Upcoming Presentations at AACR Conference to Feature Data on PD-L1 Antigen Seeding ETB and HER2 ETB
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AUSTIN, Texas, March 28, 2018 (GLOBE NEWSWIRE) — Molecular Templates, Inc. (Nasdaq:MTEM) (“Molecular”), a clinical-stage oncology organisation centered at the discovery and development of the organization’s proprietary engineered toxin bodies (ETBs), which might be differentiated, focused, biologic therapeutics for most cancers, nowadays stated financial effects for the fourth sector of 2017. As of December 31, 2017, coins and coins equivalents totaled $58.Nine million. Molecular’s cutting-edge coins stability is expected to fund operations into past due 2019.
“We are excited through the ongoing development
Stated Eric Poma, Ph.D., CEO, and CSO of Molecular Templates. “We expect the rest of 2018 to carry more records on our lead program MT-3724 in DLBCL, additional IND filings for different pipeline applications, and the ability for more commercial enterprise improvement transactions that might aid additional packages with non-dilutive capital.”
Company Highlights and Upcoming Milestones
In 4Q17, Molecular improved its senior management group with the additions of Adam Cutler as Chief Financial Officer; Barbara Ruskin J.D. Ph.D. As SVP, General Counsel and Chief Patent Officer; Nenad Sarapa M.D. M.S. As SVP of Clinical Development, and Conrad Jordaan as SVP of Finance and Corporate Controller.
On March 2, 2018, Molecular closed a $10 million debt facility with Perceptive Advisors. The proceeds have been used to pay off an present debt facility with Silicon Valley Bank and could support Molecular’s build-out of its GMP manufacturing facility, which ought to shorten the time from lead development to IND and better support Molecular’s own pipeline as well as partnerships.
MT-3724 (an ETB concentrated on CD20) is in an ongoing Phase
Ib enlargement take a look at meant to better outline the overall reaction rate to this candidate as a single-agent in closely pre-treated diffuse massive B-cell lymphoma (DLBCL) patients.
A brief update on the first 3 sufferers dosed inside the MT-3724 Phase Ib expansion examine turned into delivered at the World ADC Summit Europe nowadays. Observations included the subsequent:
One of the 3 sufferers accomplished a partial reaction (PR) after a single dose of MT-3724. The PR turned into confirmed on the quit of cycle 2 consistent with protocol and the patient stays on look at with persevered dosing of MT-3724. The different two patients have been assessed as having the stable disorder (SD) and progressive sickness (PD).
A dose interruption and discount become required in of the primary three sufferers in Phase Ib enlargement. These patients had excessive frame weights which led to high absolute doses of MT-3724 primarily based on 75 mcg/kg dosing. The destructive events found (grade 2 and three) had been reversible and dosing resumed at 50 mcg/kg, which has been usually nicely tolerated.
Based on those information, the deep and sustained clinical responses to MT-3724 found at doses as low as 5 mcg/kg, in addition to the close-to-complete peripheral B-cellular depletion at doses up to 50 mcg/kg, the most tolerated dose (MTD) of MT-3724, has been defined as 50 mcg/kg with a most general drug according to dose of 6,000 mcg, or 6 mg.
Enrollment in the Phase Ib growth examines maintains
With similar updates on effects expected in 2Q18.
Nine DLBCL patients with low serum levels of rituximab have been dealt with at doses ranging from 5 mcg/kg to 75 mcg/kg within the Phase I dose-finding and Phase Ib growth studies. In those 9 patients, one whole response, partial responses, three patients with strong sickness (along with one affected person with a forty eight% reduction in tumor length), and 3 patients with progressive disease, had been found.
Based on the peripheral B-cellular depletion observed at 50 mcg/kg and responses visible at doses as little as 5 mcg/kg, 50 mcg/kg seems to be an efficacious and well-tolerated dose.
Molecular additionally expect to provoke aggregate studies with MT-3724 in advance traces of DLBCL remedy in 2Q18.
In December 2017, Takeda decided on two targets for in addition research using Molecular’s ETBs. This has triggered $four million in milestone payments to be paid by using Takeda in 2018.
Takeda and Molecular are comparing CD38 ETBs and could select a drug candidate for development via the stop of 2Q18.
MT-4019, an ETB candidate this is designed to target CD38-expressing myeloma most cancers cells, is progressing through IND enabling studies. If Takeda and Molecular do now not select a joint candidate for improvement, Molecular anticipates filing an IND utility for MT-4019 in mid-2018 to initiate a Phase I scientific trial inside the United States in 2H18.
Preclinical data for Molecular’s ETBs targeting PD-L1
(which includes Molecular’s Antigen Seeding Technology – a differentiated immune-oncology approach) and HER2 might be presented at the American Association of Cancer Research (AACR) annual meeting in April 2018
Molecular expects to record an IND application for an ETB targeting HER2 in 4Q18
Molecular expects to report an IND application for an ETB targeting PD-L1 (with antigen seeding) in 1Q19
Several other ETB applicants are in preclinical improvement targeting both strong and hematological cancers
The net loss as a consequence of commonplace
Shareholders for the fourth region was $6.Nine million, or $zero.26 per fundamental and diluted percentage. This is compared to an internet loss attributable to common shareholders for the same length in 2016, of $2.Nine million, or $13.82 in line with a fundamental and diluted percentage.
Revenues for the fourth quarter of 2017 have been $zero.8 million, as compared to $zero.Four million for the equal length in 2016. Revenues in the fourth quarters of 2017 and 2016 have been made from grant sales from the Cancer Prevention & Research Institute of Texas (“CPRIT”). Total studies and improvement (R&D) charges for the fourth quarter of 2017 have been $4.7 million, as compared with $1.7 million for the identical length in 2016. Total trendy and administrative (G&A) prices for the fourth region of 2017 have been $three.Five million, compared with $1.1 million for the identical length in 2016.
Revenues for the 12 months ended December 31, 2017, had been $three.
4 million, in comparison to $1.Nine million for 2016. These revenues had been typically created from research and improvement sales from our collaboration with Takeda of $1.Nine million, and provide revenue from CPRIT of $1.Zero million. Revenues for the equal duration in 2016 comprised of furnish revenue from CPRIT. Total R&D fees for the yr ended December 31, 2017, had been $9.5 million, as compared to $eight.0 million for 2016. Total G&A charges for the year ended December 31, 2017, were $11.Eight million, in comparison to $4.5 million for 2016.
The internet loss because of not unusual shareholders for the 12 months ended December 31, 2017, become $24.1 million, or $2.11 in step with simple and diluted share, in comparison to a net loss because of not unusual shareholders of $12.6 million or $59.04 per sample and diluted proportion, for 2016. As of December 31, 2017, coins and coins equivalents totaled $58.9 million. Molecular’s contemporary cash stability is anticipated to fund operations into past due 2019.
About Molecular Templates
Molecular Templates is a clinical-degree oncology agency focused on the discovery and improvement of differentiated, centered, biologic therapeutics for most cancers. We believe our proprietary biologic drug platform technology, known as engineered toxin bodies, or ETBs, presents a differentiated mechanism of motion that can cope with a number of the constraints related to presently to be had most cancers therapeutics. ETBs make use of a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome-inactivating bacterial protein, that can be targeted to especially destroy most cancers cells. Additional statistics approximately Molecular Templates can be acquired at http://www.Mtem.Com.
This press release consists of forward-searching statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or responsibility to replace those forward-searching statements and claims the protection of the Act’s Safe Harbor for forward-searching statements. All statements, apart from statements of ancient facts, included in this press launch regarding approach, future operations, destiny financial position, future sales, projected fees, prospects, plans and objectives of management are ahead-looking statements. In addition, when or if used on this press release, the phrases “may additionally,” “ought to,” “have to,” “expect,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and comparable expressions and their editions, as they relate to Molecular Templates might also pick out forward-searching statements. Examples of such statements encompass, however are not restrained to, statements relating to the development of the Company’s lead application, MT-3724; the predicted timing of submitting various IND programs and beginning studies; and the Company’s notion that its proprietary biologic drug platform era, or ETBs, provides for a differentiated mechanism of movement that can cope with some of the limitations related to presently to be had most cancers therapeutics.
Forward-looking statements are not ensured of future overall
Performance and contain risks and uncertainties. Actual events or consequences may additionally fluctuate materially from the ones mentioned in the forward-looking statements because of various factors which include, but now not constrained to, the uncertainties inherent in the preclinical and clinical improvement system; whether or not the Company’s coins sources could be enough to fund its continuing operations for the durations and/or trials predicted; the ability of the Company to guard its intellectual assets rights; and legislative, regulatory, political and financial traits, in addition to the one’s risks, recognized below the heading “Risk Factors” inside the Company’s filings with the SEC. Any forward-searching statements contained in this press release communicate most effective as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking declaration, whether or not because of new records, future activities or in any other case.