CADRENAL THERAPEUTICS PROVIDES THIRD-QUARTER CORPORATE UPDATE
Cadrenal Therapeutics (NASDAQ: CVKD) provided a Q3 2024 corporate update highlighting progress in developing tecarfarin, a new vitamin K antagonist for anticoagulation. Key developments include FDA discussions regarding Phase 3 trial protocol for LVAD patients, advancement of Abbott collaboration talks, and joining the Anticoagulation Forum's Corporate Council. The company successfully raised $9.8 million through ATM and warrant exercises, increasing cash balance to $11.3 million. Q3 operating expenses were $2.5 million, with $2.2 million used in operating activities. Tecarfarin is positioned as the only anticoagulant in development for patients with implanted cardiac devices and rare cardiovascular conditions.
Cadrenal Therapeutics (NASDAQ: CVKD) ha fornito un aggiornamento aziendale per il terzo trimestre del 2024, evidenziando i progressi nello sviluppo di tecarfarin, un nuovo antagonista della vitamina K per l'anticoagulazione. Tra i principali sviluppi ci sono state discussioni con la FDA riguardo al protocollo della sperimentazione di Fase 3 per i pazienti con LVAD, l'avanzamento dei colloqui di collaborazione con Abbott e l'adesione al Corporate Council dell'Anticoagulation Forum. L'azienda ha raccolto con successo 9,8 milioni di dollari tramite esercizi di ATM e warrant, aumentando il saldo di cassa a 11,3 milioni di dollari. Le spese operative del terzo trimestre sono state di 2,5 milioni di dollari, con 2,2 milioni utilizzati per le attività operative. Tecarfarin si posiziona come l'unico anticoagulante in fase di sviluppo per i pazienti con dispositivi cardiaci impiantati e condizioni cardiovascolari rare.
Cadrenal Therapeutics (NASDAQ: CVKD) proporcionó una actualización corporativa del tercer trimestre de 2024 destacando los avances en el desarrollo de tecarfarina, un nuevo antagonista de la vitamina K para la anticoagulación. Los desarrollos clave incluyen discusiones con la FDA sobre el protocolo del ensayo de Fase 3 para pacientes con LVAD, el avance de las conversaciones de colaboración con Abbott y la incorporación al Corporate Council del Anticoagulation Forum. La compañía recaudó con éxito 9,8 millones de dólares a través de ejercicios de ATM y warrants, aumentando su saldo en efectivo a 11,3 millones de dólares. Los gastos operativos del tercer trimestre fueron de 2,5 millones de dólares, de los cuales 2,2 millones se destinaron a actividades operativas. Tecarfarina se posiciona como el único anticoagulante en desarrollo para pacientes con dispositivos cardíacos implantados y condiciones cardiovasculares raras.
카드레날 제약(CADRENAL Therapeutics, NASDAQ: CVKD)는 2024년 3분기 기업 업데이트를 제공하며 항응고제인 테카르파린의 개발 진행 상황을 강조했습니다. 주요 발전 사항으로는 LVAD 환자를 위한 3상 시험 프로토콜에 대한 FDA와의 논의, Abbott와의 협력 대화 진전, 항응고 포럼의 기업 위원회 가입이 있습니다. 회사는 ATM 및 보증 행사로 980만 달러를 성공적으로 모금하여 현금 잔고를 1,130만 달러로 증가시켰습니다. 3분기 운영 비용은 250만 달러로, 이 중 220만 달러가 운영 활동에 사용되었습니다. 테카르파린은 심장 이식 장치와 드문 심혈관 질환이 있는 환자를 위한 유일한 항응고제로 자리잡고 있습니다.
Cadrenal Therapeutics (NASDAQ: CVKD) a fourni une mise à jour corporative pour le troisième trimestre de 2024, mettant en lumière les avancées dans le développement de tecarfarine, un nouvel antagoniste de la vitamine K pour l'anticoagulation. Parmi les développements clés, on trouve des discussions avec la FDA concernant le protocole de l'essai de phase 3 pour les patients porteurs de LVAD, l'avancement des discussions de collaboration avec Abbott et l'adhésion au Corporate Council du Forum de l'anticoagulation. L'entreprise a réussi à lever 9,8 millions de dollars par le biais d'exercices d'ATM et de bons de souscription, portant solde de trésorerie à 11,3 millions de dollars. Les dépenses d'exploitation au troisième trimestre s'élevaient à 2,5 millions de dollars, dont 2,2 millions ont été utilisés pour les activités opérationnelles. Tecarfarine se positionne comme le seul anticoagulant en cours de développement pour les patients ayant des dispositifs cardiaques implantés et des pathologies cardiovasculaires rares.
Cadrenal Therapeutics (NASDAQ: CVKD) hat ein Unternehmensupdate für das dritte Quartal 2024 bereitgestellt, das die Fortschritte bei der Entwicklung von Tecarfarin, einem neuen Vitamin-K-Antagonisten für die Antikoagulation, hervorhebt. Zu den wichtigsten Entwicklungen gehören Gespräche mit der FDA über das Protokoll der Phase-3-Studie für LVAD-Patienten, das Vorankommen der Zusammenarbeit mit Abbott und der Beitritt zum Corporate Council des Antikoagulation Forums. Das Unternehmen hat erfolgreich 9,8 Millionen Dollar durch ATM- und Warrant-Übungen gesammelt, wodurch der Kassenbestand auf 11,3 Millionen Dollar gestiegen ist. Die Betriebsausgaben im dritten Quartal beliefen sich auf 2,5 Millionen Dollar, wobei 2,2 Millionen Dollar für operative Tätigkeiten verwendet wurden. Tecarfarin positioniert sich als das einzige in der Entwicklung befindliche Antikoagulans für Patienten mit implantierten Herzgeräten und seltenen kardiovaskulären Erkrankungen.
- Raised $9.8 million through ATM facility ($5.1M) and warrant exercises ($4.7M)
- Strong cash position of $11.3 million as of November 7, 2024
- Tecarfarin is the only anticoagulant in development worldwide for its target patient population
- Advanced discussions with FDA and Abbott regarding Phase 3 trial
- Operating expenses of $2.5 million in Q3 2024
- Cash burn of $2.2 million in Q3 2024
- Dilution of shareholders through ATM facility
Insights
The recent
The financing provides important working capital for advancing tecarfarin's Phase 3 trial preparations, including manufacturing readiness with their CDMO partner. While the dilutive financing impacts current shareholders, it's a necessary step for a clinical-stage biotech to fund its development programs. The company's lean operating structure, with just
Tecarfarin's development represents a potentially significant advancement in anticoagulation therapy for specific patient populations where current options are suboptimal. The focus on LVAD patients, particularly those with Abbott's HeartMate 3, targets a clear unmet medical need where DOACs are contraindicated and warfarin has limitations.
The ongoing FDA discussions regarding the Phase 3 protocol and collaboration with Abbott are critical steps toward trial initiation. The company's joining of the Anticoagulation Forum's Corporate Council provides valuable access to 15,000 healthcare professionals, potentially facilitating future commercialization efforts if the drug is approved. The expanded potential in genetic warfarin resistance and renal impairment cases could significantly broaden the drug's market opportunity.
Recent Highlights
- In early September, Cadrenal leadership met with the
U.S. Food and Drug Administration (FDA) to discuss its tecarfarin Phase 3 clinical trial protocol in left ventricular assist device (LVAD) patients and is continuing these discussions. - Cadrenal advanced Abbott collaboration discussions regarding Cadrenal's pivotal clinical trial in patients with the Abbott LVAD HeartMate 3, the only LVAD available in the
U.S. - Also, in October 2024, Cadrenal joined the Corporate Council of the Anticoagulation Forum (AC Forum), the largest professional organization of anticoagulation specialists committed to advancing the quality and safety of chronic anticoagulation care globally. Through participation in the Corporate Council, Cadrenal will collaborate with the AC Forum as it works to educate and engage the organization's 15,000 healthcare professional members to improve outcomes for patients on anticoagulants.
- Cadrenal and its pharmaceutical contract development and manufacturing organization (CDMO) completed the operational readiness activities necessary to supply active pharmaceutical ingredients and clinical trial materials in accordance with current good manufacturing principles (cGMP).
- On October 24, 2024, Cadrenal announced that it successfully raised approximately
$5.1 million through its at-the-market facility (ATM). - On November 1, 2024, Cadrenal announced the exercise of warrants generating gross proceeds of approximately
$4.7 million - Recent financing transactions totaling
$9.8 million $11.3 million and strengthened its balance sheet. The net proceeds provide Cadrenal with additional working capital as it advances tecarfarin toward a pivotal Phase 3 trial. - Q3 2024 operating expenses were
$2.5 million $0.3 million - Cash used in operating activities totaled
$2.2 million during Q3 2024. - Cash and cash equivalent balance of
$11.3 million
"Momentum is building from our achievement of several critical milestones toward beginning a pivotal clinical trial to evaluate tecarfarin's superiority to warfarin in LVAD patients," said Quang X. Pham, Founder, Chairman, and Chief Executive Officer of Cadrenal Therapeutics. "These accomplishments span finance, operations, partner relations, and clinical development and enhance our ability to execute our strategic plan going into 2025.
"Efficiently raising nearly
Tecarfarin is the only anticoagulant in development worldwide for patients with implanted cardiac devices and other rare cardiovascular conditions. The oral and reversible drug has been uniquely designed to overcome many of the challenges patients experience with warfarin and to fill a need unmet by direct oral anticoagulants (DOACs) that are contraindicated or not recommended by leading cardiology associations for these individuals. If approved, tecarfarin may be a safer and more effective chronic anticoagulant for LVAD patients in the
In addition, tecarfarin may prove valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. These include individuals with end-stage renal disease and atrial fibrillation or those with mechanical heart valves and hard-to-control anticoagulation, as determined by International Normalized Ratio (INR) measurements of how long it takes the blood to clot.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, more effective chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds, and deaths than warfarin, the most commonly used anticoagulant for these patients, despite its prevalent adverse events, drug-to-drug interactions, and frequent dosing changes. Cadrenal is focused on evaluating tecarfarin's superiority to warfarin in these patients where DOACs are not recommended in the treatment guidelines of leading cardiology associations. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted LVADs as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is opportunistically planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin. The company's plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.
About Tecarfarin
Tecarfarin is a Phase 3-ready drug candidate that Cadrenal is developing to overcome many of warfarin's challenges and fill the need for a safer and more effective VKA chronic anticoagulant. Tecarfarin is anticipated to improve outcomes and result in fewer major events for warfarin-dependent patients. Extensive data indicates that the efficacy of tecarfarin, metabolized via a different pathway than warfarin, is not affected by drug-drug interactions and kidney impairment, which are common in these patients. Phase 2/3 clinical trials show that tecarfarin may offer enhanced stability and time in therapeutic range (TTR) that inversely correlate with major events. Tecarfarin is the only new anticoagulant being developed for patients with implanted cardiac devices or rare cardiovascular conditions. Treatment with tecarfarin aims to improve anticoagulation for these underserved patients and their healthcare providers who face difficulties in managing warfarin's wide variability and risk of gastrointestinal bleeds.
Safe Harbor Statement
Any statements contained 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 statements regarding our planned pivotal trial to evaluate tecarfarin's effectiveness for LVAD patients, the success of the Company's collaborative efforts with Abbott, tecarfarin potentially being a safer and more effective chronic anticoagulant for patients with LVADs, tecarfarin filling a need unmet by DOACs that are contraindicated or not recommended, the commencement of trials to evaluate tecarfarin's superiority to warfarin in LVAD patients and potentially bring the Company's better anticoagulation solution to those in need, and tecarfarin proving valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. 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 the ability of tecarfarin to improve anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), the collaborative efforts with Abbott being successful and those with AFib and ESKD, the collaboration with Abbott being successful and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com
Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com
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SOURCE Cadrenal Therapeutics, Inc.
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