Indaptus Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Indaptus Therapeutics (Nasdaq: INDP) reported Q3 2024 financial results and corporate updates. The company announced a clinical supply agreement with BeiGene to evaluate cancer treatment combinations and progressed its Phase 1 trial of Decoy20. Research and development expenses decreased to $1.5 million from $2.2 million year-over-year. General and administrative expenses fell to $1.7 million from $2.0 million. Loss per share improved to $0.32 from $0.47. Cash position stood at $7.4 million as of September 30, 2024, expected to support operations into Q1 2025. The company completed a $3 million registered direct offering in August 2024, netting approximately $2.5 million.
Indaptus Therapeutics (Nasdaq: INDP) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. L'azienda ha annunciato un accordo di fornitura clinica con BeiGene per valutare le combinazioni di trattamenti contro il cancro e ha fatto progressi nel suo studio di Fase 1 di Decoy20. Le spese per ricerca e sviluppo sono diminuite a 1,5 milioni di dollari rispetto ai 2,2 milioni dell'anno precedente. Le spese generali e amministrative sono scese a 1,7 milioni di dollari da 2,0 milioni. La perdita per azione è migliorata a 0,32 dollari rispetto a 0,47 dollari. La posizione di liquidità si attestava a 7,4 milioni di dollari al 30 settembre 2024, con previsioni di supportare le operazioni fino al primo trimestre 2025. L'azienda ha completato un'offerta diretta registrata da 3 milioni di dollari nell'agosto 2024, con un netto di circa 2,5 milioni di dollari.
Indaptus Therapeutics (Nasdaq: INDP) informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones corporativas. La empresa anunció un acuerdo de suministro clínico con BeiGene para evaluar combinaciones de tratamientos contra el cáncer y avanzó en su ensayo de Fase 1 de Decoy20. Los gastos de investigación y desarrollo disminuyeron a 1,5 millones de dólares desde 2,2 millones del año anterior. Los gastos generales y administrativos cayeron a 1,7 millones de dólares desde 2,0 millones. La pérdida por acción mejoró a 0,32 dólares desde 0,47 dólares. La posición de efectivo se situó en 7,4 millones de dólares al 30 de septiembre de 2024, esperando que apoye las operaciones hasta el primer trimestre de 2025. La empresa completó una oferta directa registrada de 3 millones de dólares en agosto de 2024, neteando aproximadamente 2,5 millones de dólares.
Indaptus Therapeutics (Nasdaq: INDP)는 2024년 3분기 재무 결과와 기업 업데이트를 발표했습니다. 이 회사는 암 치료 조합을 평가하기 위해 BeiGene과 임상 공급 계약을 체결했으며 Decoy20의 1상 시험을 진행했습니다. 연구 및 개발 비용은 전년 대비 2.2백만 달러에서 1.5백만 달러로 감소했습니다. 일반 관리비는 2.0백만 달러에서 1.7백만 달러로 줄었습니다. 주당 손실은 0.47달러에서 0.32달러로 개선되었습니다. 2024년 9월 30일 기준 현금 보유액은 740만 달러로, 2025년 1분기까지 운영을 지원할 것으로 예상됩니다. 이 회사는 2024년 8월에 300만 달러의 등록된 직접 발행을 완료하여 약 250만 달러의 순액을 확보했습니다.
Indaptus Therapeutics (Nasdaq: INDP) a publié les résultats financiers du troisième trimestre 2024 et des mises à jour d'entreprise. La société a annoncé un accord de fourniture clinique avec BeiGene pour évaluer des combinaisons de traitements contre le cancer et a progressé dans son essai de phase 1 de Decoy20. Les dépenses de recherche et développement ont diminué à 1,5 million de dollars, contre 2,2 millions l'année précédente. Les frais généraux et administratifs ont baissé à 1,7 million de dollars, contre 2,0 millions. La perte par action s'est améliorée à 0,32 dollar, contre 0,47 dollar. La position de liquidités s'élevait à 7,4 millions de dollars au 30 septembre 2024, devant soutenir les opérations jusqu'au premier trimestre 2025. L'entreprise a réalisé une offre directe enregistrée de 3 millions de dollars en août 2024, nettant environ 2,5 millions de dollars.
Indaptus Therapeutics (Nasdaq: INDP) hat die Finanzergebnisse für das dritte Quartal 2024 und Unternehmensupdates veröffentlicht. Das Unternehmen gab eine klinische Liefervereinbarung mit BeiGene bekannt, um Kombinationen von Krebsbehandlungen zu bewerten, und hat seine Phase-1-Studie von Decoy20 vorangetrieben. Die Forschungs- und Entwicklungskosten sanken auf 1,5 Millionen USD von 2,2 Millionen USD im Vorjahr. Die allgemeinen und administrativen Kosten fielen auf 1,7 Millionen USD von 2,0 Millionen USD. Der Verlust pro Aktie verbesserte sich auf 0,32 USD von 0,47 USD. Die Liquiditätsposition betrug am 30. September 2024 7,4 Millionen USD, erwartet, um die Betriebe bis ins erste Quartal 2025 zu unterstützen. Das Unternehmen schloss im August 2024 eine registrierte Direktplatzierung über 3 Millionen USD ab und erzielte einen netto Ertrag von etwa 2,5 Millionen USD.
- Clinical supply agreement secured with BeiGene for cancer treatment combinations
- Phase 1 trial progressing with unrestricted enrollment for weekly Decoy20 dosing
- Reduced quarterly loss per share from $0.47 to $0.32 year-over-year
- Decreased R&D expenses by $0.7 million year-over-year
- Reduced G&A expenses by $0.3 million year-over-year
- Cash runway only extends into Q1 2025
- Net cash used in operations of $8.9 million for nine months
- Required additional funding through $3 million offering in August 2024
Insights
The Q3 2024 results reveal significant financial challenges for this micro-cap biotech.
The
The progression of Decoy20's clinical development shows promise but remains early-stage. The unrestricted enrollment at lower doses suggests manageable safety profile, critical for immune-stimulating therapies. The BeiGene collaboration to combine Decoy20 with tislelizumab is strategically sound - PD-1 inhibitors have proven efficacy across multiple cancers and immune system stimulation could enhance their effectiveness.
However, success remains uncertain without efficacy data. The publication in Frontiers in Immunology validates the scientific approach but doesn't guarantee clinical success. The weekly dosing schedule could provide better therapeutic coverage but needs confirmation through ongoing trials.
NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced financial results for the third quarter ended September 30, 2024, and provided a corporate update.
Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive Officer, commented, “The recent announcement highlighting our clinical supply agreement with BeiGene is an important milestone, representing a significant step forward in our clinical development as we plan the first clinical trial combining BeiGene's anti-PD-1 antibody, tislelizumab, with Indaptus’ Decoy20 product candidate for cancer treatment. PD-1 inhibitors have proven meaningful in treating multiple cancer types, and we are optimistic that we can improve patient outcomes by broadly and safely stimulating the immune system to enhance the effectiveness of currently approved treatments. We have also progressed our Phase 1 clinical trial to now allow for unrestricted enrollment of patients in weekly administration at the lower Decoy20 dose, which will enable us to gather more safety and efficacy data, which is important for assessing the full potential of Decoy20. Those data will guide how we initiate the combination trial next year. To date, Decoy20 continues to be well tolerated and we are anxiously awaiting further outcomes, which we will report as the trial progresses. We continue to carefully manage our resources and will provide status updates as they develop.”
Key recent highlights:
- Announced clinical supply agreement with BeiGene to evaluate novel cancer treatment combinations for the treatment of patients with advanced solid tumors
- Initiated unrestricted enrollment of patients in Indaptus’ Phase 1 clinical trial of Decoy20 allowing for weekly dosing based on encouraging safety data
- Announced that Dr. Michael Newman, Founder and Chief Scientific Officer, has published his groundbreaking research in the peer-reviewed journal, Frontiers in Immunology. The article was titled, "Invention and Characterization of a Systemically Administered, Attenuated and Killed Bacteria-Based Multiple Immune Receptor Agonist for Antitumor Immunotherapy"
- Completed a
$3 million registered direct offering and concurrent private placement on August 8, 2024 (the “August 2024 Offering”), for net proceeds of approximately$2.5 million - Participated in Lumanity webinar regarding the future of innate immunity in cancer immunotherapy
Financial Highlights for the Third Quarter Ended September 30, 2024
Research and development expenses for the three months ended September 30, 2024, were approximately
General and administrative expenses for the three months ended September 30, 2024, were approximately
Loss per share for the three months ended September 30, 2024, was approximately
As of September 30, 2024, the Company had cash and cash equivalents of approximately
Net cash used in operating activities was approximately
There was no net cash provided by or used in investing activities in the nine months ended September 30, 2024. Net cash provided by investing activities was approximately
Net cash provided by financing activities for the nine months ended September 30, 2024, was approximately
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product candidate, with associated “cold” to “hot” tumor inflammation signature transition. The Decoy platform has also been shown to induce activation, polarization or maturation of human macrophages, dendritic, NK, NKT, CD4 T and CD8 T cells in vitro. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product candidate. Indaptus’ Decoy product candidates have also produced meaningful single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things: our expectations and plans regarding our clinical supply agreement with BeiGene; our plans to advance clinical evaluation of the combination of BeiGene’s anti-PD-1 antibody, tislelizumab, with Decoy20; our ability to gather more safety and efficacy datafrom our Phase 1 clinical trial; our plans to seek FDA approval and to initiate a combination trial, and the timing thereof; the anticipated effects of our product candidates, including Decoy20; the plans and objectives of management for future operations; our research and development activities and costs; the sufficiency of our cash and cash equivalents to fund our ongoing activities and our cash management strategy; and our assessment of financing options to support our corporate strategy. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 to be filed with the SEC, our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2024, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.
Contact: investors@indaptusrx.com
Investor Relations Contact:
CORE IR
Louie Toma
louie@coreir.com
Media Contact:
Cuttlefish Communications
Shira Derasmo
shira@cuttlefishpr.com
917-280-2497
| INDAPTUS THERAPEUTICS, INC. Unaudited Condensed Consolidated Balance Sheets | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,380,686 | $ | 13,362,053 | ||||
| Prepaid expenses and other current assets | 248,737 | 633,156 | ||||||
| Total current assets | 7,629,423 | 13,995,209 | ||||||
| Non-current assets: | ||||||||
| Property and equipment, net | - | 735 | ||||||
| Right-of-use asset | 105,655 | 173,206 | ||||||
| Other assets | 504,728 | 754,728 | ||||||
| Total non-current assets | 610,383 | 928,669 | ||||||
| Total assets | $ | 8,239,806 | $ | 14,923,878 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other current liabilities | $ | 2,128,491 | $ | 2,672,327 | ||||
| Operating lease liability, current portion | 103,982 | 101,705 | ||||||
| Total current liabilities | 2,232,473 | 2,774,032 | ||||||
| Non-current liabilities: | ||||||||
| Operating lease liability, net of current portion | 4,007 | 73,348 | ||||||
| Total non-current liabilities | 4,007 | 73,348 | ||||||
| Total liabilities | 2,236,480 | 2,847,380 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock: | 101,969 | 84,011 | ||||||
| Additional paid in capital | 62,209,493 | 57,409,643 | ||||||
| Accumulated deficit | (56,308,136 | ) | (45,417,156 | ) | ||||
| Total stockholders’ equity | 6,003,326 | 12,076,498 | ||||||
| Total liabilities and stockholders’ equity | $ | 8,239,806 | $ | 14,923,878 | ||||
| Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,466,037 | $ | 2,226,688 | $ | 4,771,152 | $ | 5,587,073 | ||||||||
| General and administrative | 1,676,020 | 2,021,724 | 6,423,029 | 6,611,767 | ||||||||||||
| Total operating expenses | 3,142,057 | 4,248,412 | 11,194,181 | 12,198,840 | ||||||||||||
| Loss from operations | (3,142,057 | ) | (4,248,412 | ) | (11,194,181 | ) | (12,198,840 | ) | ||||||||
| Other income, net | 73,021 | 326,024 | 303,201 | 778,149 | ||||||||||||
| Net loss | $ | (3,069,036 | ) | $ | (3,922,388 | ) | $ | (10,890,980 | ) | $ | (11,420,691 | ) | ||||
| Net loss available to common stockholders per share of common stock, basic and diluted | $ | (0.32 | ) | $ | (0.47 | ) | $ | (1.23 | ) | $ | (1.36 | ) | ||||
| Weighted average number of shares used in calculating net loss per share, basic and diluted | 9,510,447 | 8,401,047 | 8,832,630 | 8,401,047 | ||||||||||||
| Net loss | $ | (3,069,036 | ) | $ | (3,922,388 | ) | $ | (10,890,980 | ) | $ | (11,420,691 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Reclassification adjustment for interest earned on marketable securities included in net loss | - | (140,567 | ) | - | (430,993 | ) | ||||||||||
| Change in unrealized gain on marketable securities | - | 6,412 | - | 334,559 | ||||||||||||
| Comprehensive loss | $ | (3,069,036 | ) | $ | (4,056,543 | ) | $ | (10,890,980 | ) | $ | (11,517,125 | ) | ||||
| Unaudited Condensed Consolidated Statements of Cash Flows | ||||||||
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (10,890,980 | ) | $ | (11,420,691 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 735 | 964 | ||||||
| Stock-based compensation | 2,001,727 | 2,220,413 | ||||||
| Interest earned on marketable securities | - | (430,993 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current and non- current assets | 634,419 | (84,568 | ) | |||||
| Accounts payable and other current liabilities | (673,829 | ) | (1,088,785 | ) | ||||
| Operating lease right-of-use asset and liability, net | 487 | 290 | ||||||
| Net cash used in operating activities | (8,927,441 | ) | (10,803,370 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Maturity of marketable securities | - | 24,000,000 | ||||||
| Purchase of marketable securities | - | (6,859,432 | ) | |||||
| Net cash provided by investing activities | - | 17,140,568 | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of shares of common stock and warrants | 3,375,590 | - | ||||||
| Issuance costs | (429,516 | ) | - | |||||
| Net cash provided by financing activities | 2,946,074 | - | ||||||
| Net (decrease) increase in cash and cash equivalents | (5,981,367 | ) | 6,337,198 | |||||
| Cash and cash equivalents at beginning of period | 13,362,053 | 9,626,800 | ||||||
| Cash and cash equivalents at end of period | $ | 7,380,686 | $ | 15,963,998 | ||||
| Noncash investing and financing activities | ||||||||
| Transaction costs in accounts payable and other current liabilities | $ | 129,993 | $ | - | ||||
| Change in unrealized gain/loss on marketable securities | $ | - | $ | (96,434 | ) | |||
| ASC 842 lease renewal option exercise | $ | - | $ | 236,506 | ||||
| Reclassification of security deposit | $ | - | $ | 16,477 | ||||
FAQ
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