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Leap Therapeutics Reports Third Quarter 2024 Financial Results

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Leap Therapeutics (LPTX) reported Q3 2024 financial results with a net loss of $18.2 million, compared to $13.7 million in Q3 2023. Research and development expenses increased to $14.9 million from $11.5 million year-over-year. The company completed enrollment in Part B of the Phase 2 DeFianCe study for DKN-01 in colorectal cancer with 188 patients, with data expected mid-2025. Patient follow-up continues in Part C of the DisTinGuish study with 170 patients, with data expected late 2024 or early 2025. Cash position stands at $62.8 million, expected to fund operations into Q2 2026.

Leap Therapeutics (LPTX) ha riportato i risultati finanziari del terzo trimestre 2024 con una perdita netta di 18,2 milioni di dollari, rispetto ai 13,7 milioni di dollari del terzo trimestre 2023. Le spese per ricerca e sviluppo sono aumentate a 14,9 milioni di dollari, rispetto agli 11,5 milioni dell'anno precedente. L'azienda ha completato l'arruolamento nella Parte B dello studio di Fase 2 DeFianCe per DKN-01 nel cancro colorectal con 188 pazienti, i cui dati sono attesi per la metà del 2025. Il follow-up dei pazienti continua nella Parte C dello studio DisTinGuish con 170 pazienti, con dati attesi a fine 2024 o all'inizio del 2025. La posizione di cassa è di 62,8 milioni di dollari, prevista per finanziare le operazioni fino al secondo trimestre del 2026.

Leap Therapeutics (LPTX) informó los resultados financieros del tercer trimestre de 2024 con una pérdida neta de 18,2 millones de dólares, en comparación con 13,7 millones en el tercer trimestre de 2023. Los gastos de investigación y desarrollo aumentaron a 14,9 millones de dólares desde 11,5 millones el año pasado. La compañía completó la inscripción en la Parte B del estudio de Fase 2 DeFianCe para DKN-01 en cáncer colorrectal con 188 pacientes, cuyos datos se esperan a mediados de 2025. El seguimiento de los pacientes continúa en la Parte C del estudio DisTinGuish con 170 pacientes, con datos previstos para finales de 2024 o principios de 2025. La posición de caja se sitúa en 62,8 millones de dólares, prevista para financiar las operaciones hasta el segundo trimestre de 2026.

Leap Therapeutics (LPTX)는 2024년 3분기 재무 결과를 발표하였으며, 1,820만 달러의 순손실을 기록했습니다. 이는 2023년 3분기의 1,370만 달러와 비교됩니다. 연구 및 개발 비용은 1,490만 달러로 연간 1,150만 달러에서 증가했습니다. 이 회사는 대장암을 위한 DKN-01의 2상 DeFianCe 연구 Part B에 188명의 환자를 등록 완료하였으며, 데이터는 2025년 중반에 예상되고 있습니다. 환자 추적 조사는 170명의 환자를 대상으로 한 DisTinGuish 연구의 Part C에서 계속되고 있으며, 데이터는 2024년 말 또는 2025년 초에 예상됩니다. 현금 자산은 6,280만 달러이며, 2026년 2분기까지 운영 자금을 지원할 것으로 예상됩니다.

Leap Therapeutics (LPTX) a annoncé ses résultats financiers du troisième trimestre 2024, avec une perte nette de 18,2 millions de dollars, contre 13,7 millions de dollars au troisième trimestre 2023. Les dépenses de recherche et développement ont augmenté à 14,9 millions de dollars contre 11,5 millions l'année précédente. La société a terminé l'inscription pour la Partie B de l'étude de Phase 2 DeFianCe pour DKN-01 dans le cancer colorectal avec 188 patients, les données étant attendues pour le milieu de 2025. Le suivi des patients se poursuit dans la Partie C de l'étude DisTinGuish avec 170 patients, les données étant attendues pour fin 2024 ou début 2025. La position de trésorerie s'élève à 62,8 millions de dollars, prévue pour financer les opérations jusqu'au deuxième trimestre 2026.

Leap Therapeutics (LPTX) berichtete über die Finanzergebnisse des dritten Quartals 2024, mit einem Nettoverlust von 18,2 Millionen Dollar, im Vergleich zu 13,7 Millionen Dollar im dritten Quartal 2023. Die Forschungs- und Entwicklungskosten stiegen auf 14,9 Millionen Dollar von 11,5 Millionen im Vorjahr. Das Unternehmen hat die Einschreibung in Teil B der Phase-2-Studie DeFianCe für DKN-01 bei kolorektalem Krebs mit 188 Patienten abgeschlossen, wobei Daten für Mitte 2025 erwartet werden. Die Patientenverfolgung wird in Teil C der DisTinGuish-Studie mit 170 Patienten fortgesetzt, wobei Daten für Ende 2024 oder Anfang 2025 erwartet werden. Die Kassenposition beträgt 62,8 Millionen Dollar, die voraussichtlich die Betriebstätigkeiten bis ins zweite Quartal 2026 finanzieren wird.

Positive
  • Strong cash position of $62.8 million, funding operations into Q2 2026
  • Completed enrollment of 188 patients in Phase 2 DeFianCe study
  • Successful enrollment of 170 patients in DisTinGuish study
Negative
  • Net loss increased 32.8% to $18.2 million in Q3 2024
  • R&D expenses increased by $3.4 million to $14.9 million

Insights

The Q3 financial results reveal significant R&D investment with $14.9M spent, up from $11.5M in 2023, reflecting aggressive pipeline development. The net loss widened to $18.2M from $13.7M year-over-year, primarily driven by increased clinical trial and manufacturing costs. With $62.8M cash on hand and projected runway into Q2 2026, the company maintains a solid financial position to support its clinical programs.

Two key Phase 2 trials are progressing well - the 188-patient DeFianCe study in colorectal cancer and 170-patient DisTinGuish study in gastric cancer, with data readouts expected in 2025 and late 2024/early 2025 respectively. The addition of FL-501 to the pipeline demonstrates portfolio expansion, though it will require additional investment. The 12% reduction in G&A expenses shows disciplined cost management in non-core areas.

CAMBRIDGE, Mass., Nov. 13, 2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the third quarter ended September 30, 2024.

Leap Highlights: 

  • Completed enrollment in the expanded randomized controlled Part B of the Phase 2 DeFianCe study evaluating DKN-01, Leap's anti-DKK1 monoclonal antibody, in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC); data expected in mid-2025
  • Patient follow-up continuing in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer; data expected in late 2024 or early 2025
  • Initiated development of FL-501, Leap's anti-GDF-15 monoclonal antibody

"We have made significant progress advancing our pipeline this quarter, including the completion of enrollment in the expanded Part B of the Phase 2 DeFianCe study of DKN-01 in patients with advanced colorectal cancer," said Douglas E. Onsi, President and Chief Executive Officer of Leap.  "We look forward to sharing initial randomized controlled data from the DisTinGuish study and the DeFianCe study in the coming months. In addition, based on positive preclinical data, we are enthusiastically moving FL-501 into development. With a strong cash position that is expected to fund operations into Q2 2026, Leap is well positioned for continued success and long-term growth to deliver personalized medicines to patients fighting against cancer."

DKN-01 Development Update

  • Enrollment completed in the expanded randomized controlled Part B of the DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced CRC. Part B of the DeFianCe study (NCT05480306) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy. Part B of the study enrolled 188 patients. The Company expects to report initial data in mid-2025.
  • Patient follow-up continuing in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with GEJ and gastric cancer, with initial data expected in late 2024 or early 2025. Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with tislelizumab and chemotherapy in first-line, HER-2 negative patients with GEJ and gastric cancer. Part C of the study enrolled 170 patients. The Company expects to report initial data in late 2024 or early 2025.

Pipeline Update: 

  • Advancing FL-501 into development as a potential best-in-class anti-GDF-15 antibody with promising preclinical data. FL-501 is a potential best-in-class monoclonal antibody designed to neutralize GDF-15 to treat patients with cachexia and other GDF-15-driven diseases. FL-501 may also enhance the activity of the immune system in the tumor micro-environment. FL-501 was engineered for higher target affinity and a longer plasma half-life compared to competing therapies. In preclinical cachexia models, FL-501 increased body weight and restored muscle mass.

Selected Third Quarter 2024 Financial Results

Net Loss was $18.2 million for the third quarter 2024, compared to $13.7 million for the same period in 2023. The increase was primarily due to an increase in research and development expenses.  

Research and development expenses were $14.9 million for the third quarter 2024, compared to $11.5 million for the same period in 2023. The increase of $3.4 million was primarily due to an increase of $1.7 million in manufacturing costs related to clinical trial material and manufacturing campaigns, and an increase of $0.8 million in clinical trial costs due to patient enrollment, the duration of patients on study, the enhancement of correlative studies, increase in site activity associated with Part C of the DisTinGuish study, and the expansion of the size of Part B of the DeFianCe study. There was also an increase of $0.5 million in consulting fees associated with research and development activities and an increase of $0.4 million in payroll and other related expenses due to an increase in headcount of our research and development full-time employees.

General and administrative expenses were $2.9 million for the third quarter 2024, compared to $3.3  million for the same period in 2023. The decrease of $0.4 million in general and administrative expenses during the three months ended September 30, 2024 as compared to the same period in 2023, was due to a $0.4 million decrease in professional fees.

Cash and cash equivalents totaled $62.8 million at September 30, 2024.

About Leap Therapeutics 
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, colorectal, and gynecological cancers. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit http://www.leaptx.com or view our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/.

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements.

All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the anticipated timing for initiation or completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability to successfully execute its clinical trials and the timing of enrollment in and cost of such clinical trials; (ii) the results of Leap's clinical trials and pre-clinical studies; (iii) Leap's ability to successfully enter into new strategic partnerships for DKN-01 or any of its other programs and to maintain its ongoing collaborations with BeiGene and Adimab; (iv) whether any Leap clinical trials and products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; and (v) exposure to inflation, currency rate and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof.

CONTACT:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com

Matthew DeYoung
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com







Leap Therapeutics, Inc.















Condensed Consolidated Statements of Operations















(in thousands, except share and per share amounts)
































(Unaudited)


(Unaudited)









Three Months Ended September 30, 


Nine Months Ended September 30, 









2024


2023


2024


2023
















Operating expenses:










Research and development


$              14,915


$             11,503


$            44,099


$               61,549


General and administrative 


2,940


3,330


9,833


10,672




    Total operating expenses


17,855


14,833


53,932


72,221

Loss from operations


(17,855)


(14,833)


(53,932)


(72,221)

Interest income 


894


1,084


2,534


3,089

Australian research and development incentives


(499)


554


-


1,124

Foreign currency loss


(8)


(501)


(18)


(953)

Change in fair value of Series X preferred stock warrant liability


-


-


-


12

Loss before income taxes


(17,468)


(13,696)


(51,416)


(68,949)

Provision for income taxes


(708)


-


(708)


-

Net loss




(18,176)


(13,696)


(52,124)


(68,949)

Dividend attributable to down round feature of warrants


-


-


(234)


-

Net loss attributable to common stockholders


$             (18,176)


$           (13,696)


$          (52,358)


$              (68,949)
















Net loss per share 












Basic & diluted


$                (0.44)


$              (0.51)


$              (1.44)


$                 (3.78)
















Weighted average common shares outstanding 












Basic & diluted


41,209,639


26,987,182


36,307,890


18,240,455

 







Leap Therapeutics, Inc.











Consolidated Balance Sheets











(in thousands, except share and per share amounts)
























September 30, 


December 31, 









2024


2023












Assets








Current assets:






Cash and cash equivalents


$              62,823


$              70,643


Research and development incentive receivable


780


771


Prepaid expenses and other current assets


209


183






Total current assets


63,812


71,597













Property and equipment, net


-


5


Right of use assets, net


370


257


Deposits



865


966






Total assets


$              65,047


$              72,825

Liabilities and Stockholders' Equity 





Current liabilities:






Accounts payable


$                5,946


$                6,465


Accrued expenses


9,049


5,957


Income tax payable


722


-


Lease liability - current portion


376


262






Total current liabilities


16,093


12,684

















Total liabilities


16,093


12,684












Stockholders' equity:






Preferred stock, $0.001 par value; 10,000,000 shares authorized; 
    0 shares issued and outstanding 


-


-


Common stock, $0.001 par value; 240,000,000 shares authorized; 38,264,464 and 25,565,414
    shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively


38


26


Additional paid-in capital


500,850


459,591


Accumulated other comprehensive income 


6


106


Accumulated deficit 


(451,940)


(399,582)






Total stockholders' equity 


48,954


60,141






Total liabilities and stockholders' equity 


$              65,047


$              72,825

 







 Leap Therapeutics, Inc. 















 Condensed Consolidated Statements of Cash Flows 















 (in thousands) 































 (Unaudited) 



 (Unaudited) 








 Three Months Ended September 30 



 Nine Months Ended September 30 








2024


2023



2024


2023












 Cash used in operating activities 

$          (15,600)


$             (10,488)



$            (44,787)


$           (33,373)

 Cash provided by investing activities 

-


-



-


48,969

 Cash provided by (used in) financing activities 

(66)


(1)



37,080


(30)

 Effect of exchange rate changes on cash and cash equivalents 

10


(183)



(113)


(323)

 Net increase (decrease) in cash and cash equivalents 

(15,656)


(10,672)



(7,820)


15,243

 Cash and cash equivalents at beginning of period 

78,479


91,415



70,643


65,500

 Cash and cash equivalents at end of period 

$            62,823


$              80,743



$             62,823


$             80,743

 

Leap Therapeutics logo (PRNewsfoto/LEAP Therapeutics)

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/leap-therapeutics-reports-third-quarter-2024-financial-results-302303295.html

SOURCE Leap Therapeutics, Inc.

FAQ

What was Leap Therapeutics (LPTX) net loss in Q3 2024?

Leap Therapeutics reported a net loss of $18.2 million for Q3 2024, an increase from $13.7 million in Q3 2023.

How many patients were enrolled in LPTX's Phase 2 DeFianCe study?

Part B of the Phase 2 DeFianCe study enrolled 188 patients, with initial data expected in mid-2025.

What is LPTX's current cash position as of Q3 2024?

Leap Therapeutics had cash and cash equivalents totaling $62.8 million as of September 30, 2024.

When will LPTX report initial data from the DisTinGuish study?

Initial data from the DisTinGuish study is expected in late 2024 or early 2025.

Leap Therapeutics, Inc.

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