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NeuroBo Pharmaceuticals Announces the Closing of up to $70 Million Concurrent Private Placement and Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Prnewswire· 2024-06-25 21:08
H.C. Wainwright & Co. acted as the exclusive placement agent for the offerings. The shares of common stock offered in the registered direct offering (but excluding the securities offered in the private placement and the shares of common stock underlying the warrants issued in the private placement) were offered and sold by NeuroBo pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-278646), including a base prospectus, previously filed with the Securities and Exchange Commission ( ...
NeuroBo Pharmaceuticals Announces up to $70 Million Concurrent Private Placement and Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Prnewswire· 2024-06-24 12:01
Company Overview - NeuroBo Pharmaceuticals Inc is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases [3] - The company is developing DA-1726 for obesity treatment and DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [3] - DA-1726 is a novel oxyntomodulin analogue acting as a GLP1R and GCGR dual agonist, potentially offering superior weight loss compared to selective GLP1R agonists [3] - DA-1241 is a GPR119 agonist that promotes release of gut peptides GLP-1, GIP, and PYY, showing positive effects on liver inflammation, lipid metabolism, and glucose control in preclinical studies [3] Financing Activities - The company entered into definitive agreements for private placement of 4,325,701 shares at $3.93 per share [6] - A concurrent registered direct offering involves 763,359 shares at the same price [6] - The offerings include Series A warrants for 5,089,060 shares and Series B warrants for 7,633,591 shares, both exercisable at $3.93 per share [6] - Aggregate gross proceeds expected to be approximately $20 million upfront, with potential additional $50 million if all warrants are exercised [11][16] - Proceeds will be used for working capital, general corporate purposes, and clinical development of DA-1726 [11] Clinical Development - Series A warrants expire upon positive Phase 1 MAD data readout for DA-1726 or 12 months after stockholder approval [6] - Series B warrants expire upon positive Phase 1 Part 3 data readout for DA-1726 or 5 years after stockholder approval [6] - The financing is expected to provide cash runway to complete Phase 1 Part 3 clinical trial of DA-1726 [16] Regulatory and Legal Aspects - The registered direct offering is made pursuant to a shelf registration statement (Form S-3, No. 333-278646) filed with SEC on April 12, 2024 and declared effective on April 23, 2024 [7] - The private placement and Series Warrants are made under Section 4(a)(2) of Securities Act and Rule 506(b) of Regulation D [18] - The company has agreed to file a registration statement with SEC covering resale of securities issued in private placement [18]
NeuroBo Pharmaceuticals' DA-1726 Demonstrated Superiority in Weight Loss, Retention of Lean Body Mass, and Lipid-Lowering Effects Compared to Survodutide, in Pre-Clinical Models
Prnewswire· 2024-06-22 12:01
DA-1726 Also Exhibited Superior Glucose Lowering Compared to Survodutide Data Presented at the ADA 84th Scientific Sessions CAMBRIDGE, Mass., June 22, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced pre-clinical data which indicates that DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor ...
NeuroBo Pharmaceuticals(NRBO) - 2024 Q1 - Quarterly Report
2024-05-09 13:00
NeuroBo Pharmaceuticals, Inc. Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 545 Concord Avenue, Suite 210 Cambridge, Massachusetts 02138 (Address of pri ...
NeuroBo Pharmaceuticals(NRBO) - 2024 Q1 - Quarterly Results
2024-05-09 12:05
Exhibit 99.1 NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024 Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA-1726 in the Third Quarter of 2024 Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway After ...
NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update
Prnewswire· 2024-05-09 12:01
Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024 Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA-1726 in the Third Quarter of 2024 Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway After Enrollment of Part 1 Completed, With Data Expected in the Fourth Quarter of 2024 Cash of $16.0 Million, Expected ...
NeuroBo to Present Latest Pre-Clinical Data on Cardiometabolic Assets, DA-1241 and DA-1726, Targeting MASH and Obesity, at Scientific Conferences in June
Prnewswire· 2024-04-30 12:01
CAMBRIDGE, Mass., April 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced the acceptance of poster presentations for its promising cardiometabolic assets, DA-1241 and DA-1726, at the EASL Congress 2024 and the American Diabetes Association (ADA) 84th Scientific Sessions in June. "Having multiple posters selected for presentation at two of the most esteemed scientific forums ...
NeuroBo Pharmaceuticals(NRBO) - 2023 Q4 - Annual Report
2024-03-28 20:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-2389984 (State or ...
NeuroBo Pharmaceuticals(NRBO) - 2023 Q4 - Annual Results
2024-03-28 12:01
Exhibit 99.1 CAMBRIDGE, March 28, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the year ended December 31, 2023 and provided a corporate strategic update. "Throughout 2023 and into the first quarter of 2024, we made remarkable progress advancing the clinical development of our two, next generation cardiometabolic assets, which address the significant metabolic dysfunction-as ...
NeuroBo Pharmaceuticals(NRBO) - 2023 Q3 - Quarterly Report
2023-11-13 21:29
[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201%3A%20FINANCIAL%20STATEMENTS) This section presents NeuroBo Pharmaceuticals' unaudited condensed consolidated financial statements, detailing clinical program focus and 'going concern' uncertainty due to recurring losses and funding needs Condensed Consolidated Balance Sheet Data (in thousands) | | September 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $25,837 | $33,364 | | Total current assets | $26,145 | $33,532 | | Total assets | $26,425 | $33,534 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $4,722 | $11,784 | | Total liabilities | $4,875 | $11,784 | | Total stockholders' equity | $21,550 | $21,750 | Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | | Three Months Ended Sep 30 | Nine Months Ended Sep 30 | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $2,292 | $571 | $5,293 | $2,473 | | General and administrative | $1,601 | $2,533 | $4,926 | $6,725 | | Loss from operations | $(3,893) | $(3,104) | $(10,219) | $(9,198) | | Net loss | $(3,818) | $(3,113) | $(7,156) | $(9,291) | | Net loss per share, basic and diluted | $(0.09) | $(3.50) | $(0.18) | $(10.45) | Condensed Consolidated Statements of Cash Flows (in thousands) | | For the Nine Months Ended September 30, | | :--- | :--- | :--- | | | **2023** | **2022** | | Net cash used in operating activities | $(7,406) | $(9,905) | | Net cash used in (provided by) investing activities | $(41) | $8 | | Net cash used in financing activities | $(80) | $(134) | | Net decrease in cash | $(7,527) | $(10,031) | | Cash at beginning of period | $33,364 | $16,387 | | Cash at end of period | $25,837 | $6,356 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's strategic shift to DA-1241 and DA-1726, discontinuation of prior programs, a 'going concern' issue with cash into Q4 2024, and unaccrued milestone payment obligations - The company is a clinical-stage biotechnology firm focusing on two primary programs: **DA-1241** for NASH and T2D, and **DA-1726** for obesity and NASH[16](index=16&type=chunk)[21](index=21&type=chunk) - In June 2023, the company discontinued the clinical development of **ANA001** (niclosamide) and **gemcabene** for the treatment of COVID-19[17](index=17&type=chunk) - The company has an accumulated deficit of **$103.0 million** as of September 30, 2023, raising substantial doubt about its ability to continue as a going concern, with existing cash projected to fund operations into the **fourth quarter of 2024**[23](index=23&type=chunk)[24](index=24&type=chunk) - The company has potential future milestone payment obligations related to license agreements with Dong-A ST (up to **$316 million**), the ANA Merger, and Pfizer, but no milestones were achieved or considered probable as of September 30, 2023[40](index=40&type=chunk)[41](index=41&type=chunk)[43](index=43&type=chunk) - The valuation methodology for the **2022 Warrant** liabilities was changed from a Level 3 (Monte Carlo simulation) to a Level 2 input, approximating the underlying stock price due to a cashless exercise provision[70](index=70&type=chunk)[71](index=71&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=ITEM%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, strategic focus on DA-1241 and DA-1726, increased R&D expenses, and liquidity challenges, including a 'going concern' disclosure due to limited cash runway into Q4 2024 - The company's primary focus is on developing **DA-1241** for NASH/T2D and **DA-1726** for obesity, having discontinued **ANA001** and **Gemcabene** for COVID-19 in June 2023[87](index=87&type=chunk)[88](index=88&type=chunk) - A Phase 2a clinical trial for **DA-1241** in NASH patients was initiated in **Q3 2023**, with plans to file an IND for **DA-1726** and begin Phase 1 trials in **Q4 2023**[92](index=92&type=chunk)[100](index=100&type=chunk) Comparison of Operating Expenses (in thousands) | | Three Months Ended Sep 30 | Nine Months Ended Sep 30 | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $2,292 | $571 | $5,293 | $2,473 | | General and administrative | $1,601 | $2,533 | $4,926 | $6,725 | - The increase in R&D expenses for **Q3 2023** (**+$1.7 million** YoY) and the nine months ended Sep 30, 2023 (**+$2.8 million** YoY) was primarily driven by **DA-1241** clinical trial costs, including toxicology studies and drug manufacturing[103](index=103&type=chunk)[111](index=111&type=chunk) - The decrease in G&A expenses was mainly due to lower professional fees related to the exploration of business opportunities in **2022** and reduced insurance costs[106](index=106&type=chunk)[114](index=114&type=chunk) - As of September 30, 2023, the company had **$25.8 million** in cash, expected to fund operations into the **fourth quarter of 2024**, raising substantial doubt about its ability to continue as a going concern[131](index=131&type=chunk)[132](index=132&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=ITEM%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is noted as not applicable for the company - Not applicable[136](index=136&type=chunk) [Controls and Procedures](index=31&type=section&id=ITEM%204%3A%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of September 30, 2023, due to material weaknesses in segregation of duties, logical access, and supervision, with a remediation plan underway - Management concluded that disclosure controls and procedures were not effective as of **September 30, 2023**[141](index=141&type=chunk) - Material weaknesses were identified in internal control over financial reporting, specifically: a lack of segregation of duties, issues with logical access to financial systems, and insufficient supervision and review[142](index=142&type=chunk) - Remediation efforts are underway, including hiring additional accounting personnel, enhancing controls over disbursements, improving review and oversight processes, and restricting system administrator rights[144](index=144&type=chunk)[153](index=153&type=chunk) [PART II OTHER INFORMATION](index=34&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=34&type=section&id=ITEM%201%3A%20Legal%20Proceedings) The company reports no current material legal proceedings expected to adversely affect its business - The company is not currently a party to any material legal proceedings[147](index=147&type=chunk) [Risk Factors](index=34&type=section&id=ITEM%201A%3A%20Risk%20Factors) This section updates the company's risk factors, emphasizing substantial doubt about its going concern ability due to losses and limited cash, alongside Nasdaq non-compliance and potential delisting risks - The company has incurred losses since inception, with an accumulated deficit of **$103.0 million** as of September 30, 2023, raising substantial doubt about its ability to continue as a going concern[149](index=149&type=chunk)[150](index=150&type=chunk)[153](index=153&type=chunk) - Existing cash of **$25.8 million** is expected to fund operations only into the **fourth quarter of 2024**, necessitating additional unsecured financing[151](index=151&type=chunk)[152](index=152&type=chunk) - The company is not in compliance with Nasdaq's minimum bid price rule (**$1.00/share**) and has an extension until **February 5, 2024**, to regain compliance[156](index=156&type=chunk)[158](index=158&type=chunk) - Failure to regain compliance with Nasdaq listing requirements could lead to delisting, adversely affecting stock liquidity, value, and capital raising ability, though a reverse stock split has been approved as a potential remedy[157](index=157&type=chunk)[159](index=159&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=ITEM%202%3A%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - None[164](index=164&type=chunk) [Default upon Senior Securities](index=37&type=section&id=ITEM%203%3A%20Default%20upon%20Senior%20Securities) This section is noted as not applicable - Not applicable[165](index=165&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=ITEM%204%3A%20Mine%20Safety%20Disclosures) This section is noted as not applicable - Not applicable[166](index=166&type=chunk) [Other Information](index=37&type=section&id=ITEM%205%3A%20Other%20Information) The company discloses that no directors or Section 16 officers adopted or terminated a Rule 10b5-1 trading plan during Q3 2023 - During the three months ended **September 30, 2023**, no directors or Section 16 officers adopted or terminated a Rule 10b5-1 trading plan[167](index=167&type=chunk) [Exhibits](index=38&type=section&id=ITEM%206%3A%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, a new lease agreement, and required officer certifications - The report includes a list of filed exhibits, notably a new Lease Agreement dated **August 23, 2023**, and required officer certifications (**302** and **906**)[169](index=169&type=chunk)