On March 15, 2018 – Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT),
a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition,
development and commercialization of novel treatments for patients with solid tumor cancers, reported its financial results and recent corporate highlights for the fourth quarter and full year ended December 31, 2017 (Press release, Checkpoint Therapeutics, MAR 15, 2018, http://www.checkpointtx.com/press-releases/checkpoint-therapeutics-reports-fourth-quarter-and-full-year-2017-financial-results-and-recent-corporate-highlights/ [SID1234525088]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Checkpoint achieved
significant financial and pipeline-related milestones in 2017. Most notably, our common stock
began trading on The NASDAQ Capital Market in June 2017, and in October, we announced the
dosing of the first patient in our Phase 1 trial of our anti-PD-L1 antibody, CK-301. In addition, the
FDA granted Orphan Drug Designation to our third-generation EGFR inhibitor, CK-101, for the
treatment of EGFR mutation-positive non-small cell lung cancer. As we enter 2018, we believe
we are well-positioned to generate initial efficacy data from our clinical trials in support of our
planned registration studies to commence in 2019."

Financial Results:
• Cash Position: As of December 31, 2017, Checkpoint’s cash and cash equivalents totaled
$19.2 million, compared to $35.1 million at December 31, 2016, a decrease of $15.9
million. On a non-GAAP basis, pro-forma cash and cash equivalents as of December 31,
2017 (excluding first quarter 2018 operations) totaled approximately $40.1 million, after
giving effect to $20.9 million of net proceeds from an underwritten public offering during
March 2018.
• R&D Expenses: Research and development expenses for the year ended December 31,
2017 were $19.1 million, compared to $20.3 million for the year ended December 31,
2016, a decrease of $1.2 million.
• G&A Expenses: General and administrative expenses for the year ended December 31,
2017 were $5.4 million, compared to $4.5 million for the year ended December 31, 2016,
an increase of $0.9 million.
• Net Loss: Net loss attributable to common stock holders for the year ended December
31, 2017 was $22.7 million, or $1.00 per share, compared to a net loss of $22.5 million,
or $1.04 per share, for the year ended December 31, 2016.

2017 and Recent Corporate Highlights:

• In February 2017, the U.S. Patent and Trademark Office issued a composition of matter
patent for CK‐101, an oral, third‐generation epidermal growth factor receptor ("EGFR")
inhibitor in development for the treatment of EGFR mutation‐positive non‐small cell lung
cancer ("NSCLC").
• In June 2017, Checkpoint’s common stock began trading on The NASDAQ Capital Market
under the ticker symbol "CKPT."
• In September 2017, Checkpoint announced that the U. S. Food and Drug Administration
granted Orphan Drug Designation to CK-101 for the treatment of EGFR mutation-positive
NSCLC.
• In October 2017, Checkpoint announced the dosing of the first patient in a Phase 1 clinical
trial evaluating the safety and tolerability of CK-301, an anti-PD-L1 antibody, in checkpoint
therapy-naïve patients with selected recurrent or metastatic cancers.
• In March 2018, Checkpoint completed an underwritten public offering that raised net
proceeds of $20.9 million.

On March 15, 2018 ProMIS Neurosciences, Inc., a biotechnology company focused on the discovery and development of precision treatments for neurodegenerative diseases, reported that it will participate in two upcoming investor conferences (Press release, ProMIS Neurosciences, MAR 15, 2018, View Source [SID1234525136]):

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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

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Eugene Williams, Executive Chairman, will present at the Sachs BioCapital USA Forum at the New York Academy of Sciences, 250 Greenwich St, New York, NY, on Wednesday, March 21st, at 2 PM, Eastern Daylight Time (EDT). Prior to the presentation, Mr. Williams will participate in a panel discussion entitled: ‘Renewed Approaches for Neuroscience’. The panel discussion will be held at 11:45 AM, EDT.
Mr. Williams will also present at the Wall Street Investor Forum 26th Annual Growth Conference at the University Club of NYC, 1 W 54th St, New York, on Thursday, March 22nd, at 9:35 AM, EDT.

BioTime has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, BioTime, 2018, MAR 15, 2018, View Source [SID1234524802]).

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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

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On March 15, 2018 Massive Bio, Inc., a leader in providing simplified and affordable access to precision oncology to cancer patients treated at community-based oncology practices, reported that the first patient has been enrolled in a global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program (Press release, Massive Bio, MAR 15, 2018, View Source [SID1234555208]). This registry will assess its clinical impact on world-wide patients with advanced cancer to facilitate clinical trial enrollment (CTE), as well as financial impact.

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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

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The SYNERGY-AI registry is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies. SYNERGY-AI is a part of Massive Bio’s global strategic collaboration with community-based oncology practices. Established in 2014, the goal of the collaboration is to promote precision oncology approaches at the point-of-care, and to ease access to clinical trials, while reducing patient and provider burden and overall cancer care costs.

"Today’s announcement marks a one-of-a-kind clinical program which utilizes a precision medicine approach to clinical trial matching that could potentially catalyze accelerated enrollment from a patient-driven perspective, while promoting access and innovation," said Dr. Arturo Loaiza-Bonilla, MD, MSEd, Chief Medical Advisor and Co-Founder of Massive Bio. "Initiation of this study also represents a significant milestone for Massive Bio, as we have the opportunity to help over 1,500 patients to enroll in therapeutic cancer trials. Most importantly, we believe this program has the potential to change the paradigm of how we approach clinical trial screening and enrollment and help many more patients in the future."

On March 15, 2018 Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses, reported financial results for the fourth quarter and full year ended December 31, 2017 and provided a corporate update (Press release, Selecta Biosciences, MAR 15, 2018, View Source [SID1234524817]).

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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

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"Several important achievements have been made over the course of the past several months, and we are excited to be in a strong position to execute on our 2018 milestones," said Werner Cautreels, Ph.D., President and CEO of Selecta. "We remain on track with the development of SEL-212 for chronic severe gout, with higher dose data from our Phase 2 trial to be presented in April and plans underway to initiate our Phase 3 program in 2018. We also recently announced that our next clinical candidate, SEL-403, has entered the clinic for the treatment of patients with mesothelioma at the National Cancer Institute. This also provides us with the opportunity to demonstrate for a second time the translation of our technology in the clinic. When coupled with the Board and management enhancements that were made over the course of the past year, we believe we have positioned Selecta for a momentous year in 2018."

Recent Business Highlights and Activities

Cohorts Added to SEL-212 Phase 2 Trial with Initial Data to be Reported in April 2018: As of March 9, 2018, a total of 111 patients had been dosed in Selecta’s ongoing Phase 2 trial of SEL-212 (SVP-Rapamycin in combination with pegsiticase) for the treatment of chronic severe gout. Selecta has now fully enrolled cohorts that are receiving three monthly doses of either 0.125 or 0.15 milligrams (mg) per kilogram (kg) of SVP-Rapamycin in combination with either 0.2 or 0.4 mg/kg of pegsiticase followed by two monthly doses of pegsiticase alone. The company plans to report further data from this ongoing trial at the upcoming Pan American League of Associations for Rheumatology (PANLAR) Congress on April 9th or 10th, 2018 and will host a conference call at 8:30 a.m. ET on the day of the presentation.

Initiated Dosing of SEL-212 Cohort Expected to Receive Five Combination Doses: In February 2018, Selecta began enrolling patients in the current Phase 2 trial who are expected to receive five monthly doses of SVP-Rapamycin in combination with pegsiticase. The patients will be receiving SVP-Rapamycin doses ranging from 0.1mg/kg-0.15mg/kg in combination with 0.2mg/kg of pegsiticase. The company expects to present data from these patients at a medical meeting in Q3 2018.

SEL-212 End of Phase 2 (EOP2) Meeting Planned for Mid-2018 and Plans for Phase 3 Program Initiation in 2018: The Selecta team is currently compiling the data package for an EOP2 meeting with the FDA, targeted for mid-2018, which will define the company’s design for the Phase 3 program. The team has also begun preparations for the Phase 3 program which the company plans to initiate in 2018.

SEL-403 Phase 1 Trial Initiated: On March 8, 2018, the first patient was dosed in a Phase 1 clinical trial of SEL-403, Selecta’s combination product candidate consisting of SVP-Rapamycin and LMB-100, for the treatment of patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy. LMB-100, which was in-licensed by Selecta in 2017, is a recombinant immunotoxin that targets mesothelin, a protein expressed in nearly all mesotheliomas and pancreatic adenocarcinomas, and a high percentage of other malignancies, including lung, breast and ovarian cancers. This open-label dose-escalation Phase 1 trial is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health, and is expected to enroll at least 18 patients. The trial will evaluate the safety and tolerability of this treatment and provide data on pharmacokinetics, anti-drug antibody (ADA) levels, as well as an objective response rate assessment.

Published SEL-403 Preclinical Data in January 2018:Proceedings of the National Academies of Sciences (PNAS) published a paper in January 2018 co-authored by the company and researchers from the NCI. The paper, entitled "Tolerogenic nanoparticles restore the anti-tumor activity of recombinant immunotoxins by mitigating immunogenicity," focuses on SEL-403 preclinical work conducted by Selecta and Dr. Ira Pastan’s lab at the NCI. Dr. Pastan is Senior Investigator, Head, Molecular Biology Section, at NCI’s Center for Cancer Research and a Fellow of the National Academy of Sciences.

Enhanced Leadership of the Company: Selecta announced the addition of two management team members in the fourth quarter of 2017: Chief Financial Officer and Head of Corporate Strategy John Leaman, M.D., and Chief Commercial Officer Stephen Smolinski. Dr. Leaman most recently served as Head of Corporate Development at InfaCare Pharmaceutical Corp., a specialty pharmaceutical company that was acquired by Mallinckrodt plc. Mr. Smolinski most recently served as Vice President and Head of Sanofi/Genzyme’s North American Rheumatology Business Unit. In early January, the company announced that Dr. Omid Farokhzad, a member of Selecta’s Board and a cofounder of the company, was appointed Chairman of the Board effective December 31, 2017.

Received Payment from Spark Therapeutics: In the fourth quarter of 2017, Selecta received a cash payment of $2.5 million under a license agreement, and proceeds from share purchases under a stock purchase agreement in the amount of $5.0 million ($7.5 million in the aggregate), bringing the total amount of proceeds received by Selecta from Spark Therapeutics to $30.0 million. These payments are associated with the December 2016 license and stock purchase agreements that provided Spark Therapeutics with exclusive worldwide rights to SVP-Rapamycin for co-administration with Spark’s gene therapy vectors for Hemophilia A and up to four additional pre-specified and undisclosed indications.
Fourth Quarter Financial Results:

Revenue: For the fourth quarter of 2017, the company’s total revenue was less than $0.1 million, which compares with $2.9 million for the fourth quarter of 2016. The decline is primarily the result of the termination of the Company’s collaboration with Sanofi, and reduced revenue recognized from the company’s nicotine vaccine candidate grant award from the National Institute on Drug Abuse.

Research and Development Expenses: Research and development expenses for the fourth quarter of 2017 were $13.6 million, which compares with $11.0 million for the fourth quarter of 2016. The increase is primarily the result of greater clinical costs related to the company’s Phase 2 trial of SEL-212, planning for the SEL-212 Phase 3 program and incremental headcount-related expenses.

General and Administrative Expenses: General and administrative expenses for the fourth quarter of 2017 were $5.7 million, which compares with $5.8 million for the fourth quarter of 2016. The decrease is primarily the result of greater headcount and related salaries needed to support a clinical-stage public company offset by a reduction in sublicensing payments made to the Massachusetts Institute of Technology resulting from the agreement with Spark Therapeutics.

Net Loss: For the fourth quarter of 2017, Selecta reported a net loss attributable to common stockholders of $(19.5) million, or $(0.88) per share, compared to a net loss of $(14.1) million, or $(0.77) per share, for the same period in 2016.

Cash Position: Selecta had $97.0 million in cash, cash equivalents, short-term deposits, investments and restricted cash as of December 31, 2017, which compares with a balance of $104.8 million at September 30, 2017. Selecta continues to expect that its cash, cash equivalents, short-term deposits, investments and restricted cash will be sufficient to fund the company’s operating expenses and capital expenditure requirements into mid-2019.
Conference Call Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company’s fourth quarter and year end 2017 financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10116990.