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Agenus Reports First Quarter 2019 Financial Results and Provides Corporate Update

On May 9, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, provided corporate updates and reported financial results for the first quarter of 2019 (Press release, Agenus, MAY 9, 2019, View Source [SID1234536002]).

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"2019 is off to a strong start. We have made significant progress towards our efforts to bring transformative treatments to cancer patients." said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "In the first quarter of this year, we have strengthened our balance sheet, accelerated enrollment in our BLA path trials, and started a new clinical trial with our second generation CTLA4."

Achievements
Strengthened balance sheet
Closed on our collaboration with Gilead, which included $120M upfront, $30M equity investment and up to $1.7B in potential additional fees and milestone payments plus royalties
Received $7.5 million from Gilead as milestone payment for IND acceptance of AGEN1423 (now GS-1423), by the FDA
Enrollment in lead trials progressing; On track for BLA in 2020
Ongoing trials in cervical cancer are designed to support BLA via accelerated pathway
We plan to expand PD-1 development in additional indications through novel funding mechanisms
Enrollment proceeding in next-gen CTLA-4 trial
Started first-in-human trial with our next-gen CTLA4.
Enrollment advancing, and combinations and data expected this year
Advanced new discoveries, towards the clinic
First-in-class bispecific licensed to Gilead, GS-1423 IND accepted by the FDA
On track to file an IND for a CD137 agonist and an off-the shelf phosphorylated neoantigen vaccine
QS-21 Updates
Sales of Shingrix, containing our QS-21 Stimulon, continue to increase; GSK projects 2019 sales will exceed $1.3Bn and pledged $100M investment to expand production of its adjuvant system
A large-scale trial with QS-21 containing Mosquirix vaccine against malaria, began in Africa
AgenTus Cell Therapy Business:
2019 INDs are on track
Partnership and private financing discussions are underway
First Quarter 2019 Financial Results

We ended the first quarter of 2019 with a cash balance of $158 million as compared to $53 million at December 31, 2018.

For the first quarter ended March 31, 2019, we reported net income of $17 million or $0.14 per share compared to a net loss for same period in 2018 of $54 million, or $0.53 per share. In the first quarter we recognized revenue of $80 million which includes revenue from our transaction with Gilead and non-cash royalties earned.

Conference Call, Webcast and Prepared Statement Information

Date: Thursday, May 9, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866) 682-6100
International Dial-in Number: (862) 298-0702
Conference ID: Agenus

Live Webcast: 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 two hours after the call and will remain available for 90 days.

Curadev Announces Licensing Agreement With Takeda for Novel STING Agonist

On May 8, 2019 Curadev announced it has licensed its novel lead small molecule Stimulator of Interferon Genes (STING) agonist (referred to by Curadev as CRD5500) and associated patents to Takeda Pharmaceutical Company Limited (Takeda) (Press release, Takeda, MAY 8, 2019, View Source [SID1234538087]). The financial terms were not disclosed.

"Our drug discovery efforts have targeted fundamental host immune mechanisms to stimulate anti-tumor immunity," said Curadev Co-Founder and Chief Scientific Officer Arjun Surya, Ph.D. "With its commitment to pursuing novel immuno-oncology targets, Takeda is an ideal partner to collaborate on the further development of a STING agonist that is potential first-in-class small molecule."

A poster presented at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (LB-061: "CRD5500: a versatile small molecule STING agonist amenable to bioconjugation as an ADC") reported that the Curadev STING agonist potently activates all major known human STING variants and activates the immune system to shrink distant tumors and combines well with anti-PD-L1/anti-CTLA4/IDO-TDOi when dosed IT or systematically. It also demonstrated that the molecule has a long tumor residence time, good drug like properties, can be dosed by multiple routes, and has been successfully conjugated with trastuzumab.

"We look forward to collaborating with Curadev to further develop this novel STING agonist," said Chris Arendt, Head Oncology Drug Discovery Unit, Takeda. "This project is an example of Takeda’s commitment to collaborating with world-class partners like Curadev to pursue novel immuno-oncology targets that may one day deliver transformational benefit to patients."

MaxCyte Progresses Phase I Clinical Trial of Lead mRNA-based Cell Therapy from its CARMA™ Platform

On May 8, 2019 MaxCyte, the global clinical-stage cell-based therapies and life sciences company, reported that it has initiated dosing for the second cohort of patients in its US Phase I clinical trial with MCY-M11, the lead, wholly-owned, non-viral mRNA-based cell therapy candidate from its CARMA platform (Press release, MaxCyte, MAY 8, 2019, View Source [SID1234537620]). MCY-M11 is a mesothelin-targeting chimeric antigen receptor (CAR) therapy being tested in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

The dose escalation trial is evaluating the safety and tolerability of MCY-M11 in approximately 15 patients across a series of cohorts.

"Successfully completing patient dosing in our first cohort and initiating dosing in a second higher-dose cohort are important milestones for MaxCyte, representing tangible progress for our lead CAR therapeutic and our proprietary CARMA autologous cell therapy platform," said Claudio Dansky Ullmann, MD, Chief Medical Officer. "We are very excited about the potential of MCY-M11 as a new, effective therapeutic in solid tumors where the majority of patients still have very limited treatment options."

The manufacturing process for MCY-M11 utilizes MaxCyte’s proprietary Flow Electroporation technology to transfect mRNA into fresh (i.e., unexpanded) peripheral blood mononuclear cells (PBMCs). This streamlined, faster manufacturing process for an autologous cell therapy is an important differentiator from other CAR technologies. In addition, the CARMA platform’s utilization of Flow Electroporation rather than viral vectors enables repeat dosing of patients, a feature that may be key for the successful treatment of solid tumors with a cell therapy. Another distinguishing feature of MaxCyte’s CARMA platform is the insertion of the CAR as mRNA into cells rather than as DNA. The transient nature of mRNA could help alleviate some of the safety limitations of other CAR treatment approaches.

About the Phase I Clinical Trial
The multi-center, non-randomized, open label, dose-escalation Phase I clinical trial is evaluating the safety and effectiveness of intraperitoneal infusions of MCY-M11 in individuals with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube, or individuals with advanced peritoneal mesothelioma with recurrence after prior chemotherapy. MaxCyte anticipates approximately 15 study participants will be enrolled across the two clinical sites participating in the study (the National Cancer Institute at the National Institutes of Health (NIH) and Washington University at St. Louis). More information about the study can be found at ClinicalTrials.gov.

About the CARMA Platform
CARMA is the autologous, mRNA-based CAR therapeutic platform developed by MaxCyte, Inc. that can be applied toward a broad range of diseases, including solid tumors. Utilizing a streamlined manufacturing process, CARMA allows for a faster turnaround of cell therapy to patients compared to traditional CAR therapies and works to trigger a patient’s own immune system to fight disease. MaxCyte’s first CARMA drug candidate, MCY-M11, is currently in a Phase I clinical trial in individuals with advanced ovarian cancer and peritoneal mesothelioma. More information on MaxCyte’s CARMA platform and pipeline is available at www.maxcyte.com/car/

OncoCyte to Report First Quarter 2019 Financial Results on Tuesday, May 14

On May 8, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported that it will release its financial and operating results for the first quarter ended March 31, 2019, on Tuesday, May 14, 2019, after the close of the U.S. financial markets (Press release, BioTime, MAY 8, 2019, View Source;p=RssLanding&cat=news&id=2397802 [SID1234535992]). The Company will host a conference call on Tuesday, May 14, 2019 at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13689785. To access the live webcast, go to the investor relations section on the Company’s website, View Source

Sunesis Pharmaceuticals Reports First Quarter 2019 Financial Results and Recent Highlights

On May 8, 2019 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the first quarter ended March 31, 2019. Loss from operations for the three months ended March 31, 2019 was $5.7 million (Press release, Sunesis, MAY 8, 2019, View Source [SID1234535991]). As of March 31, 2019, cash and cash equivalents totaled $24.8 million.

"We continue our focus on the execution of the Phase 1b/2 trial of vecabrutinib and are excited to announce that we have completed the safety evaluation period for the 100 mg cohort, enabling us to advance the trial into the 200 mg cohort," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "To date, vecabrutinib appears to be well tolerated in the context of disease, and we will be providing a clinical update on the study at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting in June."

Mr. Misfeldt continued, "Underscoring our clinical progress is a strengthened financial position. We began the first quarter by completing an equity offering with leading biotechnology investors, extending our cash runway through important clinical milestones, and just last month we announced the refinancing of our debt on favorable terms through an agreement with Silicon Valley Bank, a vote of confidence in our pipeline and its potential from a premier debt provider for life science companies."

Recent Highlights

Advancement into 200 mg Cohort. The Company has opened the 200 mg cohort in the Phase 1b/2 trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

$5.5 Million Loan with Silicon Valley Bank. In April 2019, the Company entered into a $5.5 million loan agreement with Silicon Valley Bank. The new agreement allows the company to retire its existing loan and defer any principal repayment on the new loan for more than 18 months. The new facility includes interest-only payments through 2020, with principal repayment over 24 months beginning in 2021, as well as a lower interest rate than the previous loan. The loan was used for the repayment of the Company’s existing indebtedness.

Completion of $20 Million Financing. In January, Sunesis completed an equity financing with net proceeds of approximately $18.6 million. The financing attracted participation from leading biotechnology investors and will allow Sunesis to advance vecabrutinib through important clinical milestones as the ongoing dose-escalation study explores potentially active dose levels.

Financial Highlights

Cash and cash equivalents totaled $24.8 million as of March 31, 2019, as compared to $13.7 million as of December 31, 2018. The increase of $11.1 million was primarily due to $18.6 million

net proceeds from issuance of common and preferred stock, offset by $6.1 million net cash used in operating activities and $1.4 million principal payment on the Loan Agreement with Western Alliance Bank and Solar Capital Ltd.

Research and development expense was $3.2 million for the three months ended March 31, 2019, as compared to $4.0 million for the same period in 2018. The decrease of $0.8 million between the comparable three-month periods was primarily due to a $0.4 million decrease in salary and personnel expenses due to lower headcount and a $0.4 million decrease in professional services related to higher expenses incurred in the first quarter of 2018 for the start-up cost of Phase 1b/2 trial for vecabrutinib.

General and administrative expense was $2.4 million for the three months ended March 31, 2019, as compared to $3.4 million for the same period in 2018. The decrease of $1.0 million between the comparable three-month periods was primarily due to a $0.7 million decrease in salary and personnel expenses due to lower headcount and a $0.4 million decrease in professional services expenses due in part to lower vosaroxin patent expenses.

Interest expense was $0.3 million for the three months ended March 31, 2019 and 2018. The interest expenses from both periods resulted from payments on our Loan Agreement with Western Alliance Bank and Solar Capital Ltd.

Cash used in operating activities was $6.1 million for the three months ended March 31, 2019, as compared to $6.6 million for the same period in 2018. Net cash used in the three months ended March 31, 2019 resulted primarily from the net loss of $5.9 million, partially offset by adjustments for non-cash items of $0.5 million and changes in operating assets and liabilities of $0.7 million. Net cash used in the three months ended March 31, 2018, resulted primarily from the net loss of $7.3 million and changes in operating assets and liabilities of $0.2 million, offset by net adjustments for non-cash items of $0.9 million.

Loss from operations was $5.7 million for the three months ended March 31, 2019, as compared to $7.1 million for the same period in 2018. Net loss was $5.9 million for the three months ended March 31, 2019, as compared to $7.3 million for the same period in 2018.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 1396684. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.