On May 14, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal third quarter ended March 31, 2021 and provided a corporate update (Press release, Kintara Therapeutics, MAY 14, 2021, View Source [SID1234579980]).

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Fiscal Third Quarter Highlights and Recent Developments

Commenced patient recruitment of Kintara’s VAL-083 arm of the glioblastoma multiforme (GBM) AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). VAL-083 is currently the only therapeutic agent being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.

Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of our CMBC Phase 3 trial for CMBC patients.

Extended calendar year cash runway from previously announced Q4 2021 to Q2 2022 primarily due to the exercise of previously issued warrants as well as operational and resource synergies realized through the Adgero acquisition.

Enhanced corporate and scientific leadership teams with appointments of Tamara A. Seymour to the Board of Directors and Dr. Mario Lacouture to the Scientific Advisory Board with an initial focus on CMBC.

Completed patient enrollment of the recurrent arm of the Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) for GBM patients who have been pre-treated with temozolomide prior to disease recurrence.

Presented positive data updates at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from the ongoing Phase 2 clinical studies in newly-diagnosed first-line, newly-diagnosed adjuvant, and recurrent GBM.
"As we head into the final fiscal quarter of 2021, we continue to make steady progress on our late-stage clinical pipeline, as well as making valuable additions to our leadership and advisory teams, and continuing to secure our foothold as a leader in oncology indications with clear unmet medical needs," commented Saiid Zarrabian, Kintara’s President and Chief Executive Officer. "Commencing VAL-083’s enrollment in the GBM AGILE registrational study was a significant milestone during the period, along with continued progress with both of our ongoing Phase 2 clinical trials, of which the MD Anderson study is anticipated to report topline results in the second quarter of calendar 2021."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 THIRD QUARTER ENDED MARCH 31, 2021

At March 31, 2021, the Company had cash and cash equivalents of approximately $15.7 million. The cash and cash equivalents at March 31, 2021 are expected to be sufficient to fund the Company’s planned operations into the second quarter of calendar year 2022.

For the three months ended March 31, 2021, the Company reported a net loss of approximately $6.6 million, or $0.23 per share, compared to a net loss of approximately $2.0 million, or $0.17 per share, for the three months ended March 31, 2020. For the nine months ended March 31, 2021, the Company reported a net loss of approximately $31.6 million, or $1.47 per share, compared to a net loss of approximately $5.3 million, or $0.52 per share, for the nine months ended March 31, 2020. The increase in loss for the nine months ended March 31, 2021 compared to the nine months ended March 31, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the merger with Adgero Biopharmaceuticals Holdings, Inc. and an expanded rate of expenditures with the initiation of the GCAR study and REM-001 development.

On May 14, 2021 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, 2021 (Press release, Dr Reddy’s, MAY 14, 2021, View Source [SID1234580010])
. The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

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COVID portfolio We continue to play our role in the fight against Covid-19 by acting proactively to bring multiple preventive and curative treatment options, including a vaccine. Some of our major Covid-19 products are:

Sputnik V vaccine: The trials demonstrated efficacy @ 91.6%, consistent safety and immunogenicity results. In April, 2021 we received Emergency Use Authorization (EUA) for the vaccine. We have launched it today and the first dose of the vaccine was administered. Our priority is to ensure widest reach in the shortest possible time.

Remdesivir: We launched it in India and have ramped up our supplies to meet with the higher demand due to surge of the COVID cases in India.

Avigan (Favipiravir): We are selling it in India and few other markets. We are conducting phase 3 trials in North America for outpatient setting with mild to moderate symptoms. 2-deoxy-D-glucose (2-DG): We developed it in collaboration with DRDO lab. Received EUA as adjunct therapy for hospitalized moderate to severe Covid-19 patients.

Other Covid drugs: We are also working on Molnupiravir, Baricitinib and several other covid drugs for treatment ranging from mild to severe conditions. Revenue Analysis [Q4 and full year FY21] Global Generics (GG)
 Revenues from GG segment at Rs. 154.4 billion higher by 12% over FY20, on account of growth across all our markets. We witnessed double digit growth in Europe and India during the year.
Q4 revenue at Rs. 38.7 billion, YoY growth of 6% and QoQ decline of 5%. The YoY growth was driven by branded markets (India and emerging markets), Europe partly offset by decline in NAG. QoQ decline was on account of branded markets & Europe. North America 
Revenues from North America Generics for the year at Rs. 70.5 billion, YoY growth of 9%. The year was benefited by new launches, scale up of existing products and a favorable forex rate, which was partially offset by price erosion.
 Revenues for Q4 at Rs. 17.5 billion, YoY decline of 3% and QoQ growth of 1%. The YoY decline was primarily on account of higher volumes during Q4 last year due to COVID-19 related stocking up and price erosion. The QoQ growth was driven by volume traction in our base business and new product launches partly offset by price erosion.
 During this quarter, we launched 6 new products – Vigabatrin tablets (CGT status granted), Febuxostat tablets, Capecitabine tablets, Fluphenazine Hydrochloride tablets, Lansoprazole OD tablets and Abiraterone Acetate in Canada.
As of 31st March 2021, cumulatively 95 generic filings are pending for approval with the USFDA (92 ANDAs and 3 NDAs under 505(b)(2) route). Out of the pending ANDAs, 47 are Para IVs, and we believe 23 have ‘First to File’ status. Europe
 Revenues from Europe for the year at Rs. 15.4 billion. YoY growth of 32%, primarily on account of volume traction in base business, new product launches across our markets including newer markets of France, Italy and Spain and favorable fo ex, which was partially offset by price erosion. 7
 Revenues for Q4 at Rs. 4.0 billion, YoY growth of 15% and QoQ decline of 5%. QoQ decline was on account of lower volumes in our base business and price erosion which was partly offset by new products launched during the quarter. India
 Revenues from India for the year at Rs. 33.4 billion. Year-on-year growth of 15%, driven by revenues from the acquired business of Wockhardt and contribution from new product launches.
 Revenues for Q4 at Rs. 8.4 billion, YoY growth of 23%, QoQ decline of 12%. QoQ decline was led by reduction in covid drugs sales and seasonality. Emerging Markets
 Revenues from Emerging Markets for the year at Rs. 35.1 billion, growth of 7%.-Revenues from Russia for the year at Rs. 15.8 billion, YoY decline of 6%. The decline was primarily driven by adverse forex and lower volumes of some of our key molecules.-Revenues from other CIS countries and Romania for the year at Rs. 7.4 billion, YoY growth of 15%. Growth was on account of increase in volumes and new launches.-Revenues from Rest of World (RoW) territories for the year at Rs. 11.8 billion, YoY growth of 25%. Growth primarily on account of new launches and volume traction in key products, partially impacted by price erosion in certain markets.
 Revenues for the quarter are Rs. 8.8 billion, YoY growth of 10%, QoQ decline of 8%.-Revenues for Russia for the Q4 at Rs. 4.0 billion, YoY growth of 3%, QoQ decline of 11%.-Revenues from other CIS countries and Romania for the quarter are Rs. 1.9 billion, YoY growth of 7%, QoQ decline of 11%.-Revenues from Rest of World (RoW) territories for this quarter are Rs. 2.9 billion, YoY growth of 24%, QoQ decline of 1%. Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 32.0 billion. Year-on-year growth of 24% driven by new products, increase in volumes of key products of API business and favorable forex partially offset by price erosion.
 Revenues for Q4 at Rs. 7.9 billion, YoY growth of 10% and QoQ growth of 13%.
 During the year, we have filed 14 DMFs in the US. Proprietary Products (PP) & Others  Revenues from PP & Others for the year at Rs. 3.3 billion, YoY decline of 69%. FY20 was higher due to income from sale of the US and select territory rights for two of Neurology franchise products pertaining to PP.  Revenues for Q4 are Rs. 632 million. 8 Income Statement Highlights:  Gross profit margin for the year at 54.3%, an increase of ~50 bps over previous year. The increase was driven by a better product mix and increased leverage from manufacturing overheads. This was partly offset by price erosion, lower export incentives and benefit from PP out-licensing income in FY 20. Gross profit margin for GG and PSAI business segments are at 59.0% and 29.5% respectively. 
Gross profit margin for the Q4 at 53.7% (GG: 57.9%, PSAI: 31.7%).-YoY gross margin increased by ~220 bps, primarily due to a better product mix and increased leverage from manufacturing overheads, partly offset by price erosion and lower export benefits-QoQ gross margin declined by ~10 bps.  Selling, general & administrative (SG&A) expenses for FY21 at Rs. 54.6 billion, an increase of 9% on a YoY basis. This increase was primarily due to incremental costs post the integration of the acquired divisions from Wockhardt in this year and increased freight expenses. SG&A expenses for Q4 at Rs. 14.3 billion, YoY increase of 17% and QoQ decline of 1%. SG&A as a % to sales for the full year remained in line with FY20.  Impairment charge at Rs. 6.8 billion in FY21, which were taken considering the triggers which occurred during the year.  Research & development (R&D) expenses in FY21 at Rs. 16.5 billion. As % to Revenues – FY21: 8.7% | FY20: 8.8%. R&D expenses for Q4 at Rs. 4.1 billion, as % to revenues stood at 8.7%. Our focus continues on building a healthy pipeline of new products across our markets including development of products pertaining to COVID-19 treatment.  Other operating income for the year at Rs. 982 million compared to Rs. 4.3 billion in FY20. Previous year included Rs. 3.5 billion received from Celgene pursuant to a settlement agreement in Canada.  Net Finance income for the year at Rs. 1.7 billion compared to Rs. 1.5 billion in FY20. The increase is primarily on account of higher foreign exchange gain in current year as compared to FY20. Net finance income in Q4 is Rs. 0.3 billion.  Profit before Tax for the year at Rs. 28.3 billion, YoY growth of 57%. Profit before Tax for Q4 is at Rs. 8.1 billion. 

Profit after Tax for the year at Rs. 19.1 billion and for Q4 at Rs. 5.5 billion. The tax rate in FY21 is higher due to non-recognition of deferred tax asset (DTA) on losses arising out of impairment. It was lower in FY20 due to recognition of deferred tax asset (DTA) on losses arising out of impairment, recognition of MAT credit, and others in line with the requirements of accounting standards.  Diluted earnings per share for the year is Rs. 115.14. Diluted earnings per share for Q4 is Rs. 33.29. Other Highlights:  EBITDA for FY21 at Rs. 47.5 billion and the EBITDA margin is 25.0%. EBITDA for Q4 FY21 is at 11.3 billion and the EBITDA margin in 24.0%.  Capital expenditure for FY21 is at Rs. 9.7 billion. Capital expenditure for Q4 FY21 is at Rs. 2.9 billion.  Free cash-flow at Rs. 24.6 billion before acquisitions. Free cash-flow for Q4 FY21 at Rs. 7.9 billion.  Net cash surplus for the company is at Rs. 7.5 billion as on March 31, 2021. Consequently, net debt to equity ratio is (0.04).  The Board has recommended payment of a dividend of Rs. 25 per equity share of face value Rs 5/-each (500% of face value) for the year ended March 31, 2021 subject to approval of members. 9 Earnings Call Details (05:30 pm IST, 08:00 am EDT, May 14, 2021) The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

On May 14, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that management team members will be attending and presenting at Bio€quity Europe (17-19 May) (Press release, Mission Therapeutics, MAY 14, 2021, View Source [SID1234579981]).

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Anker Lundemose, CEO, David Luther, CFO, and Paul Wallace, CBO, will attend the digital event and will be available for partnering meetings. Mission’s corporate presentation is available to all delegates via the partneringONE digital event platform.

In addition, Anker will present on 19 May at 10:00 CET as part of the 10th CEO Workshop: Hiring and Team Building in the Age of COVID. The workshop will explore how best practices for hiring A-list talent have evolved during the pandemic, including what is expected to be the long-term impact. The panel will also discuss how they have kept their teams motivated and productive over the past year.

Bio€quity Europe Digital is an international networking platform that enables financial dealmakers and biopharma executives to meet rising biotechs. Industry leaders will debate the big questions framing the future of biopharma innovation and identify where Europe will continue to be a global leader. The three-day virtual event will include strategic panels focused on ‘Europe’s Next Act’ and will support one-to-one virtual meetings, with over 130 corporate presentations available from European and Asian biotechs.

On May 14, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data demonstrating the ability of the Percepta Genomic Atlas to detect alterations that may inform lung cancer treatment decisions for patients from the same small biopsy that was used for diagnosis (Press release, Veracyte, MAY 14, 2021, View Source [SID1234580028]). Study findings presented today at the American Thoracic Society (ATS) 2021 International Conference show that the test accurately detects known lung-cancer gene variants using small biopsy samples, which may help guide treatment with targeted therapies.

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The in-development Percepta Genomic Atlas will provide comprehensive genomic profiling information on cancerous lung nodules, masses or lymph nodes, utilizing small samples from the same biopsy procedure used for diagnosis (i.e., transbronchial needle aspirate biopsies or TBNA). The test uses targeted DNA and whole-transcriptome RNA sequencing to detect alterations in more than 50 genes known to be present in lung cancer. Veracyte plans to launch the test in the second half of 2021 as part of the company’s comprehensive portfolio of genomic tests in lung cancer.

For the analyses presented at the ATS Conference today, researchers evaluated the feasibility of detecting National Comprehensive Cancer Network (NCCN)-recommended gene alterations with the Percepta Genomic Atlas, using samples from 25 patients obtained during initial bronchoscopy procedures. Results show that the in-development test accurately detected the gene variants in these samples with over 95 percent concordance to a reference next-generation sequencing assay.

"Physicians today are often challenged to obtain genomic profiling information on their lung cancer patients’ tumors, due to inadequate tissue, logistical delays and other factors. As a result, patients often do not receive optimal treatment," said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. "These findings give us confidence that the Percepta Genomic Atlas will be able to accurately detect gene alterations that may allow patients to be treated with targeted therapies that are available now and that will be available in the future. Importantly, we believe it will be able to provide this critical information near the time of diagnosis, enabling earlier and more appropriate treatment."

The Percepta Genomic Atlas ATS 2021 abstract can be viewed here. The poster presentation is available on demand to ATS conference registrants through July 2.

The Percepta Genomic Atlas will be a key part of Veracyte’s lung cancer portfolio, which aims to transform care at every step of the patient journey. Collectively, the company’s tests are leveraging cutting-edge genomic science and technology to provide answers and insights that enable physicians and patients to make better, faster and more confident care decisions.

On May 14, 2021 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, reported financial results for the quarter ended March 31, 2021 and provided corporate highlights (Press release, PMV Pharma, MAY 14, 2021, View Source [SID1234579983]).

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"PMV had a successful first quarter. We continued to advance our clinical and discovery programs, and our presentation at AACR (Free AACR Whitepaper) provided compelling evidence that PC14586 selectively reactivates the p53 Y220C mutant protein, both in vitro and in vivo," said David Mack, Ph.D., President and Chief Executive Officer. "Enrollment in our Phase 1/2 trial of PC14586, our first in class p53 Y220C reactivator, is progressing as planned. We are also thrilled to have welcomed Chuck Baum to our Board and Gigi Lozano to our SAB and look forward to leveraging their deep expertise in precision therapeutics and genetic drivers of cancer."

Corporate Highlights:

In March 2021, PMV Pharma presented late breaking preclinical data on PC14586, the Company’s first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. The Oral presentation titled, "PC14586: The First Orally Bioavailable Small Molecule Reactivator of Y220C Mutant p53 in Clinical Development" was given by Melissa L. Dumble, Ph.D., Vice President Preclinical Development and Translational Science of PMV.
PMV Pharma continued to enroll patients in the Phase 1 portion of a Phase 1/2 clinical trial of PC14586 (NCT04585750). PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
Appointment of Charles Baum, M.D., Ph.D., to the Board of Directors. Dr. Baum is the President and Chief Executive Officer and a Board Member of Mirati Therapeutics Inc.
Expanded Scientific Advisory Board with the appointment of p53 pioneer Dr. Guillermina (Gigi) Lozano, Professor and Chair, Department of Genetics, MD Anderson Cancer Center.
PMV Pharma is the process of relocating to a state-of-the-art laboratory and office building located in Princeton, NJ.
First Quarter 2021 Financial Results

PMV Pharma ended the fourth quarter with $348.4 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $12.9 million for the three months ended March 31, 2021 compared to $8.1 million for the three months ended March 31, 2020.
Net loss for the quarter ended March 31, 2021 was $11.6 million compared to $7.3 million for the quarter ended March 31, 2020.
Research and development (R&D) expenses were $7.5 million for the three months ended March 31, 2021 compared to $6.0 million for the three months ended March 31, 2020. The increase in R&D expenses was primarily related to increased headcount and clinical expenses for advancing development of PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $4.2 million for the three months ended March 31, 2021, compared to $1.7 million for the three months ended March 31, 2020. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.
About p53

p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation and has been granted Fast Track designation by the U.S. FDA.