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Molecular Templates, Inc. reports second quarter 2019 financial results

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

TAK-169

  • 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.

MT-3724

  • 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.
  • Five of those 13 patients have been handled with MTD of 50 mcg / kg. Three of these 5 patients responded (1 CR, 2 PR).
    The CR patient has left the research for personal causes after 5 cycles whereas nonetheless in complete response.
  • One of the different sufferers with PR continues to reply and is presently in its ninth dose cycle. 19659005] The remaining affected person with heterogeneous CD20 standing at enrollment had a partial response after which progressed after about 5 cycles. A dose of 50 micrograms / kg has usually been nicely tolerated; no life-threatening toxicity was noticed at any dose of MT-3724.
  • MTEM performs a Part II monotherapy research of MT-3724 in relapsed / refractory DLBCL. This research has the potential to function a registration research. MTEM expects to offer an update for this research in 4Q19. MTEM additionally conducts two Part II research on earlier DLBCL strains; one with MT-3724 in combination chemotherapy (gemcitabine and oxaliplatin) and the opposite with MT-3724 together with Revlimid. The corporate expects to announce an update for each MT-3724 mixture research in 4Q19.
  • MT-5111

    • 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.

  • Several different ETB candidates are in preclinical improvement and target each strong and haematological cancers.
  • 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 .

    Ahead-Wanting Statements

    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.

    Contact:
    Adam Cutler
    CFO
    adam.cutler@mtem.com
    862-204-4006

    Molecular Templates, Inc.
    CONSOLIDATED (CONSOLIDATED) , excluding inventory and share info)
    (unaudited)

    three months ended
    June 30
    six months ended
    June 30
    .
    2019 2018 2019 2018
    Research and Improvement Income – Associated Get together $ 5211 $ 932 [19659057] 11,624 1095
    [muut]. 19659076] 12 80
    donation revenue 23 423 831 674 674 19659061] complete revenue . 5447 1367 12455 1849
    Operating Expenses: [19659053]
    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 [19659073] 1,053 200
    ] curiosity expenses (301 ) . ] (98 ) (594 ) (393 )
    Modifications in the truthful value of choice loans 6 ] 298 2 912 [19659044] Internet loss attributable to worldwide shareholders 9 153 9 695 15 321

    . $ 18,409
    Internet loss per share attributable to international shareholders: . [19659074]
    primary and diluted $ zero.25 $ 0.36 $ [19659074] 0.42 ] 0.68
    Weighted average variety of shares used for internet loss per share: [19659073]
    primary and diluted 36,819,846 . 27062440 36779638 27026263
    [19659074]

    Molecular Templates, Inc.
    CONDENSE D GROUP BALANCE SHEET
    (in hundreds excluding inventory and share info)

    30. June
    2019
    December 31,
    2018
    (unaudited)
    ASSETS
    Current Belongings:
    Cash and Money 16,795 $. ] 87,721
    marketable securities, current 55,529 10,234
    prepayments 2,244
    5,500
    5,195
    4,329 [19659365] Receivables from associated events to 240
    Other current belongings 98 [19659089] 95
    Complete inventories 79,840 104,863
    operating leasing, long-term 10,796
    fastened belongings 9151 6,851
    in-process analysis and improvement 26,623 26,623
    different property four,737 1,821 [19659155] Complete Belongings $ [$ 1,9659172] 131,147 140,158
    LIABILITIES AND SHARES SHARES
    trade payables 2,577 780
    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 [19659073]
    other liabilities 748 819
    complete liabilities . ]
    Complete Liabilities and Fairness $ 131,147 $ 140,158

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