Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Concorde International Group Ltd. (CIGL) increased by 53% to $3.94 [3] - Fermi Inc. Common Stock (FRMI) rose by 13% to $36.99 [3] - Kodiak AI, Inc. (KDK) also saw a 13% increase, reaching $6.76 [3] - AngioDynamics, Inc. (ANGO) gained 12%, trading at $12.45 [3] - Angel Studios, Inc. (ANGX) was up 11% at $8.51 [3] - Spruce Biosciences, Inc. (SPRB) increased by 9% to $9.75 [3] - K Wave Media Ltd. (KWM) rose by 9% to $2.66 [3] - Shoals Technologies Group, Inc. (SHLS) saw an 8% increase, trading at $8.59 [3] - StableX Technologies, Inc. (SBLX) was up 7% at $5.65 [3] Premarket Losers - Uni-Fuels Holdings Limited (UFG) decreased by 51% to $2.42 [4] - Akanda Corp. (AKAN) fell by 13% to $2.91 [4] - Equifax Inc. (EFX) dropped 11%, trading at $224.57 [4] - TransUnion (TRU) also saw an 11% decline, reaching $73.24 [4] - Bolt Biotherapeutics, Inc. (BOLT) decreased by 11% to $4.99 [4] - Dogwood Therapeutics, Inc. (DWTX) fell by 8% to $6.50 [4] - Galaxy Payroll Group Limited (GLXG) decreased by 8% to $4.52 [4] - Old Market Capital Corporation (OMCC) dropped 7% to $5.08 [4] - Entero Therapeutics, Inc. (ENTO) fell by 7% to $3.96 [4] - Flux Power Holdings, Inc. (FLUX) decreased by 7% to $3.74 [4]

U.S. stock futures were fluctuating on Thursday following Wednesday’s record advances. Futures of major benchmark indices were mixed.The Donald Trump administration has reportedly warned that the shutdown could cut $15 billion from weekly GDP and leave 43,000 more people jobless if it lasts a month. After the Senate rejected competing government funding bills from both Republicans and Democrats on Wednesday, the next opportunity to hold a vote will be on Friday. The chamber will be out on Thursday in observ ...

With U.S. stock futures trading mixed this morning on Thursday, some of the stocks that may grab investor focus today are as follows:Wall Street expects AngioDynamics, Inc. (NASDAQ:ANGO) to report a quarterly loss at 12 cents per share on revenue of $72.72 million before the opening bell, according to data from Benzinga Pro. AngioDynamics shares gained 2.1% to $11.30 in after-hours trading.Grindr Inc (NYSE:GRND) named John North as chief financial officer, effective immediately. Grindr shares fell 0.9% to c ...

Transaction positions ENTO in the high-growth AI energy-infrastructure market, amid a surge of multi-billion- dollar hyperscaler spending on data centers, and rapid growth in behind-the-meter energy storage solutions BOCA RATON, FL / ACCESS Newswire / October 1, 2025 / Entero Therapeutics, Inc. (NASDAQ:ENTO) ("ENTO" or the "Company") today announced it has acquired 100% of GRID AI Corp ("GRID AI"), a grid- edge, AI-driven software and device platform that enables utilities, retailers, and large power users ...

ENTERO THERAPEUTICS (ENTO) Acquires 100% of GRID AI, a Grid-Edge AI Platform Optimizing Next-Gen Power DemandTransaction positions ENTO in the high-growth AI energy-infrastructure market, amid a surge of multi-billion-dollar hyperscaler spending on data centers, and rapid growth in behind-the-meter energy storage solutionsOctober 01, 2025 8:30 AM EDT | Source: Entero Therapeutics, Inc.Boca Raton, Florida--(Newsfile Corp. - October 1, 2025) - Entero Therapeutics, Inc. (NASDAQ: ENTO) ("ENTO" or ...

In this article, we will be taking a look at the 15 Best Biotech Penny Stocks to Invest in Right Now. Entero Therapeutics, Inc. is included in them. Entero Therapeutics, Inc. (NASDAQ:ENTO) is a clinical-stage biopharmaceutical company developing targeted, non-systemic therapies for gastrointestinal disorders, including celiac disease, gastroparesis, and pancreatic insufficiency. The company has recently drawn attention as a biotech penny stock due to key developments in September 2025. A major change in ...

PART I. FINANCIAL INFORMATION [Item 1. Unaudited Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, detailing financial position and performance [Consolidated Balance Sheets (unaudited)](index=6&type=section&id=Consolidated%20Balance%20Sheets%20(unaudited)) This section details the company's unaudited consolidated balance sheets for June 30, 2025, and December 31, 2024 | ASSETS (in $) | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Cash and cash equivalents | 4,474 | 163,476 | | Prepaid expenses | 144,159 | 145,319 | | Assets of disposal group held-for-sale | 83,170,009 | 83,170,009 | | Total Current Assets | 83,318,642 | 83,478,804 | | Restricted cash | 7,005 | 21,516 | | Goodwill | 1,684,182 | 1,684,182 | | Operating lease right-of-use assets | — | 126,753 | | Deposits | 49,122 | 98,251 | | Total Other Assets | 1,740,309 | 1,930,702 | | **Total Assets** | **85,058,951**| **85,409,506** | | LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) (in $) | June 30, 2025 | December 31, 2024 | | :---------------------------------------------------- | :------------ | :---------------- | | Accounts payable | 3,298,447 | 2,959,248 | | Accrued expenses | 415,444 | 252,048 | | Accrued dividend payable | 1,474,009 | 1,310,581 | | Line of credit | 700,000 | — | | Operating lease liabilities - current | 135,609 | 81,510 | | Liabilities held-for-sale | 23,546,478 | 22,941,497 | | Other current liabilities | 105,918 | 1,236 | | Total Current Liabilities | 29,675,905 | 27,546,120 | | Operating lease liabilities – non-current | — | 59,024 | | Total Liabilities | 29,675,905 | 27,605,144 | | Series G preferred stock | 61,681,100 | 61,681,100 | | Common stock | 477 | 475 | | Additional paid-in capital | 198,347,367 | 198,510,795 | | Accumulated deficit | (204,645,898) | (202,388,008) | | Total Stockholders' Equity (Deficit) | (6,298,054) | (3,876,738) | | **Total Liabilities, Mezzanine Equity and Stockholders' Equity (Deficit)** | **85,058,951**| **85,409,506** | [Consolidated Statements of Operations (unaudited)](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20(unaudited)) This section presents the unaudited consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 | Operating Expenses (in $) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | 10,631 | 219,591 | 26,458 | 675,523 | | General and administrative| 628,233 | 3,206,517 | 1,433,791 | 11,849,633 | | Total operating expenses | 638,864 | 3,426,108 | 1,460,249 | 12,525,156 | | Loss from operations | (638,864) | (3,426,108) | (1,460,249) | (12,525,156) | | Other expenses, net | (36,067) | (4,114) | (162,786) | (4,539) | | Loss from continued operations | (674,931) | (3,430,222) | (1,623,035) | (12,529,695) | | Income tax benefit | — | (4,255,247) | — | 10,604,640 | | Net loss from continued operations | (674,931) | (7,685,469) | (1,623,035) | 1,925,055 | | Loss from discontinued operations net of tax | (323,340) | (1,122,233) | (634,855) | (1,315,041) | | **Net loss** | **(998,271)** | **(8,807,702)** | **(2,257,890)** | **(3,240,096)** | | Preferred stock dividends | (82,165) | (38,058) | (163,428) | (104,202) | | Net loss applicable to common shareholders | (1,080,436) | (8,845,760) | (2,421,318) | (3,344,298) | | Weighted average shares outstanding, basic and diluted | 4,765,004 | 2,294,208 | 4,765,004 | 2,028,080 | | Loss per share, basic and diluted | (0.21) | (3.86) | (0.51) | (1.65) | | Loss per share from discontinued operations, basic and diluted | (0.07) | (0.49) | (0.13) | (0.65) | [Consolidated Statements of Mezzanine Equity and Changes in Stockholders' Equity (Deficit) (unaudited)](index=8&type=section&id=Consolidated%20Statements%20of%20Mezzanine%20Equity%20and%20Changes%20in%20Stockholders'%20Equity%20(Deficit)%20(unaudited)) This section outlines changes in mezzanine equity and stockholders' equity (deficit) for the periods ended June 30, 2025 and 2024 - The company's total stockholders' equity (deficit) decreased from **$(3,876,738)** at January 1, 2025, to **$(6,298,054)** at June 30, 2025, primarily due to a net loss of **$(998,270)** and deemed dividends of Series B preferred stock of **$(163,428)**[25](index=25&type=chunk) - For the six months ended June 30, 2024, the company's total stockholders' equity increased from **$3,602,929** to **$9,120,595**, driven by common stock issuances from offerings (**$4,495,526**), Series G preferred stock issuance for IMGX acquisition (**$57,790,474**), and common stock issued for IMGX acquisition (**$2,300,500**), despite a net loss of **$(3,240,096)**[25](index=25&type=chunk) [Consolidated Statements of Cash Flows (unaudited)](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) This section presents the unaudited consolidated statements of cash flows for the six months ended June 30, 2025 and 2024 | Cash Flows (in $) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | (873,513) | (7,197,816) | | Net cash provided by investing activities | — | 88,169 | | Net cash provided by financing activities | 700,000 | 4,060,350 | | Net (decrease) in cash, cash equivalents and restricted cash | (173,513) | (3,049,297) | | Cash, cash equivalents and restricted cash, beginning balance | 184,992 | 3,733,292 | | Cash, cash equivalents and restricted cash, ending balance | 11,479 | 683,995 | [Note 1 - The Company and Basis of Presentation](index=11&type=section&id=Note%201%20-%20The%20Company%20and%20Basis%20of%20Presentation) This note describes the company's business, strategic shifts, and going concern status, including the IMGX acquisition and rescission - Entero Therapeutics, Inc. (formerly First Wave Biopharma, Inc.) focuses on developing non-systemic therapies for gastrointestinal (GI) diseases, with Adrulipase as its primary development program[28](index=28&type=chunk)[29](index=29&type=chunk) - The company acquired ImmunogenX (IMGX) in March 2024, but subsequently classified IMGX's assets and liabilities as held for sale, representing a strategic shift[30](index=30&type=chunk) - The company faces substantial doubt about its ability to continue as a going concern due to significant operating losses, negative cash flows, and an accumulated deficit of approximately **$204.6 million** as of June 30, 2025, necessitating additional capital funding[37](index=37&type=chunk)[39](index=39&type=chunk) [Note 2 - Significant Accounting Policies and Recent Accounting Pronouncements](index=13&type=section&id=Note%202%20-%20Significant%20Accounting%20Policies%20and%20Recent%20Accounting%20Pronouncements) This note details the company's significant accounting policies and recent accounting pronouncements, including R&D costs and lease impairments - The company operates as a single operating segment focused on research and development[42](index=42&type=chunk) - Research and development costs are expensed as incurred, including compensation, third-party fees for preclinical and clinical activities, drug supply costs, and license fees[60](index=60&type=chunk) - In March 2025, the company defaulted on its Boca Raton office lease, leading to a full impairment of the related Right-of-Use (ROU) asset of **$108,759** and an accrual of **$100,902** for outstanding payments and penalties[157](index=157&type=chunk)[159](index=159&type=chunk) [Note 3 – Business Acquisition](index=23&type=section&id=Note%203%20%E2%80%93%20Business%20Acquisition) This note describes the acquisition of ImmunogenX (IMGX) in March 2024, including consideration and purchase price allocation - On March 13, 2024, Entero Therapeutics acquired ImmunogenX, Inc. (IMGX) in a merger, issuing **36,830** shares of Common Stock and **11,777.418** shares of Series G Preferred Stock to IMGX stockholders, and assuming IMGX stock options and warrants[80](index=80&type=chunk)[81](index=81&type=chunk)[83](index=83&type=chunk) - The total consideration for the IMGX acquisition was approximately **$60.1 million**, with a purchase price allocation that included **$63.37 million** in intangibles (primarily IPR&D for Latiglutenase and CypCel) and **$18.35 million** in goodwill[86](index=86&type=chunk)[87](index=87&type=chunk) - Transaction costs for the IMGX merger amounted to **$5,456,038**, including approximately **$4.0 million** in financial advisory fees paid to Tungsten Partners LLC[82](index=82&type=chunk)[84](index=84&type=chunk) [Note 4 – Discontinued Operations and Assets and Liabilities Held for Sale](index=26&type=section&id=Note%204%20%E2%80%93%20Discontinued%20Operations%20and%20Assets%20and%20Liabilities%20Held%20for%20Sale) This note details the classification of IMGX assets and liabilities as held for sale and the subsequent rescission agreement - The company initiated a plan to dispose of IMGX assets and liabilities within **12 months** of the March 2024 merger, classifying them as held for sale due to a strategic shift[90](index=90&type=chunk) - A Rescission Agreement was entered into in March 2025 (amended July 2025) with IMGX shareholders to rescind the merger, convey IMGX membership interests back, and cancel related stock and warrants. The company will retain up to **$695,000** of IMGX's accounts payable, while IMGX remains responsible for approximately **$9.28 million** of secured debt[91](index=91&type=chunk) Loss from Discontinued Operations (in $) | Loss from Discontinued Operations (in $) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | — | 802,470 | — | 923,872 | | General and administrative expenses | — | 70,012 | — | 75,216 | | Total operating expenses | — | 872,482 | — | 999,088 | | Interest expense | (323,340) | (298,480) | (634,855) | (364,682) | | Other (expense) income | — | 48,729 | — | 48,729 | | **Loss from discontinued operations** | **(323,340)** | **(1,122,233)** | **(634,855)** | **(1,315,041)** | Assets and Liabilities Held for Sale (in $) | Assets and Liabilities Held for Sale (in $) | June 30, 2025 | | :---------------------------------------- | :------------ | | **Assets held for sale:** | | | Prepaid expenses and other current assets | 3,131,929 | | Property and equipment, net | 16,180 | | Goodwill and intangible assets | 80,021,900 | | **Total assets held for sale** | **83,170,009**| | **Liabilities held for sale:** | | | Accounts payable | 141,906 | | Accrued expenses and other current liabilities | 3,128,151 | | Debt | 6,403,737 | | Deferred tax liability | 13,872,684 | | **Total liabilities held for sale** | **23,546,478**| [Note 5 - Fair Value Disclosures](index=28&type=section&id=Note%205%20-%20Fair%20Value%20Disclosures) This note provides fair value disclosures for financial instruments, including money market funds and a note payable Financial Instruments (in $) | Financial Instruments (in $) | Carrying Amount (June 30, 2025) | Fair Value (Level 1) | Fair Value (Level 2) | Fair Value (Level 3) | | :--------------------------- | :------------------------------ | :------------------- | :------------------- | :------------------- | | Money market funds | 18 | 18 | — | — | | Note Payable | 700,000 | — | 700,000 | — | | Financial Instruments (in $) | Carrying Amount (Dec 31, 2024) | Fair Value (Level 1) | Fair Value (Level 2) | Fair Value (Level 3) | | :--------------------------- | :----------------------------- | :------------------- | :------------------- | :------------------- | | Money market funds | 12,723 | 12,723 | — | — | [Note 6 – Goodwill](index=28&type=section&id=Note%206%20%E2%80%93%20Goodwill) This note details the changes in goodwill, including amounts associated with the IMGX acquisition and reclassification Goodwill (in $) | Goodwill (in $) | Amount | | :------------------------------------ | :------- | | Balance on Dec 31, 2024 | 1,684,182| | Balance on March 31, 2025 | 1,684,182| | Goodwill associated with IMGX acquisition | 18,354,326| | Goodwill reclassified as held for sale | (18,354,326)| | **Balance on June 30, 2025 (unaudited)** | **1,684,182**| [Note 7 – Intangible Assets and In-Process R&D](index=29&type=section&id=Note%207%20%E2%80%93%20Intangible%20Assets%20and%20In-Process%20R%26D) This note explains the reclassification of all intangible assets and in-process R&D acquired from ImmunogenX as held for sale - As of June 30, 2025, all intangible assets, including patents, trademarks, trade names, and in-process R&D (IPR&D) acquired from ImmunogenX, have been reclassified as held for sale, resulting in a net balance of **$0**[98](index=98&type=chunk) [Note 8 - Accrued Expenses](index=29&type=section&id=Note%208%20-%20Accrued%20Expenses) This note provides a breakdown of accrued expenses, including professional and consulting fees, for June 30, 2025, and December 31, 2024 Accrued Expenses (in $) | Accrued Expenses (in $) | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Professional fees | 103,530 | 186,173 | | Consulting fees | 129,262 | 65,875 | | **Total accrued expenses**| **232,792** | **252,048** | [Note 9 – Capital Stock](index=29&type=section&id=Note%209%20%E2%80%93%20Capital%20Stock) This note details the company's capital stock, including common stock, Series G preferred stock, and warrant inducement offers - As of June 30, 2025, the company had **4,765,729** shares of Common Stock issued and outstanding, an increase from **4,754,038** shares at December 31, 2024[104](index=104&type=chunk) - The company issued **12,373.226** shares of Series G Preferred Stock in connection with the IMGX Merger on March 13, 2024. These shares are convertible into **1,000** shares of Common Stock each upon stockholder approval and are redeemable for cash at the holder's option after **six months**[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) - In July 2024, the company completed an inducement offer, generating approximately **$1.9 million** from the exercise of existing warrants and the issuance of new inducement warrants[125](index=125&type=chunk) [Note 10 – Warrants](index=37&type=section&id=Note%2010%20%E2%80%93%20Warrants) This note summarizes warrant activity, including outstanding warrants, exercise prices, and remaining terms for the reported periods Warrant Activity | Warrant Activity | Number of Warrants (June 30, 2025) | Weighted Average Exercise Price Per Share (June 30, 2025) | Weighted Average Remaining Term in Years (June 30, 2025) | | :--------------- | :--------------------------------- | :-------------------------------------------------------- | :------------------------------------------------------- | | Outstanding at January 1, 2025 | 4,927,714 | $6.98 | 4.71 | | Expired during the period | (23) | $50,107.83 | — | | **Outstanding at June 30, 2025** | **4,927,691** | **$6.75** | **4.21** | | Warrant Activity | Number of Warrants (June 30, 2024) | Weighted Average Exercise Price Per Share (June 30, 2024) | Weighted Average Remaining Term in Years (June 30, 2024) | | :--------------- | :--------------------------------- | :-------------------------------------------------------- | :------------------------------------------------------- | | Outstanding at January 1, 2024 | 1,779,780 | $19.29 | 4.99 | | Issued during the period | 1,701,150 | $3.47 | 5.26 | | Assumed from IMGX | 127,680 | $3.48 | 8.72 | | Exercised during the period | (443,525) | — | 4.93 | | **Outstanding at June 30, 2024** | **3,165,085** | **$12.85** | **5.01** | [Note 11 – Equity Incentive Plan](index=37&type=section&id=Note%2011%20%E2%80%93%20Equity%20Incentive%20Plan) This note provides details on the company's equity incentive plan, including outstanding stock options and stock-based compensation expense - As of June 30, 2025, the company had **8,268** stock options outstanding and exercisable, with a weighted average exercise price of **$13,041.72** and a remaining contractual life of **6.29 years**[144](index=144&type=chunk) - For the six months ended June 30, 2025, there were no new option grants, and total stock-based compensation expense was **$0**, a significant decrease from **$390,449** in the prior year period[144](index=144&type=chunk)[150](index=150&type=chunk) [Note 12 – Agreements](index=39&type=section&id=Note%2012%20%E2%80%93%20Agreements) This note discusses significant agreements, including the termination of the license agreement with Sanofi for the Capeserod program - The company terminated its license agreement with Sanofi for the Capeserod program on February 26, 2025, with no payments due to Sanofi upon termination[156](index=156&type=chunk) [Note 13 – Leases](index=41&type=section&id=Note%2013%20%E2%80%93%20Leases) This note details the company's lease obligations, including the default on its Boca Raton office lease and related impairment - The company defaulted on its Boca Raton office lease in March 2025, leading to a full impairment of the Right-of-Use (ROU) asset by **$108,759** and an accrual of **$100,902** for outstanding payments and penalties[157](index=157&type=chunk)[159](index=159&type=chunk) [Note 14 – Debt](index=41&type=section&id=Note%2014%20%E2%80%93%20Debt) This note outlines the company's debt, including a new revolving loan agreement and reclassification of IMGX-assumed debt - Effective January 31, 2025, the company entered into a Revolving Loan Agreement for a principal amount of **$2.0 million**, with an initial disbursement of **$700,000** at an **18%** annual interest rate[161](index=161&type=chunk) - Debt assumed from the IMGX acquisition, including a revolving line of credit, promissory notes, and an EIDL loan, has been reclassified to liabilities of disposal group held for sale[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) [Note 15 – Net (Loss) Income per Common Share](index=42&type=section&id=Note%2015%20%E2%80%93%20Net%20(Loss)%20Income%20per%20Common%20Share) This note explains the calculation of net loss per common share, including the exclusion of anti-dilutive securities - For the six months ended June 30, 2025, stock options (**8,268**) and warrants (**4,927,691**) were excluded from diluted net loss per share calculation as their inclusion would be anti-dilutive[167](index=167&type=chunk) Potentially Issuable Common Shares | Potentially Issuable Common Shares | June 30, 2025 (unaudited) | June 30, 2024 (unaudited) | | :--------------------------------- | :------------------------ | :------------------------ | | Series G convertible preferred stock | 12,373,226 | 12,373,226 | | Common stock warrants | 4,927,691 | 3,165,085 | | Stock options | 8,268 | 201,077 | | RSUs not yet issued | 1 | 119,539 | | Series B convertible preferred stock | 138 | 135 | | Restricted stock not yet issued | 4 | 4 | | **Total shares of common stock issuable** | **17,309,328** | **15,859,066** | [Note 16 - Employee Benefit Plans](index=43&type=section&id=Note%2016%20-%20Employee%20Benefit%20Plans) This note details changes in employer contributions to the 401(k) plan for the six months ended June 30, 2025 and 2024 - Employer contributions to the 401(k) plan decreased significantly from approximately **$30,000** for the six months ended June 30, 2024, to approximately **$1,000** for the same period in 2025[170](index=170&type=chunk) [Note 17 - Income Taxes](index=43&type=section&id=Note%2017%20-%20Income%20Taxes) This note discusses the company's effective income tax rate, influenced by valuation allowances and the IMGX Merger - The company's effective income tax rate was approximately **0%** for the six months ended June 30, 2025, primarily due to a valuation allowance against deferred tax assets, compared to **160%** for the same period in 2024, which was influenced by the IMGX Merger[174](index=174&type=chunk)[176](index=176&type=chunk) [Note 18 - Contingencies](index=45&type=section&id=Note%2018%20-%20Contingencies) This note outlines legal contingencies, including a settled lawsuit against IMGX and a new lawsuit against the company for legal fees - A lawsuit by Mattress Liquidators, Inc. against IMGX for breach of a credit agreement, claiming **$7.58 million**, was settled in May 2025. The settlement involved Guarantors paying **$5.5 million**, Immuno LLC paying **$62,000** in legal fees, and a new revolving loan for Immuno LLC[177](index=177&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk) - Ellenoff Grossman & Schole LLP filed a lawsuit against the company in March 2025, seeking **$749,301** for alleged unpaid legal services, with the company currently investigating and planning to defend the action[187](index=187&type=chunk)[280](index=280&type=chunk) [Note 19 - Subsequent Events](index=47&type=section&id=Note%2019%20-%20Subsequent%20Events) This note reports subsequent events, including Nasdaq compliance and a securities purchase agreement for approximately $3.0 million - The company regained compliance with Nasdaq Listing Rule 5620(a) by holding its annual meeting on June 30, 2025, but received an extension until October 8, 2025, to comply with the minimum stockholders' equity requirement[188](index=188&type=chunk)[189](index=189&type=chunk) - On August 9, 2025, the company entered into a Securities Purchase Agreement with institutional investors to issue pre-funded and common warrants for aggregate gross proceeds of approximately **$3.0 million**[190](index=190&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition, operations, strategic shifts, and liquidity challenges [Overview](index=48&type=section&id=Overview) This overview discusses the company's focus on Adrulipase, discontinuation of other programs, IMGX merger rescission, and Nasdaq compliance - The company is focused on developing Adrulipase for exocrine pancreatic insufficiency (EPI) in cystic fibrosis and chronic pancreatitis patients, planning to advance the program in 2025 despite not achieving the primary efficacy endpoint in a Phase 2b study[195](index=195&type=chunk)[202](index=202&type=chunk) - The company has discontinued its Latiglutenase, Capeserod, and Niclosamide programs, with the Capeserod license agreement with Sanofi terminated in February 2025[195](index=195&type=chunk)[199](index=199&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk) - The merger with ImmunogenX (IMGX) in March 2024 is being rescinded, with a Rescission Agreement signed in March 2025 (amended July 2025) to reverse the transaction and convey IMGX interests back to its former shareholders[196](index=196&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk) - The company received a **180-day** extension until September 1, 2025, to regain compliance with Nasdaq's minimum bid price requirement, while compliance with the annual meeting rule was regained on June 30, 2025[205](index=205&type=chunk)[209](index=209&type=chunk) [Liquidity and Capital Resources](index=54&type=section&id=Liquidity%20and%20Capital%20Resources) This section addresses the company's liquidity challenges, going concern doubt, and ongoing efforts to secure additional funding - As of June 30, 2025, the company had cash and cash equivalents of approximately **$4,474** and sustained cumulative losses of approximately **$2.3 million**, raising substantial doubt about its ability to continue as a going concern[221](index=221&type=chunk)[222](index=222&type=chunk) - The company is dependent on obtaining additional funding through equity and/or debt financings, collaborations, or other arrangements to support its operations and Adrulipase development[224](index=224&type=chunk) - A Revolving Loan Agreement effective January 31, 2025, provided an initial loan of **$700,000** out of a **$2.0 million** principal amount, bearing **18%** annual interest[227](index=227&type=chunk) [Financial Operations Overview](index=58&type=section&id=Financial%20Operations%20Overview) This overview discusses the company's lack of revenue, expected future revenue sources, and significant changes in operating expenses and net loss - The company has not generated any revenue to date and expects future revenue primarily from product sales, research funding, development and milestone payments, and royalties[232](index=232&type=chunk) Operating Expenses (in $) | Operating Expenses (in $) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | 10,631 | 219,591 | 26,458 | 675,523 | | General and administrative| 628,233 | 3,206,517 | 1,433,791 | 11,849,633 | | Total operating expenses | 638,864 | 3,426,108 | 1,460,249 | 12,525,156 | | Other expenses | (36,067) | (4,114) | (162,786) | (4,539) | | Loss from discontinued operations | (323,344) | (1,122,233) | (634,855) | (1,315,041) | | **Net income (loss)** | **(998,271)** | **(8,807,702)** | **(2,257,890)** | **(3,240,096)** | - Research and development expenses decreased by approximately **$0.2 million** (YoY) for the three months ended June 30, 2025, and by approximately **$0.7 million** (YoY) for the six months ended June 30, 2025, primarily due to a decrease in clinical-related expenses[241](index=241&type=chunk)[251](index=251&type=chunk) - General and administrative expenses decreased by approximately **$2.6 million** (**80%** YoY) for the three months and **$10.4 million** (**88%** YoY) for the six months ended June 30, 2025, mainly due to reduced consultant compensation, headcount, public company costs, IMGX merger costs, and legal fees[244](index=244&type=chunk)[245](index=245&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk) [Cash Flows for the six months Ended June 30, 2025 and 2024](index=64&type=section&id=Cash%20Flows%20for%20the%20six%20months%20Ended%20June%2030,%202025%20and%202024) This section analyzes cash flows from operating and financing activities for the six months ended June 30, 2025 and 2024 - Net cash used in operating activities significantly decreased from approximately **$7.2 million** in the six months ended June 30, 2024, to approximately **$0.9 million** in the same period of 2025, primarily due to a lower net loss and changes in working capital[261](index=261&type=chunk)[262](index=262&type=chunk) - Net cash provided by financing activities decreased from approximately **$4.1 million** in the six months ended June 30, 2024 (driven by registered direct offerings), to approximately **$0.7 million** in the same period of 2025 (from a revolver loan draw)[265](index=265&type=chunk)[266](index=266&type=chunk) [Critical Accounting Policies and Estimates](index=66&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section states that there were no material changes to the company's critical accounting policies and estimates during the reported period - There were no material changes to the company's critical accounting policies and significant judgments and estimates during the three months ended June 30, 2025, as discussed in its Annual Report on Form 10-K/A[268](index=268&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=66&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that quantitative and qualitative disclosures about market risk are not applicable to the company for the reported period - Quantitative and qualitative disclosures about market risk are not applicable[269](index=269&type=chunk) [Item 4. Controls and Procedures](index=66&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control - The CEO and CFO evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, and concluded they are effective[270](index=270&type=chunk) - There were no material changes in internal control over financial reporting during the period covered by this Quarterly Report on Form 10-Q[271](index=271&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=67&type=section&id=Item%201.%20Legal%20Proceedings) This section details ongoing legal proceedings, including a settled lawsuit against IMGX and a new lawsuit against the company for legal fees - The lawsuit by Mattress Liquidators, Inc. against IMGX for **$7.58 million** was settled in May 2025, with the company being released from obligations related to this complaint under the terms of the IMGX Rescission Agreement[273](index=273&type=chunk)[275](index=275&type=chunk)[277](index=277&type=chunk)[278](index=278&type=chunk) - Ellenoff Grossman & Schole LLP filed a lawsuit against the company in March 2025, seeking **$749,301** for alleged unpaid legal services, with the company currently evaluating the claims and negotiating a settlement[280](index=280&type=chunk) [Item 1A. Risk Factors](index=68&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the company's Annual Report on Form 10-K/A for risk factors, noting no material changes during the period - There have been no material changes to the risk factors set forth in the company's Annual Report on Form 10-K/A for the year ended December 31, 2024[281](index=281&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=68&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates no unregistered sales of equity securities or use of proceeds occurred during the reported quarter - There were no unregistered sales of equity securities or use of proceeds during the quarter ended June 30, 2025[282](index=282&type=chunk) [Item 3. Defaults Upon Senior Securities](index=68&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the quarter ended June 30, 2025 - There were no defaults upon senior securities during the quarter ended June 30, 2025[283](index=283&type=chunk) [Item 4. Mine Safety Disclosures](index=68&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the company for the reported period - Mine safety disclosures are not applicable to the company[284](index=284&type=chunk) [Item 5. Other Information](index=68&type=section&id=Item%205.%20Other%20Information) This section reports that no directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements during the quarter - None of the company's directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[285](index=285&type=chunk) [Item 6. Exhibits](index=69&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including organizational documents and certifications - The exhibits include the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, certifications from the Principal Executive Officer and Principal Financial Officer (pursuant to Sections 302 and 906 of Sarbanes-Oxley Act), and Inline XBRL documents[287](index=287&type=chunk)

Richard Paolone, the Company's Interim Chief Executive Officer, commented, "The reverse split is a necessary step in our efforts to maintain our listing on the Nasdaq market. The visibility and credibility that comes with a Nasdaq listing is an important component in our efforts to enhance shareholder value." Boca Raton, Florida--(Newsfile Corp. - August 14, 2025) - Entero Therapeutics, Inc. (NASDAQ: ENTO) (the "Company"), a clinical-stage biopharmaceutical company specializing in the development of targete ...

PART I. FINANCIAL INFORMATION [Unaudited Condensed Consolidated Financial Statements](index=6&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Q1 2025 unaudited financials show a $1.3 million net loss, lower operating expenses, and a going concern issue due to low cash [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) Total assets slightly decreased to $85.2 million, with most held-for-sale, and cash declined to $59,000 Consolidated Balance Sheet Highlights (unaudited) | Account | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $59,352 | $163,476 | | Assets of disposal group held-for-sale | $83,170,009 | $83,170,009 | | Total Assets | $85,203,539 | $85,409,506 | | **Liabilities & Equity** | | | | Line of credit | $700,000 | $0 | | Liabilities held-for-sale | $23,223,137 | $22,941,497 | | Total Liabilities | $28,740,057 | $27,605,144 | | Total Stockholders' Equity (Deficit) | ($5,217,618) | ($3,876,738) | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2025 net loss of $1.3 million contrasts with prior year's $5.6 million net income, driven by reduced operating expenses Consolidated Statement of Operations Summary (unaudited) | Metric | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Research and development expenses | $15,827 | $554,662 | | General and administrative expenses | $805,559 | $8,544,386 | | **Loss from operations** | **($821,386)** | **($9,099,048)** | | Loss from discontinued operations | ($311,515) | ($192,808) | | Income tax benefit | $0 | $14,859,887 | | **Net income (loss)** | **($1,259,620)** | **$5,567,606** | | **Income (loss) per share - diluted** | **($0.28)** | **$0.38** | [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 net cash used in operations was $0.8 million, offset by $0.7 million from financing, ending with $66,357 cash Consolidated Statement of Cash Flows Summary (unaudited) | Activity | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($818,635) | ($3,746,956) | | Net cash provided by investing activities | $0 | $88,169 | | Net cash provided by financing activities | $700,000 | $3,378,930 | | **Net (decrease) in cash** | **($118,635)** | **($279,857)** | | **Cash, cash equivalents and restricted cash, ending balance** | **$66,357** | **$3,453,435** | [Note 1 - The Company and Basis of Presentation](index=11&type=section&id=Note%201%20-%20The%20Company%20and%20Basis%20of%20Presentation) Entero Therapeutics focuses on Adrulipase, plans to dispose of IMGX assets, and faces substantial doubt about its going concern - The company is focused on the research and development of Adrulipase for GI diseases and plans to dispose of the recently acquired IMGX assets[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern. As of March 31, 2025, cash and cash equivalents were approximately **$66,000** with an accumulated deficit of **$203.6 million**[33](index=33&type=chunk) - The company is exploring all strategic options, including merger, sale, wind-down, or bankruptcy protection, to address its financial situation[34](index=34&type=chunk)[35](index=35&type=chunk) [Note 3 – Business Acquisition](index=21&type=section&id=Note%203%20%E2%80%93%20Business%20Acquisition) The company acquired ImmunogenX (IMGX) on March 13, 2024, for $60.1 million, adding $63 million in intangible assets - The company acquired ImmunogenX, Inc. on March 13, 2024, in a merger intended to be a tax-free reorganization[68](index=68&type=chunk) IMGX Merger Consideration (March 13, 2024) | Component | Amount ($) | | :--- | :--- | | Common stock issued to ImmunogenX stockholders | $240,500 | | Replacement options | $1,271,000 | | Replacement warrants | $789,000 | | Preferred stock issued to ImmunogenX stockholders | $57,790,474 | | **Total consideration paid** | **$60,090,974** | [Note 4 – Discontinued Operations and Assets and Liabilities Held for Sale](index=24&type=section&id=Note%204%20%E2%80%93%20Discontinued%20Operations%20and%20Assets%20and%20Liabilities%20Held%20for%20Sale) The company plans to dispose of IMGX assets and liabilities, classified as held for sale, with a Q1 2025 loss of $0.3 million - The company plans to dispose of the IMGX assets and liabilities, which represents a strategic shift and is now classified as discontinued operations[79](index=79&type=chunk) Assets and Liabilities Held for Sale (as of March 31, 2025) | Category | Amount ($) | | :--- | :--- | | **Assets held for sale:** | | | Goodwill and intangible assets | $80,021,900 | | Other assets | $3,148,109 | | **Total assets held for sale** | **$83,170,009** | | **Liabilities held for sale:** | | | Debt | $6,403,737 | | Deferred tax liability | $13,872,684 | | Other liabilities | $2,946,716 | | **Total liabilities held for sale** | **$23,223,137** | [Note 12 – Agreements](index=35&type=section&id=Note%2012%20%E2%80%93%20Agreements) The company terminated its license agreement with Sanofi for the Capeserod program on February 26, 2025 - On February 26, 2025, the Company provided notice to Sanofi to terminate the License Agreement for Capeserod. No payments are due to Sanofi[138](index=138&type=chunk) [Note 18 - Contingencies](index=41&type=section&id=Note%2018%20-%20Contingencies) The company faces two legal proceedings: a settled loan default case against IMGX and a new lawsuit for $749,000 in unpaid legal fees - A lawsuit from Mattress Liquidators, Inc. against subsidiary IMGX was settled on May 8, 2025. The settlement involved a payment of **$5.5 million** by the guarantors and approximately **$62,000** by ImmunogenX, LLC for legal fees[163](index=163&type=chunk)[168](index=168&type=chunk) - On March 17, 2025, law firm Ellenoff Grossman & Schole LLP filed a lawsuit against the Company for **$749,301** in alleged unpaid legal fees for services rendered between September 2023 and January 2025[166](index=166&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strategic shift to Adrulipase, IMGX merger rescission, and critical liquidity issues with only $66,000 cash - The company is now focused on developing Adrulipase and has discontinued its Latiglutenase, Capeserod, and Niclosamide programs[173](index=173&type=chunk) - In March 2025, the company entered into a Rescission Agreement to unwind the merger with IMGX, returning IMGX to its former shareholders and canceling the stock issued in the transaction[175](index=175&type=chunk)[192](index=192&type=chunk)[193](index=193&type=chunk) - The company's liquidity is severely constrained, with only **$66,000** in cash and cash equivalents as of March 31, 2025. Management has concluded there is substantial doubt about the company's ability to continue as a going concern and is dependent on raising additional capital[201](index=201&type=chunk)[203](index=203&type=chunk) Comparison of Consolidated Results of Operations | Metric | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and development expenses | $15,827 | $554,662 | ($538,835) | | General and administrative expenses | $805,559 | $8,544,386 | ($7,738,827) | | **Total operating expenses** | **$821,386** | **$9,099,048** | **($8,277,662)** | | **Net income (loss)** | **($1,259,620)** | **$5,567,606** | **($6,827,226)** | - The **$7.7 million** decrease in G&A expenses was primarily due to a **$4.2 million** non-cash expense for financial advisor fees related to the IMGX merger in Q1 2024, along with lower legal fees, share-based compensation, and public company costs in Q1 2025[223](index=223&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable to the company - Not applicable[237](index=237&type=chunk) [Controls and Procedures](index=58&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures are effective as of the end of the period covered by the report[238](index=238&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[239](index=239&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) The company reports two legal proceedings: a settled loan default case against IMGX and a new lawsuit for $749,301 in unpaid legal fees - A lawsuit by Mattress Liquidators, Inc. against subsidiary IMGX concerning a loan default was settled. The settlement involved a payment of **$5.5 million** by guarantors and approximately **$62,000** by ImmunogenX, LLC for legal fees, with amended loan documents established[242](index=242&type=chunk)[247](index=247&type=chunk)[248](index=248&type=chunk) - On March 17, 2025, law firm Ellenoff Grossman & Schole LLP sued the company for **$749,301** in alleged unpaid legal fees. The company is investigating and plans to defend the action[249](index=249&type=chunk)[250](index=250&type=chunk) [Risk Factors](index=61&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the Annual Report on Form 10-K/A for the year ended December 31, 2024 - No material changes from the risk factors set forth in the Annual Report on Form 10-K/A for the year ended December 31, 2024[251](index=251&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=61&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) None reported for the period - None[252](index=252&type=chunk) [Defaults Upon Senior Securities](index=61&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None reported for the period - None[253](index=253&type=chunk) [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[254](index=254&type=chunk) [Other Information](index=61&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading plan during the quarter - No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement during the quarter[255](index=255&type=chunk) [Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents and Sarbanes-Oxley Act certifications - Lists exhibits filed with the report, including Sarbanes-Oxley Act certifications and Inline XBRL documents[257](index=257&type=chunk)

Company Focus and Strategy - The company is focused on developing Adrulipase, a recombinant lipase enzyme for patients with cystic fibrosis and chronic pancreatitis, while discontinuing programs for Latiglutenase, Capeserod, and Niclosamide [367]. - In March 2024, the company completed a merger with ImmunogenX, acquiring assets including Latiglutenase and CypCel, but plans to dispose of these assets within 12 months [368]. - The company has initiated a plan to dispose of the Latiglutenase program, which was aimed at treating celiac disease [375]. - The company is no longer pursuing the Niclosamide program, which included multiple Phase 2 clinical trials for various GI conditions [377]. - The company is focused on expanding its product pipeline through collaborations and acquisitions, evaluating potential asset acquisitions and business combinations [406]. Financial Performance - The net loss for the year ended December 31, 2024 was approximately $18 million, an increase of approximately $2.2 million, or 15%, over the net loss of approximately $15.8 million recorded for the year ended December 31, 2023 [415]. - Research and development expenses for the year ended December 31, 2024 totaled approximately $0.9 million, a decrease of approximately $4.1 million, or 82%, compared to $5.0 million in 2023 [409]. - General and administrative expenses for the year ended December 31, 2024 totaled approximately $14.7 million, an increase of approximately $3.9 million, or 36%, compared to $10.7 million in 2023 [411]. - Net cash used in operating activities during the year ended December 31, 2024 was approximately $9.2 million, primarily attributable to the net loss of approximately $18 million [417]. - Net cash provided by financing activities for the year ended December 31, 2024 was approximately $5.6 million, primarily due to net proceeds from the exercise of warrants and issuance of Common Stock [420]. - As of December 31, 2024, the company had cash and cash equivalents of approximately $185,000 and negative working capital of approximately $4.3 million [403]. Compliance and Agreements - The company received a letter from Nasdaq on September 6, 2024, indicating non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance deadline extended to September 1, 2025 [378][379]. - A rescission agreement was announced in March 2025, which will result in the cancellation of shares and options issued during the merger, with the company retaining approximately $695,000 of IMGX's accounts payable and IMGX responsible for about $9,278,400 of secured debt [369][390]. - The company terminated its license agreement with Sanofi for Capeserod, effective April 2025, with no payments due to Sanofi [370]. - A Revolving Loan Agreement was entered into on January 31, 2025, providing $2,000,000 in loans, with an initial disbursement of $550,000 and an interest rate of 18% per annum [383]. - The company plans to conduct a Qualified Public Equity Offering of at least $5,000,000 as part of the Revolving Loan Agreement [384]. Goodwill and Stock-Based Compensation - Goodwill related to the acquisition of ProteaBio Europe SAS is approximately $1.7 million as of December 31, 2024 and 2023 [427]. - Goodwill is subject to periodic review for impairment, with judgment used to determine when events indicate potential recoverability issues [426]. - The fair value of stock-based compensation is recognized over the requisite service period, generally the vesting period [424]. Clinical Trials and Research - The company announced topline results from a Phase 2b study of Adrulipase, indicating safety and tolerability, although the primary efficacy endpoint was not achieved [374]. - The company anticipates continued increases in general and administrative expenses to support expanded research and development activities and business development efforts [401].