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AUSTIN, Texas, Aug. 06, 2020 (GLOBE NEWSWIRE) — Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” “MTEM” or “the Company”), a clinical-stage biopharmaceutical aggregation focused on the analysis and development of proprietary targeted biologic therapeutics, engineered adulteration bodies (ETBs), today appear banking after-effects for the added division of 2020.
“Since our aftermost annual update, we presented preclinical abstracts at AACR on four preclinical ETB programs, provided an amend on the advancing Phase I abstraction for MT-5111, and adequate our antithesis area through a new debt adeptness and our ATM,” said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Chief Scientific Officer. “In the added bisected of 2020, we apprehend to abode acting analytic abstracts from our three MT-3724 Phase 2 studies and added abstracts from the MT-5111 Phase 1 study, and additionally book the IND for MT-6402, our PD-L1-targeted ETB with antigen seeding.”
Company Highlights, Activity Status, and Accessible Milestones
On May 22, 2020, MTEM appear it had anchored a debt costs adeptness for up to $45 actor from K2 HealthVentures, a healthcare-focused specialty accounts company. MTEM accustomed a aboriginal tranche of $15 actor aloft closing. Two consecutive tranches accretion $30 actor will become accessible aloft the accomplishment of assertive milestones.
In July 2020, MTEM aloft $50 actor in gross gain from its At-The-Market Adeptness (ATM).
MT-3724 (CD20 ETB)
MTEM is currently administering three Phase 2 studies with MT-3724 in relapsed/refractory broadcast ample B-cell lymphoma (DLBCL): a monotherapy abstraction that has the abeyant to be pivotal, a aggregate abstraction with chemotherapy, and a aggregate abstraction with lenalidomide.
Interim after-effects for the abstraction of MT-3724 in aggregate with lenalidomide were presented at the 25th Congress of the European Hematology Association (EHA) basal affair in June 2020. This abstracts approved basal affirmation of tolerability and adeptness with lenalidomide at accepted doses and MT-3724. Among 7 evaluable subjects, 2 had CRs and 3 had PRs. While there were no abiding discontinuations due to adverse events, brand 2 capillary aperture affection occurred at 25 mcg/kg, arch to the aperture of a new accomplice at 20 mcg/kg. The abstraction now has a new agenda of analysis with MT-3724 actuality dosed alert rather than three times account for the aboriginal two cycles, and again on a account agenda thereafter.
MTEM expects to abode updates on all three MT-3724 DLBCL studies in 2H20.
MTEM additionally expects to admit Phase 2 studies for MT-3724 in follicular lymphoma and crimson corpuscle lymphoma in 2H20.
TAK-169 (CD38 ETB)
MT-5111 (HER2 ETB)
MTEM is administering a Phase 1 abstraction of MT-5111 in HER2-positive cancers.
In June 2020, MTEM provided an acting amend from the aboriginal three dosage cohorts of the dosage accretion allocation of the Phase 1 study. That amend acclaimed that 10 subjects, with a boilerplate of 5 above-mentioned curve of analysis and a boilerplate of 2 above-mentioned HER2-targeting regimens, accept been advised with MT-5111 (metastatic cholangiocarcinoma n=5, metastatic breast blight n=4, metastatic gastro-esophageal alliance blight n=1). Thus far, no dosage attached toxicities (DLTs) accept been empiric in any accomplice and MT-5111 appears to be able-bodied tolerated, with no cardiotoxicity empiric to date (cardiotoxicity is a accepted abeyant toxicity for HER2 targeted therapies).
Further to the June 2020 acting update, MTEM expects to accommodate an amend on after-effects from the capacity still on analysis as able-bodied as college dosage cohorts from the dosage accretion allocation of the Phase 1 abstraction (including doses that are predicted to be clinically alive based on preclinical data) in 4Q20.
MTEM presented preclinical abstracts on ETB programs targeting PD-L1, CTLA-4, SLAMF-7 and CD45 at the American Association for Blight Analysis (AACR) Basal Annual Affair II, which took abode June 22-24, 2020.
MTEM expects to book an investigational new biologic (IND) appliance for MT-6402, its ETB targeting PD-L1 (with antigen seeding), in 2H20.
MTEM expects to book an IND appliance for its ETB targeting CTLA-4 in 2021.
The COVID-19 communicable has resulted in a cogent arrest in the clip of armpit initiations and accommodating acceptance beyond our MT-3724 Phase 2 programs. Much like added sponsors with studies in patients with hematologic malignancies, we are alive with sites to actuate back a accommodating is acceptable for anniversary analysis abstraction and to ensure the connected assurance of all analysis participants.
To date, screening and acceptance for the MT-5111 Phase 1 abstraction has been beneath abnormally afflicted than the MT-3724 studies but it is enrolling at slower clip than was projected pre-COVID-19.
To date, MTEM has been able to abide to assignment at its cGMP accomplishment adeptness and laboratories afterwards abeyance from COVID-19. As a result, accomplishment of artefact accumulation for analytic trials and analysis activities to abutment advance of our preclinical activity (including partnered programs) accept not been abnormally afflicted by COVID-19 to date.
The net accident attributable to accepted shareholders for the added division of 2020 was $31.2 million, or $0.68 per basal and adulterated share. This compares with a net accident attributable to accepted shareholders of $9.2 million, or $0.25 per basal and adulterated share, for the aforementioned aeon in 2019.
Revenues for the added division of 2020 were $6.9 million, compared to $5.4 actor for the aforementioned aeon in 2019. Revenues for the added division of 2020 were comprised of revenues from collaborative analysis and development agreements with Takeda and Vertex, as able-bodied as admission acquirement from CPRIT. Total analysis and development costs for the added division of 2020 were $30.4 million, compared with $10.2 actor for the aforementioned aeon in 2019. Total accepted and authoritative costs for the added division of 2020 were $6.4 million, compared with $4.6 actor for the aforementioned aeon in 2019.
As of June 30, 2020, MTEM’s banknote and investments totaled $91.0 million. With the accession of $50 actor in gross gain aloft through MTEM’s ATM adeptness afterwards the end of the quarter, MTEM expects to be able to armamentarium operations into 2H22.
About Molecular Templates
Molecular Templates is a clinical-stage aggregation focused on the analysis and development of targeted biologic therapeutics. Our proprietary biologic belvedere technology, accepted as engineered adulteration bodies, or ETBs, leverages the citizen analysis of a genetically engineered anatomy of Shiga-like Adulteration A subunit to actualize atypical therapies with almighty and differentiated mechanisms of activity for blight and added austere diseases.
This columnist absolution contains advanced statements for purposes of the Private Balance Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any absorbed or obligation to amend these advanced statements, and claims the aegis of the Act’s Safe Harbor for advanced statements. All statements, added than statements of actual facts, included in this columnist absolution apropos strategy, approaching operations, approaching banking position, approaching revenue, projected expenses, prospects, affairs and objectives of administration are advanced statements. In addition, back or if acclimated in this columnist release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and agnate expressions and their variants, as they chronicle to Molecular Templates may analyze advanced statements. Examples of such statements include, but are not bound to, statements apropos to the development of the MT-3724, MT-5111, TAK-169, and MT-6402; the accepted timing of appointment assorted IND applications and administering studies; the accepted accord and presentation at accessible medical conferences; the advancing furnishings of the COVID-19 communicable on the Company’s advancing analytic studies, accomplishment and preclinical development; and the Company’s acceptance that its proprietary biologic biologic belvedere technology, or ETBs, provides for a differentiated apparatus of activity that may abode some of the limitations associated with currently accessible blight therapeutics.
Forward-looking statements are not guarantees of approaching achievement and absorb risks and uncertainties. Actual contest or after-effects may alter materially from those discussed in the advanced statements as a aftereffect of assorted factors including, but not bound to, the uncertainties inherent in the preclinical and analytic development process; whether the Company’s banknote assets will be acceptable to armamentarium its continuing operations for the periods and/or trials anticipated; the adeptness of the Aggregation to assure its bookish acreage rights; risks from all-around pandemics including COVID-19; and legislative, regulatory, political and bread-and-butter developments, as able-bodied as those risks articular beneath the branch “Risk Factors” in the Company’s filings with the SEC. Any advanced statements independent in this columnist absolution allege alone as of the date hereof, and the Aggregation accurately disclaims any obligation to amend any advanced statement, whether because of new information, approaching contest or otherwise.
Adam CutlerChief Banking [email protected]
Molecular Templates, Inc.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except allotment and per allotment data)(unaudited)
Three Months EndedJune 30,
Six Months EndedJune 30,
Research and development revenue, accompanying party
Research and development revenue, other
Research and development
General and administrative
Total operating expenses
Loss from operations
Interest and added income, net
Interest and added expense, net
Loss on concealment of debt
Change in fair amount of accreditation liabilities
Loss afore accouterment for assets taxes
Provision for assets taxes
Net accident attributable to accepted shareholders
Net accident per allotment attributable to accepted shareholders:
Basic and diluted
Weighted boilerplate cardinal of shares acclimated in net accident per allotment calculations:
Basic and diluted
Molecular Templates, Inc.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except allotment and per allotment data)
June 30,2020 (unaudited)
Cash and banknote equivalents
Marketable securities, current
Grants acquirement receivable
Accounts receivable, accompanying party
In-process analysis and development – captivated for sale
Other accepted assets
Total accepted assets
Marketable securities, non-current
Operating charter right-of-use assets, non-current
Property and equipment, net
LIABILITIES AND STOCKHOLDERS’ EQUITY
Deferred revenue, current
Deferred revenue, current, accompanying party
Other accepted liabilities, accompanying party
Other accepted liabilities
Total accepted liabilities
Deferred revenue, long-term
Deferred revenue, long-term, accompanying party
Long-term debt, net
Operating charter liabilities, non-current
Other liabilities, accompanying party
Commitments and contingencies (Note 10)
Preferred stock, $0.001 par value:
Authorized: 2,000,000 shares at June 30, 2020 and December 31, 2019; issued and outstanding: 250 shares at June 30, 2020 and December 31, 2019
Common stock, $0.001 par value:
Authorized: 150,000,000 shares; issued and outstanding: 45,778,876 shares at June 30, 2020 and 45,589,157 shares at December 31, 2019
Additional paid-in capital
Accumulated added absolute income
Total stockholders’ equity
Total liabilities and stockholders’ equity
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