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NeuroBo Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Corporate Update

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NeuroBo Pharmaceuticals (NRBO) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

  • Completed a $70 million financing, with $20 million upfront and $50 million in milestone-based warrants
  • $27.9 million cash at quarter-end, expected to fund operations into Q2 2025
  • Fully enrolled SAD Part 1 of DA-1726 Phase 1 trial for obesity, with top-line data expected in Q3 2024
  • Entered joint research agreement to develop long-acting formulation of DA-1726
  • Part 2 of DA-1241 Phase 2a trial for MASH underway, top-line data expected in Q4 2024
  • Net loss of $10.1 million for Q2 2024, compared to $0.7 million in Q2 2023

The company is advancing its cardiometabolic pipeline with multiple upcoming milestones for DA-1726 and DA-1241.

NeuroBo Pharmaceuticals (NRBO) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I punti salienti includono:

  • Completato un finanziamento di 70 milioni di dollari, con 20 milioni di dollari anticipati e 50 milioni in warrant basati su milestones
  • 27,9 milioni di dollari in cassa alla fine del trimestre, previsti per finanziare le operazioni fino al secondo trimestre 2025
  • Completata la registrazione totale della Parte 1 SAD del trial di Fase 1 DA-1726 per l'obesità, con i dati preliminari attesi nel terzo trimestre 2024
  • Entrato in un accordo di ricerca congiunto per sviluppare una formulazione a lungo termine di DA-1726
  • In corso la Parte 2 del trial di Fase 2a DA-1241 per MASH, con i dati preliminari attesi nel quarto trimestre 2024
  • Perdita netta di 10,1 milioni di dollari per il secondo trimestre 2024, rispetto a 0,7 milioni nel secondo trimestre 2023

L'azienda sta avanzando il suo pipeline cardiometabolico con molteplici traguardi in arrivo per DA-1726 e DA-1241.

NeuroBo Pharmaceuticals (NRBO) informó sobre los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los aspectos más destacados incluyen:

  • Completada una financiación de 70 millones de dólares, con 20 millones de dólares por adelantado y 50 millones en warrants basados en hitos
  • 27,9 millones de dólares en efectivo al final del trimestre, se espera que financie las operaciones hasta el segundo trimestre de 2025
  • Inscripto por completo en la Parte 1 SAD del ensayo de Fase 1 DA-1726 para la obesidad, con datos preliminares esperados en el tercer trimestre de 2024
  • Entrado en un acuerdo de investigación conjunta para desarrollar una formulación de liberación prolongada de DA-1726
  • En marcha la Parte 2 del ensayo de Fase 2a DA-1241 para MASH, con datos preliminares esperados en el cuarto trimestre de 2024
  • pérdida neta de 10,1 millones de dólares para el segundo trimestre de 2024, en comparación con 0,7 millones en el segundo trimestre de 2023

La empresa está avanzando en su pipeline cardiometabólico con múltiples hitos próximos para DA-1726 y DA-1241.

NeuroBo Pharmaceuticals (NRBO)는 2024년 2분기 재무 결과를 보고하고 회사 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:

  • 7천만 달러의 자금 조달 완료, 2천만 달러가 선불로, 5천만 달러는 성과 기반 보증으로 제공됨
  • 분기 말 기준 2790만 달러의 현금 보유, 2025년 2분기까지 운영 자금으로 예정됨
  • 비만을 위한 DA-1726 1상 시험의 SAD 파트 1에 완전히 등록, 2024년 3분기 데이터 공개 예정
  • DA-1726의 장기 작용 제형 개발을 위한 공동 연구 협약 체결
  • MASH를 위한 DA-1241 2a상 시험의 파트 2 진행 중, 2024년 4분기 데이터 공개 예정
  • 2024년 2분기 순손실 1천만 1천 달러, 2023년 2분기 70만 달러와 비교됨

회사는 DA-1726과 DA-1241에 대한 다수의 예정된 이정표를 가지고 심혈관 대사 파이프라인을 발전시키고 있습니다.

NeuroBo Pharmaceuticals (NRBO) a rapporté les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les points clés comprennent :

  • Achèvement d'un financement de 70 millions USD, avec 20 millions USD versés d'avance et 50 millions USD en bons de souscription basés sur des jalons
  • 27,9 millions USD de liquidités à la fin du trimestre, prévu pour financer les opérations jusqu'au 2e trimestre 2025
  • Inscription complète de la Partie 1 SAD de l' pour l'obésité, avec des données préliminaires attendues au 3e trimestre 2024
  • Entrée dans un accord de recherche conjointe pour développer une formulation à action prolongée de DA-1726
  • Partie 2 de l' pour MASH en cours, avec des données préliminaires attendues au 4e trimestre 2024
  • Perte nette de 10,1 millions USD pour le 2e trimestre 2024, par rapport à 0,7 million USD au 2e trimestre 2023

L'entreprise fait progresser son pipeline cardiométabolique avec plusieurs jalons à venir pour DA-1726 et DA-1241.

NeuroBo Pharmaceuticals (NRBO) berichtete über die finanziellen Ergebnisse des 2. Quartals 2024 und gab ein Unternehmensupdate. Zu den wichtigsten Punkten gehören:

  • Abgeschlossene Finanzierung in Höhe von 70 Millionen USD, wobei 20 Millionen USD im Voraus und 50 Millionen USD in meilensteinbasierten Optionen
  • 27,9 Millionen USD Bargeld zum Quartalsende, das voraussichtlich die Betriebsführung bis zum 2. Quartal 2025 finanziert
  • Volle Registrierung der SAD-Teil 1 der DA-1726 Phase 1 Studie für Adipositas, mit erwarteten Top-Line-Daten im 3. Quartal 2024
  • Eintritt in eine gemeinsame Forschungsvereinbarung zur Entwicklung einer langwirksamen Formulierung von DA-1726
  • Teil 2 der DA-1241 Phase 2a Studie für MASH in Arbeit, Top-Line-Daten sollen im 4. Quartal 2024 erwartet werden
  • Nettoverlust von 10,1 Millionen USD für das 2. Quartal 2024, im Vergleich zu 0,7 Millionen USD im 2. Quartal 2023

Das Unternehmen entwickelt sein kardiometabolisches Pipeline mit mehreren bevorstehenden Meilensteinen für DA-1726 und DA-1241 weiter.

Positive
  • Secured $70 million financing, with $20 million upfront and $50 million in milestone-based warrants
  • Strong cash position of $27.9 million, expected to fund operations into Q2 2025
  • Fully enrolled SAD Part 1 of DA-1726 Phase 1 trial for obesity
  • Entered joint research agreement to develop long-acting formulation of DA-1726
  • Part 2 of DA-1241 Phase 2a trial for MASH progressing with top-line data expected in Q4 2024
Negative
  • Net loss increased to $10.1 million in Q2 2024 from $0.7 million in Q2 2023
  • R&D expenses increased to $8.1 million in Q2 2024 from $2.4 million in Q2 2023
  • G&A expenses increased to $2.0 million in Q2 2024 from $1.4 million in Q2 2023

NeuroBo Pharmaceuticals' Q2 2024 results reveal significant progress in their clinical pipeline, but with increased expenses. R&D costs rose to $8.1 million from $2.4 million year-over-year, primarily due to advancing trials for DA-1241 and DA-1726. The net loss widened to $10.1 million from $0.7 million. However, the company secured up to $70 million in financing, with $20 million upfront, strengthening their cash position to $27.9 million. This funding is expected to support operations into Q2 2025, with potential for an additional $20 million from warrant exercises in H1 2025. The financial strategy aligns with their clinical milestones, particularly for DA-1726's obesity trial, but investors should monitor cash burn rate closely.

NeuroBo's progress with DA-1726 for obesity treatment is noteworthy. Pre-clinical data suggests superior efficacy in weight loss, lean body mass retention and lipid-lowering compared to competitors like survodutide and tirzepatide. The fully enrolled SAD Part 1 trial with expected Q3 2024 readout and the ongoing MAD Part 2 trial, are critical near-term catalysts. The planned Phase 1 Part 3 trial, assessing 24-week weight loss and exploring maximum titratable dose, could provide significant insights by mid-2026. Additionally, the joint research for a long-acting monthly formulation could enhance DA-1726's market potential. For DA-1241 in MASH, the ongoing Phase 2a trial, combining it with sitagliptin, could offer a novel treatment approach, with results expected in Q4 2024.

NeuroBo's focus on cardiometabolic diseases, particularly obesity and MASH, positions them in high-growth markets. The global obesity treatment market is projected to reach $54 billion by 2030, driven by increasing prevalence and demand for effective therapies. DA-1726's potential as a best-in-class obesity drug with improved tolerability could capture significant market share if clinical results confirm pre-clinical findings. The MASH market, estimated to grow to $61 billion by 2028, lacks approved treatments, giving DA-1241 a first-mover advantage if successful. The company's strategy of developing dual-action therapies and exploring combination treatments aligns with market trends towards more effective, multi-target approaches in metabolic disorders.

Successfully Completed a Financing of up to $70 Million, With $20 Million Upfront and an Additional $50 Million of Aggregate Gross Proceeds Upon the Exercise in Full of Clinical Milestone-Based Warrants

$27.9 Million in Cash at End of Second Quarter is Expected to Fund the Company Though Multiple Value-Creating Milestones, Into the Second Quarter of 2025. Assuming Positive Results From the DA-1726 Phase 1 MAD Study, the Company Anticipates That the Series A Warrants From the June Financing Could be Exercised in the First Half of 2025, Resulting in Gross Proceeds of $20 Million

In Pre-Clinical Models, DA-1726 Demonstrated Superiority in Weight Loss, Retention of Lean Body Mass and Lipid-Lowering Effects, Plus Superior Glucose Lowering Effects Compared to Survodutide; Lipid-Lowering Effect Also Shown to be Superior Compared to Tirzepatide

Fully Enrolled the SAD Part 1 of the Phase 1 Trial of DA-1726, With Top-Line Data Readout Expected in the Third Quarter of 2024, and From the MAD Part 2 in the First Quarter of 2025

Planned Phase 1 Part 3 Trial of DA-1726 in Obesity Will Assess Total Weight Loss at 24 Weeks, Exploring Maximum Titratable Dose and Dietary Changes; Interim Data Readout Expected Mid-2026 with Top-Line Data in the Second Half of 2026

Entered into a Joint Research Agreement, Together With Dong-A ST and ImmunoForge to Develop a Long-Acting Once-Monthly Formulation of DA-1726

Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway With Top-Line Data Expected in the Fourth Quarter of 2024

CAMBRIDGE, Mass., Aug. 14, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2024 and provided a corporate update.

"During the second quarter and subsequently, we made remarkable progress advancing the clinical development of our two, next generation cardiometabolic assets and are now well capitalized to execute on our upcoming DA-1726 milestones following our recent, successful financing of up to $70 million in aggregate gross proceeds, with $20 million upfront and $50 million of clinical milestone-based warrants," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "We expect this financing will enable us to fully fund an early proof-of-concept multicenter, randomized, double-blind, placebo-controlled Part 3 of the Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. Part 3, which will begin upon completion of Part 2, will explore changes in baseline, at 24 weeks, for total weight loss, weight loss through fat or lean muscle mass reduction, dietary changes, maximum-tolerated individualized dose and other exploratory endpoints. Additionally, dosing of the first patient in Part 2 of this trial, late in the second quarter, ahead of schedule, is a further reflection of our strong commitment to swiftly advancing the clinical development of DA-1726, which holds promise as a highly differentiated therapy for the treatment of obesity. It is also worth noting that, just last week, we signed a joint research agreement, together with our collaboration partner, Dong-A ST and ImmunoForge, as a first step toward potentially developing a long-acting formulation of DA-1726 which would both enhance patient compliance and ease of administration.

"During the American Diabetes Association (ADA) 84th Scientific Sessions in June, we shared pre-clinical data that highlighted the unique characteristics of DA-1726 compared to other obesity drugs in the same class. The data suggests that DA-1726's unique GLP-1 and glucagon receptor activity ratio may be responsible for its differentiated profile. In obese mouse models, DA-1726 demonstrated significant reductions in cholesterol levels and superior weight loss, compared to survodutide, a drug with the same mechanism of action, while also exhibiting superior glucose lowering and retention of relative lean body mass preservation. Previous pre-clinical research also indicated that DA-1726 led to weight reduction while consuming more food than tirzepatide. Additional data presented at the ADA, from a hypercholesterolemia rat model, confirmed that DA-1726 is also more effective than tirzepatide in lowering cholesterol levels potentially due to its glucagon action and GLP-1 effect, while also preventing weight gain. These pre-clinical findings suggest that DA-1726 could emerge as a best-in-class obesity drug with improved tolerability compared to current GLP-1 agonists and those in late-stage clinical trials, given its balanced activation of GLP1R and glucagon receptors, while increasing energy expenditure. Yesterday, we announced the full enrollment of the single ascending dose (SAD) Part 1, for which we anticipate reporting top-line data in the third quarter of this year and top-line data from the MAD Part 2 in the first quarter of 2025. Upon clearance of an updated Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), we expect to dose the first patient in Part 3 during the third quarter of 2025, providing an interim data readout in or around mid-2026 and issuing top-line results in the second half of 2026."

Mr. Kim concluded, "Additionally, early in the quarter, we fully enrolled Part 1 of the Phase 2a clinical trial for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for treating MASH, exploring the efficacy of DA-1241 in combination with sitagliptin, a DPP-4 inhibitor, which we believe will show synergistic effects compared to DA-1241, alone. New pre-clinical evidence on DA-1241 in combination with semaglutide (Wegovy®), was presented at the EASL Congress 2024, in June. Based on both pre-clinical and clinical evidence generated to date, we continue to believe that DA-1241 has the potential to be a safe and effective treatment for MASH and anticipate reporting top-line results in the fourth quarter of this year."

First Quarter 2024 and Subsequent Highlights

  • August 2024: Completed enrollment in the SAD Part 1 of the Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity. A total of 45 participants were enrolled and randomized into one of 5 cohorts, with each cohort having been randomized in a 6:3 ratio of DA-1726 to placebo.
  • August 2024: Signed a joint research agreement, along with Dong-A ST and ImmunoForge, to develop a long-acting, once-monthly, formulation of DA-1726 utilizing ImmunoForge's long-lasting half-life extension Elastin-Like Polypeptide (ELP) platform technology.
  • July 2024: Signed an exclusive out-license agreement, providing MThera Pharma Co., Ltd. (MTHERA) with the rights to develop and commercialize NB-01, one of four legacy assets, for the treatment of painful diabetic neuropathy, allowing MTHERA to conduct research and clinical trials, including, but not limited to, a potential Phase 3 clinical trial in the United States and South Korea, for the future commercialization of NB-01.
  • July 2024: Engaged veteran biotech and pharmaceutical professional, Chris Fang, MD, as Advisor/Consulting Chief Medical Officer, effective July, 2, 2024.
  • June 2024: Completed enrollment of Part 2 of the Phase 2a trial evaluating the efficacy and safety of DA-1241 in MASH. Approximately 37 patients with presumed MASH were randomized with a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo.
  • June 2024: Dosed the first patient in the MAD Part 2 of its two-part Phase 1 clinical trial of DA-1726 a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity.
  • June 2024: Closed a concurrent placement and registered direct offering priced at-the-market under Nasdaq rules, with $20 million up front with up to an additional $50 million of aggregate gross proceeds upon the exercise in full of clinical milestone-based warrants.
  • June 2024: Presented pre-clinical data at the American Diabetes Association (ADA) 84th Scientific Sessions, suggesting that DA-1726 demonstrated superiority in weight loss, retention of lean body mass, and lipid-lowering effects compared to survodutide.
  • June 2024: Presented new pre-clinical data, at the EASL Congress, that suggests DA-1241, in combination with semaglutide (Wegovy®), a GLP1R agonist, improves liver fibrosis and demonstrates additive hepatoprotective effects in pre-clinical metabolic dysfunction-associated steatohepatitis (MASH) models compared to either treatment alone.
  • April 2024: Dosed the first patient in the SAD Part 1 of its Phase 1 clinical trial of DA-1726 for the treatment of obesity.
  • April 2024: Completed enrollment of Part 1 of its two-part Phase 2a trial evaluating the efficacy and safety of DA-1241 in MASH. Approximately 49 patients with presumed MASH were randomized with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo.

Anticipated Clinical Milestones

  • DA-1726 in Obesity: Top-line data from the single ascending dose (SAD) Part 1 is expected in the third quarter of 2024. The last patient visit in the multiple ascending dose (MAD) study Part 2 is expected in the fourth quarter of 2024 and the top-line data is expected in the first quarter of 2025. Upon clearance of an updated IND application with the FDA, the first patient in Part 3 is expected to be enrolled during the third quarter of 2025, with an interim data readout in or around mid-2026 and top-line results are expected in the second half of 2026.
  • DA-1241 in MASH: Top-line results from the two-part Phase 2a clinical trial of DA-1241 in MASH are expected to be available in the fourth quarter of 2024.

Second Quarter Financial and Operating Results

  • Research and Development (R&D) Expenses were approximately $8.1 million for the three months ended June 30, 2024, as compared to approximately $2.4 million for the three months ended June 30, 2023. The increase of approximately $5.7 million was primarily related to increased R&D activities for DA-1241 and DA-1726 for the three months ended June 30, 2024 following commencement of the Phase 2a clinical trial for DA-1241 and Phase 1 trial for DA-1726, compared to the three months ended June 30, 2023 when R&D activities were starting to ramp up following the acquisition of DA-1241 and DA-1726 in the fourth quarter of 2022. Specifically, the $5.7 million increase in R&D expenses was primarily attributable to (i) $5.4 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.3 million in higher employee compensation and benefits.

    R&D expenses were approximately $13.0 million for the six months ended June 30, 2024, as compared to approximately $3.0 million for the six months ended June 30, 2023. The approximately $10.0 million increase was primarily related to increased R&D activities for DA-1241 and DA-1726. Specifically, the $10.0 million increase in R&D expenses was primarily attributable to (i) $9.3 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.7 million in higher employee compensation and benefits.

  • General and Administrative (G&A) Expenses were approximately $2.0 million for the three months ended June 30, 2024, compared to approximately $1.4 million for the three months ended June 30, 2023. The increase of approximately $0.6 million was primarily attributable to $0.4 million in higher employee compensation and benefits and $0.1 million in higher non-cash stock-based compensation.

    G&A expenses were approximately $4.0 million for the six months ended June 30, 2024, as compared to approximately $3.3 million for the six months ended June 30, 2023. The approximately $0.7 million increase was primarily attributable to $0.4 million in higher employee compensation and benefits and $0.2 million in higher non-cash stock-based compensation.

  • Other Income was approximately $31 thousand for the three months ended June 30, 2024, as compared to approximately $3.1 million for the three months ended June 30, 2023. The approximately $3.0 million decrease was primarily attributable to a loss of $0.1 million related to the change in fair value of warrant liabilities for the three months ended June 30, 2024, compared to a gain of $3.1 million for the three months ended June 30, 2023, partially offset by $0.2 million of interest income earned on the cash balance for the three months ended June 30, 2024, of which there was none for the three months ended June 30, 2023.

    Other income was approximately $0.2 million for the six months ended June 30, 2024, as compared to approximately $3.0 million for the six months ended June 30, 2023. The approximately $2.8 million decrease was primarily attributable to the recording of a loss of $0.2 million related to the change in fair value of warrant liabilities for the six months ended June 30, 2024 compared to a gain of $3.0 million for three months ended June 30, 2023, partially offset by $0.4 million of interest income earned on the cash balance for the six months ended June 30, 2024, of which there was none for the six months ended June 30, 2023.

  • Net Loss for the three months ended June 30, 2024, was approximately $10.1 million, or $1.85 per basic and diluted share, based on 5,428,906 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately $0.7 million, or $0.15 per basic and diluted share, based on 5,059,003 weighted average shares of common stock, basic and diluted, for the three months ended June 30, 2023.

    Net loss for the six months ended June 30, 2024, was approximately $16.8 million, or $3.19 per basic and diluted share, based on 5,259,939 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately $3.3 million, or $0.66 per basic and diluted share, based on 5,059,003 weighted average shares of common stock, basic and diluted, for the six months ended June 30, 2023.

  • Cash was approximately $27.9 million as of June 30, 2024, compared to approximately $22.4 million as of December 31, 2023. The company expects its cash position will be adequate to fund operations into the second quarter of 2025. The Company anticipates that the Series A Warrants from the June financing could be exercised in the first half of 2025, resulting in gross proceeds of $20 million.

About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control.

For more information, please visit www.neurobopharma.com.

Forward Looking Statements
Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K.. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

NeuroBo Pharmaceuticals, Inc.
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com

Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

- Tables to Follow -

NeuroBo Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except per share amounts)




As of



June 30, 2024


December 31, 2023



(Unaudited)




Assets







Current assets:







 Cash


$

27,934


$

22,435

 Prepaid expenses and other current assets



583



77

Total current assets



28,517



22,512

Property and equipment, net



44



46

Right-of-use asset



169



202

Other assets



21



21

Total assets


$

28,751


$

22,781

Liabilities and stockholders' equity







Current liabilities:







Accounts payable


$

2,632


$

821

Clinical trial accrued liabilities



2,066



3,033

Accrued expenses and other current liabilities



463



592

Warrant liabilities



861



658

Related party payable



3,617



789

Lease liability, short-term



72



67

Total current liabilities



9,711



5,960

Lease liability, long-term



98



136

Total liabilities



9,809



6,096

Commitments and contingencies







Stockholders' equity







Preferred stock, $0.001 par value per share; 10,000 shares authorized as of
June 30, 2024 and December 31, 2023; no shares issued or outstanding as
of June 30, 2024 and December 31, 2023





Common stock, $0.001 par value per share, 100,000 shares authorized as
of June 30, 2024 and December 31, 2023; 8,221 and 4,906 shares issued
and outstanding as of June 30, 2024 and December 31, 2023, respectively



8



5

Additional paid–in capital



143,966



124,945

Accumulated deficit



(125,032)



(108,265)

Total stockholders' equity



18,942



16,685

Total liabilities and stockholders' equity


$

28,751


$

22,781

 

NeuroBo Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(Unaudited - In thousands, except share and per share amounts)




Three Months Ended June 30,


Six Months Ended June 30,



2024


2023


2024


2023

Operating expenses:













Research and development


$

8,074


$

2,364


$

12,978


$

3,001

General and administrative



2,010



1,442



3,987



3,325

Total operating expenses



10,084



3,806



16,965



6,326

Loss from operations



(10,084)



(3,806)



(16,965)



(6,326)

Other income (expense):













     Change in fair value of warrant liabilities



(133)



3,072



(203)



2,988

     Interest income



164





401



Total other income



31



3,072



198



2,988

Loss before income taxes



(10,053)



(734)



(16,767)



(3,338)

Provision for income taxes









Net loss and comprehensive net loss



(10,053)



(734)



(16,767)



(3,338)

Loss per share of common stock, basic and diluted


$

(1.85)


$

(0.15)


$

(3.19)


$

(0.66)

Weighted average shares of common stock, basic and
diluted



5,428,906



5,059,003



5,259,939



5,059,003

 

Cision View original content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-second-quarter-2024-financial-results-and-provides-corporate-update-302222264.html

SOURCE NeuroBo Pharmaceuticals, Inc.

FAQ

What were NeuroBo Pharmaceuticals' (NRBO) key financial results for Q2 2024?

NeuroBo Pharmaceuticals reported a net loss of $10.1 million for Q2 2024, compared to $0.7 million in Q2 2023. The company had $27.9 million in cash as of June 30, 2024, which is expected to fund operations into Q2 2025.

What is the status of NeuroBo's (NRBO) DA-1726 clinical trial for obesity?

NeuroBo has fully enrolled the SAD Part 1 of the Phase 1 trial for DA-1726 in obesity. Top-line data from this part is expected in Q3 2024, while top-line data from the MAD Part 2 is anticipated in Q1 2025.

When does NeuroBo (NRBO) expect top-line results for its DA-1241 MASH trial?

NeuroBo expects to report top-line results from the two-part Phase 2a clinical trial of DA-1241 in MASH in the fourth quarter of 2024.

What recent financing did NeuroBo Pharmaceuticals (NRBO) complete?

NeuroBo completed a financing of up to $70 million, with $20 million upfront and an additional $50 million of aggregate gross proceeds upon the exercise in full of clinical milestone-based warrants.

NeuroBo Pharmaceuticals, Inc.

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Biotechnology
Pharmaceutical Preparations
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