On August 7, 2020 Acceleron Pharma Inc. (Nasdaq:XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported financial results for the second quarter ended June 30, 2020 (Press release, Acceleron Pharma, AUG 7, 2020, View Source [SID1234563181]).

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"Acceleron had another productive quarter marked by additional regulatory approvals of REBLOZYL in the U.S. and E.U., strong product uptake resulting in subsequent royalty revenues, and multiple important updates for our lead program in pulmonary disease," said Habib Dable, President and Chief Executive Officer of Acceleron. "Alongside our global collaboration partner, Bristol Myers Squibb, the U.S. commercial launch of REBLOZYL is off to a great start in only its second full quarter since we received our first approval late last year. We also continue to make progress in evaluating additional patient populations in which this erythroid maturation agent could potentially reduce or eliminate red blood cell transfusion burden in patients with anemia-related blood disorders."

Added Mr. Dable: "Beyond our hematology franchise, we continue to make significant progress in advancing our pulmonary program in pulmonary arterial hypertension. Recently, we presented positive topline results from the Phase 2 PULSAR trial at the country’s premiere thoracic medical meeting, ATS 2020. In early October, we look forward to hosting a call to discuss the trial design for our first planned registrational trial, called STELLAR, which we expect to initiate by year-end. Our future development plan will support our long-term vision for sotatercept to become a backbone therapy for patients with PAH across all stages of disease."

Program Highlights

Hematology

REBLOZYL (luspatercept-aamt): Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)

REBLOZYL is the first and only approved erythroid maturation agent designed to promote red blood cell (RBC) production. Luspatercept is also being developed for the treatment of anemia in additional patient populations of MDS, beta-thalassemia, and MF. REBLOZYL is part of the global collaboration between Acceleron and Bristol Myers Squibb.

Commercial launch of REBLOZYL:
The Company recognized approximately $11.1 million in royalty revenue from approximately $55.0 million of net U.S. sales of REBLOZYL in the second quarter of 2020. This compares with approximately $1.5 million in royalty revenue from approximately $8 million of net U.S. sales of REBLOZYL in the first quarter of 2020.
In April, Acceleron and partner Bristol Myers Squibb announced the FDA approved REBLOZYL for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk MDS with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
In June, the European Commission (EC) approved REBLOZYL for the treatment of adult patients with transfusion-dependent anemia:
due to very low-, low- and intermediate-risk MDS with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy; or
associated with beta thalassemia.
The Centers for Medicare and Medicaid Services (CMS) established a REBLOZYL specific, permanent billing code (J code), which became effective on July 1, 2020.
Six distinct clinical presentations highlighting new and long-term analyses from the pivotal Phase 3 MEDALIST and BELIEVE trials were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program and the 25th Annual European Hematology Association (EHA) (Free EHA Whitepaper) (EHA25) Virtual Congress.
The BEYOND Phase 2 trial in adult patients with non-transfusion-dependent beta-thalassemia is ongoing, with topline results expected by year-end 2020 or early 2021.
Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with treatment-naïve, lower-risk MDS, with topline results expected in 2022+.
Bristol Myers Squibb expects to initiate the Phase 3 INDEPENDENCE trial in patients with MF on concomitant JAK 2 inhibitor therapy who require RBC transfusions by year-end 2020 or early 2021.
Pulmonary

Sotatercept: Pulmonary Arterial Hypertension (PAH)

Sotatercept is an investigational agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR2 signaling, which is a key molecular driver of PAH. In preclinical studies of PAH, sotatercept (RAP-011) reversed pulmonary vessel muscularization and improved indicators of right heart failure.

In June, Acceleron presented positive topline results of the PULSAR Phase 2 trial of sotatercept in patients with PAH during the "Breaking News: Clinical Trials in Pulmonary Medicine" session of the American Thoracic Society (ATS) 2020 Virtual Conference. The press release highlighting the presentation is available here.
The Company expects to initiate the pivotal Phase 3 STELLAR trial in PAH by year-end 2020.
Acceleron plans to host an investor and analyst webinar to discuss the Phase 3 STELLAR trial design in October 2020.
In the second quarter, sotatercept was granted Breakthrough Therapy and Priority Medicines (PRIME) designations for the treatment of patients with PAH by the FDA and EMA, respectively.
Preclinical research describing the underlying biology behind sotatercept’s potential as a novel therapy in PAH were published in the journal of Science Translational Medicine in May.
Enrollment is ongoing in the exploratory SPECTRA trial in patients with PAH, with preliminary results expected in the first half of 2021.
Corporate Highlights

In July, Acceleron closed a follow-on public offering of common stock, including the full exercise of the underwriters’ option to purchase additional shares, for net proceeds of $492.5 million.
In June, Christopher Hite was appointed to the Board of Directors. Mr. Hite brings more than 20 years of industry experience in advising hundreds of healthcare companies on projects ranging from mergers and acquisitions to capital formation.
Financial Results

Cash Position – Cash, cash equivalents, and investments as of June 30, 2020 were $389.8 million, as compared to $453.8 million as of December 31, 2019. Based on Acceleron’s current operating plan and projections, the Company believes that its cash, cash equivalents, and investments, together with the net proceeds of $492.5 million from its recent public offering of common stock and expected royalty revenue from REBLOZYL sales, will be sufficient to fund the Company’s projected operating requirements for the foreseeable future.
Revenue – Revenue for the second quarter of 2020 was $39.8 million, which includes $3.7 million of cost share revenue, $11.1 million of royalty revenue from net U.S. sales of REBLOZYL, and the recognition of a $25.0 million regulatory-based milestone for the approval of REBLOZYL in Europe. This compares with total revenue of $4.3 million, which includes $2.8 million of cost share revenue, and $1.5 million of royalty revenue from net U.S. sales of REBLOZYL in the first quarter of 2020. All revenue was derived from the Company’s partnership with Bristol Myers Squibb.
Costs and Expenses – Total costs and expenses for the second quarter of 2020 were $58.7 million. This includes R&D expenses of $38.3 million and SG&A expenses of $20.4 million.
Net Loss – The Company’s net loss for the second quarter of 2020 was $18.5 million.

Conference Call and Webcast

The Company will host a webcast and conference call to discuss its second quarter 2020 financial results and provide an update on recent corporate activities on August 6, 2020, at 5:00 p.m. EDT.

The webcast will be accessible under "Events & Presentations" in the Investors & Media page of the Company’s website at acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the "Acceleron Second Quarter 2020 Earnings Call."

The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

On August 7, 2020 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the Phase III IMpassion131 study, evaluating Tecentriq (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population (Press release, Genentech, AUG 7, 2020, View Source [SID1234563180]).

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The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoint of OS and data were immature at time of analysis. OS follow-up is planned to continue until final analysis. Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified.

In the previous IMpassion130 study, Tecentriq in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension [albumin-bound]; nab-paclitaxel) demonstrated a statistically significant PFS benefit and, while not formally tested, showed clinically meaningful improvements in OS for people with metastatic TNBC and whose tumors express PD-L1 (≥1%). Tecentriq in combination with nab-paclitaxel is approved under accelerated approval by the U.S. Food and Drug Administration for the treatment of adults with unresectable locally advanced or metastatic TNBC and whose tumors express PD-L1 (≥1%).

"While we are disappointed by the results from the IMpassion131 study, we are grateful for all the patients, families and physicians who were involved in the study," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens. We remain committed to finding optimal treatments for all people living with this aggressive disease."

Full results from IMpassion131 are being discussed with global health authorities and will be presented at a future medical meeting. The insights will also be used to inform existing and future studies in TNBC with Tecentriq in combination with paclitaxel.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpassion131 study

The IMpassion131 study is a Phase III, multi-center, randomized, double-blind study evaluating the efficacy and safety of Tecentriq in combination with paclitaxel, in comparison to placebo plus paclitaxel, in people with previously untreated, inoperable, locally advanced or metastatic TNBC. The study enrolled 651 people who were randomized in a 2:1 ratio to receive Tecentriq or placebo plus paclitaxel. The primary endpoint is PFS per investigator assessment (RECIST 1.1) in the PD-L1-positive population, followed by intention-to-treat (ITT) population. Secondary endpoints include OS, objective response rate, and duration of response in the PD-L1-positive and ITT populations.

About triple-negative breast cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, close to 280,000 people in the United States will be diagnosed with invasive breast cancer, and more than 42,000 will die from the disease in 2020. Breast cancer is not one, but many diseases based on the biology of each tumor. In triple-negative breast cancer, tumor cells lack hormone receptors and do not have excess HER2 protein. Approximately 15 percent of breast cancers are triple-negative based on the results of diagnostic tests. It is an aggressive form of the disease with few treatment options.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications (pronounced ‘tē-SEN-trik’)

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for "PD-L1" or
They are not able to take chemotherapy that contains any platinum regardless of the levels of "PD-L1" status or
They have tried chemotherapy that contains platinum and it did not work or is no longer working.
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as the first treatment in patients with lung cancer if:

Their cancer has spread or grown and
Their cancer tests positive for "high PD-L1", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

Their cancer has spread or grown, and
Is a type called "non-squamous NSCLC", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

Their cancer has spread or grown, and
Is a type called "non-squamous NSCLC", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used alone in patients with lung cancer if:

Their cancer has spread or grown and
They have tried chemotherapy that contains platinum, and it did not work or is no longer working.
If a patient’s tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

Has spread or cannot be removed by surgery and
Their cancer tests positive for "PD-L1".
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer is a type of lung cancer called "extensive-stage small cell lung cancer," which means that it has spread or grown.
A type of liver cancer called hepatocellular carcinoma (HCC).

Tecentriq may be used with the medicine bevacizumab when a patient’s liver cancer:

Has spread or cannot be removed by surgery, and
The patient has not received other medicines by mouth or injection through their vein (IV) to treat their cancer.
A type of skin cancer called melanoma.

Tecentriq may be used with the medicines cobimetinib and vemurafenib when a patient’s melanoma:

Has spread or cannot be removed by surgery, and
Their cancer has a certain type of abnormal "BRAF" gene. Their healthcare provider will perform a test to make sure this Tecentriq combination is right for them.
It is not known if Tecentriq is safe and effective in children.

Important Safety Information

The most important information about Tecentriq is:

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Tecentriq can cause serious side effects, including:

Lung problems (pneumonitis)–signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath and chest pain
Liver problems (hepatitis)–signs and symptoms of hepatitis may include yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea-colored), bleeding or bruising more easily than normal and feeling less hungry than usual
Intestinal problems (colitis)–signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual; blood or mucus in stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness
Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)–signs and symptoms that the hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, the voice gets deeper, urinating more often than usual, nausea or vomiting and stomach area (abdomen) pain
Problems in other organs–signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath or swelling of the ankles
Severe infections–signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating and frequent urination or back pain
Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of the face or lips, dizziness, fever, feeling like passing out and back or neck pain
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

Have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection
Are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq.
Females who are able to become pregnant:
Should have a healthcare provider do a pregnancy test before they start treatment with Tecentriq and
Should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
Are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

Feeling tired or weak
Nausea
Cough
Shortness of breath
Decreased appetite
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

Feeling tired or weak
Nausea
Hair loss
Constipation
Diarrhea
Decreased appetite
The most common side effects of Tecentriq when used in TNBC with paclitaxel protein-bound include:

Hair loss
Tingling or numbness in hands and feet
Feeling tired
Nausea
Diarrhea
Low red blood cells (anemia)
Constipation
Cough
Headache
Low white blood cells
Vomiting
Decreased appetite
The most common side effects of Tecentriq when used in hepatocellular carcinoma with bevacizumab include:

High blood pressure
Feeling tired or weak
Too much protein in the urine
The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

Skin rash
Pain in the joint, muscle, or bone
Feeling tired or weak
Liver injury
Fever
Nausea
Itching
Swelling of legs or arms
Swelling of the mouth (sometimes with sores)
Low thyroid hormone levels
Vomiting
Skin sensitivity to sunlight
Tecentriq may cause fertility problems in females, which may affect their ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects of Tecentriq.

Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.

Please visit View Source for the full Tecentriq Prescribing Information for additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit View Source

On August 7, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported U.S. Food and Drug Administration (FDA) approval of GlaxoSmithKline’s (GSK) BLENREP (belantamab mafodotin-blmf), an antibody-drug conjugate (ADC) targeting B-cell maturation antigen (BCMA) that utilizes Seattle Genetics’ proprietary technology (Press release, Seattle Genetics, AUG 7, 2020, View Source [SID1234563177]). BLENREP was developed and will be commercialized by GSK. The approval triggers a $20 million milestone payment and entitles Seattle Genetics to royalties on BLENREP product sales. BLENREP was approved for the treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.

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"BLENREP is the first BCMA-targeted treatment to be approved by FDA, becoming another first-in-class medicine utilizing our ADC technology for the treatment of patients with cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Notably, this ADC uses our novel mafodotin cell-killing payload. There are now multiple drugs approved by FDA using our ADC technology, and each addresses an important unmet medical need."

In July 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the approval of belantamab mafodotin as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which has the authority to approve medicines for use throughout the European Union.

Seattle Genetics’ ADC technology combines the specificity of monoclonal antibodies, innovative linker systems and potent cell-killing agents to treat cancer. The technology has been licensed to several companies. Under the terms of these agreements, each licensee company has rights to use the technology with antibodies against specified targets. The licensee is responsible for research, product development, manufacturing and commercialization. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on worldwide net sales of any resulting ADC products.

On August 7, 2020 Celsion Corporation (NASDAQ: CLSN) reported that the Company will host a conference call to discuss financial results for the second quarter ended June 30, 2020 and provide an update on its development programs for GEN-1, an IL-12 DNA plasmid vector formulated into a nanoparticle with a non-viral delivery system and ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin at 11:00 a.m. EDT on Friday, August 14, 2020 (Press release, Celsion, AUG 7, 2020, View Source [SID1234563168]).

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To participate in the call, interested parties may dial 1-800-353-6461 (Toll-Free/North America) or 1-334-323-0501 (International/Toll) and ask for the Celsion Corporation Second Quarter 2020 Earnings Call (Conference Code: 4777957) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Friday, August 14, 2020 and will remain available until August 28, 2020. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 4777957. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Friday, August 14, 2020.

On August 7, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that the Company intends to release its second quarter financial results on Wednesday, August 12, 2020 (Press release, Onconova, AUG 7, 2020, View Source [SID1234563167]). Management plans to host a conference call and live webcast at 4:30 p.m. ET on that day to discuss these results and provide an update on its pipeline programs.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call and Webcast Information
Interested parties who wish to participate in the conference call may do so by dialing (855) 428-5741 for domestic and (210) 229-8823 for international callers and using conference ID 2875654.

To facilitate an on-time conference call start, Onconova recommends that participants dial in 15 minutes before the 4:30 p.m. ET start time.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.