Sierra Oncology to Hold KOL Call to Discuss Anemia & Transfusion Dependency as Critical Unmet Needs in Myelofibrosis

On May 7, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that it will host an Analyst & Investor Call to discuss anemia and transfusion dependency, two critical unmet medical needs in treating patients with myelofibrosis, on Wednesday, May 13th at 10:00 am ET (Press release, Sierra Oncology, MAY 7, 2020, View Source [SID1234557322]). The event will feature a presentation by renowned myelofibrosis expert Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center.

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"Cytopenias are very common in myelofibrosis, with anemia and the resulting transfusion dependency being strongly associated with poor prognosis and impaired survival in this disease," said Dr. Mesa. "In clinical trials, momelotinib has consistently demonstrated immediate and sustained anemia benefits that manifest in an overall reduced transfusion burden, while sparing platelets and achieving clinically comparable benefits on symptoms and splenomegaly to that of the standard-of-care agent, ruxolitinib. With treatments desperately lacking both for first line patients with either severe anemia or transfusion dependency at presentation, and for the largely cytopenic second line population, momelotinib may offer a potentially important and broadly used new therapeutic option for patients. As such advancing the MOMENTUM Phase 3 trial, which is currently enrolling patients, is a high priority for the MF clinical community."

Dr. Mesa’s practice builds on his role as an international expert on myeloproliferative neoplasms (MPNs), a group of bone marrow disorders which include myelofibrosis. He has been involved in MPN research for more than 20 years. He led the development of National Comprehensive Cancer Network’s panel guidelines, the first U.S. guidelines on the diagnosis and treatment of myelofibrosis, polycythemia vera and essential thrombocythemia. Dr. Mesa was elected to sit on the National Board of Directors for the Leukemia and Lymphoma Society and sits on the board of the MPN Education Foundation. Dr. Mesa is an investigator in the MOMENTUM Phase 3 trial of momelotinib, which is intended to confirm the array of clinical benefits previously described for the drug candidate.

Dr. Mesa and members of Sierra Oncology’s senior management team will be available to answer questions from analysts at the conclusion of the event.

Analyst and Investor Event and Webcast Information

Date and Time: Wednesday, May 13th at 10:00 am ET

Domestic (Toll Free- US): 1-877-407-4018
International (Toll): 1-201-689-8471
Conference ID: 13702348
Webcast Link: View Source;tp_key=8595ee9eeb

Call registration is available through the Sierra Oncology website at www.sierraoncology.com. An archive of the presentation will be accessible after the event through the Sierra Oncology website.

SELLAS to Present at UBS Virtual Global Healthcare Conference

On May 7, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that Angelos Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS, will present a corporate overview at the UBS Virtual Global Healthcare Conference on Monday, May 18, 2020 at 4:40 pm EDT (1:40 pm PDT) (Press release, Sellas Life Sciences, MAY 7, 2020, View Source [SID1234557321]).

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To access a live webcast of the presentation, please visit the Investors, Events and Presentations section of the Company’s website at www.sellaslifesciences.com. A replay of the webcast will be available on the Company’s website following the live presentation.

Agenus First Quarter Results and Update

On May 7, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers provided a corporate update and reported financial results for the first quarter of 2020 (Press release, Agenus, MAY 7, 2020, View Source [SID1234557320]).

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"We accelerated the development of AGEN1181, advanced our plans to file our BLAs and filed two INDs for our allogeneic iNKT cell therapy to treat cancer and COVID-19," said Garo Armen, Ph.D., Chairman and CEO, Agenus. "Our ability to rapidly enroll in our bali and zali trials, in just 2 years, underscores the speed with which we can advance our AGEN1181 +/- bali and our innovative pipeline of products including allogeneic cell therapy programs."

AGEN1181, reveals clinical benefit1 in >70% of response-evaluable patients
Early data suggest that AGEN1181 could be a breakthrough in IO treatment:
Confirmed CR with AGEN1181 (1 mg/kg) in advanced endometrial cancer with a poor prognosis
Confirmed PR (significant tumor reduction) in advanced endometrial cancer with low-dose AGEN1181 + balstilimab
Disease stabilization in the majority of response-evaluable patients
Advisory board endorsed accelerated plans for AGEN1181 development

Balstilimab & zalifrelimab demonstrate ~26% response rates which are durable in an all-comer, non-biomarker selected population
Large cohort analysis (n=55) bali + zali demonstrate ~26% response rates (4 CRs, 10 PRs) in refractory cervical cancer
Responses are durable over 12 months

Allogeneic iNKTs advancing to clinic for the treatment of cancer and COVID-19
COVID-19: iNKTs designed to eliminate COVID-19 virus, dampen harmful inflammation, and promote protection from reinfection (FIM 1H2020)
CANCER: iNKTs designed to promote anti-tumor immunity in cancer & enable optimal combinations with Agenus checkpoint antibodies

Potential best and first in class TIGIT programs advancing to IND filing starting in 4Q2020
Fc enhanced TIGIT antibody (AGEN1327) has outperformed all tested competitor antibodies with superior T cell activation in PD-1 or LAG-3 combos
TIGIT bispecific (AGEN1777) demonstrated potent tumor killing in a difficult to treat colon cancer model where PD-1 antibodies alone are ineffective

Key Upcoming Milestones Expected
BLA filings and pre-commercial activities
IND filings for (2) TIGIT programs in 4Q2020 & 1H2021
Ongoing read-outs from lead clinical trials (AGEN1181, Balstilimab, Zalifrelimab)
Deliver new partnerships
Reduce annualized burn by $50M to mitigate any pandemic related business risk
First Quarter Financial Results

We ended the first quarter of 2020 with a cash balance of $92.3 million as compared to $61.8 million at December 31, 2019.

For the first quarter ended March 31, 2020, we reported a cash burn from our operations of $32 million. Net loss for the quarter was $45 million or $0.31 per share which included non-cash expenses of $16 million. We generated net income for the same period in 2019 of $17 million or $0.14 per share. In the first quarter of 2019 we recognized revenue of $80 million which included revenue related to the upfront license fee from our transaction with Gilead in addition to non-cash royalties earned. For the same period in 2020 we recorded revenue of $15 million primarily related to non-cash royalties earned.

To access the live call, dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (International) and ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately one hour after the call and will remain available until July 7, 2020.

Lineage Cell Therapeutics Announces Early Exercise of Option with Cancer Research UK for Immuno-Oncology Cell Therapy Program

On May 7, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that Cancer Research UK’s Commercial Partnerships has permitted Lineage to conduct an early exercise of its option to acquire data from Cancer Research UK’s ongoing Phase 1 clinical trial of VAC2 in non-small cell lung cancer (NCT03371485), and develop an allogeneic dendritic cell therapy platform ("VAC") (Press release, Lineage Cell Therapeutics, MAY 7, 2020, View Source [SID1234557319]). Lineage will assume responsibility for further development of the VAC2 product candidate as well as future development opportunities derived from the VAC platform, while Cancer Research UK concludes the ongoing trial. This decision was based on an early review of the data collected by Cancer Research UK in the VAC2 trial under a clinical trial and option agreement. In addition, Cancer Research UK will provide input on the potential use of VAC in the infectious disease space to develop a vaccine against SARS-CoV-2, the virus which causes COVID-19. Cancer Research UK is the world’s largest cancer charity dedicated to saving lives through research.

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"Clinical data recently collected by Cancer Research UK in the ongoing trial of VAC2 has shown peripheral immunogenicity in patients with non-small cell lung cancer, providing validation of the underlying mechanism of using allogeneic dendritic cells to present antigens to the body’s immune system. Evidence of immunogenicity was a key clinical signal which was necessary before we would consider taking over the program," stated Brian M. Culley, Lineage CEO. "This encouraging evidence builds upon earlier clinical studies of VAC which supported not only the safety of the VAC platform, but also evidence that patients developed antigen-specific T cell immune responses. We are excited to assume responsibility for advancing this promising program and move Lineage more aggressively into the field of cancer immunotherapy. Given the scientific evidence supporting our approach, the opportunity to also apply our VAC program to SARS-CoV-2 vaccine development was another positive consideration and we are pleased that Cancer Research UK facilitated this decision. Presenting a viral antigen will require transferring the program from Cancer Research UK’s Centre for Drug Development to our cGMP facility, scaling the manufacturing process, and eventually submitting an IND for clinical testing. We also will be evaluating opportunities for non-dilutive funding for this new initiative."

Dr. Nigel Blackburn, Cancer Research UK’s Director of the Centre for Drug Development, said: "We are pleased that our development efforts on the VAC2 program over the past several years have generated initial evidence of an immune response in cancer patients and have resulted in an early exercise of the option by Lineage. We are excited to transfer the next phase of development to our partners and to assist the expansion of those efforts into SARS-CoV-2 vaccine development and other areas with significant unmet need."

About VAC2

VAC2 is an allogeneic, or non-patient specific, cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry any antigen, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

About Cancer Research UK

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public.
Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.

Apellis Pharmaceuticals Announces Private Placement of Convertible Senior Notes

On May 7, 2020 Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a global biopharmaceutical company pioneering targeted C3 therapies, reported that it had entered into subscription agreements with a number of institutional investors for a private placement of $300.0 million aggregate principal amount of 3.500% convertible senior notes due 2026 (the "notes") for an aggregate purchase price of $328.9 million (Press release, Apellis Pharmaceuticals, MAY 7, 2020, View Source [SID1234557318]). The private placement is expected to close on May 12, 2020, subject to satisfaction of customary closing conditions.

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The notes issuance is a reopening of, and will form a single series with, and have the same terms as, Apellis’ $220 million aggregate principal amount of 3.500% convertible senior notes due 2026 (the "existing notes") issued on September 16, 2019, but will have a different issue date, issue price, CUSIP number and different restrictions on transfer. The notes will be issued as additional notes under the indenture dated September 16, 2019 and will rank equal in right of payment to the existing notes.

The notes will be unsecured, senior obligations of Apellis, and will bear interest at a rate of 3.500% per annum, payable semi-annually in arrears on March 15 and September 15 of each year, beginning on September 15, 2020. The notes will mature on September 15, 2026, unless earlier repurchased, redeemed or converted in accordance with their terms.

The notes will be convertible into cash, shares of Apellis common stock, or a combination of cash and shares of Apellis common stock, at Apellis’ election. Prior to March 15, 2026, the notes will be convertible only upon the occurrence of certain events and during certain periods, and thereafter, at any time until the second scheduled trading day immediately preceding the maturity date.

The conversion rate for the notes will initially be 25.3405 shares of Apellis common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $39.46 per share. The conversion rate will be subject to adjustment upon the occurrence of certain events.

Apellis estimates that the net proceeds of the offering will be approximately $323.0 million, after deducting placement agent fees and estimated offering expenses payable by Apellis. Apellis intends to use $43.1 million of the net proceeds from the offering to pay the cost of the capped call transactions entered into in connection with the private placement. Apellis intends to use the remainder of the net proceeds from the sale of the notes to fund clinical development of pegcetacoplan, including preparation of a new drug application submission, to support the potential commercialization of pegcetacoplan, if Apellis decides to commercialize on its own, including the build-out of a commercial infrastructure and sales force, to procure clinical and commercial supply of pegcetacoplan, to conduct research activities and for working capital and other general corporate purposes.

J. Wood Capital Advisors LLC is acting as sole placement agent in connection with the private placement.

The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes, if any, have not been and will not be registered under the Securities Act of 1933, as amended, or the securities laws of any other jurisdiction, and the notes and any such shares may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy the notes, nor shall there be any sale of, the notes in any state or jurisdiction in which such offer, solicitation or sale would be unlawful under the securities laws of any such state or jurisdiction.