Spruce Biosciences Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
Spruce Biosciences (SPRB) reported Q3 2024 financial results and provided corporate updates. The company anticipates topline data from two key clinical trials of tildacerfont in December 2024: the CAHmelia-204 study in adult CAH patients and the CAHptain-205 study in adult and pediatric CAH patients. Financial highlights include cash position of $60.1 million, expected to fund operations through end of 2025. Q3 collaboration revenue was $0.6 million, while R&D expenses decreased to $6.6 million. Net loss for Q3 was $8.7 million, improved from $12.4 million in the same period of 2023.
Spruce Biosciences (SPRB) ha riportato i risultati finanziari del terzo trimestre 2024 e fornito aggiornamenti aziendali. L'azienda prevede dati preliminari da due studi clinici chiave su tildacerfont a dicembre 2024: lo studio CAHmelia-204 sui pazienti adulti con CAH e lo studio CAHptain-205 sui pazienti adulti e pediatrici con CAH. Tra i punti salienti finanziari, si segnala una posizione di cassa di 60,1 milioni di dollari, prevista per finanziare le operazioni fino alla fine del 2025. I ricavi da collaborazioni del terzo trimestre sono stati di 0,6 milioni di dollari, mentre le spese per R&S sono diminuite a 6,6 milioni di dollari. La perdita netta per il terzo trimestre è stata di 8,7 milioni di dollari, migliorata rispetto ai 12,4 milioni di dollari dello stesso periodo del 2023.
Spruce Biosciences (SPRB) reportó los resultados financieros del tercer trimestre de 2024 y brindó actualizaciones corporativas. La compañía anticipa datos preliminares de dos ensayos clínicos clave de tildacerfont en diciembre de 2024: el estudio CAHmelia-204 en pacientes adultos con CAH y el estudio CAHptain-205 en pacientes adultos y pediátricos con CAH. Los aspectos financieros destacados incluyen una posición de efectivo de 60,1 millones de dólares, que se espera financie las operaciones hasta finales de 2025. Los ingresos por colaboraciones del tercer trimestre fueron de 0,6 millones de dólares, mientras que los gastos de I+D se redujeron a 6,6 millones de dólares. La pérdida neta para el tercer trimestre fue de 8,7 millones de dólares, mejorando desde los 12,4 millones de dólares del mismo período en 2023.
Spruce Biosciences (SPRB)는 2024년 3분기 재무 결과를 보고하고 회사 업데이트를 제공했습니다. 이 회사는 2024년 12월에 두 개의 주요 임상 시험에 대한 데이터를 예상하고 있습니다: 성인 CAH 환자에 대한 CAHmelia-204 연구와 성인 및 소아 CAH 환자에 대한 CAHptain-205 연구. 재무 하이라이트에는 6,010만 달러의 현금 보유액이 포함되어 있으며, 이는 2025년 말까지 운영 자금을 지원할 것으로 예상됩니다. 3분기 협력 수익은 60만 달러였고, 연구개발 비용은 660만 달러로 감소했습니다. 3분기 순손실은 870만 달러로, 2023년 같은 기간의 1,240만 달러에서 개선되었습니다.
Spruce Biosciences (SPRB) a rapporté les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur l'entreprise. La société s'attend à des données préliminaires de deux essais cliniques clés sur tildacerfont en décembre 2024 : l'étude CAHmelia-204 chez des patients adultes atteints de CAH et l'étude CAHptain-205 chez des patients adultes et pédiatriques atteints de CAH. Les faits marquants financiers incluent une trésorerie de 60,1 millions de dollars, qui devrait financer les opérations jusqu'à la fin de 2025. Les revenus de collaboration pour le troisième trimestre s'élevaient à 0,6 million de dollars, tandis que les dépenses de R&D ont diminué à 6,6 millions de dollars. La perte nette pour le troisième trimestre était de 8,7 millions de dollars, améliorée par rapport à 12,4 millions de dollars pour la même période en 2023.
Spruce Biosciences (SPRB) hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht und Unternehmensupdates bereitgestellt. Das Unternehmen erwartet vorläufige Daten aus zwei wichtigen klinischen Studien zu Tildacerfont im Dezember 2024: die CAHmelia-204-Studie bei erwachsenen CAH-Patienten und die CAHptain-205-Studie bei erwachsenen und pädiatrischen CAH-Patienten. Zu den finanziellen Höhepunkten gehört eine Barmittelposition von 60,1 Millionen Dollar, die voraussichtlich die Betriebe bis Ende 2025 finanzieren wird. Die Kooperationsumsätze im dritten Quartal betrugen 0,6 Millionen Dollar, während die F&E-Ausgaben auf 6,6 Millionen Dollar gesenkt wurden. Der Nettoverlust im dritten Quartal betrug 8,7 Millionen Dollar, was eine Verbesserung gegenüber 12,4 Millionen Dollar im selben Zeitraum 2023 darstellt.
- Cash runway extended through end of 2025 with $60.1M in cash
- Net loss improved to $8.7M in Q3 2024 from $12.4M in Q3 2023
- R&D expenses decreased to $6.6M from $13.5M year-over-year
- Total operating expenses reduced to $10.0M from $16.7M year-over-year
- Collaboration revenue declined to $0.6M in Q3 2024 from $3.1M in Q3 2023
- G&A expenses increased to $3.5M from $3.2M year-over-year
Insights
The Q3 2024 results show mixed signals.
The upcoming December 2024 data readouts from both CAHmelia-204 and CAHptain-205 trials for tildacerfont represent important milestones. The CAHmelia-204 study focuses on reducing glucocorticoid usage in adult CAH patients, while CAHptain-205 examines multiple dosing regimens across adult and pediatric populations. The strategic focus on both adult and pediatric populations could maximize market potential if successful. The planned FDA End of Phase 2 meeting in H1 2025 suggests confidence in the clinical program's progression.
Topline Data from CAHmelia-204 Study of Tildacerfont in Adult Congenital Adrenal Hyperplasia (CAH) Anticipated in December 2024
Topline Data from CAHptain-205 Study of Tildacerfont in Adult and Pediatric CAH Anticipated in December 2024
Cash Runway Through the End of 2025
“We remain on track to report primary efficacy and safety data plus interim data from the open-label extension of the CAHmelia-204 study of tildacerfont in adult CAH patients in December 2024. At the same time, we will also report topline dose-ranging efficacy and safety data from the CAHptain-205 study of tildacerfont in adult and pediatric CAH patients,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. “It is an honor to continue partnering with the CAH community to open a new chapter in the management of CAH. We recognize the potentially transformative impact of tildacerfont, and we have a strong sense of urgency to deliver on our commitment to CAH patients.”
Corporate Updates
CAHmelia-204 Study of Tildacerfont in Adult CAH: CAHmelia-204 is a Phase 2b, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of tildacerfont in reducing supraphysiologic glucocorticoid (GC) usage, a potentially registrational endpoint, in 90 adults with classic CAH on supraphysiologic doses of GCs with normal or near normal levels of androstenedione (A4) at baseline. In the first part of the clinical trial, patients were randomized to receive 200mg of tildacerfont once-daily (QD) or placebo for 24 weeks. During the second part of the clinical trial, all patients received 200mg of tildacerfont QD for 52 weeks. Throughout the trial, tapering of GCs is guided according to a pre-specified algorithm and continue to physiologic replacement levels, as long as patients remain well controlled based on standard biomarkers and clinical assessments. The primary endpoint of this clinical trial is the absolute change in daily GC dose in hydrocortisone equivalents (HCe) from baseline through week 24.
CAHptain-205 Study of Tildacerfont in Adult and Pediatric CAH: CAHptain-205 is a Phase 2 open-label clinical trial, which utilizes a sequential nine cohort design, to evaluate the safety, efficacy, and pharmacokinetics of tildacerfont in adults and children between two and 17 years of age. Cohorts 1-3 evaluated weight-adjusted doses of tildacerfont between 50mg QD and 200mg QD in pediatric CAH patients between two and 17 years of age, and assessed changes in androgen levels over 12 weeks of treatment as well as the ability to reduce daily GC dose based on A4 normalization. Cohorts 4-9 are evaluating weight-adjusted doses of tildacerfont of 200mg twice-daily (BID) and 400mg BID in adults and children between two and 17 years of age and is assessing changes in androgen levels over four weeks of treatment. An optional open-label extension period will provide additional open-label treatment with tildacerfont to provide long-term safety data for up to two years.
Anticipated Upcoming Milestones
- Topline results from the CAHmelia-204 clinical trial of tildacerfont 200mg QD in adult classic CAH patients on supraphysiologic doses of GCs with normal or near normal levels of A4 anticipated in December 2024
- Topline results from the CAHptain-205 clinical trial of tildacerfont 200mg BID and 400mg BID adult and pediatric cohorts anticipated in December 2024
-
End of Phase 2 (EOP2) meeting with the
U.S. Food and Drug Administration anticipated in the first half of 2025
Third Quarter 2024 Financial Results
-
Cash and Cash Equivalents: Cash and cash equivalents as of September 30, 2024 were
$60.1 million -
Collaboration Revenue: Collaboration revenue was
$0.6 million $4.2 million $3.1 million $7.2 million $15.0 million -
Research and Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2024 were
$6.6 million $25.0 million $13.5 million $38.3 million -
General and Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2024 were
$3.5 million $11.3 million $3.2 million $9.7 million -
Total Operating Expenses: Total operating expenses for the three and nine months ended September 30, 2024 were
$10.0 million $36.3 million $16.7 million $48.0 million $1.1 million $4.4 million $1.1 million $3.4 million -
Net Loss: Net loss for the three and nine months ended September 30, 2024 was
$8.7 million $29.5 million $12.4 million $38.0 million
Upcoming Investor Conferences
Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer, will present at the Guggenheim Securities Healthcare Innovation Conference on November 11, 2024, at 3:30 p.m. ET.
Interested parties can access the live webcast here. An archived copy of the webcast will be available on the events section of the company’s investor relations website for approximately 90 days.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for endocrine and neurological disorders with significant unmet medical need. Spruce is developing its product candidate, tildacerfont, an oral, second-generation CRF1 receptor antagonist, for the treatment of congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS) and major depressive disorder (MDD). To learn more, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the design, results, conduct, progress and timing of Spruce’s clinical trials; Spruce’s expectations regarding reporting results of its clinical trials in 2024; Spruce’s plans to meet with the FDA to discuss the potential registrational path forward of tildacerfont for adult and pediatric classic CAH; and Spruce’s product candidate, strategy and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “continue,” “will,” “potential,” “on track,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the
SPRUCE BIOSCIENCES, INC. CONDENSED BALANCE SHEETS (unaudited) (in thousands, except share and per share amounts) |
||||||||
|
|
September 30, |
|
December 31, |
||||
|
|
2024 |
|
2023 |
||||
ASSETS |
|
|
|
|
||||
Current assets: |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
60,055 |
|
|
$ |
96,339 |
|
Prepaid expenses |
|
|
2,658 |
|
|
|
3,876 |
|
Other current assets |
|
|
860 |
|
|
|
1,968 |
|
Total current assets |
|
|
63,573 |
|
|
|
102,183 |
|
Right-of-use assets |
|
|
998 |
|
|
|
1,181 |
|
Other assets |
|
|
531 |
|
|
|
582 |
|
Total assets |
|
$ |
65,102 |
|
|
$ |
103,946 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
||||
Current liabilities: |
|
|
|
|
||||
Accounts payable |
|
$ |
1,799 |
|
|
$ |
3,332 |
|
Accrued expenses and other current liabilities |
|
|
7,740 |
|
|
|
14,600 |
|
Term loan, current portion |
|
|
1,622 |
|
|
|
1,622 |
|
Deferred revenue, current portion |
|
|
697 |
|
|
|
4,911 |
|
Total current liabilities |
|
|
11,858 |
|
|
|
24,465 |
|
Lease liabilities, net of current portion |
|
|
809 |
|
|
|
1,019 |
|
Term loan, net of current portion |
|
|
524 |
|
|
|
1,717 |
|
Other liabilities |
|
|
273 |
|
|
|
236 |
|
Total liabilities |
|
|
13,464 |
|
|
|
27,437 |
|
Commitments and contingencies |
|
|
|
|
||||
Stockholders’ equity: |
|
|
|
|
||||
Preferred stock, |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
278,343 |
|
|
|
273,737 |
|
Accumulated deficit |
|
|
(226,709 |
) |
|
|
(197,232 |
) |
Total stockholders’ equity |
|
|
51,638 |
|
|
|
76,509 |
|
Total liabilities and stockholders’ equity |
|
$ |
65,102 |
|
|
$ |
103,946 |
|
SPRUCE BIOSCIENCES, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except share and per share amounts) |
||||||||||||||||
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||
Collaboration revenue |
|
$ |
602 |
|
|
$ |
3,073 |
|
|
$ |
4,214 |
|
|
$ |
7,202 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
|
6,554 |
|
|
|
13,494 |
|
|
|
24,961 |
|
|
|
38,332 |
|
General and administrative |
|
|
3,456 |
|
|
|
3,237 |
|
|
|
11,330 |
|
|
|
9,699 |
|
Total operating expenses |
|
|
10,010 |
|
|
|
16,731 |
|
|
|
36,291 |
|
|
|
48,031 |
|
Loss from operations |
|
|
(9,408 |
) |
|
|
(13,658 |
) |
|
|
(32,077 |
) |
|
|
(40,829 |
) |
Interest expense |
|
|
(71 |
) |
|
|
(119 |
) |
|
|
(251 |
) |
|
|
(377 |
) |
Interest income and other expense, net |
|
|
808 |
|
|
|
1,423 |
|
|
|
2,851 |
|
|
|
3,237 |
|
Net loss |
|
|
(8,671 |
) |
|
|
(12,354 |
) |
|
|
(29,477 |
) |
|
|
(37,969 |
) |
Other comprehensive gain, net of tax: |
|
|
|
|
|
|
|
|
||||||||
Unrealized gain on available for sale securities |
|
|
— |
|
|
|
52 |
|
|
|
— |
|
|
|
555 |
|
Total comprehensive loss |
|
$ |
(8,671 |
) |
|
$ |
(12,302 |
) |
|
$ |
(29,477 |
) |
|
$ |
(37,414 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.01 |
) |
Weighted-average shares of common stock outstanding, basic and diluted |
|
|
41,302,599 |
|
|
|
40,710,692 |
|
|
|
41,187,766 |
|
|
|
37,751,865 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20241111107317/en/
Media
Katie Beach Oltsik
Inizio Evoke Comms
(937) 232-4889
Katherine.Beach@inizioevoke.com
media@sprucebio.com
Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.
investors@sprucebio.com
Source: Spruce Biosciences, Inc.
FAQ
When will Spruce Biosciences (SPRB) report topline data from the CAHmelia-204 trial?
What is SPRB's current cash position as of Q3 2024?
What was Spruce Biosciences' (SPRB) net loss in Q3 2024?
How long will SPRB's current cash runway last?
