AUSTIN, Texas, August 12, 2019 (GLOBE NEWSWIRE) – Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular”, “Molecular Templates” or “MTEM”), a clinical-phase biopharmaceutical company targeted on The invention and improvement of toxin our bodies (ETBs), a differentiated, focused, biological anticancer drug, at this time reported second-quarter financial results for 2019. As of June 30, 2019, MTEM cash and investments totaled $ 72.3 million. , and is predicted to fund cuts for the first half of 2021.
“Updated information from our MTL-3724 Phase I / Ib study in DLBCL continues to show promising activity in heavily pretreated patients. In three ongoing phase II studies of MT-3724, we hope to replicate monotherapy activity in a larger patient population and demonstrate the utility and safety of combination dosing in separate chemotherapy and Revlimid combination studies, ”stated Eric Poma, Ph. .D., Basic Supervisor and Scientific Director of Molecular Fashions. “Each MT-5111 (HER2 Targeted ETB) and TAK-169 (CD38 ETB) have been accredited new investigational medicine (IND) and Part I dosing is predicted to begin soon for each packages. We look ahead to receiving analysis updates for three ongoing MT-3724 Part II trials and MT-5111 Part I trials by the top of the yr. "
Firm Highlights and Future Milestones
- Takeda and MTEM announced the approval of IND to TAK-169 (CD38 Focused ETB) in June 2019. Dosing of the research is predicted to begin in 2H19.
- As introduced at the American Cancer Research Affiliation Annual Meeting. As of April 2019, the TAK-169 is stronger than the MT-3724 (CD20-targeted ETB) and can also be very a lot tolerant at greater doses than the MT-3724 primates. The preliminary dose to extend the dose for TAK-169 is 50 micrograms / kg, which is the MTD for MT-3724. The protocol consists of dosing schedules once every week and as soon as each two weeks.
- The MT-3724 Part I / Ib Monotherapy Research accomplished enrollment in 1Q19. The final details of this research are anticipated to be introduced at a medical convention. A total of 27 sufferers have been handled on this research at totally different dose ranges (5 micrograms / kg to 100 micrograms / kg); 50 micrograms / kg was identified as the utmost tolerated dose (MTD).
13 of these sufferers with diffuse B cell lymphoma (DLBCL) have been relapsed / refractory DLBCL patients (including modified and mixed histology) with assay unfavourable serum rituximab levels.
- The results for these 13 sufferers have been:
5 sufferers had responses (1 full response, 1 full metabolic response, 3 partial responses) with a 38% response fee. The median variety of prior remedies was 3; 4 of the respondents have been main R-CHOP refractory.
- Three patients had secure illness (together with two sufferers with 49% and 47% tumor reduction, respectively).
- Five sufferers had advanced disease.
- The results for these 13 sufferers have been:
The CR patient has left the research for personal causes after 5 cycles whereas nonetheless in complete response.
- MTEM announced that it will approve its IND software for MT-5111 with ETB concentrating on HER2, April 2019. Part. Investigators in sufferers with HER2-positive strong tumors are anticipated to start out dosing at 3Q19. Research
MTEM expects to submit an MT software to MT-6035, its ETB targeted to PD-L1 (antigen insertion), in 4Q19.
Takeda Multi-site Collaboration
- Takeda and MTEM are implementing ETB optimization to lead to two undisclosed websites that Takeda has selected as a part of the collaboration. If Takeda used its option to license ETBs for both properties, MTEM would receive $ 25.0 million and can be eligible for up to $ 547.zero million in milestone fees and staggered royalties on gross sales.
Financial results. shareholders within the second quarter of 2019 have been $ 9.2 million, or $ zero.25 per share and diluted share. That is compared to a internet loss to peculiar shareholders of $ 9.7 million, or $ zero.36 per share and diluted share, for a similar period in 2018.
Second-quarter 2019 revenue was $ 5.four million, down from $ 1.four million million dollars. Q2 2019 income consisted of revenue from collaborative R&D agreements and CPRIT grants with Takeda. R&D bills totaled $ 10.2 million within the second quarter of 2019, in contrast with $ 7.7 million in the corresponding period in 2018. Q2 2019 second-quarter common and administrative bills have been $ four.6 million, in contrast with $ 3.7 million in the corresponding period in 2018.
Molecular Templates is a clinical-phase biopharmaceutical firm targeted on differentiated, targeted , for the invention and improvement of organic therapeutic medicine for most cancers. We consider that our patented organic drug substrate know-how, known as a designed toxin moiety or ETB, offers a differentiated mechanism of motion which will lack a number of the limitations related to presently out there cancer remedies. ETBs use a genetically engineered form of Shiga-like Toxin A unit or SLTA, a ribosome-inactivating bacterial protein that can be particularly targeted to kill cancer cells. Further info on molecular fashions is obtainable at http://www.mtem.com .
This press release incorporates forward-looking statements for a personal equity litigation. Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intention or obligation to update these forward-looking statements and requires using Protected Harbor safety for forward-looking statements. All statements, except statements relating to historic information, contained in this press release relating to strategy, future actions, future financial place, future revenues, estimated bills, prospects, plans and management aims are forward-looking statements. In addition, the phrases "may", "could", "should", "anticipate", "believe", "estimate", "wait", "plan", or if they are used on this press release. "Predict" and comparable expressions and their variants as they relate to a molecular model can determine forward-looking statements. Examples of such statements embrace, however aren’t restricted to, statements associated to the event of the Company's Main Program MT-3724 and the repetition of monotherapy in Part II studies with MT-3724; the expected timetable for submitting the varied IND purposes, conducting the research, dosing the patients and providing further research updates or info from the varied research; and the company's perception that its proprietary biological media know-how or ETBs provide a differentiated mechanism of motion which will tackle a few of the limitations related to presently out there most cancers remedy.
Forward-looking statements do not guarantee future performance and contain dangers and uncertainties. Precise events or results might differ materially from these addressed in forward-looking statements because of quite a lot of elements including, however not limited to, preclinical and medical developmental uncertainties; whether the corporate's money and cash equivalents are enough to finance its continuing operations through the durations foreseen and / or tested; the company's capability to protect its intellectual property rights; and legal, regulatory, political and financial developments, as well as the dangers recognized beneath the heading "Risk Factors" in the company's submitting with the SEC. All forward-looking statements contained in this press launch confer with the date only, and the corporate expressly disclaims any obligation to update the forward-looking statements, whether because of new info, future occasions, or otherwise.
Molecular Templates, Inc.
CONSOLIDATED (CONSOLIDATED) , excluding inventory and share info)
| three months ended
| six months ended
|Research and Improvement Income – Associated Get together||$||5211||$||932 ||11,624||1095|
|donation revenue||23||423||831||674||674||19659061] complete revenue||.||5447||1367||12455||1849|
|Research and Improvement pment||10243||7662||18697||14350|
|Basic and Administrative||four,605 ||3,718||9,540||. ] 6,627|
|Complete working bills||14,848||11,380||28,237||.||20,977|
|losses from operations||9,401||10,013||. 19659073]||19 128|
|curiosity and other revenue, internet||543||118 ||1,053||200|
|] curiosity expenses||(301||)||. ]||(98||)||(594||)||(393||)|
|Modifications in the truthful value of choice loans||6||] 298||2||912|| Internet loss attributable to worldwide shareholders||9 153||9 695|| 15 321
|Internet loss per share attributable to international shareholders:||.|||
|primary and diluted||$||zero.25||$||0.36||$  0.42||]||0.68|
|Weighted average variety of shares used for internet loss per share:|||
|primary and diluted||36,819,846||.||27062440||36779638||27026263|
Molecular Templates, Inc.
CONDENSE D GROUP BALANCE SHEET
(in hundreds excluding inventory and share info)
| 30. June
| December 31,
|Cash and Money||16,795||$. ] 87,721|
|marketable securities, current||55,529||10,234|
|4,329|| Receivables from associated events||to||240|
|Other current belongings||98||||95|
|operating leasing, long-term||10,796||–|
|in-process analysis and improvement||26,623||26,623|
|different property||four,737||1,821  Complete Belongings $||[$ 1,9659172] 131,147||140,158|
|LIABILITIES AND SHARES SHARES|
|accrued liabilities||. ]||5,357|
|Delayed income, current||14,561||26,231||1435||141|
|Complete Current Liabilities||25,693||19659372]|
|Deferred Long-Time period Yield||1,644||] 2,670|
|long-term liabilities, long-term, internet||3,075||three,254|
|working lease liabilities, long-term||10,707 |
|complete liabilities||. ]|
|Complete Liabilities and Fairness||$||131,147||$||140,158|