 05, 2022. The abstract is available here.

“Checkpoint inhibitors, such as anti-PD-1 and anti-PDL1 antibodies, have revolutionized cancer treatment by enabling the immune system to attack tumor cells,” said Luca Rastelli. “However, these antibodies have poor brain penetrance and shown limited efficacy in brain cancers. Employing our structure-based drug design and computational algorithms, we have designed oral small molecule checkpoint inhibitors that address this limitation. We are focused on completing our IND-enabling studies and hope to initiate shortly the clinical trials with JBI-2174 in patients with specific brain tumors.” he further added.

The potency, pharmacokinetics and in vivo activity of rationally designed small molecule inhibitors of PD-L1 were evaluated. The Company’s lead anti-PD-L1 candidate, JBI-2174, demonstrated strong affinity for PD-L1 with an IC50 of approximately 1 nM. In selectivity assays for immune-oncology targets, JBI-2174 was highly selective for PD-L1 and also inhibited PD-L1/PD-1 mediated signaling essential for T-cell modulation.  In multiple animal models where tumor cells were injected in the brain, JBI-2174 demonstrated sustained brain exposure, efficacy equivalent to an anti-PD-L1 antibody and increased survival compared to control. The results suggest an orally administered brain penetrant small molecule PD-L1 inhibitor could achieve efficacy in brain tumors that do not usually respond to immune-checkpoint antibodies