Equillium(EQ)
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Equillium to Host Ulcerative Colitis KOL Event on November 5, 2025
Globenewswire· 2025-10-22 12:00
Virtual webinar to feature expert insights on unmet need, treatment landscape and potential clinical utility of Aryl Hydrocarbon Receptor (AhR) modulation in ulcerative colitisLA JOLLA, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced they will host a virtual key opinion leader (KOL) event on Wednes ...
Equillium Announces Leadership and Corporate Updates
Globenewswire· 2025-10-06 20:02
LA JOLLA, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced changes to its Board of Directors (BoD) and senior leadership, and other corporate updates. “The updates we announced today mark an important and timely step as we sharpen our therapeutic pipeline focus on advancing EQ504, our novel aryl hyd ...
NeuraClick Welcomes Biotech Veteran Daniel M. Bradbury as Strategic and Metabolic Programs Advisor
Globenewswire· 2025-09-23 09:30
SAN DIEGO, Sept. 23, 2025 (GLOBE NEWSWIRE) -- NeuraClick, Inc., an innovative, preclinical-stage biopharmaceutical company reimagining patient health through the development of novel, long-acting neurotherapeutics, today announced the appointment of industry veteran and biotech executive Daniel M. Bradbury as Strategic and Metabolic Programs Advisor. “We are thrilled to welcome Dan to NeuraClick,” said Dr. Subhi Marwari, Chief Executive Officer. “For an early-stage venture, experienced guidance is essential ...
Biotech Stocks Surge After Hours: Cassava, Helius, Werewolf, Aytu, Equillium Lead Late-Day Moves
RTTNews· 2025-09-23 04:43
Core Insights - Several biotech companies experienced significant stock price increases in after-hours trading, driven by clinical updates, strategic shifts, and upcoming catalysts [1] Cassava Sciences (SAVA) - Shares surged 37.1% to $3.18 in after-hours trading, following a regular session close of $2.32, which marked a 1.75% gain [2] - The rally is attributed to renewed interest in the investigational drug simufilam, particularly its potential in treating TSC-related epilepsy, following positive preclinical data [3] - Leadership changes, including the appointment of Dr. Joseph Hulihan as Chief Medical Officer, indicate a strategic pivot in clinical priorities [3] - Future updates on simufilam and the diagnostic candidate SavaDx could serve as near-term catalysts [4] Helius Medical Technologies (HSDT) - Stock rose 15.67% to $18.53 in after-hours trading after a regular session close of $16.02, where it had dropped 33.61% [4] - The rebound followed a $500 million private placement announcement, marking a significant pivot from its core neurotech focus [5] - Helius continues to advance its medical device pipeline, with positive results from the Portable Neuromodulation Stimulator (PoNS) stroke registrational program and plans for FDA submission [6] Werewolf Therapeutics (HOWL) - Shares increased 9.78% to $2.02 in after-hours trading, following a regular session close of $1.84, which was up 23.49% [6] - The company is advancing multiple conditionally activated cytokine therapies through its INDUKINE platform, with lead candidate WTX-124 in a Phase 1/1b trial targeting advanced solid tumors [7] - Participation in the H.C. Wainwright 27th Annual Global Investment Conference highlighted management's timelines for clinical readouts and pipeline progress [8] Aytu BioPharma Inc. (AYTU) - Stock rose 7.63% to $2.68 in after-hours trading after closing at $2.49, up 2.05% [8] - The price action follows the announcement of full-year and Q4 fiscal 2025 results expected on September 23, 2025, which will clarify commercial performance and progress with EXXUA [9] - Aytu maintains a portfolio of pediatric and ADHD-focused therapeutics and has extended its loan agreement with Eclipse to boost liquidity [10] Equillium Inc. (EQ) - Shares increased 10.34% to $1.60 in after-hours trading after closing at $1.45, down 0.68% [10] - The company announced up to $50 million in financing to advance EQ504 into clinical development, with positive feedback from the FDA regarding its regulatory pathway [11] - Its lead candidate, itolizumab (EQ001), is in Phase 3 trials for acute graft-versus-host disease and has completed earlier-stage studies in lupus nephritis and ulcerative colitis [11]
Equillium(EQ) - 2025 Q2 - Quarterly Report
2025-08-14 20:02
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: 001-38692 EQUILLIUM, INC. (Exact name of registrant as specified in its charter) | Delaware | 82-1554746 | | --- | --- | | (State or ...
Equillium(EQ) - 2025 Q2 - Quarterly Results
2025-08-04 12:35
[Open Market Sale AgreementSM](index=1&type=section&id=Open%20Market%20Sale%20AgreementSM) This agreement outlines the terms and conditions for the issuance and sale of common shares through an agent in the open market [1. Definitions](index=1&type=section&id=Section%201.%20DEFINITIONS) This section defines key terms used throughout the Open Market Sale Agreement, establishing the scope and meaning of various operational and legal concepts for the issuance and sale of common shares - The 'Agency Period' commences on the agreement date and expires upon the Agent placing the 'Maximum Program Amount' or termination per Section 7[2](index=2&type=chunk) - The 'Floor Price' is the minimum price set by the Company for share sales, adjustable by written notice, and cannot be less than $1.00 without Agent's consent[5](index=5&type=chunk) - The 'Selling Commission' is **three percent (3.0%)** of the gross proceeds from shares sold, or as otherwise agreed[13](index=13&type=chunk) - The 'Maximum Program Amount' is the lesser of (a) registered shares, (b) authorized but unissued shares, (c) shares permitted under Form S-3, or (d) shares for which a Prospectus has been filed[10](index=10&type=chunk) [2. Company Representations and Warranties](index=2&type=section&id=Section%202.%20REPRESENTATIONS%20AND%20WARRANTIES%20OF%20THE%20COMPANY) This section outlines the Company's extensive representations and warranties to the Agent, covering legal, financial, operational, and regulatory aspects, which must be true and correct as of various 'Representation Dates' throughout the agreement term - Representations and warranties are affirmed as of the agreement date, each Issuance Notice Date, each Settlement Date, each Triggering Event Date, and each Time of Sale[17](index=17&type=chunk) - The Company confirms it is not an 'ineligible issuer' and complies with Rule 433(d) for Free Writing Prospectuses[24](index=24&type=chunk) - The Company warrants that there has been no 'Material Adverse Change' since the last reporting dates, except as disclosed[29](index=29&type=chunk) [2.1 Registration Statement Compliance](index=3&type=section&id=2(a)%20Registration%20Statement) The Company represents that its S-3 shelf registration statement and related prospectus comply with the Securities Act, including all incorporated documents, and that the Company meets Form S-3 requirements - The Company filed a shelf registration statement on Form S-3 (File No. 333-269153) and meets the requirements for its use[18](index=18&type=chunk)[20](index=20&type=chunk) [2.2 Effectiveness and Accuracy of Filings](index=4&type=section&id=2(b)%20Compliance%20with%20Registration%20Requirements) The Company warrants that its registration statements are effective, free of stop orders, and that the Prospectus and Time of Sale Information contain no material misstatements or omissions - The Original Registration Statement and any Rule 462(b) Registration Statement have been declared effective, and no stop order is in effect or threatened[22](index=22&type=chunk) - The Registration Statement and Prospectus, as of their respective dates and each Representation Date, comply materially with the Securities Act and do not contain untrue statements or omissions of material fact[23](index=23&type=chunk) [2.3 Agreement Authorization and Validity](index=5&type=section&id=2(d)%20This%20Agreement) The Company affirms that the Agreement has been duly authorized, executed, and delivered, constituting a valid and binding obligation, enforceable in accordance with its terms - This Agreement has been duly authorized, executed, and delivered by the Company, making it a valid and binding agreement[26](index=26&type=chunk) [2.4 Shares Authorization and Status](index=5&type=section&id=2(e)%20Authorization%20of%20the%20Shares) The Company represents that the Shares are duly authorized, will be validly issued, fully paid, and nonassessable upon delivery, and are not subject to any preemptive or similar rights - The Shares are duly authorized for issuance and sale and, when issued, will be validly issued, fully paid, and nonassessable, free from preemptive rights[27](index=27&type=chunk) [2.5 Absence of Material Adverse Changes](index=5&type=section&id=2(g)%20No%20Material%20Adverse%20Change) The Company warrants that, except as disclosed, there has been no material adverse change in its condition, earnings, business, or ability to perform its obligations, nor any material liabilities or changes in capital structure, other than specified share repurchases - No material adverse change has occurred in the Company's condition, financial or otherwise, or its ability to consummate transactions, except as disclosed[29](index=29&type=chunk) - No material decrease in capital stock or material increase in indebtedness has occurred, nor any dividends or distributions, except for repurchases under the Company Repurchase Program announced August 2, 2023[29](index=29&type=chunk) [2.6 Financial Statement Accuracy](index=6&type=section&id=2(i)%20Financial%20Statements) The Company asserts that its financial statements filed with the Commission fairly present its consolidated financial position, results of operations, and cash flows in accordance with GAAP - Financial statements filed with the Commission present fairly the consolidated financial position, results of operations, changes in stockholders' equity, and cash flows, prepared in conformity with GAAP[32](index=32&type=chunk) [2.7 Internal Controls and Procedures](index=6&type=section&id=2(k)%20Disclosure%20Controls%20and%20Procedures%3B%20Deficiencies%20in%20or%20Changes%20to%20Internal%20Control%20Over%20Financial%20Reporting) The Company maintains effective disclosure controls and procedures and has no significant deficiencies or material weaknesses in internal control over financial reporting, nor any material changes to such controls - The Company maintains effective disclosure controls and procedures and has no significant deficiencies or material weaknesses in internal control over financial reporting since its most recent audited fiscal year[34](index=34&type=chunk) [2.8 Corporate Status and Authority](index=7&type=section&id=2(l)%20Incorporation%20and%20Good%20Standing%20of%20the%20Company) The Company is duly incorporated, validly existing, and in good standing in its jurisdiction of incorporation, possessing the corporate power and authority to conduct its business and perform its obligations under the Agreement - The Company is duly incorporated, validly existing, and in good standing under Delaware law, with corporate power to conduct business and perform Agreement obligations[36](index=36&type=chunk) [2.9 Capitalization and Stock Matters](index=7&type=section&id=2(n)%20Capitalization%20and%20Other%20Capital%20Stock%20Matters) The Company's capitalization is as disclosed in its filings, and all outstanding Common Shares are duly authorized, validly issued, fully paid, and nonassessable, without violating preemptive rights - The Company's authorized, issued, and outstanding capital stock is as set forth in the Registration Statement and Prospectus, with exceptions for employee benefit plans or outstanding options/warrants, or repurchases under the Company Repurchase Program[38](index=38&type=chunk) - All issued and outstanding Common Shares are duly authorized, validly issued, fully paid, and nonassessable, and were issued in compliance with all applicable securities laws[38](index=38&type=chunk) [2.10 Non-Contravention and Approvals](index=8&type=section&id=2(p)%20Non-Contravention%20of%20Existing%20Instruments%3B%20No%20Further%20Authorizations%20or%20Approvals%20Required) The Company and its subsidiaries are not in violation or default of their organizational documents or any existing instruments, and the execution and performance of this Agreement will not conflict with these or require additional governmental approvals, except as already obtained or required under securities laws - Neither the Company nor its subsidiaries are in violation of their organizational documents or in default under any Existing Instrument, except for those not expected to result in a Material Adverse Change[41](index=41&type=chunk) - The Company's execution and performance of this Agreement will not violate organizational documents, conflict with Existing Instruments, or result in liens, and requires no further governmental approvals beyond those obtained or required under Securities Act/blue sky/FINRA[41](index=41&type=chunk) [2.11 Intellectual Property](index=9&type=section&id=2(s)%20Intellectual%20Property%20Rights) The Company and its subsidiaries own or license all necessary intellectual property, and there are no known infringements by or against third parties, nor any challenges to the Company's IP rights - The Company and its subsidiaries own or have licenses for the Intellectual Property necessary for their business, and such licenses are valid and enforceable[45](index=45&type=chunk) - To the Company's knowledge, there is no infringement by third parties of its Intellectual Property, nor is the Company infringing third-party IP rights[45](index=45&type=chunk) - There are no pending or threatened actions challenging the Company's IP rights, validity, enforceability, or asserting infringement by the Company[46](index=46&type=chunk) [2.12 Regulatory Compliance and Product Status](index=10&type=section&id=2(u)%20Regulatory%20Matters%3B%20Products%20and%20Product%20Candidates) The Company operates its business in material compliance with applicable Health Care Laws and possesses all required Regulatory Authorizations, with no adverse notices or actions from regulatory authorities - The Company operates its business in material compliance with Health Care Laws and possesses all required Regulatory Authorizations, which are valid and in full force[48](index=48&type=chunk) - The Company has not received any FDA Form 483, warning letters, or other notices alleging non-compliance with Health Care Laws or Regulatory Authorizations[48](index=48&type=chunk) [2.13 Clinical Trial Compliance and Data Integrity](index=11&type=section&id=2(x)%20Regulatory%20Matters%3A%20Clinical%20Trials) The Company's clinical and pre-clinical trials (Company Trials and Biocon Trials) are conducted in material compliance with Health Care Laws and Good Clinical Practices, with accurate and complete descriptions of results, and no knowledge of inconsistent studies or threatened terminations - All Company Trials and Biocon Trials are conducted in material compliance with Health Care Laws and current Good Clinical Practices[52](index=52&type=chunk)[53](index=53&type=chunk) - Descriptions of trial results in the Registration Statement and Prospectus are accurate and complete, and the Company has no knowledge of inconsistent studies[53](index=53&type=chunk) - No investigational new drug application has been terminated or suspended by the FDA, and informed consent was obtained for human subjects[53](index=53&type=chunk) [2.14 Tax Compliance](index=13&type=section&id=2(aa)%20Tax%20Law%20Compliance) The Company and its consolidated subsidiaries have filed all required tax returns, paid all due taxes, and made adequate accruals in conformity with GAAP - The Company and its consolidated subsidiaries have filed all necessary federal, state, and foreign income and franchise tax returns and paid all required taxes, with adequate accruals in financial statements[57](index=57&type=chunk) [2.15 Insurance Coverage](index=13&type=section&id=2(bb)%20Insurance) The Company and its subsidiaries maintain adequate and customary insurance coverage, including product liability and clinical trial liability, and expect to renew policies without material adverse cost - The Company and its subsidiaries are insured by recognized institutions with adequate and customary policies for their businesses, including product liability and clinical trial liability[58](index=58&type=chunk) [2.16 Environmental Law Compliance](index=13&type=section&id=2(cc)%20Compliance%20with%20Environmental%20Laws) The Company and its subsidiaries are in material compliance with all Environmental Laws, possess all required permits, and have no pending or threatened actions related to environmental matters - The Company and its subsidiaries are in material compliance with all Environmental Laws and possess all required permits, authorizations, and approvals[59](index=59&type=chunk)[60](index=60&type=chunk) - There are no pending or threatened administrative, regulatory, or judicial actions relating to Environmental Law against the Company or its subsidiaries[60](index=60&type=chunk) [2.17 ERISA Compliance](index=14&type=section&id=2(dd)%20ERISA%20Compliance) The Company and its employee benefit plans are in material compliance with ERISA, with no reportable events, unfunded benefit liabilities, or liabilities under Title IV of ERISA or specific Code sections - The Company and its employee benefit plans are in material compliance with ERISA, and no 'reportable event' has occurred or is expected[61](index=61&type=chunk) - No employee benefit plan would have 'unfunded benefit liabilities' if terminated, and no liability has been incurred under Title IV of ERISA or Sections 412, 4971, 4975, or 4980B of the Code[61](index=61&type=chunk) [2.18 Market Activities and Regulation M](index=14&type=section&id=2(ff)%20No%20Price%20Stabilization%20or%20Manipulation%3B%20Compliance%20with%20Regulation%20M) The Company has not taken actions to stabilize or manipulate the price of Common Shares, complies with Regulation M (except for its repurchase program outside restricted periods), and its shares are 'actively traded securities' - The Company has not taken action to stabilize or manipulate the price of Common Shares, except for the Company Repurchase Program, which will not operate during 'restricted periods' under Regulation M[63](index=63&type=chunk) - The Common Shares are 'actively traded securities' as defined in Regulation M[63](index=63&type=chunk) [2.19 FCPA Compliance](index=15&type=section&id=2(kk)%20Foreign%20Corrupt%20Practices%20Act) The Company and its affiliates comply with the FCPA and other anti-bribery statutes, having instituted policies and procedures to ensure continued compliance, and have not engaged in unlawful payments - Neither the Company nor its subsidiaries, nor any associated person, has violated the FCPA or applicable non-U.S. anti-bribery statutes, or made unlawful payments[69](index=69&type=chunk) - The Company maintains policies and procedures designed to ensure compliance with the FCPA[69](index=69&type=chunk) [2.20 Money Laundering Compliance](index=16&type=section&id=2(ll)%20Money%20Laundering%20Laws) The Company's operations comply with applicable Money Laundering Laws, and there are no pending or threatened actions related to these laws - The Company's operations comply with applicable Money Laundering Laws, and no related actions are pending or threatened[71](index=71&type=chunk) [2.21 OFAC Compliance](index=16&type=section&id=2(mm)%20OFAC) Neither the Company nor its associated persons are subject to U.S. Sanctions administered by OFAC, and proceeds from the offering will not be used in violation of such sanctions - Neither the Company nor its associated persons are subject to U.S. Sanctions administered by OFAC[72](index=72&type=chunk) - Proceeds from the offering will not be used to finance activities with persons or in countries subject to U.S. Sanctions[72](index=72&type=chunk) [2.22 Emerging Growth Company Status](index=16&type=section&id=2(qq)%20Emerging%20Growth%20Company%20Status) The Company confirms its status as an 'emerging growth company' as defined in the Securities Act since its initial filing - The Company has been and is an 'emerging growth company' as defined in Section 2(a) of the Securities Act since its initial filing[76](index=76&type=chunk) [2.23 Sarbanes-Oxley Compliance](index=18&type=section&id=2(yy)%20Sarbanes-Oxley) The Company is in material compliance with all applicable provisions of the Sarbanes-Oxley Act of 2002 and its regulations - The Company is in material compliance with all applicable provisions of the Sarbanes-Oxley Act of 2002 and its rules and regulations[85](index=85&type=chunk) [2.24 Cybersecurity and Data Security](index=18&type=section&id=2(zz)%20Cybersecurity) The Company's IT Systems are adequate and secure, with commercially reasonable controls, and there have been no material breaches or non-compliance with privacy and security laws - The Company's IT Systems are adequate and operate as required, free of material bugs or corruptants[86](index=86&type=chunk) - The Company has implemented and maintained commercially reasonable controls to protect confidential information and IT Systems, with no material breaches or non-compliance with privacy and security laws[86](index=86&type=chunk) [2.25 Data Privacy Law Compliance](index=19&type=section&id=2(aaa)%20Compliance%20with%20Data%20Privacy%20Laws) The Company and its subsidiaries are in material compliance with all applicable state and federal data privacy and security laws, including HIPAA and GDPR, and have appropriate policies in place - The Company and its subsidiaries are in material compliance with all applicable state and federal data privacy and security laws, including HIPAA and GDPR[88](index=88&type=chunk) - The Company has policies and procedures relating to data privacy and security and has made all required disclosures to users or customers[88](index=88&type=chunk) [3. Issuance and Sale of Common Shares](index=19&type=section&id=Section%203.%20ISSUANCE%20AND%20SALE%20OF%20COMMON%20SHARES) This section details the mechanics of how the Company will issue and sell Common Shares through the Agent, including the issuance notice process, methods of sale, settlement procedures, and associated fees and expenses - The Company may sell Shares through the Agent, acting as sales agent or principal, up to the Maximum Program Amount, based on Issuance Notices[91](index=91&type=chunk) - The Agent will use commercially reasonable efforts to place Shares upon receipt of an Issuance Notice, unless sales are suspended or terminated[95](index=95&type=chunk) - Shares may be offered and sold in privately negotiated transactions, block transactions, or as 'at the market offerings' on the Principal Market[96](index=96&type=chunk) [3.1 Issuance Mechanics](index=19&type=section&id=3(b)%20Mechanics%20of%20Issuances) This sub-section outlines the specific procedures for issuing shares, including conditions for delivering an Issuance Notice, the Agent's sales efforts, permitted sales methods, confirmation, settlement, and provisions for suspending or terminating sales - The Company delivers an 'Issuance Notice' on a Trading Day, subject to conditions like not exceeding the Maximum Program Amount and prior notices having expired[92](index=92&type=chunk)[94](index=94&type=chunk) - Settlement occurs on the second business day after sale, with the Company delivering shares and the Agent delivering the 'Issuance Price' (Sales Price less Selling Commission)[14](index=14&type=chunk)[98](index=98&type=chunk) - Either party may suspend sales with notice, but obligations for already placed/sold shares remain; the Company indemnifies the Agent for default in delivering shares[100](index=100&type=chunk) - The Company acknowledges no assurance of placement and the Agent incurs no liability for unsold shares[101](index=101&type=chunk) - The Company will not deliver an Issuance Notice if in possession of material non-public information[102](index=102&type=chunk) [3.2 Agent Fees](index=21&type=section&id=3(c)%20Fees) The Company agrees to pay the Agent a Selling Commission of 3.0% of the gross proceeds from shares sold, deducted directly from the Issuance Amount - The Company shall pay the Agent a Selling Commission of **three percent (3.0%)** of the gross proceeds of Shares sold, deducted from the Issuance Amount[13](index=13&type=chunk)[103](index=103&type=chunk) [3.3 Offering Expenses](index=21&type=section&id=3(d)%20Expenses) The Company is responsible for all costs and expenses related to the offering, including legal, accounting, filing, printing, and listing fees, with specific caps on Agent's counsel fees - The Company agrees to pay all costs, fees, and expenses incurred in connection with the offering, including issuance and delivery costs, registrar and transfer agent fees, taxes, counsel and accountant fees, and filing fees[104](index=104&type=chunk) - Agent's counsel fees are capped at **$75,000** for agreement execution and **$15,000** for each Triggering Event Date requiring a certificate[105](index=105&type=chunk) [4. Additional Covenants](index=22&type=section&id=Section%204.%20ADDITIONAL%20COVENANTS) This section details additional ongoing obligations of the Company, including compliance with securities laws, timely filings, maintaining listing, cooperating with due diligence, and providing various legal and financial documents to the Agent - The Company will file all required reports under the Exchange Act and include summaries of Shares sold and net proceeds in its quarterly and annual reports[106](index=106&type=chunk) - The Company will promptly advise the Agent of Commission comments, filings, effectiveness of amendments, and any stop orders or delisting proceedings[107](index=107&type=chunk)[108](index=108&type=chunk) - The Company will furnish the Agent with certificates, legal opinions, and comfort letters on specific 'Triggering Event Dates' (e.g., filing of 10-K, 10-Q, material 8-K, or prospectus amendments)[122](index=122&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk) [4.1 Exchange Act Reporting](index=22&type=section&id=4(a)%20Exchange%20Act%20Compliance) The Company covenants to timely file all reports and documents required under the Exchange Act and to provide summaries of shares sold and net proceeds in its periodic reports - The Company shall file all reports and documents required under Section 13, 14, or 15 of the Exchange Act on a timely basis[106](index=106&type=chunk) - The Company will include a summary in its 10-Q and 10-K reports detailing the number of Shares sold through the Agent and net proceeds received, or file an Interim Prospectus Supplement quarterly[106](index=106&type=chunk) [4.2 Prospectus Amendments and Supplements](index=23&type=section&id=4(c)%20Amendments%20and%20Supplements%20to%20the%20Prospectus%20and%20Other%20Securities%20Act%20Matters) The Company agrees to promptly amend or supplement the Prospectus if necessary to prevent material misstatements or omissions, or to comply with applicable law, subject to Agent's consent - The Company agrees to promptly prepare, file, and furnish amendments or supplements to the Prospectus if necessary to avoid material misstatements or omissions, or to comply with applicable law[109](index=109&type=chunk) - The Company shall not file or use any proposed amendment or supplement to the Registration Statement or Prospectus without the Agent's prior consent[110](index=110&type=chunk) [4.3 Provision of Filings and Suspension of Offers](index=24&type=section&id=4(h)%20Copies%20of%20Registration%20Statement%20and%20Prospectus) The Company will furnish the Agent with copies of the Registration Statement and Prospectus, and will notify the Agent and request suspension of offers if the Prospectus becomes misleading or requires amendment - The Company agrees to furnish the Agent with copies of the Registration Statement and Prospectus and any amendments or supplements thereto[115](index=115&type=chunk) - If the Prospectus becomes misleading or requires amendment, the Company will notify the Agent, request suspension of offers to sell Shares, and promptly file an amendment or supplement[115](index=115&type=chunk)[116](index=116&type=chunk) [4.4 Triggering Event Deliverables](index=26&type=section&id=4(o)%20Deliverables%20at%20Triggering%20Event%20Dates%3B%20Certificates) On or prior to the first Issuance Notice and each 'Triggering Event Date' (e.g., filing of 10-K, 10-Q, material 8-K, or prospectus amendment), the Company must provide the Agent with a certificate affirming the accuracy of representations and performance of obligations - The Company shall furnish a certificate to the Agent on or prior to the first Issuance Notice and each Triggering Event Date[122](index=122&type=chunk) - The certificate confirms the truth and correctness of the Company's representations and warranties and the performance of its obligations[123](index=123&type=chunk) - Triggering Event Dates include the filing of prospectus amendments, annual reports on Form 10-K, quarterly reports on Form 10-Q, or current reports on Form 8-K containing material amended financial information[122](index=122&type=chunk) [4.5 Legal Opinions](index=27&type=section&id=4(p)%20Legal%20Opinions) On or prior to the first Issuance Notice and each relevant Triggering Event Date, counsel to the Company and intellectual property counsels will deliver legal opinions and negative assurance letters to the Agent - Legal opinions and negative assurance letters from Cooley LLP (Company counsel), Latham & Watkins LLP (Agent counsel), and Knobbe Martens Olson & Bear, LLP (IP counsel) are required on specific dates[124](index=124&type=chunk) [4.6 Comfort Letters](index=27&type=section&id=4(q)%20Comfort%20Letter) KPMG LLP, the Company's independent accountants, will furnish a comfort letter to the Agent on or prior to the first Issuance Notice and each relevant Triggering Event Date, limited to one per calendar quarter - KPMG LLP shall furnish a comfort letter to the Agent on or prior to the first Issuance Notice and each Triggering Event Date where financial statements are filed[125](index=125&type=chunk) - The Company is required to furnish no more than **one comfort letter per calendar quarter**[125](index=125&type=chunk) [4.7 Market Activities and Regulation M Compliance](index=28&type=section&id=4(u)%20Market%20Activities) The Company covenants not to engage in market stabilization or manipulation, and to comply with Regulation M, with an exception for its share repurchase program outside of restricted periods - The Company will not take action to stabilize or manipulate the price of Shares and will comply with Regulation M, except for repurchases under the Company Repurchase Program outside of 'restricted periods'[130](index=130&type=chunk) [4.8 Restrictions on Other Sales](index=28&type=section&id=4(v)%20Notice%20of%20Other%20Sale) Without Agent's consent, the Company will not offer or sell other common shares or convertible securities during specific periods around Issuance Notices, effect reverse stock splits, or enter other 'at the market' transactions, with exceptions for employee plans, conversions, and certain M&A activities - The Company will not offer or sell other Common Shares or convertible securities during the period beginning three Trading Days prior to an Issuance Notice and ending three Trading Days after the Settlement Date[131](index=131&type=chunk) - The Company will not effect a reverse stock split or enter into other 'at the market' transactions prior to the termination of this Agreement[131](index=131&type=chunk) - Exceptions to these restrictions include issuances under employee benefit plans, conversions of outstanding securities, and M&A transactions (up to **5%** of outstanding Common Shares)[132](index=132&type=chunk) [4.9 Emerging Growth Company Status Update](index=29&type=section&id=4(w)%20Emerging%20Growth%20Company%20Status) The Company will cease to be an Emerging Growth Company effective December 31, 2023, and will notify the Agent if this status changes earlier - The Company will cease to be an Emerging Growth Company effective December 31, 2023, and will promptly notify the Agent of any earlier change in status[133](index=133&type=chunk) [5. Conditions for Issuance and Settlement](index=29&type=section&id=Section%205.%20CONDITIONS%20TO%20DELIVERY%20OF%20ISSUANCE%20NOTICES%20AND%20TO%20SETTLEMENT) This section outlines the conditions that must be met for the Company to deliver an Issuance Notice and for the Agent to be obligated to sell shares, including the accuracy of representations, absence of injunctions, no material adverse changes, and stable market conditions - Conditions for delivering an Issuance Notice and Agent's obligation to sell shares include the accuracy of Company's representations and warranties, performance of covenants, and delivery of required certificates[134](index=134&type=chunk)[135](index=135&type=chunk) - No statute, rule, regulation, or injunction prohibiting or materially adversely affecting the transactions can be in effect, and no such proceeding can be pending[135](index=135&type=chunk) - There must be no Material Adverse Change, no downgrading of securities ratings, and no suspension of trading or delisting of Common Shares[138](index=138&type=chunk) - General market conditions must not make it impracticable to market the Shares, including no general banking moratorium or major national/international crisis[138](index=138&type=chunk) [6. Indemnification and Contribution](index=31&type=section&id=Section%206.%20INDEMNIFICATION%20AND%20CONTRIBUTION) This section establishes mutual indemnification obligations between the Company and the Agent for losses, claims, damages, and expenses arising from untrue statements or omissions in offering documents, or actions related to the offering, with provisions for contribution if indemnification is unavailable - The Company agrees to indemnify the Agent, its officers, employees, and controlling persons against losses arising from untrue statements or omissions in the Registration Statement, Free Writing Prospectus, or Prospectus, or related actions, except for those resulting from Agent's bad faith or willful misconduct[139](index=139&type=chunk) - The Agent agrees to indemnify the Company, its directors, officers, and controlling persons against losses arising from untrue statements or omissions in offering documents, but only to the extent based on written information furnished by the Agent for use therein[140](index=140&type=chunk)[141](index=141&type=chunk) - If indemnification is unavailable, parties will contribute to losses based on relative benefits received from the offering and relative fault, with the Agent's contribution capped at its received fees[145](index=145&type=chunk)[146](index=146&type=chunk)[149](index=149&type=chunk) [7. Termination and Survival](index=34&type=section&id=Section%207.%20TERMINATION%20%26%20SURVIVAL) This section defines the term of the Agreement and the conditions under which either party may terminate it, specifying which obligations, representations, and warranties survive termination - The Agreement continues until the end of the Agency Period, unless terminated earlier by either party with **10 calendar days'** written notice[150](index=150&type=chunk)[151](index=151&type=chunk) - Sections 2 (Representations and Warranties), 6 (Indemnification and Contribution), 7 (Termination & Survival), and 8 (Miscellaneous) survive the termination of the Agreement[151](index=151&type=chunk)[152](index=152&type=chunk) - If the Company terminates after a sale confirmation, it remains obligated to settle those shares[151](index=151&type=chunk) [8. Miscellaneous Provisions](index=35&type=section&id=Section%208.%20MISCELLANEOUS) This section covers various general provisions of the Agreement, including rules for press releases, the nature of the relationship between the Company and Agent, notice procedures, governing law, and the overall enforceability of the agreement - The Company may issue a press release and file an 8-K describing the transaction, consulting with the Agent for mutually satisfactory text[153](index=153&type=chunk) - The Company acknowledges that the Agent acts solely as a principal and does not assume an advisory or fiduciary responsibility[154](index=154&type=chunk) - The Agreement is governed by the internal laws of the State of New York, with exclusive jurisdiction in specified New York courts[161](index=161&type=chunk) - This Agreement constitutes the entire agreement, superseding all prior agreements, and can only be amended or modified in writing by all parties[162](index=162&type=chunk) [Signatures](index=39&type=section&id=Signatures) This section contains the signatures of the authorized representatives of Equillium, Inc. and Jefferies LLC, confirming their agreement to the terms of the Open Market Sale Agreement [Exhibit A: Issuance Notice Form](index=40&type=section&id=EXHIBIT%20A%20ISSUANCE%20NOTICE) Exhibit A provides the template for the 'Issuance Notice' that the Company uses to request the Agent to sell shares, specifying details such as the Issuance Amount, selling period, and floor price - The Issuance Notice form requires specifying the Issuance Amount, number of days in the selling period, first and last dates of the selling period, settlement date(s), and a Floor Price Limitation[169](index=169&type=chunk) [Schedule A: Notice Parties](index=41&type=section&id=Schedule%20A%20Notice%20Parties) Schedule A lists the specific individuals at the Company and the Agent who are designated to receive notices and communications related to the Agreement - Schedule A identifies Jason A. Keyes for the Company and Michael Magarro, Donald Lynaugh, and Jack Fabbri for the Agent as the designated notice parties[171](index=171&type=chunk) [Amendment No. 1 to Open Market Sale AgreementSM](index=42&type=section&id=AMENDMENT%20NO.%201%20TO%20THE%20OPEN%20MARKET%20SALE%20AGREEMENTSM) This amendment modifies the original Open Market Sale Agreement by changing the agent and updating related provisions, while preserving prior obligations [1. Amendment Details](index=42&type=section&id=Amendment%20Details) The amendment formally replaces Jefferies LLC with LifeSci Capital LLC as the 'Agent' and updates the contact information for notices. It specifies that the amendment does not retroactively affect prior sales and that key sections of the original agreement, including indemnification, survive - Jefferies LLC is replaced by LifeSci Capital LLC as the 'Agent' in the Agreement, effective August 3, 2025[172](index=172&type=chunk)[174](index=174&type=chunk) - Section 8(d) of the Agreement, pertaining to notices, is entirely replaced with updated contact information for LifeSci Capital LLC[175](index=175&type=chunk) - The amendment does not affect offerings or sales of Common Shares prior to the Effective Date, and Sections 2, 6, 7, and 8 of the original Agreement survive with respect to the Prior Agent[176](index=176&type=chunk) [2. Legal Provisions of Amendment](index=43&type=section&id=Amendment%20Legal%20Provisions) This section confirms the legal validity and binding nature of the amendment, outlines consultation requirements for disclosures, and reiterates the governing law and jurisdiction for any disputes arising from the amendment - The Amendment is duly authorized, executed, and delivered by the Company, making it a valid and binding agreement[177](index=177&type=chunk) - The Company will consult with both the Prior Agent and the New Agent for disclosures related to this Amendment[178](index=178&type=chunk) - The Amendment is governed by New York law, with exclusive jurisdiction in the Specified Courts in New York City[179](index=179&type=chunk) [3. Amendment Signatures](index=45&type=section&id=Amendment%20Signatures) This section contains the signatures of the authorized representatives from Equillium, Inc., Jefferies LLC (Prior Agent), and LifeSci Capital LLC (New Agent), confirming their acceptance and agreement to Amendment No. 1
Equillium (EQ) Earnings Call Presentation
2025-06-18 11:13
Corporate Presentation Actual results or events could differ materially from the plans, intentions and expectations disclosed or implied in the forward-looking statements the Company makes due to the risks and uncertainties inherent in the Company's business, including without limitation, the risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). You are cautioned not to place undue reliance on these forward-looking statements, which represent the Company's views as of ...
Equillium(EQ) - 2025 Q1 - Quarterly Report
2025-05-14 20:10
Financial Position - As of March 31, 2025, the company had $14.5 million in cash and cash equivalents, with an accumulated deficit of $202.5 million[91][100]. - The accumulated deficit as of March 31, 2025, was $202.5 million, indicating ongoing financial challenges[136]. - The company believes its cash and cash equivalents can fund operations into the third quarter of 2025, but there is substantial doubt about its ability to continue as a going concern[129]. - The company will need to raise additional capital to fund operations beyond the third quarter of 2025, with uncertainty regarding the ability to secure such funding[130]. - The company has no material non-cancelable purchase commitments with service providers, indicating flexibility in cash management[135]. - The company has experienced extreme volatility in financial markets, impacting liquidity and credit availability, which may affect future financing efforts[134]. Revenue and Expenses - The company has not generated any revenues from product sales, with past revenues derived from an upfront payment of $26.4 million under the Asset Purchase Agreement with Ono[104][105]. - Revenue for the three months ended March 31, 2025, was $0, a decrease of $10.7 million compared to $10.7 million in the same period of 2024[118]. - Research and development expenses primarily consist of costs associated with non-clinical research and clinical development of product candidates[108]. - Research and development expenses decreased to $5.9 million for the three months ended March 31, 2025, down from $9.7 million in 2024, a reduction of $3.8 million[120]. - General and administrative expenses were $2.9 million for the three months ended March 31, 2025, compared to $3.7 million in 2024, a decrease of $0.8 million[122]. - Interest income decreased to $0.2 million for the three months ended March 31, 2025, from $0.4 million in 2024, a decline of $0.2 million[123]. - Other income was $43,000 for the three months ended March 31, 2025, compared to an expense of $0.4 million in 2024, reflecting a change of $0.4 million[124]. - Cash used in operating activities was $8.2 million for the three months ended March 31, 2025, a decrease from $8.8 million in the prior year[137]. - The company expects to continue incurring operating losses and negative cash flows for at least the next several years due to ongoing development costs[136]. Clinical Development - The company plans to initiate a first-in-human Phase 1 clinical study for EQ504 in the first quarter of 2026, pending additional capital[92]. - Itolizumab (EQ001) did not meet primary outcomes in the Phase 3 EQUATOR study for acute graft-versus-host disease, but showed clinically meaningful improvements in durable complete response from Day 29 to 99[94][95]. - The company submitted data from the EQUATOR study to the FDA for Breakthrough Therapy Designation, but the FDA declined to grant it based on the current data[96]. - EQ302, a preclinical-stage product candidate, is on hold due to financial constraints, with plans to resume development contingent on securing additional funding[98]. - The company anticipates significant increases in expenses as it resumes development activities for EQ504, itolizumab (EQ001), and EQ302, contingent on raising additional capital[127]. - The company paused research and development activities pending the ability to raise capital in the second quarter of 2025, with potential strategic alternatives including mergers[91][102]. Capital Raising Activities - The company entered into a 2023 ATM Facility allowing for the sale of up to $21.95 million in common stock, with gross proceeds of approximately $55,000 from 109,410 shares sold during the three months ended March 31, 2025[126]. - The company raised approximately $53,000 from the sale of shares under the 2023 ATM Facility during the three months ended March 31, 2025[139]. - The company has contingent consideration liabilities related to potential milestone payments under various agreements, but these are considered unlikely to come due within the next 12 months[141].
Equillium(EQ) - 2025 Q1 - Quarterly Results
2025-04-24 13:05
Financial Position - As of March 31, 2025, Equillium, Inc. reported estimated cash, cash equivalents, and short-term investments of approximately $14.5 million[6]. Financial Reporting - The actual financial statements for the quarter ended March 31, 2025, are not yet available and will be subject to final adjustments[7]. - The preliminary financial data should not be viewed as a substitute for financial statements prepared in accordance with generally accepted accounting principles[7]. - The company has not audited or reviewed the preliminary financial data, which reflects information available only at this time[9]. - Risks related to preliminary financial results include potential discrepancies upon completion of financial closing procedures[9]. Forward-Looking Statements - Forward-looking statements in the report are based on current management expectations and reasonable assumptions, but actual results may differ materially[9]. - The company undertakes no obligation to update any forward-looking statements to reflect new information or events[9]. Regulatory Information - The company is registered with the SEC under the Securities Exchange Act of 1934[1]. - Equillium, Inc. is listed on the Nasdaq Capital Market under the symbol EQ[4]. Press Release - The report includes a press release dated April 24, 2025, which is incorporated by reference[9].
Equillium (EQ) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now
ZACKS· 2025-04-01 15:01
Core Viewpoint - Equillium, Inc. (EQ) has experienced a significant decline of 52.2% in its stock price over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1][2]. Technical Analysis - The hammer chart pattern indicates a minor difference between opening and closing prices, with a long lower wick suggesting that the stock found support after hitting a new low during a downtrend [4][5]. - This pattern signals that bears may have lost control, and the success of bulls in preventing further price declines indicates a potential trend reversal [5]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for EQ, with the consensus EPS estimate for the current year increasing by 11.2% over the last 30 days, indicating that analysts expect better earnings than previously predicted [7][8]. - EQ holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9]. This rank serves as a strong indicator of improving company prospects and potential trend reversal [9].