Shuttle Pharma Provides Third Quarter 2024 Corporate Update
Shuttle Pharmaceuticals Holdings (NASDAQ: SHPH) provided a Q3 2024 corporate update highlighting key developments. The company successfully dosed the first three patients in its Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment and finalized agreements with all six planned enrollment sites. Financial updates include paying off a $4.3M Senior Secured Convertible Note, completing a $4.5M public offering, and closing a $790,000 convertible note offering. The company reported a cash balance of $4.1M as of October 31, 2024.
The Phase 2 trial will enroll 40 patients initially, randomized into two dosage groups, with plans to add 14 more patients once the optimal dose is determined. The trial is expected to complete in 18-24 months.
Shuttle Pharmaceuticals Holdings (NASDAQ: SHPH) ha fornito un aggiornamento aziendale per il terzo trimestre del 2024 evidenziando sviluppi chiave. L'azienda ha dosato con successo i primi tre pazienti nel suo studio clinico di Fase 2 di Ropidoxuridina per il trattamento del glioblastoma e ha finalizzato gli accordi con tutti e sei i siti di arruolamento previsti. Gli aggiornamenti finanziari includono il rimborso di un Nota Convertibile Senior Garantita di $4,3 milioni, il completamento di un'offerta pubblica di $4,5 milioni e la chiusura di un'offerta di nota convertibile di $790.000. L'azienda ha riportato un saldo di cassa di $4,1 milioni al 31 ottobre 2024.
Lo studio di Fase 2 arruolerà inizialmente 40 pazienti, randomizzati in due gruppi di dosaggio, con piani per aggiungere 14 pazienti ulteriori una volta determinato il dosaggio ottimale. Si prevede che lo studio si completi in 18-24 mesi.
Shuttle Pharmaceuticals Holdings (NASDAQ: SHPH) proporcionó una actualización corporativa del tercer trimestre de 2024 destacando desarrollos clave. La empresa ha administrado con éxito la dosis a los tres primeros pacientes en su ensayo clínico de Fase 2 de Ropidoxuridina para el tratamiento del glioblastoma y ha finalizado los acuerdos con los seis sitios de inscripción planeados. Las actualizaciones financieras incluyen el pago de un Bono Convertible Senior Garantizado de $4.3 millones, la finalización de una oferta pública de $4.5 millones y el cierre de una oferta de notas convertibles de $790,000. La empresa reportó un saldo de efectivo de $4.1 millones hasta el 31 de octubre de 2024.
El ensayo de Fase 2 inscribirá inicialmente a 40 pacientes, aleatorizados en dos grupos de dosis, con planes de agregar 14 pacientes más una vez que se determine la dosis óptima. Se espera que el ensayo finalice en 18-24 meses.
셔틀 제약 홀딩스(NASDAQ: SHPH)는 2024년 3분기 기업 업데이트를 제공하며 주요 개발 사항을 강조했습니다. 이 회사는 뇌교종 치료를 위한 로피독수리딘의 2상 임상 시험에 처음으로 세 명의 환자에게 성공적으로 투여했으며, 계획된 여섯 개의 등록 사이트와의 계약을 완료했습니다. 재무 업데이트에는 430만 달러의 선순위 전환 사채 상환, 450만 달러의 공모 완료, 79만 달러의 전환 사채 발행 종료가 포함됩니다. 이 회사는 2024년 10월 31일 기준으로 410만 달러의 현금 잔액을 보고했습니다.
2상 시험은 처음에 40명의 환자를 등록하며, 두 개의 용량 그룹으로 무작위 배정됩니다. 최적 용량이 결정되면 14명의 환자를 추가할 계획입니다. 시험은 18-24개월 내에 완료될 것으로 예상됩니다.
Shuttle Pharmaceuticals Holdings (NASDAQ: SHPH) a fourni une mise à jour corporate pour le troisième trimestre 2024, soulignant des développements clés. L'entreprise a réussi à administrer le traitement aux trois premiers patients dans son essai clinique de Phase 2 de Ropidoxuridine pour le traitement du glioblastome et a finalisé les accords avec tous les six sites d'inscription prévus. Les mises à jour financières incluent le remboursement d'une Obligation Convertible Senior Garanties de 4,3 millions de dollars, la réalisation d'une offre publique de 4,5 millions de dollars et la clôture d'une offre d'obligations convertibles de 790 000 dollars. L'entreprise a déclaré un solde de trésorerie de 4,1 millions de dollars au 31 octobre 2024.
L'essai de Phase 2 enrollera initialement 40 patients, randomisés en deux groupes de dosage, avec des plans d'ajouter 14 patients supplémentaires une fois que la dose optimale aura été déterminée. L'essai devrait se terminer dans 18 à 24 mois.
Shuttle Pharmaceuticals Holdings (NASDAQ: SHPH) hat ein Unternehmensupdate für das dritte Quartal 2024 veröffentlicht, das wichtige Entwicklungen hervorhebt. Das Unternehmen hat erfolgreich die ersten drei Patienten in seiner Phase-2-Studie zu Ropidoxuridin zur Behandlung von Glioblastom behandelt und die Verträge mit allen sechs geplanten Rekrutierungsstandorten abgeschlossen. Die finanziellen Updates umfassen die Rückzahlung einer garantierten Senior- Wandelanleihe in Höhe von 4,3 Millionen US-Dollar, den Abschluss eines öffentlichen Angebots in Höhe von 4,5 Millionen US-Dollar und den Abschluss eines Wandeldarlehensangebots in Höhe von 790.000 US-Dollar. Das Unternehmen berichtete von einem Barguthaben von 4,1 Millionen US-Dollar zum 31. Oktober 2024.
Die Phase-2-Studie wird zunächst 40 Patienten einschließen, die in zwei Dosierungsgruppen randomisiert werden. Es sind Pläne vorhanden, 14 weitere Patienten hinzuzufügen, sobald die optimale Dosis bestimmt ist. Die Studie wird voraussichtlich in 18-24 Monaten abgeschlossen sein.
- Successfully initiated Phase 2 clinical trial with first three patients dosed
- Secured all six planned clinical trial site locations
- Completed $4.5M public offering
- Paid off $4.3M Senior Secured Convertible Note ahead of schedule
- Maintained $4.1M cash balance as of October 31, 2024
- Additional funding needed through convertible notes indicating potential cash constraints
- Extended timeline of 18-24 months for trial completion suggests delayed revenue potential
Insights
The Phase 2 clinical trial progress for Ropidoxuridine in glioblastoma treatment represents a significant milestone. The successful dosing of the first three patients and finalization of agreements with six major cancer centers demonstrates strong execution. The trial's focus on IDH wild-type, methylation negative glioblastoma patients addresses an urgent unmet need, as current survival rates are under 12 months.
The company's financial position has improved with a
GAITHERSBURG, Md., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the third quarter ended September 30, 2024.
Shuttle Pharma’s recent highlights include the following:
- Successfully dosed first three patients in the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with brain tumors (glioblastoma). Ropidoxuridine is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat glioblastoma, a deadly malignancy of the brain with no known cure. Additional patients are currently undergoing screening for enrollment in the trial.
- Finalized agreements with all six of the planned site enrollment locations which will be administering the Phase 2 clinical trial following the Company’s entry into agreements with Georgetown University Medical Center and UNC Medical Center. The Company previously entered agreements with the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida.
- Paid off the entirety of the outstanding balance due under Shuttle Pharma’s Senior Secured Convertible Note issued on January 11, 2023. The initial balance of the Note was
$4.3 million and was originally repayable over a 26-month period ending March 11, 2025. - Completed a
$4.5 million public offering priced At-The-Market under Nasdaq rules. The Company intends to use the net proceeds from this offering to fund IND-enabling and Phase 1 and 2 clinical trials of product candidates, including payments that will be made to the clinical research organization supporting the Phase 2 clinical trial for Ropidoxuridine, and for working capital and general corporate purposes. - The Company also closed on a convertible note and warrant offering, receiving a total of
$790,000 in gross proceeds, including$237,500 invested by the Company’s Chief Executive Officer, Dr. Anatoly Dritschilo. - Cash balance as of October 31, 2024 was
$4.1 million .
“We made tremendous progress over the past few months to advance our Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma, with the first three patients dosed in October 2024,” stated Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “The initial patient dosing followed the successful engagement of all six of the planned clinical trial site locations, each of which are nationally recognized cancer centers that are most likely to treat IDH wild-type, methylation negative glioblastoma patients – the target of the clinical trial. The initiation of the Phase 2 trial is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies.”
“Beyond these critical clinical developments, we also made progress in improving our balance sheet and funding the Phase 2 clinical trial. I want to thank all of the investors who have committed to helping us advance our mission to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma,” Dr. Dritschilo concluded.
About the Phase 2 Clinical Trial
The Phase 2 clinical trial has begun enrolling patients with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma. Presently, radiation is the only approved standard of care for this particular group of patients, with more than half of the patients surviving for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will initially consist of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dosage allowing for the achievement of statistical significance with the end point being that of survival as compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.
An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about
More information about Shuttle Pharma’s Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.
About Shuttle Pharmaceuticals
Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. Shuttle Pharma’s Chairman and CEO, Dr. Anatoly Dritschilo, is currently Professor Emeritus at the Georgetown University Medical Center. For more information, please visit our website at www.shuttlepharma.com.
Safe Harbor Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning the development of our company. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ended December 31, 2023, as amended, filed with the SEC on September 4, 2024, as well other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Shuttle Pharmaceuticals
Anatoly Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com
Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com
FAQ
What is the current status of Shuttle Pharma's (SHPH) Phase 2 clinical trial for Ropidoxuridine?
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