On December 2, 2020 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported financial results and provided a business update for the quarter ended September 30, 2020 (Press release, Immatics, DEC 2, 2020, View Source [SID1234572076]).

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"The third quarter was highlighted by meaningful progress in our ACTengine IMA200 clinical trial series. Seven clinical sites in Germany and the US are now initiated and screening patients. These advancements mark critical steps towards delivering our clinical milestones for the coming year including reporting on initial data for ACTengine patients in dose escalation in Q1," said Harpreet Singh, Ph.D., CEO of Immatics. "In conjunction with our clinical and operational progress, we are pleased to further strengthen the Company’s capabilities with the appointments of both Eliot Forster to the Board and Arnd Christ as Chief Financial Officer."

Third Quarter 2020 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA200 Series – Immatics continued to select and initiate additional clinical trial sites in Germany and the US. The increased patient enrollment seen at sites in Germany was able to mitigate the impact of the global COVID-19 pandemic at US sites. These patients are expected to be treated within the fourth quarter this year, moving Immatics towards delivering the clinical milestones for ACTengine in the coming year. Combined initial data readout for ACTengine programs, IMA201, IMA202 and IMA203, continues to be expected in Q1 2021. Reported initial data will focus on safety and pharmacodynamic data including engraftment level, persistence and molecular phenotype of infused T cells as well as clinical change of target tumor lesions.
ACTengine IMA204 – Immatics presented preclinical data from the ACTengine cell therapy program targeting the tumor microenvironment on September 10. IMA204 is directed at a novel target, COL6A3 exon 6, which is highly expressed in the tumor stroma of a variety of solid cancers. An affinity-enhanced TCR candidate directed to this target demonstrated full functionality in CD8+ and CD4+ T cells indicating that this TCR could be employed in a next-generation ACTengine approach without the need of CD8 co-receptor transduction. Submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for IMA204 remains anticipated for 2021.
ACTolog IMA101 – On November 10, Immatics presented topline data from its clinical pilot trial IMA101, a personalized multi-target ACT approach using the patient’s own, non-engineered T cells. The trial demonstrated feasibility and tolerability of this approach as well as very high persistence of endogenous T cells directed against defined pHLA targets. Clinical course observations in patients treated with T cells directed at the tumor stroma target COL6A3 exon 6 warrant further exploration of this target within ACTengine. The results also support further development of a multi-target approach using multiple engineered TCRs simultaneously in ACTengine.

TCR Bispecifics Programs

IMA401 – A preclinical data update from Immatics’ first TCR Bispecifics (TCER) program on October 29, delivered pre-clinical proof-of-concept for IMA401 demonstrating complete remission of transplanted human tumors in mice as well as favorable CMC characteristics. The IMA401 cancer target, an HLA-A*02-bound peptide derived from both MAGEA4 and MAGEA8, showed more than 5-fold higher target copy numbers per tumor cell than a commonly used target peptide derived from MAGEA4. Submission of the IMA401 IND/IMPD application remains expected by the end of 2021.
Corporate Development

Management and Board of Directors Updates

Eliot Forster, Ph.D., joined Immatics’ Board of Directors as a new member in September 2020. He brings to Immatics extensive experience, including leadership of trailblazing biopharmaceutical companies in the field of immuno-oncology as well as other therapeutic areas.
In October 2020, Arnd Christ joined Immatics’ leadership team as Chief Financial Officer (CFO). He was previously the CFO of Nasdaq-listed InflaRx and brings nearly two decades of experience serving as the CFO of both private and public biotechnology companies.

Collaborations and Strategic Alliances

On August 6, Immatics announced the extension of its strategic alliance with UTHealth. The continued collaboration will provide Immatics exclusive access to three cGMP suites enabling manufacturing and supply of its ACT products for current and upcoming Phase 1 clinical trials in the US and Europe for an additional four years until end of 2024.

Third Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets sum up to €259.3 million ($303.6 million1) as of September 30, 2020 compared to €86.1 million ($100.8 million1) as of June 30. The increase is mainly due to the business combination with ARYA Sciences Acquisition Corporation completed in July 2020 (ARYA merger) and the concurrent PIPE Financing.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €7.8 million ($9.1 million1) for the three months ended September 30, 2020, compared to €5.1 million ($6.0 million1) for the three months ended September 30, 2019.

Research and Development Expenses: R&D expenses were €17.5 million ($20.5 million1) for the three months ended September 30, 2020, compared to €10.2 million ($11.9 million1) for the three months ended September 30, 2019. The increase is mainly due to increased share-based compensation (€4.6 million; $5.4 million1).

General and Administrative Expenses: G&A expenses were €9.2 million ($10.8 million1) for the three months ended September 30, 2020, compared to €2.7 million ($3.2 million1) for the three months ended September 30, 2019. The increase is mainly due to increased share-based compensation (€3.6 million; $4.2 million1) as well as one-time transaction costs of the NASDAQ listing in connection with the ARYA merger in July.

Net Loss: Net loss was €177.1 million ($207.3 million1) for the three months ended September 30, 2020, compared to €5.0 million ($5.9 million1) for the three months ended September 30, 2019 of which €152.8 million ($178.9 million1) resulted from a one-time, non-cash expense in connection with the ARYA merger. The main part of this €152.8 million ($178.9 million1) non-cash expense resulted from the share price increase between signing and closing of the ARYA merger. For detailed information, please refer to Note 9 of the Notes to the Financial Statements.

Upcoming Investor Conferences

Piper Sandler Healthcare Conference – December 1-3, 2020
10th Annual SVB Leerink Global Healthcare Conference – February 24-26, 2021

To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under View Source

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of September 30, 2020 (1 EUR = 1.1708 USD).

On December 2, 2020 During the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, principal investigators from The US Oncology Network (The Network) and US Oncology Research reported that it will share detailed results from 30 studies covering topics that include Hodgkin lymphoma, multiple myeloma and the effects of cancers on older patient populations (Press release, US Oncology, DEC 2, 2020, View Source [SID1234572098]). The ASH (Free ASH Whitepaper) Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will be taking place virtually from Dec. 5-8, 2020.

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"In this landscape impacted by COVID-19, real-world evidence shows that our collective fight against cancer must include advancing clinical research and empowering patients through timely health screenings," said Robert L. Coleman, MD, chief scientific officer, US Oncology Research. "At this year’s ASH (Free ASH Whitepaper) virtual meeting, we are looking forward to sharing the latest advances from investigators in The Network and to exploring ways we can continue working together to navigate the unprecedented challenges and risks that patients with cancer are facing today."

Christopher A. Yasenchak, MD, associate chair of hematology research for US Oncology Research and a hematologist with Willamette Valley Cancer Institute and Research Center, will present an oral abstract titled, "Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients," on Sunday, Dec. 6, at 2:15 p.m. ET.

"Older patients with Hodgkin lymphoma often have poorer outcomes than younger patients due to comorbidities and the toxicity of conventional first-line chemotherapy," said Dr. Yasenchak. "Brentuximab vedotin, as monotherapy and in combination with other agents, shows high response rates and clinically meaningful improvements in progression-free survival and tolerability compared to conventional combination chemotherapy. The study, SGN35-015, presents compelling evidence underscoring the growing interest and urgency in research to advance cancer treatment and care for older populations."

In addition, Robert Rifkin, MD, FACP, medical director of biosimilars for McKesson, associate chair of hematology research and myeloma disease lead for US Oncology Research and a hematologist with Rocky Mountain Cancer Centers, a practice in The Network, co-authored "The Phase 3 TOURMALINE-MM2 Trial: Oral Ixazomib, Lenalidomide, and Dexamethasone (IRd) Vs Placebo-Rd for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (NDMM)." The oral presentation will take place on Monday, Dec. 7, at 7:45 a.m. ET.

"Patients who are newly diagnosed with multiple myeloma and not eligible for autologous stem cell transplants need additional treatment options," said Dr. Rifkin. "We believe the findings from TOURMALINE-MM2 emphasize the need for all-oral, proteasome inhibitor-based treatment options and will help pave the way for future innovation on behalf of the multiple myeloma community."

Dr. Rifkin will also present a trial-in-progress poster, "DREAMM-7: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) With Bortezomib, and Dexamethasone (B-Vd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)," on Monday, Dec. 7, from 7:00 a.m.–3:30 p.m. ET.

Another oral abstract, "Subgroup Analyses of Elderly Patients Aged ≥ 70 Years in MAGNIFY: A Phase IIIb Interim Analysis of Induction R2 Followed By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma," was co-authored by David Andorsky, MD, a hematologist with Rocky Mountain Cancer Centers. The presentation will take place on Sunday, Dec. 6, at 10:30 a.m. ET.

"Results from MAGNIFY indicate an important option for older, high-risk patients with non-Hodgkin lymphoma who have relapsed or did not respond to previous treatment with chemotherapy," said Dr. Andorsky. "In this patient population, lenalidomide combined with rituximab—with close attention to dose reduction—demonstrated encouraging efficacy and a tolerable safety profile."

Mitul Gandhi, MD, a medical oncologist with Virginia Cancer Specialists, a practice in The Network, co-authored the poster, "Safety and Antitumor Activity Study Evaluating Loncastuximab Tesirine and Rituximab Versus Immunochemotherapy in Diffuse Large B-Cell Lymphoma." The presentation will take place on Sunday, Dec. 6, from 7:00 a.m.–3:30 p.m. ET.

"Options are critically needed to improve outcomes for patients with diffuse large B-cell lymphoma who did not respond to previous therapy, are unsuitable for autologous stem cell transplantation or relapsed shortly after a transplantation," said Dr. Gandhi. "I am looking forward to presenting findings that indicate the potential to meet the needs of more patients with this aggressive form of lymphoma."

Furthermore, Houston Holmes, MD, a medical oncologist and hematologist at Texas Oncology, a practice in The Network, co-authored the oral abstract "Single-Agent Mosunetuzumab Is a Promising Safe and Efficacious Chemotherapy-Free Regimen for Elderly/Unfit Patients With Previously Untreated Diffuse Large B‑Cell Lymphoma." The presentation will take place on Sunday, Dec. 6, at 12:15 p.m. ET.

"Among patients with diffuse large B-cell lymphoma, approximately 30% over age 75 do not receive standard chemotherapy as a first-line treatment due to concerns about frailty and comorbidities," said Dr. Holmes. "Based on early clinical data, single-agent mosunetuzumab could offer a promising chemotherapy-free regimen for these patients who otherwise have limited options."

Researchers with McKesson Data, Evidence and Insights also worked with US Oncology Research and The US Oncology Network physicians on studies advancing the applications of real-world evidence, which will be presented this year.

Dr. Yasenchak will present a real-world evidence study titled, "Real-World Adherence to National Comprehensive Cancer Network (NCCN) Guidelines Regarding the Usage of PET/CT and Reported Deauville Scores in Advanced Stage Classical Hodgkin Lymphoma: A Community Oncology Practice Perspective." The poster presentation will take place on Sunday, Dec. 6, from 7:00 a.m.–3:30 p.m. ET.

"Providers may not always have the comprehensive information needed to optimize treatment modifications for patients with Hodgkin lymphoma," added Dr. Yasenchak. "Based on our findings, there is an opportunity to educate oncologists and radiologists about the importance of consistently reporting PET/CT Deauville scores in the initial staging and assessment of treatment response for these patients."

An additional real-world evidence poster, "NHL Patients and Nurses in the US Prefer Subcutaneous Rituximab Injection Versus Intravenous Rituximab Infusion: A Real-World Study," will be presented by Dr. Gandhi on Saturday, Dec. 5 from 7:00 a.m.–3:30 p.m. ET.

"As the COVID-19 pandemic adds new barriers to our health systems and the completion of clinical trials, real-world evidence is pivotal in providing insights into how we can improve outcomes," said Nicholas J. Robert, MD, medical director, McKesson Data, Evidence and Insights. "By leveraging data from our electronic medical records, healthcare providers and researchers are making an impact and optimizing care for patients managing cancer."

The full schedule of affiliated data presentations, including timing and author information, can be found here. For more information or to interview a trial investigator, contact Claire Crye at 281.825.9927 or [email protected] or Edie DeVine at 209.814.9564 or [email protected].

On December 3, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of data from a Phase 2 study evaluating umbralisib, the Company’s investigational once daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy, in Blood, the Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, TG Therapeutics, DEC 2, 2020, View Source [SID1234572077]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are extremely encouraged by the data published today demonstrating that umbralisib monotherapy induced durable responses and enhanced progression-free survival in patients who were unable to tolerate their prior BTKi or PI3K delta therapy. Despite many advances in the treatment of CLL in recent years, early termination of kinase inhibitors due to tolerability is an emerging issue leaving too many CLL patients without adequate therapy." Mr. Weiss continued, "With our rolling BLA submission recently initiated for ublituximab in combination with umbralisib for patients with CLL, and our ongoing clinical studies evaluating triplet regimens in this disease, we remain committed to addressing unmet needs in CLL."

The manuscript includes data from 51 chronic lymphocytic leukemia (CLL) patients who were previously treated with and became intolerant to prior BTK or PI3K inhibitor therapy (44 BTK intolerant and 7 PI3K intolerant patients). Patients were treated with 800 mg of umbralisib once daily. The primary endpoint was progression-free survival (PFS). Safety data was available from all patients enrolled (n=51). Key highlights from this manuscript include:

The most common (≥5%) grade ≥3 AEs were neutropenia (18%), leukocytosis (14%), thrombocytopenia (12%), pneumonia (12%), and diarrhea (8%).
Six patients (12%) discontinued umbralisib due to an AE. Eight patients (16%) had dose reductions and were successfully re‐challenged allowing them to continue on umbralisib.
Median progression free survival (PFS) was 23.5 months (95% CI 13.1‐not estimable).
As of the data cut off, 58% of patients had been on umbralisib for a longer duration than their prior kinase inhibitor.
These data are described further in the manuscript entitled, "Phase 2 Study of the Safety and Efficacy of Umbralisib in Patients with CLL Who Are Intolerant to BTK or PI3Kδ Inhibitor Therapy," which was published online in the First Edition section of Blood, the Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The online version of the article can be accessed at www.bloodjournal.org.

On December 2, 2020 Taiho Oncology, Inc. and Astex Pharmaceuticals, Inc. reported that data for oral decitabine and cedazuridine (INQOVI [decitabine and cedazuridine] 35mg/100mg tablets) in intermediate and high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) will be presented during the 62nd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition (ASH 2020), taking place virtually from December 5-8, 2020 (Press release, Taiho, DEC 2, 2020, View Source [SID1234572099]). Key presentations include:

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Clinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML): Michael R. Savona, MD, Chief of Hematology, Cellular Therapy and Stem Cell Transplantation, Associate Director, Division of Hematology/Oncology, Director, Hematology Research and the Early Therapy Program, and Professor of Medicine and Cancer Biology, Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine (Abstract 1230). Results will be shared online as a poster presentation on December 5, 2020. The abstract for this presentation is available on the ASH (Free ASH Whitepaper) website: View Source
The Direct Medical Costs of Treatment Discontinuation Among Higher-Risk Myelodysplastic Syndrome Patients Receiving Hypomethylating Agents: Namita Joshi, PhD, MS, BPharm, Associate Director, Patient-Centered Outcomes and Real-World Evidence & Data Analytics Centers of Excellence, Pharmerit International (Abstract 1618). Results will be shared online as a poster presentation on December 5, 2020. The abstract for this presentation is available on the ASH (Free ASH Whitepaper) website: View Source
Under-Use of Hypomethylating Agents in Patients with Higher-Risk Myelodysplastic Syndrome in the United States: A Large Population-Based Analysis: Shelby Corman, PharmD, MS, BCPS, Executive Director and Head of the Real-World Evidence & Data Analytics Center of Excellence, Pharmerit International (Abstract 2522). Results will be shared online as a poster presentation on December 6, 2020. The abstract for this presentation is available on the ASH (Free ASH Whitepaper) website: View Source
Additional information can be found at Taiho Oncology’s Medical Booth when the exhibit opens on December 5, 2020.

"We are pleased to present new data for oral decitabine and cedazuridine that adds to the body of evidence supporting treatment for patients living with intermediate and high-risk MDS and CMML," said Harold Keer, MD, PhD, Chief Medical Officer, Astex Pharmaceuticals, Inc. "INQOVI is emerging as an important treatment option that can be taken at home."

The U.S. Food and Drug Administration approved INQOVI in July 2020 for the treatment of adults with intermediate and high-risk MDS and CMML. Taiho Oncology, Inc. previously announced that it has assumed commercialization responsibility from Astex Pharmaceuticals, Inc. and its parent company, Otsuka Pharmaceutical Co., Ltd., for INQOVI in the U.S.

About Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. U.S. incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.1,2 The prevalence has been estimated to be from 60,000 to 170,000 in the U.S.3 MDS may evolve into acute myeloid leukemia (AML) in approximately one-third of patients.4 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML.

About INQOVI (See View Source)
INQOVI is an orally administered, fixed-dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine,5 an inhibitor of cytidine deaminase.6 By inhibiting cytidine deaminase in the gut and the liver, INQOVI is designed to allow for oral delivery of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine (geometric mean ratio of the 5-day cumulative decitabine area-under-the-curve following 5 consecutive once daily doses of INQOVI compared to that of intravenous decitabine was 99% (90% CI:93, 106).7 The phase 1 and phase 2 clinical study results have been published in Lancet Haematology8 and Blood,9 respectively. The phase 3 ASCERTAIN study data was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in Orlando, Florida, in December 2019 by Dr. Garcia-Manero.10

INDICATIONS
INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Myelosuppression
Fatal and serious myelosuppression can occur with INQOVI. Based on laboratory values, new or worsening thrombocytopenia occurred in 82% of patients, with Grade 3 or 4 occurring in 76%. Neutropenia occurred in 73% of patients, with Grade 3 or 4 occurring in 71%. Anemia occurred in 71% of patients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients, with Grade 3 or 4 occurring in 32%. Myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia) is the most frequent cause of INQOVI dose reduction or interruption, occurring in 36% of patients. Permanent discontinuation due to myelosuppression (febrile neutropenia) occurred in 1% of patients. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS.

Fatal and serious infectious complications can occur with INQOVI. Pneumonia occurred in 21% of patients, with Grade 3 or 4 occurring in 15%. Sepsis occurred in 14% of patients, with Grade 3 or 4 occurring in 11%. Fatal pneumonia occurred in 1% of patients, fatal sepsis in 1%, and fatal septic shock in 1%.

Obtain complete blood cell counts prior to initiation of INQOVI, prior to each cycle, and as clinically indicated to monitor response and toxicity. Administer growth factors and anti–infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.

Embryo-Fetal Toxicity
INQOVI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise patients to use effective contraception during treatment and for 6 months (females) or 3 months (males) after last dose.

ADVERSE REACTIONS
Serious adverse reactions in > 5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and one case each of cerebral hemorrhage and sudden death.

The most common adverse reactions (≥ 20%) were fatigue (55%), constipation (44%), hemorrhage (43%), myalgia (42%), mucositis (41%), arthralgia (40%), nausea (40%), dyspnea (38%), diarrhea (37%), rash (33%), dizziness (33%), febrile neutropenia (33%), edema (30%), headache (30%), cough (28%), decreased appetite (24%), upper respiratory tract infection (23%), pneumonia (21%), and transaminase increased (21%). The most common Grade 3 or 4 laboratory abnormalities (≥ 50%) were leukocytes decreased (81%), platelet count decreased (76%), neutrophil count decreased (71%), and hemoglobin decreased (55%).

USE IN SPECIFIC POPULATIONS
Lactation
Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with INQOVI and for at least 2 weeks after the last dose.

Renal Impairment
No dosage modification of INQOVI is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] of 30 to 89 mL/min based on Cockcroft-Gault). Due to the potential for increased adverse reactions, monitor patients with moderate renal impairment (CLcr 30 to 59 mL/min) frequently for adverse reactions. INQOVI has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min) or end-stage renal disease (ESRD: CLcr <15 mL/min).

On December 2, 2020, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with Geneva Roth Remark Holdings, Inc. ("Geneva"), pursuant to which Geneva purchased a convertible promissory note (the "December 2020 Geneva Note") from the Company in the aggregate principal amount of $78,000, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Geneva (Filing, 8-K, Propanc, DEC 2, 2020, View Source [SID1234572318]). The transaction contemplated by the Purchase Agreement closed on or about December 4, 2020. The Company intends to use the net proceeds ($75,000) from the December 2020 Geneva Note for general working capital purposes.

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The maturity date of the December 2020 Geneva Note is December 2, 2021 (the "Maturity Date"). The December 2020 Geneva Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to Geneva in shares of common stock, but shall not be payable until the December 2020 Geneva Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. Geneva has the option to convert all or any amount of the principal face amount of the December 2020 Geneva Note, starting on May 30, 2021 and ending on the later of the Maturity Date and the date of payment of the Default Amount (as defined below) is paid if an event of default occurs, for shares of the Company’s common stock at the then-applicable conversion price. The conversion price for the December 2020 Geneva Note shall be equal to the Variable Conversion Price (as defined herein) (subject to equitable adjustments for stock splits, stock dividends or rights offerings by the Company relating to the Company’s securities or the securities of any subsidiary of the Company, combinations, recapitalization, reclassifications, extraordinary distributions and similar events). The "Variable Conversion Price" shall mean 65% multiplied by the Market Price (as defined herein) (representing a discount rate of 35%). "Market Price" means the average of the lowest three (3) Trading Prices (as defined below) for the Common Stock during the ten (10) Trading Day period ending on the latest complete Trading Day prior to the Conversion Date. "Trading Price" means, for any security as of any date, the closing bid price on the OTCQB, OTCQX, Pink Sheets electronic quotation system or applicable trading market (the "OTC") as reported by a reliable reporting service ("Reporting Service") designated by Geneva (i.e. Bloomberg) or, if the OTC is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the "pink sheets". Notwithstanding the foregoing, Geneva shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by Geneva and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The December 2020 Geneva Note may be prepaid until 180 days from the issuance date. If the December 2020 Geneva Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 110% of the face amount plus any accrued interest, if prepaid after 61 days from the issuance date, but less than 91 days from the issuance date, then the prepayment premium shall be 115% of the face amount plus any accrued interest, if prepaid after 91 days from the issuance date, but less than 121 days from the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 121 days from the issuance date, but less than 151 days from the issuance date, then the prepayment premium shall be 125% of the face amount plus any accrued interest, and if prepaid after 151 days from the issuance date, but less than 181 days from the issuance date, then the prepayment premium shall be 129% of the face amount plus any accrued interest. So long as the December 2020 Geneva Note is outstanding, the Company covenants not to, without prior written consent from Geneva, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144. Pursuant to the terms of the Purchase Agreement, the Company paid Geneva’s fees and expenses in the aggregate amount of $3,000.

Other than as described above, the December 2020 Geneva Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the December 2020 Geneva Note. Additional events of default shall include, among others: (i) failure to reserve at least five times the number of shares issuable upon full conversion of the December 2020 Geneva Note; (ii) bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for relief under any bankruptcy law or any law for the relief of debtors shall be instituted by or against the Company or any subsidiary of the Company; provided, that in the event such event is triggered without the Company’s consent, the Company shall have sixty (60) days after such event is triggered to discharge such event, (iii) the Company’s failure to maintain the listing of the common stock on at least one of the OTC markets (which specifically includes the quotation platforms maintained by the OTC Markets Group) or an equivalent replacement exchange, the Nasdaq National Market, the Nasdaq Small Cap Market, the New York Stock Exchange, or the American Stock Exchange, (iv) The restatement of any financial statements filed by the Company with the SEC at any time after 180 days after the issuance date for any date or period until this note is no longer outstanding, if the result of such restatement would, by comparison to the un-restated financial statement, have reasonably constituted a material adverse effect on the rights of Geneva with respect to this note or the Purchase Agreement, and (v) the Company’s failure to comply with its reporting requirements of the Securities and Exchange Act of 1934 (the "Exchange Act"), and/or the Company ceases to be subject to the reporting requirements of the Exchange Act.

In the event that the Company fails to deliver to Geneva shares of common stock issuable upon conversion of principal or interest under the December 2020 Geneva Note within three business days of a notice of conversion by Geneva, the Company shall incur a penalty of $1,000, provided, however, that such fee shall not be due if the failure to deliver the shares is a result of a third party such as the transfer agent.

Upon the occurrence and during the continuation of certain events of default, the December 2020 Geneva Note will become immediately due and payable and the Company will pay Geneva, in full satisfaction of its obligations in the December 2020 Geneva Note an amount equal to 150% of an amount equal to the then outstanding principal amount of the December 2020 Geneva Note plus any interest accrued upon such event of default or prior events of default (the "Default Amount").

The December 2020 Geneva Note was issued, and any shares to be issued pursuant to any conversion of the December 2020 Geneva Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing description of the Purchase Agreement and the December 2020 Geneva Note does not purport to be complete and is qualified in their entirety by reference to the full text of the Purchase Agreement and the December 2020 Geneva Note, which are filed as Exhibits 10.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.