Cocrystal(COCP) - 2025 Q2 - Quarterly Report
2025-08-14 12:01
FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 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: 001-38418 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 COCRYSTAL PHARMA, INC. (Exact name of registrant as specified in its charter) | Delaware | 35-2528215 | | --- | --- | | (State or Oth ...
Synergy CHC Corp.(SNYR) - 2025 Q2 - Quarterly Results
2025-08-14 12:00
Exhibit 99.1 Synergy CHC Corp Reports Second Quarter 2025 Financial Results and its Tenth Consecutive Quarter of Profitability WESTBROOK, Maine, August 14, 2025 – Synergy CHC Corp. (NASDAQ: SNYR) ("Synergy" or the "Company"), a consumer health and wellness company, is announcing its financial results for the three months ended June 30, 2025. "We are pleased to report another strong quarter, marking our tenth consecutive quarter of profitability," said Jack Ross, CEO of Synergy. "Revenue, gross profit, net i ...
Brainstorm Cell Therapeutics(BCLI) - 2025 Q2 - Quarterly Report
2025-08-14 12:00
PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited interim financial statements show a net loss of $5.8 million and substantial doubt about its ability to continue as a going concern [Interim Condensed Consolidated Balance Sheets](index=7&type=section&id=Interim%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of $2.6 million and a total stockholders' deficit of $6.1 million Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $824 | $187 | | Total current assets | $1,515 | $385 | | Total assets | $2,566 | $1,832 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $8,528 | $8,978 | | Total liabilities | $8,623 | $9,596 | | Accumulated deficit | $(232,403) | $(226,636) | | Total stockholders' deficit | $(6,057) | $(7,764) | [Interim Condensed Consolidated Statements of Comprehensive Loss](index=9&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The company recorded a net loss of $5.77 million for the six months ended June 30, 2025, a slight decrease from the prior year Statement of Comprehensive Loss (in thousands, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development, net | $2,424 | $1,883 | $1,120 | $922 | | General and administrative | $3,238 | $3,573 | $1,453 | $2,060 | | **Operating loss** | **$(5,662)** | **$(5,456)** | **$(2,573)** | **$(2,982)** | | **Net loss** | **$(5,767)** | **$(5,942)** | **$(2,903)** | **$(2,541)** | | Basic and diluted net loss per share | $(0.77) | $(1.35) | $(0.34) | $(0.60) | [Interim Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $5.1 million, offset by $5.8 million raised from financing activities during the first half of 2025 Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,133) | $(4,746) | | Net cash provided by financing activities | $5,787 | $6,909 | | Increase (decrease) in cash, cash equivalents and restricted cash | $654 | $2,163 | | Cash, cash equivalents and restricted cash at end of the period | $1,025 | $3,648 | [Notes to Interim Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Key notes highlight the company's delisting to the OTCQB market, substantial doubt about its going concern status, and recent capital-raising activities - The company's common stock was **delisted from The Nasdaq Capital Market** and began trading on the OTCQB Venture Market on July 18, 2025, due to failure to meet the minimum shareholder equity requirement[38](index=38&type=chunk)[39](index=39&type=chunk)[82](index=82&type=chunk) - The company has incurred operating losses since inception, with an **accumulated deficit of approximately $232 million** as of June 30, 2025, raising **substantial doubts about its ability to continue as a going concern**[40](index=40&type=chunk)[41](index=41&type=chunk) - During the six months ended June 30, 2025, the company sold **2,311,940 shares for gross proceeds of approximately $4.15 million** under its At-the-Market (ATM) offering[54](index=54&type=chunk) - In March 2025, the company entered into a warrant inducement agreement, **raising approximately $1.64 million** and issuing new warrants to purchase additional shares[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the regulatory pathway for its NurOwn® cell therapy, its precarious financial condition, and reliance on equity financing [Company Overview and Recent Highlights](index=26&type=section&id=Company%20Overview%20and%20Recent%20Highlights) Recent highlights include the delisting from Nasdaq, FDA clearance for a Phase 3b trial for NurOwn® in ALS, and a new manufacturing agreement - The company's common stock was **delisted from Nasdaq** and began trading on the OTCQB market on July 18, 2025, due to non-compliance with the minimum shareholder equity requirement[90](index=90&type=chunk) - On May 19, 2025, the company announced that the **FDA cleared the initiation of its Phase 3b clinical trial** of NurOwn® for the treatment of ALS[90](index=90&type=chunk) - The company signed a Letter of Intent with Minaris Advanced Therapies on May 27, 2025, to **manufacture NurOwn® for its upcoming clinical trial**[97](index=97&type=chunk) [NurOwn® Clinical Program](index=32&type=section&id=NurOwn%C2%AE%20Clinical%20Program) The company withdrew its BLA for NurOwn® in ALS but subsequently secured an FDA Special Protocol Assessment for a new Phase 3b trial - The company **withdrew its Biologics License Application (BLA) for NurOwn® in ALS** on November 3, 2023, after an Advisory Committee voted against its effectiveness[100](index=100&type=chunk)[123](index=123&type=chunk) - In April 2024, the company received **written agreement from the FDA under a Special Protocol Assessment (SPA)** for the design of a new Phase 3b trial of NurOwn® in ALS[86](index=86&type=chunk)[100](index=100&type=chunk)[123](index=123&type=chunk) - The Phase 2 trial for NurOwn® in Progressive Multiple Sclerosis (PMS) showed positive top-line data, with **38% of patients showing improvement in walking function**[146](index=146&type=chunk) [Research and Development](index=49&type=section&id=Research%20and%20Development) R&D efforts are focused on NurOwn® and its derivative, MSC-NTF derived Exosomes, for various neurodegenerative disorders - R&D efforts are focused on **MSC-NTF derived Exosomes**, which are nano-vesicles that can cross the blood-brain barrier and may treat multiple neurodegenerative diseases[161](index=161&type=chunk) - A preclinical study showed that intratracheal administration of NurOwn® derived exosomes resulted in a **statistically significant improvement in multiple lung parameters** in a mouse model of ARDS[166](index=166&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) The company generated no revenue and incurred a net loss of $5.8 million for the first six months of 2025, with R&D expenses increasing by 28.7% Comparison of Operating Results (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and Development, net | $2,424 | $1,883 | $541 | +28.7% | | General and Administrative | $3,238 | $3,573 | $(335) | -9.4% | | **Operating Loss** | **$5,662** | **$5,456** | **$206** | **+3.8%** | | **Net Loss** | **$5,767** | **$5,942** | **$(175)** | **-2.9%** | - The increase in R&D expenses for the first six months of 2025 was primarily due to a **$387,000 increase in payroll** and a **$294,000 increase in clinical activities**[180](index=180&type=chunk) - The decrease in G&A expenses for the first six months of 2025 was mainly due to **lower costs for payroll, PR activities, rent, and consultants**[182](index=182&type=chunk) [Liquidity and Capital Resources](index=55&type=section&id=Liquidity%20and%20Capital%20Resources) The company's ability to continue as a going concern is in doubt, as it requires substantial additional funding which may be hampered by its delisting - As of June 30, 2025, the company had **cash, cash equivalents, and restricted cash of $1,025,000**[190](index=190&type=chunk) - For the six months ended June 30, 2025, the company **raised $5.8 million from financing activities**, including approximately $4.1 million from its ATM stock offering[192](index=192&type=chunk)[193](index=193&type=chunk) - The company anticipates needing to **raise substantial additional financing** to fund operations and the planned Phase 3b trial, but its ability to do so is uncertain[187](index=187&type=chunk)[189](index=189&type=chunk)[205](index=205&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=61&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is omitted as the company qualifies as a smaller reporting company - The company is a **smaller reporting company** and is not required to provide the information under this item[211](index=211&type=chunk) [Item 4. Controls and Procedures](index=63&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were not effective due to a material weakness in internal controls over short-term loans - Management concluded that **disclosure controls and procedures were not effective** as of June 30, 2025, due to a material weakness in internal control over financial reporting[213](index=213&type=chunk) - The material weakness was related to controls over the **initiation, review, authorization, and execution of short-term loans** but did not result in a misstatement[216](index=216&type=chunk) - A **remediation plan has been adopted** to address the material weakness, though the weakness is not yet considered fully remediated[217](index=217&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=63&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in several lawsuits, including a securities class action and shareholder derivative actions related to FDA communications - A **putative securities class action** was filed against the company, alleging violations related to communications with the FDA about NurOwn® for ALS[220](index=220&type=chunk)[221](index=221&type=chunk) - **Four shareholder derivative actions** have been filed, asserting claims for breach of fiduciary duty and unjust enrichment against officers and directors[222](index=222&type=chunk) - 3D Communications, LLC filed a **breach of contract lawsuit** against the company in November 2024, alleging non-payment for consulting services[223](index=223&type=chunk) [Item 1A. Risk Factors](index=65&type=section&id=Item%201A.%20Risk%20Factors) Key risks include the consequences of delisting from Nasdaq, adverse macroeconomic conditions, and a material weakness in internal controls - The **delisting from Nasdaq** could lead to limited liquidity, reduced trading activity, less analyst coverage, and a decreased ability to raise future financing[228](index=228&type=chunk)[229](index=229&type=chunk) - The company faces risks from **adverse macroeconomic conditions**, including inflation and rising interest rates, which could impair its ability to raise additional funding[232](index=232&type=chunk) - The company has incurred **unsecured short-term debt**, which increases financial obligations and could adversely affect its financial condition[234](index=234&type=chunk) - The identified **material weakness in internal controls**, if not remediated, could result in material misstatements in future financial statements[235](index=235&type=chunk)[236](index=236&type=chunk) [Item 5. Other Information](index=69&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement during the quarter - No directors or officers adopted, terminated, or modified a **Rule 10b5-1 trading plan** during the second quarter of 2025[240](index=240&type=chunk) [Item 6. Exhibits](index=71&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications and XBRL data files
PAVmed(PAVM) - 2025 Q2 - Quarterly Results
2025-08-14 12:00
Exhibit 99.1 PAVmed Provides Business Update and Reports Second Quarter 2025 Financial Results Lucid processed 2,756 EsoGuard 2Q25 tests, recognized revenue of $1.2 million, and secured CAC meeting on Medicare LCD for EsoGuard to be held on September 4 Veris Health completed 2Q25 financing, relaunched development of implantable physiological monitor, and initiated integration steps to launch commercial phase with OSU-The James Conference call and webcast to be held today, August 14, at 8:30 AM EDT Business ...
Cocrystal(COCP) - 2025 Q2 - Quarterly Results
2025-08-14 12:00
Exhibit 99.1 Cocrystal Pharma Reports Second Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs BOTHELL, Wash. (August 14, 2025) – Cocrystal Pharma, Inc. (Nasdaq: COCP) ("Cocrystal" or the "Company") reports financial results for the three and six months ended June 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. "Preparations are underway for a Phase 1b norovirus challenge study to evaluate our potent, ...
Enveric Biosciences(ENVB) - 2025 Q2 - Quarterly Results
2025-08-14 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Commission File Number) (I.R.S. Employer Identification No.) FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 August 14, 2025 Date of Report (Date of earliest event reported) Enveric Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 001-38286 95-4484725 (State or other jurisdiction of incorporation) Enveric Biosciences, Inc. 4851 Tamiami Trail N, Suite 200 Na ...
Falcon's Beyond (FBYD) - 2025 Q2 - Quarterly Results
2025-08-14 12:00
Exhibit 99.1 Falcon's Beyond Reports Second Quarter 2025 Financial Results Company Reports Consolidated Revenue of $2.5 Million Company's Unconsolidated Subsidiary, Falcon's Creative Group generated Q2 Revenue of $12.3 Million Company's Unconsolidated Joint Venture, Producciones de Parques, recognized a $59.6 Million gain on sale of the Sol Tenerife hotel and generated Q2 revenue of $6.5 Million from continuing operations EBITDA: • Falcon's Beyond's adjusted EBITDA (1) loss decreased $0.2 million to $(1.7) ...
Pieris Pharmaceuticals(PIRS) - 2025 Q2 - Quarterly Report
2025-08-14 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 June 30, 2025 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 001-37471 Palvella Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Nevada 30-0784 ...
Galectin Therapeutics(GALT) - 2025 Q2 - Quarterly Results
2025-08-14 11:55
Exhibit 99.1 Khurram Jamil, M.D., Chief Medical Officer, added, "The 18-month analysis showed a lower incidence of both liver stiffness progression and varices in the 2 mg belapectin arm compared to placebo — an encouraging signal, given that increasing liver stiffness is a well-established predictor of liver-related complications. We are pleased that these effects were maintained in patients who continued into the second 18-month treatment period. Using all available data and LOCF (Last Observation Carried ...
Galectin Therapeutics(GALT) - 2025 Q2 - Quarterly Report
2025-08-14 11:53
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2025 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. (State or other jurisdiction of incorporation) (I.R.S. Employer Identification No.) Nevada 04-3562325 4960 Peacht ...