AUSTIN, Texas, Aug. 10, 2023 (GLOBE NEWSWIRE) — Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical firm targeted on the invention and improvement of proprietary focused biologic therapeutics, engineered toxin our bodies (“ETBs”), to create novel therapies with potent differentiated mechanisms of motion for most cancers, right now reported monetary outcomes and enterprise updates for the second quarter of 2023.

Eric Poma, PhD., Chief Government and Chief Scientific Officer of MTEM, acknowledged, “ETBs characterize a novel strategy to the therapy of most cancers with differentiated biology and distinctive mechanisms of motion. We anticipate to see substantial knowledge throughout all three of our medical applications with updates all through this yr and into 2024.”

Firm Highlights

• As much as $40 million Personal Placement entered with current and new buyers to fund medical improvement of MT-6402, MT-8421, and MT-0169

• Excellent debt absolutely discharged and happy in Restructuring Settlement with K2 Well being Ventures LLC

• MT-0169 screening and enrollment resumed following removing of partial medical maintain on affected person enrollment by U.S. Meals and Drug Administration

• First-in-human part I examine for MT-8421 concentrating on CTLA-4-expressing regulatory T-cells (“Tregs”) within the tumor microenvironment (“TME”) for elimination with out affecting Tregs within the periphery to start in 3Q 2023

• Medical knowledge for every program continues to exhibit novel mechanisms of motion, distinctive pharmacodynamic (“PD”) results, and single agent exercise in closely relapsed / refractory sufferers throughout immuno-oncology, hematologic, and strong tumor indications

• No situations of capillary leak syndrome or different manifestations of innate immunity have been noticed up to now with any next-generation ETB

• Concentrate on preclinical actions associated to Bristol Myers Squibb collaboration strikes ahead

July 2023 Personal Placement

On July 12, 2023, and as described in Be aware 14 “Subsequent Occasions” of the monetary statements included in Merchandise 1 of the Quarterly Report on Type 10-Q, we entered into the July 2023 Buy Settlement which gives for the non-public placement of shares of our widespread inventory and warrants to buy shares of our widespread inventory in two tranches. The preliminary tranche of the July 2023 Personal Placement closed on July 17, 2023, and consisted of the issuance of (i) 24,260,644 shares of our widespread inventory at a value of $0.47 per share (the closing value per share of our widespread inventory as reported by the Nasdaq Capital Market on July 12, 2023), and (ii) July 2023 Pre-Funded Warrants exercisable for as much as 18,331,547 shares of our widespread inventory. The value of the July 2023 Pre-Funded Warrants was $0.469 per underlying share of our widespread inventory. We acquired roughly $20 million in gross proceeds in reference to the closing of the preliminary tranche and internet proceeds, following the cost of associated providing bills, of roughly $18.7 million. The second tranche would come with gross proceeds of roughly $20 million and would include the sale and issuance of an extra 42.6 million shares of widespread inventory (or pre-funded warrants in lieu thereof) on the identical pricing phrases, and would shut if sure situations had been met throughout the 12 month interval described within the July 2023 Buy Settlement, together with necessities that shares of our widespread inventory commerce for a 10-day quantity weighted common value of not less than $1.41 per share with mixture buying and selling quantity throughout the identical 10-day interval of not less than 10 million shares. As well as, upon this second tranche closing, we might problem to the July 2023 Purchasers Second Closing Warrants representing the fitting to buy an extra 85.2 million shares of our widespread inventory at an train value of $0.47 per share, in change for the cost of $0.125 per underlying share of inventory. Within the mixture, these Second Closing Warrants would characterize 100% warrant protection of the variety of shares of widespread inventory (or pre-funded warrants) bought within the preliminary and second tranche, and it might have a time period of 5 years. We intend to make use of the online proceeds from the July 2023 Personal Placement to fund our ongoing medical research, working capital and for common company functions and to proceed our collaboration actions with BMS.

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Restructuring Settlement with K2 HealthVentures LLC (“K2HV”)

On June 16, 2023 and as described in Be aware 8 “Borrowing Preparations and Debt Extinguishment” in our monetary statements included in Merchandise 1 of the Quarterly Report on Type 10-Q, we entered into the Convertible Secured Contingent Worth Proper Settlement (the “CVR Settlement”) with K2HV to completely fulfill and discharge our excellent secured debt obligations and terminate all different obligations beneath the present debt financing facility between us and K2HV in change for an mixture compensation in money of $27.5 million, the granting of a contingent worth proper to K2HV and the issuance of a warrant to buy shares of our widespread inventory to K2HV’s affiliated holder. These contingent worth rights require funds to K2HV upon the incidence of sure occasions or Acceleration Occasions described within the CVR Settlement, and funds due for these occasions is initially capped at $10.3 million which, if not repaid, is topic to varied escalating multipliers, as additional described within the CVR Settlement. As well as, upon a Change in Management, as outlined within the CVR Settlement, we’re required to pay an extra cost of $2.5 million. In lieu of a portion of those contingent worth rights, K2HV could convert as much as $3,000,000 of the Remaining Worth, as outlined within the CVR Settlement, into an mixture of 6,124,011 shares of our widespread inventory, topic to adjustment for any inventory splits and related occasions as long as the variety of shares of widespread inventory underlying such conversion proper, along with the shares of widespread inventory underlying the warrant, don’t exceed 19.99% of the variety of shares of our widespread inventory excellent rapid previous to the execution of the CVR Settlement. In satisfaction of our obligations to problem the warrant to K2HV’s affiliate pursuant to the CVR Settlement, we issued a warrant to buy as much as 5,103,343 shares of our widespread inventory at an train value of $0.3919 per share. This warrant has a time period of 10 years. To guard its curiosity in any potential cost of the Remaining Worth, K2HV has a safety curiosity in, topic to sure restricted exceptions, all property (together with mental property) of the Firm. Additional and pursuant to the phrases of the CVR Settlement, we could not (i) incur any indebtedness for borrowed cash that’s structured as senior or pari passu to K2HV’s excellent funds with out K2HV’s consent or (ii) allow some other liens (apart from customary permitted liens) on this collateral with out K2HV’s consent.

MT-0169 (CD38 ETB)

• MT-0169 was designed to destroy CD38+ tumor cells by means of internalization of CD38 and cell destruction through a novel mechanism of motion (enzymatic ribosomal destruction and immunogenic cell dying).

• On June 1, 2023, we introduced that the U.S. Meals and Drug Administration (the “FDA”), after reviewing security knowledge on this system, eliminated the partial medical maintain (positioned April 2023) on affected person enrollment for our MT-0169 trial efficient as of Could 31, 2023.

  • In April 2023, the FDA positioned the Part I examine for MT-0169 on a partial medical maintain primarily based on beforehand disclosed cardiac AEs famous in two sufferers dosed at 50 mcg/kg that prompted the dose discount to five mcg/kg final yr. Below the partial medical maintain, present examine members might proceed therapy, however no new sufferers had been to be enrolled till the partial maintain was lifted by the FDA. We submitted our response to the partial medical maintain to the FDA in Could 2023, and the partial medical maintain was lifted by the FDA on Could 31, 2023.

• Screening and enrollment have resumed for cohort 3 at 15 mcg/kg following a evaluation of the security knowledge from cohorts 1 (5 mcg/kg) and a couple of (10 mcg/kg) during which no cardiac AEs had been noticed.

• Of the sufferers handled, one affected person with extramedullary IgA myeloma handled at 5 mcg/kg has had a marked discount in IgA serum protein, conversion from immunofixation optimistic to destructive and backbone of uptake on bone scan of skeletal lesions demonstrating a stringent Full Response (“CR”).

  • The affected person’s illness was quad-agent refractory together with CD38-targeting antibody, proteosome inhibitor, IMiD, and a BCMA bispecific antibody.

  • The affected person continues on examine in a stringent CR at cycle 12. 

MT-8421 (CTLA-4 ETB) 

• MT-8421, together with MT-6402, characterize our distinctive strategy to immuno-oncology primarily based on dismantling the TME by means of direct cell-kill of tumor and immune cells and never solely the blocking of ligand-ligand interactions seen with present antibody therapeutics.

• The ETB strategy contains potent destruction of CTLA4+ regulatory T cells (“Tregs”) through enzymatic ribosome destruction, and the mechanism of cell kill is unbiased of TME.

• MT-8421 preferentially destroys excessive CTLA4 expressing Tregs within the TME relative to peripheral Tregs that are decrease CTLA4 expressing.

• Medical websites are open, and we anticipate the primary affected person to be enrolled on this Part 1 examine in 3Q 2023. 

MT-6402 (PD-L1-targeting ETB with Antigen Seeding Know-how)

• MT-6402 was designed to activate T-cells by means of direct cell-kill of immunosuppressive PD-L1+ immune cells. As well as, MT-6402 can ship and induce the presentation of an MHC class I CMV antigen on tumor cells (antigen seeding mechanism of motion) for pre-existing CD8 T-cell recognition and destruction in HLA-A*02/CMV+ sufferers with excessive PD-L1 expression on their tumors.

• MT-6402 continues to exhibit PD results and monotherapy exercise in closely pre-treated checkpoint remedy skilled sufferers.

• Dose escalation within the Part I examine continues as deliberate for 2023, with one enlargement for sufferers with excessive PD-L1 tumor expression (≥ 50%) and the opposite enlargement for sufferers with low (1-49%) PD-L1 tumor expression.

• As of June 2023, sufferers have been handled throughout seven dose escalation cohorts of 16 mcg/kg, 24 mcg/kg, 32 mcg/kg, 42 mcg/kg, 63 mcg/kg, 83 mcg/kg, and 100 mcg/kg within the MT-6402 examine of sufferers with relapsed/refractory tumors that categorical PD-L1. We proceed to watch pharmacodynamic (“PD”) results together with the depletion of PD-L1+ monocytes, MDSCs, PD-L1+ dendritic cells, in addition to T cell activation.

• One affected person with excessive tumor PD-L1 expression who additionally had Antigen Seeding functionality, demonstrated tumor regression whereas being dosed with MT-6402 for over 7 months.

  • This affected person, with NSCLC, was handled in cohort 1 (16 mcg/kg) and demonstrated decision of three osseous lesions and a discount in uptake within the remaining lesion.

  • This affected person additionally skilled grade 2 cytokine launch syndrome (“CRS”) in step with T-cell activation and was dose decreased to eight mcg/kg.

  • This affected person had evaluable-only a number of websites of bone illness that appeared to have resolved on bone scan after 3 – 4 months on MT-6402 with just one remaining web site which confirmed decreased uptake.

• One affected person in cohort 5 (63 mcg/kg) with metastatic squamous cell nasopharynx carcinoma with illness development after radiation remedy, chemotherapy, and pembrolizumab had a Partial Response (“PR”) (RECIST) with a 63% discount within the index lesion after cycle 2.

  • The PR was confirmed after cycle 4 with a 71% discount and the affected person stays on therapy and in a response in cycle 10.

  • This affected person’s tumor had 2% PD-L1 expression and was not HLA-A*02, suggesting the response is because of T-cell activation by means of the clearance of PD-L1+ immune cells. The affected person confirmed a >250% improve in CD8/CD4 T-cell ratios.

  • Thus far, treatment-related AEs together with immune associated AEs have been largely restricted to grade 1 or grade 2.

Analysis and Collaboration

MTEM continues to develop and develop its distinctive strategy to immuno-oncology targets in collaboration with Bristol Myers Squibb.

Key Milestones for 2023

• Accelerating enrollment throughout all medical applications

• Initiation of first-in-human Part I examine for MT-8421 in 3Q 2023

• Development of Bristol Myers Squibb analysis collaboration throughout a number of targets

• MTEM expects to offer periodic updates on MT-6402, MT-8421, and MT-0169 all through 2023.

Upcoming Conferences

MTEM will make a digital presentation 7:00am Monday, September 11, 2023, on the H.C. Wainwright 25^th Annual World Convention going down on the Lotte Palace Resort in New York, NY from September 11 – 13, 2023. The presentation might be accessible through the company web site. One-on-one conferences could also be scheduled through H.C. Wainwright consultant or by immediately contacting Molecular Templates.

Monetary Outcomes

The web loss attributable to widespread shareholders for the second quarter of 2023 was $10.9 million, or $0.19 per fundamental share and per diluted share. This compares with a internet loss attributable to widespread shareholders of $24.4 million, or $0.43 per fundamental and diluted share, for a similar interval in 2022.

Revenues for the second quarter of 2023 had been $6.9 million, in comparison with $4.4 million for a similar interval in 2022. Revenues for the second quarter of 2023 had been comprised of revenues from collaborative analysis and improvement agreements with Bristol Myers Squibb and grant income from CPRIT.

Whole analysis and improvement bills for the second quarter of 2023 had been $13.4 million, in contrast with $21.4 million for a similar interval in 2022. Whole common and administrative bills for the second quarter of 2023 had been $5.2 million, in contrast with $6.6 million for a similar interval in 2022.

As of June 30, 2023, MTEM’s money and money equivalents totaled $5.0 million. Primarily based on the MTEM’s money and money equivalents, the proceeds from the primary tranche of the July 2023 non-public placement described above, the anticipated cost-savings from inside restructuring associated actions, and different assumptions, administration anticipates that MTEM will be capable to fund its deliberate working bills and capital expenditure necessities to the third quarter 2024.

About Molecular Templates

Molecular Templates is a clinical-stage biopharmaceutical firm targeted on the invention and improvement of focused biologic therapeutics. Our proprietary drug platform know-how, often known as engineered toxin our bodies, or ETBs, leverages the resident biology of a genetically engineered type of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of motion for most cancers.

Ahead-Trying Statements

This press launch incorporates forward-looking statements for functions of the Personal Securities Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or obligation to replace these forward-looking statements and claims the safety of the Act’s Protected Harbor for forward-looking statements. All statements, apart from statements of historic information, included on this press launch, together with, however not restricted to these concerning technique, future operations, the Firm’s capacity to execute on its targets, prospects, plans, and future execution of company objectives. As well as, when or if used on this press launch, the phrases “could,” “might,” “ought to,” “anticipate,” “imagine,” “estimate,” “anticipate,” “intend,” “plan,” “predict” and related expressions and their variants, as they relate to Molecular Templates could establish forward-looking statements. Ahead-looking statements aren’t ensures of future efficiency and contain dangers and uncertainties. Precise occasions or outcomes could differ materially from these mentioned within the forward-looking statements on account of numerous elements together with, however not restricted to the next: the continued availability of financing on commercially affordable phrases, whether or not Molecular Templates’ money assets might be ample to fund its persevering with operations; the outcomes of MTEM’s ongoing medical research and its collaboration actions with BMS, the power to successfully function MTEM, and people dangers recognized beneath the heading “Threat Elements” in Molecular Templates’ filings with the Securities and Trade Fee, together with its Quarterly Report on Type 10-Q for the quarter ended June 30, 2023 and any subsequent studies filed with the Securities and Trade Fee. Any forward-looking statements contained on this press launch communicate solely as of the date hereof, and Molecular Templates particularly disclaims any obligation to replace any forward-looking assertion, whether or not due to new info, future occasions or in any other case.

Contacts:
Grace Kim
[email protected]