On May 24, 2017 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical stage immuno-oncology company focused on the development of antibody based therapeutic and diagnostic products for cancer, reported its first quarter financial results and provided a corporate update (Press release, MabVax, MAY 24, 2017, View Source [SID1234519285]). Schedule your 30 min Free 1stOncology Demo! "We are very pleased with the progress we’ve made in the first quarter. The outcome of our recent financing provides valuable operational runway, enabling us to execute on our plans as well as continue our efforts in finalizing partnering collaborations, all of which we believe has the potential to drive significant value in MabVax," stated President and CEO, David Hansen.
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First Quarter 2017 Corporate Highlights
Closed on a total of $5 million in new financing with proceeds intended to fund the early MVT-1075 radioimmunotherapy trial anticipated to enroll the first patient before mid-year;
Presented non-clinical IND enabling data for MVT-1075 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 in April. These data showed that in xenograft and orthotopic models of human pancreatic cancer tumor growth suppression and regression were achieved after a single dose of MVT-1075;
Presented the chemistry, manufacturing, and controls (CMC) IND enabling investigations for MVT-1075 at the AACR (Free AACR Whitepaper) Annual Meeting. These data demonstrated that MVT-1075 can be reproducibly manufactured as a high-quality product and support the manufacture and clinical use of MVT-1075 drug product; and
Provided a progress update for HuMab-5B1 MVT-5873 therapeutic and MVT-2163 imaging clinical programs at the PEGS Protein Engineering Summit. The interim data included safety, changes in circulating biomarker and time on treatment, as well as PET images of patients with cancer that demonstrate antibody targeting specificity and accumulation on tumor.
Mr. Hansen added, "We have made noteworthy clinical progress in the last six months, and have announced encouraging interim clinical study results for both our MVT-5873 therapeutic antibody product, as well as our MVT-2163 immunoPET imaging agent. We expect to continue our clinical progress with the commencement of patient enrollment in our MVT-1075 novel radioimmunotherapy in the Phase 1 trial for the treatment of difficult solid tumor cancers by mid-year. We remain focused on advancing our clinical programs, participating in key scientific meetings and building shareholder value in both the near and long-term."
Expected Near-Term Milestones
Poster presentation of the clinical safety profile, maximum tolerated dose, serum CA19-9 levels, and pharmacokinetics of the single agent MVT-5873 therapeutic antibody targeting pancreatic and other CA19-9 expressing cancers at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3rd;
Poster presentation at Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting on June 11, describing the biodistribution and radiation dose estimates for the Company’s PET imaging product MVT-2163 (89Zr-DFO-HuMab-5B1) in patients with CA19-9 positive pancreatic cancer;
Podium presentation at SNMMI on June 13, discussing the Company’s immunoPET imaging agent First-in-Human (Phase 1) study of MVT-2163 (89Zr-DFO-HuMab-5B1) in patients with pancreatic cancer and other CA19-9 positive malignancies;
Commencement of first-in-human (Phase 1) clinical study of MVT-1075 (177Lu- CHX-A˝-DTPA-HuMab-5B1) in patients with pancreatic cancer or other CA19-9 positive malignancies in June of 2017;
Poster presentation at Mucins in Health and Disease on July 24 – 28, discussing the development of translational approaches to understand the distribution of the sLea in patient samples;
Present additional data from the MVT-5873 Phase 1 program including interim results from the administration of MVT-5873 in combination with gemcitabine and Abraxane in first line therapy in the second half of 2017;
Present the preclinical data from our HuMab-GD2 immunoPET imaging agent in a human tumor xenograft model in the second half of 2017; and
Present the initial data from the Company’s HuMab-Tn preclinical program summarizing the selection of lead candidate next generation fully human antibodies, in the second half of 2017. This program is a novel fully human antibody and a follow-on development product.
Summary of Financial Results for First Quarter 2017
Cash and cash equivalents totaled approximately $600,000 as of March 31, 2017, compared with $4.0 million as of December 31, 2016. Cash and cash equivalents at March 31, 2017 does not include the approximate $5.0 million in capital raised by the Company in May 2017. Management expects that current cash and cash equivalents, together with the closing of the $4.1 million public offering and completion of the $850,000 private placement in May 2017, and without assuming additional near term funds from potential licensing agreements, will be sufficient to fund current operations into August 2017.
Research and development expenses for the first quarter of 2017 were $2.8 million, compared to $1.7 million for the first quarter of 2016.
General and administrative expenses for the first quarter of 2017 were $2.3 million, compared to $2.7 million for the first quarter of 2016.
Net loss for the first quarter of 2017 was $5.4 million, or $0.85 per share, compared to a net loss of $4.4 million, or $1.12 per share, for the first quarter of 2016.