Molecular Templates, Inc. Reports Second Quarter 2024 Financial Results and Corporate Update
Molecular Templates (MTEM) reported Q2 2024 financial results and corporate updates. Key highlights include:
1. Continued monotherapy activity in MT-6402 (PD-L1 ETB) program, with durable responses in heavily pretreated patients.
2. Early indication of monotherapy activity in MT-8421 (CTLA-4 ETB) program.
3. Exploring MT-0169's potential in severe autoimmune diseases.
Financial results: Q2 2024 net loss of $8.1 million ($1.23 per share), compared to $10.9 million ($2.89 per share) in Q2 2023. Revenues decreased to $0.6 million from $6.9 million year-over-year. Cash and equivalents totaled $9.7 million as of June 30, 2024, expected to support operations into Q4 2024.
Molecular Templates (MTEM) ha riportato i risultati finanziari e aggiornamenti aziendali per il secondo trimestre del 2024. Punti salienti includono:
1. Continuità dell'attività di monoterapia nel programma MT-6402 (PD-L1 ETB), con risposte durature in pazienti con precedenti trattamenti intensivi.
2. Prime indicazioni di attività di monoterapia nel programma MT-8421 (CTLA-4 ETB).
3. Esplorazione del potenziale di MT-0169 nelle malattie autoimmuni gravi.
Risultati finanziari: perdita netta di 8,1 milioni di dollari nel secondo trimestre del 2024 (1,23 dollari per azione), rispetto a 10,9 milioni di dollari (2,89 dollari per azione) nel secondo trimestre del 2023. I ricavi sono diminuiti a 0,6 milioni di dollari rispetto a 6,9 milioni di dollari nell'anno precedente. Liquidità e equivalenti ammontavano a 9,7 milioni di dollari al 30 giugno 2024, previsti per supportare le operazioni fino al quarto trimestre del 2024.
Molecular Templates (MTEM) informó los resultados financieros y actualizaciones corporativas para el segundo trimestre de 2024. Puntos destacados incluyen:
1. Actividad continua de monoterapia en el programa MT-6402 (PD-L1 ETB), con respuestas duraderas en pacientes que han recibido múltiples tratamientos previos.
2. Indicación temprana de actividad de monoterapia en el programa MT-8421 (CTLA-4 ETB).
3. Exploración del potencial de MT-0169 en enfermedades autoinmunes severas.
Resultados financieros: pérdida neta de 8,1 millones de dólares en el segundo trimestre de 2024 (1,23 dólares por acción), en comparación con 10,9 millones de dólares (2,89 dólares por acción) en el segundo trimestre de 2023. Los ingresos disminuyeron a 0,6 millones de dólares desde 6,9 millones de dólares interanualmente. El efectivo y equivalentes totalizaron 9,7 millones de dólares al 30 de junio de 2024, se espera que apoyen las operaciones hasta el cuarto trimestre de 2024.
분자 템플릿(MTEM)은 2024년 2분기 재무 결과 및 기업 업데이트를 보고했습니다. 주요 하이라이트는 다음과 같습니다:
1. MT-6402(PD-L1 ETB) 프로그램에서 여러 차례 치료를 받은 환자에서 지속적인 반응을 보이며 단독 치료 활동이 계속되고 있습니다.
2. MT-8421(CTLA-4 ETB) 프로그램에서 단독 치료 활동의 초기 징후가 나타났습니다.
3. 심각한 자가면역질환에서 MT-0169의 잠재력을 탐색하고 있습니다.
재무 결과: 2024년 2분기 순손실이 810만 달러(주당 1.23 달러)로, 2023년 2분기 1090만 달러(주당 2.89 달러)와 비교됩니다. 연간 수익은 690만 달러에서 60만 달러로 감소했습니다. 2024년 6월 30일 기준 현금 및 현금성 자산은 970만 달러로, 2024년 4분기까지 운영을 지원할 것으로 예상됩니다.
Molecular Templates (MTEM) a annoncé les résultats financiers et les mises à jour de l'entreprise pour le deuxième trimestre 2024. Points clés :
1. Activité continue de monothérapie dans le programme MT-6402 (PD-L1 ETB), avec des réponses durables chez des patients ayant reçu de nombreux traitements préalables.
2. Indication précoce d'une activité de monothérapie dans le programme MT-8421 (CTLA-4 ETB).
3. Exploration du potentiel de MT-0169 dans les maladies auto-immunes sévères.
Résultats financiers : perte nette de 8,1 millions de dollars au deuxième trimestre 2024 (1,23 dollar par action), par rapport à 10,9 millions de dollars (2,89 dollars par action) au deuxième trimestre 2023. Les revenus ont diminué à 0,6 million de dollars contre 6,9 millions de dollars d'une année sur l'autre. La trésorerie et équivalents totalisaient 9,7 millions de dollars au 30 juin 2024, prévus pour soutenir les opérations jusqu'au quatrième trimestre 2024.
Molecular Templates (MTEM) hat die Finanzergebnisse und Unternehmensaktualisierungen für das zweite Quartal 2024 veröffentlicht. Wichtige Highlights sind:
1. Fortgesetzte Monotherapie-Aktivität im MT-6402 (PD-L1 ETB) Programm mit nachhaltigen Antworten bei stark vorbehandelten Patienten.
2. Erste Hinweise auf Monotherapie-Aktivität im MT-8421 (CTLA-4 ETB) Programm.
3. Erforschung des Potenzials von MT-0169 bei schweren Autoimmunerkrankungen.
Finanzergebnisse: Im zweiten Quartal 2024 wurde ein Nettoverlust von 8,1 Millionen Dollar (1,23 Dollar pro Aktie) verzeichnet, verglichen mit einem Verlust von 10,9 Millionen Dollar (2,89 Dollar pro Aktie) im zweiten Quartal 2023. Die Einnahmen sanken von 6,9 Millionen Dollar auf 0,6 Millionen Dollar im Jahresvergleich. Bargeld und Zahlungsmitteläquivalente beliefen sich zum 30. Juni 2024 auf 9,7 Millionen Dollar und sollen die Betriebskosten bis ins vierte Quartal 2024 unterstützen.
- Durable responses observed in MT-6402 program for patients who progressed on checkpoint therapy
- Early signs of monotherapy activity in MT-8421 program with no drug-related adverse events > grade 2
- Potential of MT-0169 in severe autoimmune diseases being explored
- Closed second tranche of July 2023 Private Placement with gross proceeds of approximately $9.5M
- Net loss of $8.1 million in Q2 2024
- Revenues decreased to $0.6 million from $6.9 million year-over-year
- Cash and equivalents of $9.7 million only expected to support operations into Q4 2024
Insights
Molecular Templates' Q2 2024 financials reveal a concerning picture. Revenue dropped significantly to
MTEM's ETB platform shows promising clinical progress. MT-6402 (PD-L1 ETB) demonstrates durable responses in heavily pretreated patients who progressed on checkpoint therapy, a notoriously difficult-to-treat population. MT-8421 (CTLA-4 ETB) exhibits early efficacy signs through T-reg depletion. These novel mechanisms could potentially address unmet needs in immuno-oncology. However, the small patient numbers and early-stage nature of the trials necessitate caution. The company needs larger studies to confirm these encouraging results and establish a clear path to market, which will require significant time and resources.
MTEM's pipeline shows scientific promise but faces significant commercialization hurdles. The company's focus on novel ETB therapeutics in oncology and potentially autoimmune diseases is innovative. However, the path to market is long and capital-intensive. With a precarious financial position, MTEM may struggle to fund the extensive clinical trials needed for regulatory approval. The company might need to consider strategic partnerships or asset sales to continue development. While the science is intriguing, investors should be wary of the high risk and uncertain timeline to profitability. MTEM's future hinges on both clinical success and securing substantial additional funding.
- Monotherapy activity of long duration in patients who have progressed on checkpoint therapy via a novel immuno-oncology mechanism of action with PD-L1 ETB (MT-6402) program
- Early indication of monotherapy activity in CTLA-4 ETB (MT-8421) program through T-reg depletion; no drug-related adverse events > grade 2
- Novel mechanism of action targeting CD38+ immune cells of B-cell, T-cell, and monocytic lineage representing enhanced potency in I&I without the need for conditioning therapy
AUSTIN, Texas, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (“ETBs”), to create novel therapies with potent differentiated mechanisms of action, today reported financial results and business updates for the second quarter of 2024.
“ETBs can eliminate immune cells that monoclonal antibodies cannot. Eliminating MDSCs with MT-6402 and Tregs with MT-8421 is a novel approach to immuno-oncology that is demonstrating durable responses in patients who have progressed or were refractory to checkpoint therapy. The elimination of immunosuppressive cells in patients with tumor microenvironments that promote immune evasion may drive long-lasting responses in patients who have exhausted other treatment options,” said Eric Poma, PhD., Chief Executive and Chief Scientific Officer of MTEM. “Similarly, we believe MT-0169 can eliminate CD38+ immune cells that antibodies cannot, allowing for potentially greater potency in both hematologic malignancies and autoimmune diseases.”
Recent Company Highlights
- MT-6402: Continued monotherapy activity in patients who progressed or were refractory to checkpoint therapy
Nine patients (seven evaluable) with low PD-L1+ HNSCC were dosed in the MT-6402 phase I dose escalation study. Two patients remain in partial responses at cycle 23 and cycle 14 (one cycle is 4 weeks). Both patients had progressed after multiple lines of checkpoint therapy. In the high PD-L1+ dose expansion cohort, four NSCLC patients (three evaluable) have been enrolled. and one patient is in a partial response at cycle 11; the patient had progressed on chemotherapy, targeted therapy, and checkpoint therapy. All responding patients were heavily pretreated (3 or more lines of previous therapy including checkpoint) and have been on MT-6402 longer than any other previous therapy. MTEM continues to enroll HNSCC patients with low PD-L1 expression (1-49% ) and patients with solid tumors with high PD-L1 expression (≥50% ).
- MT-8421: Enrollment in Phase 1 dose escalation ongoing with continued observation of unique pharmacodynamic profile (peripheral and TME Treg depletion) and signs of monotherapy activity
Five melanoma patients were evaluable in the first two dose cohorts (32 and 48 mcg/kg); no drug related adverse events > grade 2 were observed. One patient remains on study in cycle 11 with a27% decrease in tumor volume and reduction in circulating tumor DNA from 3.13 to 0 MTM/mL. This patient had a >90% reduction in peripheral Tregs and a ~66% reduction of Tregs in the TME. The patient had progressed on pembrolizumab in the adjuvant setting and then progressed on ipilimumab (4 doses at 3mg/kg) and nivolumab in the metastatic setting.
- MT-0169: Potential in severe autoimmune diseases being explored based on clinical demonstration of complete elimination of CD38+ immune cells at dose levels with no drug-related adverse events > grade 2.
The potent and unique mechanism of action of MT-0169 is not subject to resistance mechanisms associated with monoclonal antibodies like trogocytosis and can eliminate high-expressing CD38 immune cells like plasma cells as well as low-expressing CD38+ cells like HLA-DR CD38+ T-cells. This mechanism of action does not require conditioning therapy. MTEM will continue to develop MT-0169 in hematologic malignancies and is evaluating the potential of MT-0169 in severe immune-mediated diseases.
Upcoming Milestones for 2H 2024
- Additional updates from the MT-6402 low PD-L1+ HNSCC and high PD-L1+ solid tumor expansions studies in 3Q24.
- Additional updates from the MT-8421 dose escalation study in 3Q24.
- MT-0169 Phase 1 study initiation in CD38+ hematological malignancies and continued evaluation in autoimmune disease.
Upcoming Conferences
MTEM will participate at the H.C. Wainwright 26th Annual Global Investment Conference taking place at the New York Lotte Palace Hotel, September 9 – 11, 2024. An on-demand presentation will be accessible virtually starting 7:00am ET September 9, 2024 via MTEM corporate website. One-on-one meetings may be scheduled by directly contacting MTEM.
Second Quarter 2024 Financial Results
The net loss attributable to common shareholders for the second quarter of 2024 was
Revenues for the second quarter of 2024 were
Total research and development expenses for the second quarter of 2024 were
As of June 30, 2024, MTEM’s cash and cash equivalents totaled
| Molecular Templates, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Research and development revenue | $ | 189 | $ | 6,627 | $ | 11,113 | $ | 40,254 | ||||||||
| Grant revenue | 383 | 238 | 545 | 3,240 | ||||||||||||
| Total revenue | 572 | 6,865 | 11,658 | 43,494 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,402 | 13,413 | 12,807 | 32,455 | ||||||||||||
| General and administrative | 3,466 | 5,195 | 7,197 | 10,997 | ||||||||||||
| Total operating expenses | 8,868 | 18,608 | 20,004 | 43,452 | ||||||||||||
| Income/(loss) from operations | (8,296 | ) | (11,743 | ) | (8,346 | ) | 42 | |||||||||
| Interest and other income, net | 130 | 365 | 239 | 820 | ||||||||||||
| Interest and other expense, net | (38 | ) | (1,189 | ) | (69 | ) | (2,584 | ) | ||||||||
| Gain on extinguishment of debt | — | 1,795 | — | 1,795 | ||||||||||||
| Change in valuation of contingent value right | 107 | 303 | 651 | 303 | ||||||||||||
| Loss on disposal of property and equipment | — | (399 | ) | — | (399 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (8,097 | ) | $ | (10,868 | ) | $ | (7,525 | ) | $ | (23 | ) | ||||
| Net loss per share attributable to common stockholders: | ||||||||||||||||
| Basic and diluted | $ | (1.23 | ) | $ | (2.89 | ) | $ | (1.26 | ) | $ | (0.01 | ) | ||||
| Weighted average number of shares used in net loss per share calculations: | ||||||||||||||||
| Basic and diluted | 6,557,295 | 3,756,711 | 5,965,781 | 3,756,711 | ||||||||||||
| Molecular Templates, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) | ||||||||
| June 30, 2024 (unaudited) | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,657 | $ | 11,523 | ||||
| Prepaid expenses | 787 | 2,195 | ||||||
| Grants revenue receivable | 795 | 250 | ||||||
| Other current assets | 777 | 2,804 | ||||||
| Total current assets | 12,016 | 16,772 | ||||||
| Operating lease right-of-use assets | 8,124 | 9,161 | ||||||
| Property and equipment, net | 5,238 | 7,393 | ||||||
| Other assets | 1,319 | 2,057 | ||||||
| Total assets | $ | 26,697 | $ | 35,383 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,773 | $ | 1,523 | ||||
| Accrued liabilities | 2,270 | 4,279 | ||||||
| Deferred revenue, current | — | 9,031 | ||||||
| Other current liabilities | 2,637 | 2,488 | ||||||
| Total current liabilities | 7,680 | 17,321 | ||||||
| Operating lease liabilities, long term portion | 8,390 | 9,742 | ||||||
| Contingent value right liability | 2,051 | 2,702 | ||||||
| Other liabilities | 1,465 | 1,406 | ||||||
| Total liabilities | 19,586 | 31,171 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Preferred stock, | ||||||||
| Authorized: 2,000,000 shares as of June 30, 2024 and December 31, 2023; Issued and outstanding: 250 shares as of June 30, 2024 and December 31, 2023 | — | — | ||||||
| Common stock, | ||||||||
| Authorized: 150,000,000 shares as of June 30, 2024 and December 31, 2023; Issued and outstanding: 6,583,880 and 5,374,268 shares as of June 30, 2024 and December 31, 2023, respectively | 7 | 5 | ||||||
| Additional paid-in capital | 467,521 | 457,099 | ||||||
| Accumulated deficit | (460,417 | ) | (452,892 | ) | ||||
| Total stockholders’ equity | 7,111 | 4,212 | ||||||
| Total liabilities and stockholders’ equity | $ | 26,697 | $ | 35,383 | ||||
Second tranche of July 2023 Private Placement
We closed the second tranche of the July 2023 Private Placement on April 2, 2024 with gross proceeds of approximately
About Molecular Templates
Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation ADCs. Our drug platform technology, known as Engineered Toxin Bodies (ETBs), leverages the resident biology of a genetically engineered toxin payload to create novel therapies with potent and differentiated mechanisms of action for cancer and various disease indications.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. All statements, other than statements of historical facts, included in this press release, including, but not limited to those regarding strategy, future operations, the Company’s ability to execute on its objectives, prospects, plans, future clinical development of the Company’s product candidates, any implication that the preliminary results, interim results, or the results of earlier clinical trials or ongoing clinical trials will be representative of the results of future or later clinical trials or final results, the potential benefits, safety or efficacy and any evaluations or judgments regarding the Company’s product candidates, and future execution of corporate goals. In addition, when or if used in this press release, the words “may,” “could,” “should,” “continue”, “anticipate,” “potential”, “believe,” “estimate,” “appears”, “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Molecular Templates may identify forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differ materially from those discussed in the forward-looking statements as a result of various factors including, but not limited to the following: the continued availability of financing on commercially reasonable terms, whether Molecular Templates’ cash resources will be sufficient to fund its continuing operations; the results of MTEM’s ongoing clinical studies and the ability to effectively operate MTEM, and those risks identified under the heading “Risk Factors” in Molecular Templates’ filings with the Securities and Exchange Commission (the “SEC”), including its Form 10-Q for the second quarter year ended June 31, 2024 and any subsequent reports filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Molecular Templates specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.
Contacts:
Grace Kim
grace.kim@mtem.com
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