ON May 18, 2022 Pharma major Lupin Limited [BSE: 500257 | NSE: LUPIN] reported its financial performance for the quarter and fiscal year ending March 31, 2022 (Press release, Lupin, MAY 18, 2022, View Source [SID1234614804]). These audited results were taken on record by the Board of Directors at a meeting held today. Basis the long-term outlook, the Board has recommended a dividend of 200%.

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Financial Highlights – Consolidated IND-AS

* Excluding one-time expenses of INR 1932 mn Q3 FY22 EBIDTA was INR 5971 mn and PBT was INR 3603 mn

**EBIDTA before Business Compensation expense

***Adjusted for Solosec Impairment & Business Compensation expense for Glumetza in Q2 FY 22

Income Statement highlights – Q4 FY2022

Gross Profit was INR 22,323 mn compared to INR 23,929 mn in Q3 FY2022, with margin of 57.8%
Personnel cost was 18.2% of sales at INR 7,032 mn compared to INR 7,438 mn in Q3 FY2022
Manufacturing and other expenses were 34.2% of sales at INR 13,212 mn compared to INR 13,518 mn in Q3 FY2022
Investment in R&D for the quarter was INR 3,442 mn (8.9% of sales)
Balance Sheet highlights

Operating working capital was INR 60,303 mn as on March 31, 2022
Capital Expenditure for the quarter was INR 1,577 mn and INR 6,872 mn for FY2022
Net Debt as on March 31, 2022 stands at INR 19,227 mn
Net Debt-Equity for the company as on March 31, 2022 stands at 0.16
Commenting on the results, Mr. Nilesh Gupta, Managing Director, Lupin Limited said, "The current quarter was challenging with headwinds in the U.S. on account of price erosion, and inflation in input materials and freight. Our other markets continue solid growth in revenues and profitability. We are focused on optimizing operating expenses and spend and ensuring the evolution of our complex generic platforms along with global portfolio maximization while doubling down on markets like India. We expect our efforts to yield meaningful uptick in profitability, especially in the second half of this fiscal and beyond"

Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 63.3% of sales in Q4 FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 28% of sales in Q4 FY2021.
In Q3 FY22, other expenses include the impact of one-time expenses of INR 1,932 mn related to residual Metformin returns from retail and consumers not identified previously, and a provision for aged stock returns of Oseltamivir given lack of an active flu season for the past two years.
Depreciation & Amortization & impairment expense of Q4 FY22 includes INR 1,267 mn on account of impairment of Gavis IPs.

1> Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 63.1% of sales in FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 27.9% of sales in FY2021.

2. In Q3 FY22, other expenses include the impact of one-time expenses of INR 1932 mn related to residual Metformin returns from retail and consumers not identified previously, and a provision for aged stock returns of Oseltamivir given lack of an active flu season for the past two years.

3. In Q2 FY2022 we had created a provision of INR 18,795 mn [including INR 375 mn towards litigation and settlement related expenses] under Glumetza class actions. The amounts due to the two plantiffs group was settled in Q3. We had a small reversal on account of litigation expense in Q4 of INR 12 mn.

4. Q2 FY2022 includes impairment expense of INR 7,077 mn for Solosec IP.

Operational Highlights
North America

North America sales for FY2022 were INR 57,556 mn compared to INR 55,520 mn in FY 2021; accounting for 36% of Lupin’s global sales. Q4 FY2022 sales were INR 14,162 mn, down 10.2% compared to INR 15,775 mn in Q3 FY2022, down 5.3% as compared to INR 14,952 mn in Q4 FY2021; accounting for 37% of Lupin’s global sales.

U.S. FY2022 sales were USD 738 mn compared to USD 720 mn in FY2021.

Q4 FY2022 sales were USD 181 mn compared to USD 202 mn in Q3 FY2022 and USD 195 mn in Q4 FY2021.

The Company filed 10 ANDAs in the quarter, received 2 ANDA approvals from the U.S. FDA, and launched 2 products in the quarter in the U.S. The Company now has 166 generic products in the U.S.

Lupin continues to be the 3rd largest pharmaceutical player in both U.S. generic market and U.S. total market by prescriptions (IQVIA MAT March 2022). Lupin is the leader in 44 of its marketed generics in the U.S. and amongst the Top 3 in 113 of its marketed products (IQVIA MAT March 2022).

India

India formulation sales for FY2022 were INR 60,042 mn, up 13.9% as compared to INR 52,712 mn in FY2021; accounting for 38% of Lupin’s global sales. Q4 FY2022 sales were INR 13,511 mn, down 8.3% as compared to INR 14,733 mn in Q3 FY2022, up 5.0% as compared to INR 12,866 mn in Q4 FY2021; accounting for 35% of Lupin’s global sales.

India Region Formulations sales grew by 13.3% in the quarter as compared to Q4 FY2021. The company launched 1 brand in the Anti-Diabetic therapy, 1 brand in the Anti-Viral therapy and 1 brand in the VMS therapy in the quarter.

Lupin is the 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT March 2022).

Growth Markets (LATAM and APAC)

Growth Markets sales for FY2022 were INR 14,019 mn, up 17.2% as compared to INR 11,964 mn in FY2021; accounting for 9% of Lupin’s global sales. Q4 FY2022 sales were INR 3,810 mn, up 12.4% compared to INR 3,390 mn in Q3 FY2022, up 25.6% as compared to INR 3,033 mn in Q4 FY2021; accounting for 10% of Lupin’s global sales.

Brazil sales were BRL 224 mn for FY2022, compared to a sales of BRL 239 mn for FY2021. Q4 FY2022 sales were BRL 64 mn, compared to BRL 49 mn for Q3 FY2022 and BRL 59 mn for Q4 FY2021.

Mexico sales were MXN 713 mn for FY2022, compared to a sales of MXN 621 mn for FY2021. Q4 FY2022 sales were MXN 183 mn, compared to MXN 195 mn for Q3 FY2022 and MXN 154 mn for Q4 FY2021.

Philippines sales were PHP 1,881 mn for FY2022, compared to a sales of PHP 1,388 mn for FY2021. Q4 FY2022 sales were PHP 475 mn, compared to PHP 401 mn for Q3 FY2022 and PHP 402 mn for Q4 FY2021.

Australia sales were AUD 74 mn for FY2022, compared to a sales of AUD 57 mn for FY2021. Q4 FY2022 sales were AUD 20.8 mn, compared to AUD 17.8 mn for Q3 FY2022 and AUD 14.2 mn for Q4 FY2021.

Europe, Middle-East and Africa (EMEA)

EMEA sales for FY2022 were INR 13,592 mn, up 6.3% as compared to INR 12,781 mn in FY 2021; accounting for 9% of Lupin’s global sales. Q4 FY2022 sales were INR 4,072 mn, up 19.0% compared to INR 3,422 mn in Q3 FY2022, up 8.6% compared to INR 3,749 mn in Q4 FY2021; accounting for 10% of Lupin’s global sales.

South Africa sales were ZAR 1,375 mn for FY2022, compared to a sales of ZAR 1,295 mn for FY2021. Q4 FY2022 sales were ZAR 426 mn, compared to ZAR 319 mn in Q3 FY2022 and ZAR 431 mn in Q4 FY2021. Lupin is the 6th largest player in South Africa in the total generics market (IQVIA February 2022).

Germany sales were EUR 32.4 mn for FY2022, compared to a sales of EUR 29.2 mn for FY2021. Q4 FY2022 sales were EUR 8.4 mn, compared to EUR 8.8 mn in Q3 FY2022 and EUR 5.4 mn in Q4 FY2021.

Global API

Global API sales for FY2022 were INR 9,904 mn, down 28.4% as compared to INR 13,823 mn in FY2021; accounting for 6% of Lupin’s global sales. Q4 FY2022 sales were INR 2,203 mn, down 14.1% as compared to INR 2,564 mn in Q3 FY2022, down 13.8% as compared to INR 2,556 mn in Q4 FY2021; accounting for 6% of Lupin’s global sales.

Research and Development

Investment in R&D was INR 14,024 mn (8.7% of sales) for FY2022 and INR 3,442 mn (8.9% of sales) in Q4 FY2022.

Lupin received approval for 2 ANDAs from the U.S. FDA in the quarter. Cumulative ANDA filings with the U.S. FDA stand at 457 as of March 31, 2022, with the company having received 297 approvals to date.

The Company now has 53 First-to-File (FTF) filings including 21 exclusive FTF opportunities. Cumulative U.S. DMF filings stand at 196 as of March 31, 2022.

On May 18, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company is undertaking manufacturing and development of PRP for human use (Press release, Propanc, MAY 18, 2022, View Source [SID1234614820]). PRP is the Company’s lead product candidate and is a novel pharmaceutical formulation consisting of two proenzymes to be administered by I.V. injection in a world first, First-In-Human (FIH) study in advanced cancer patients. It is a long-term therapy for the treatment and prevention of metastatic cancer in patients suffering from solid tumors.

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To date, the Company has sourced the two proenzymes from a raw material supplier, where an isolation process for both ingredients have been established and scaled up. The proenzymes are extracted, precipitated and lyophilized (freeze dried by a low temperature dehydration process), serving as the raw materials for GMP (Good Manufacturing Practice) manufacture of the finished drug product. A proprietary purification process has been developed by Propanc and successful scale up of the bulk drug substances has been completed. Over 95% purity for each of the proenzymes was achieved to reach pharmaceutical standard for the final drug product. This reduces impurities, resulting in a more stable product with a longer shelf life, as the active enzymes have the potential to ‘auto-catalyze’ meaning they can potentially self-activate. Therefore, the novel formulation consists of two proenzymes prepared in individual vials ready to be mixed into a solution for I.V. injection for the upcoming Phase I, FIH study.

According to Dr. Linda Isaacs M.D., Integrative Cancer Therapies, January 2022, since the turn of the last century, based on the original hypothesis of Professor John Beard from Edinburgh University, the trophoblastic theory and the origin of cancer, numerous physicians have been injecting enzyme preparations into cancer patients with both startling, but also mixed success. One reason was attributed by Beard to the "wide variation" in the quality available enzymes that he believed explained why the treatment was sometimes unsuccessful. In the following years, there were numerous attempts at injection of enzymes, which led to the US Food and Drug Administration prohibiting intravenous and injectable enzymes, presumably due to the uncontrolled nature of the administration to patients. Despite this, Dr Isaacs concludes that an intravenous formulation for use in humans would offer "considerable advantages", whilst also acknowledging the considerable developmental costs.

Over the last decade, Propanc has undertaken the manufacturing and development of proenzymes as an I.V. formulation and conducted several scientific advice meetings with the Medicines and Healthcare Products Regulatory Agency (MHRA) UK to determine the pathway for the clinical development of PRP. The Company has also sourced suitable quality proenzymes for the commercial scale quantities needed for global pharmaceutical distribution and is ready to undertake the full scale GMP manufacture of PRP in preparation for the upcoming Phase I FIH study in advanced cancer patients.

"We have spent significant time and resources on the manufacturing and development of PRP as we prepare for our Phase I, FIH study in advanced cancer patients," said James Nathanielsz, Propanc’s Chief Executive Officer. "Undertaking the steps necessary to purify and scale up the bulk drug substances is critical to producing a quality product according to pharmaceutical standard, which we intend to seek regulatory approval for worldwide distribution. Our novel pharmaceutical formulation is a world-first approach using a technology with over 100 years of clinical experience, since Professor John Beard first proposed the use of enzymes as a novel way to treat cancer. By advancing PRP through the drug development process, we remain committed to achieving a vision of producing a long-term approach for the treatment and prevention of metastatic cancer from solid tumors, which remains the main cause of patient death for sufferers."

Professor Klaus Kutz, Propanc’s Chief Medical Officer said, "Our lead product candidate, PRP, is a novel, targeted cancer therapy, free from the side effects normally associated with standard treatment approaches. That is why we have worked over several years to overcome the technical challenges to produce a novel pharmaceutical formulation to GMP standard for I.V injection, which is our preferred route of administration in order to increase systemic exposure to treat solid tumors, which may result in better therapeutic efficacy."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

On May 18, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the uses of XPOVIO(selinexor) for Multiple Myeloma (MM) patients with first relapse or multiple relapses were incorporated into the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) (Press release, Antengene, MAY 18, 2022, View Source [SID1234614836]). This is the first time that selinexor has been included in the guidelines.

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The Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) was jointly developed and revised by the Chinese Hematology Association of the Chinese Medical Doctor Association (CMDA) and the Chinese Society of Hematology of the Chinese Medical Association (CMA), and was published in the Chinese Journal of Internal Medicine in May 2022.

The 2022 Guidelines for MM incorporated four selinexor combination therapy regimens comprised of selinexor and other biological and/or chemotherapy agents. Recommendations for the treatment of relapsed/refractory MM (R/R MM) are based on the multiple sources of medical evidence including patients’ response to prior treatment. As one of the most recognized guidelines in China, the guidelines are widely adopted among Chinese oncologists in their clinical practice.

Prof. Jin Lu, at Peking University People’s Hospital, commented, "MM is a malignancy that arises from plasma cells in the bone marrow, commonly occurring in middle-aged and elderly populations. As a result of an aging population, the incidence of MM has been rising sharply in China in recent years. Despite the medical advances in MM in the past two decades, R/R MM still remains a major clinical challenge faced by clinicians in day-to-day practices. Selinexor, the world’s first oral inhibitor of the nuclear export protein, was jointly recommended by the CMDA and CMA in the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision), which indicates strong recognition of selinexor’s therapeutic utility in Myeloma. Meanwhile, we hope that other on-going studies will generate additional data supporting even wider clinical adoption of selinexor."

Dr. Jay Mei, Antengene’s Founder, Chairman and CEO said, "Antengene is pleased to fulfill our mission of treating cancer patients with relapsed/refractory disease by bringing selinexor to the market in China and other Asia Pacific geographies. Inclusion in the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) is important because it highlights the robust clinical evidence that supports the use of selinexor in patients with R/R MM from first relapse through the full spectrum of disease progression. We believe that the combination of strong clinical data and inclusion into the guidelines for MM will make it easier for practitioners to incorporate selinexor into patient care and pave the way for patients with R/R MM to benefit from this novel therapy."

Dr. Kevin Lynch, Antengene’s Chief Medical Officer added, "Antengene is especially pleased for the use of selinexor to be recommended from the first relapse or multiple relapses. We understand that cancer care is complex and that having effective treatment options for the first relapse that offers the potential for durable disease control is especially important to patients and their families. We look forward to bringing this important therapy to patients in China and other Asia Pacific geographies."

Practice Guidelines for the treatment of relapsed myeloma

The patient’s response to prior treatment

Recommended Regimens

Lenalidomide-sensitive

XDd, XPd, XKd

Lenalidomide-resistant

XDd, XVd, XPd, XKd

Bortezomib-sensitive

XVd, XPd, XKd

Bortezomib-resistant

XDd, XPd, XKd

Resistant to both lenalidomide and bortezomib

XDd, XPd, XKd

*XDd, selinexor plus daratumumab plus dexamethasone; XPd, selinexor plus pomalidomide plus
dexamethasone; XKd, selinexor plus carfilzomib plus dexamethasone; XVd; selinexor plus
bortezomib plus dexamethasone

About Multiple Myeloma (MM)

MM is caused by the dysregulated proliferation of plasma cells. It is the second most common hematologic malignancy in many countries. Despite availability of a number of treatments for relapsed patients, MM is prone to relapse and most patients still succumb to their disease. MM is the second most common hematological malignancy in China, with an estimated about 15,000 to 20,000 new MM patients and 10,300 deaths per year.[1]

About XPOVIO (selinexor)

Selinexor is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. Due to its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens to improve treatment efficacy.

Antengene secured approval of selinexor in China in December 2021 for R/R MM and plans to launch the product in the second quarter of 2022. Antengene has also secured approval for selinexor in South Korea for use in R/R MM and R/R DLBCL in July 2021, in Singapore for use in R/R MM and R/R DLBCL and in Australia for use in R/R MM in March 2022. Antengene is conducting 10 clinical studies in mainland China (3 are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]) for relapsed/refractory hematological malignancies and advanced solid tumors.

On May 18, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported that the first patient has been dosed in the IMA203 and nivolumab combination Phase 1b dose expansion cohort (Press release, Immatics, MAY 18, 2022, View Source [SID1234614788]). This cohort will evaluate Immatics’ TCR-engineered cell therapy (TCR-T) approach ACTengine IMA203 targeting an HLA-A*02-presented peptide derived from PRAME, in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor nivolumab, in patients with advanced solid tumors. The objectives of the study will be to evaluate the safety, biological activity, and initial anti-tumor activity of the IMA203 and nivolumab combination.

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"Initiating the second of three dose expansion cohorts is an important milestone in our comprehensive approach to target PRAME. It builds on the successful completion of the dose escalation part of the Phase 1 trial and the early positive clinical data we observed with IMA203," said Cedrik Britten, Chief Medical Officer at Immatics. "We are excited to elucidate how the combination with an immune checkpoint inhibitor could enhance the potency of our engineered IMA203 T cells. We also look forward to initiating the third Phase 1b cohort with IMA203CD8, our next generation approach that additionally harnesses the power of CD4 T cells."

The IMA203 and nivolumab combination Phase 1b dose expansion cohort is expected to enroll up to 18 patients with different types of solid tumors across 10 clinical trial sites in Germany and the U.S. Bristol Myers Squibb will provide Immatics, the study sponsor of the combination trial, with nivolumab as part of a clinical supply agreement. Nivolumab has become the standard of care treatment for many solid cancer indications and we believe it fits well into the IMA203 treatment and observation schedule. According to the clinical trial protocol for ACTengine IMA203, nivolumab will be administered at regular intervals following IMA203 treatment. The primary endpoint of this cohort is to assess the safety of the combination. Anti-tumor activity resulting from the drug combination is a secondary endpoint, which will be assessed through imaging and measured according to the standard Response Evaluation Criteria In Solid Tumors (RECIST).

The combination treatment of IMA203 and nivolumab is part of Immatics’ strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. Based on this strategy, the company has expanded the IMA203 trial to a total of three Phase 1b dose expansion cohorts – each designed to assess observed objective response rates, demonstrate durability of response, and form the basis for enrollment in pivotal studies. In addition to the IMA203 and nivolumab combination (first patient treated, initial data read-out planned for YE 2022), Immatics will also investigate IMA203 as monotherapy (patient enrollment ongoing, next data read-out planned in 2H 2022) and IMA203CD8, a next-generation cell therapy where IMA203-engineered T cells are co-transduced with a CD8αβ co-receptor (initiation planned for 2Q 2022, initial data read-out planned for YE 2022).

About IMA203 and target PRAME
ACTengine IMA203 T cells are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine IMA203.

About ACTengine
ACTengine is a personalized approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

On May 18, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that management is scheduled to present at the H.C. Wainwright Global Investment Conference on Wednesday, May 25, 2022 at 9:30 AM EDT (Press release, Pieris Pharmaceuticals, MAY 18, 2022, View Source [SID1234614805]). A webcast of the company’s presentation will be available at this link.

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