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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
Shares of Equillium, Inc. (EQ) have been struggling lately and have lost 52.2% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road. While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the future ea ...
Penny Stock Equillium Falls After Itolizumab Treatment Fails To Show Improvement In Response Rates In Graft Versus Host Disease Patients
Benzinga· 2025-03-27 15:16
Equillium, Inc. EQ released topline data on Thursday from the Phase 3 EQUATOR study. The study evaluated itolizumab in the first-line treatment of patients with acute graft-versus-host disease (aGVHD).The study results did not demonstrate a meaningful difference in complete response (CR) or overall response rate (ORR) at Day 29 between patients treated with itolizumab and placebo.However, the company said that statistically significant and clinically meaningful benefits in longer-term outcomes were achieved ...
Equillium(EQ) - 2024 Q4 - Annual Report
2025-03-27 11:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38692 EQUILLIUM, INC. (Exact name of registrant as specified in its Charter) Delaware 82-1554746 (State or other jurisdiction of inco ...
Equillium(EQ) - 2024 Q4 - Annual Results
2025-03-27 11:05
Financial Performance - Revenue for Q4 2024 was $4.4 million, down from $9.2 million in Q4 2023; full year revenue increased to $41.1 million from $36.1 million in 2023[6] - R&D expenses for Q4 2024 were $7.3 million, compared to $9.2 million in Q4 2023; full year R&D expenses slightly increased to $37.4 million from $37.0 million[7] - G&A expenses for Q4 2024 decreased to $1.8 million from $3.2 million in Q4 2023; full year G&A expenses were $11.9 million, down from $13.6 million[8] - Net loss for Q4 2024 was $5.8 million, or $(0.16) per share, compared to a net loss of $2.3 million, or $(0.07) per share in Q4 2023; full year net loss was $8.1 million, or $(0.23) per share, down from $13.3 million, or $(0.38) per share in 2023[9] Clinical Results - Itolizumab demonstrated a median duration of complete response of 336 days compared to 72 days for placebo, with a p-value of 0.017[4] - Itolizumab showed a median failure-free survival of 154 days versus 70 days for placebo, with a p-value of 0.043[4] Future Plans - The company expects FDA feedback on the Breakthrough Therapy designation request and Accelerated Approval pathway in May 2025[5] - The company plans to submit a biologics license application in the first half of 2026, pending positive FDA feedback and additional capital[2] Financial Position - Cash, cash equivalents, and short-term investments totaled $22.6 million as of December 31, 2024, down from $40.9 million as of December 31, 2023[11] - The total assets decreased to $25.6 million in 2024 from $50.5 million in 2023[18]
Here's Why Equillium (EQ) Is a Great 'Buy the Bottom' Stock Now
ZACKS· 2025-02-21 15:55
A downtrend has been apparent in Equillium, Inc. (EQ) lately. While the stock has lost 5.3% over the past week, it could witness a trend reversal as a hammer chart pattern was formed in its last trading session. This could mean that the bulls have been able to counteract the bears to help the stock find support.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the future earnin ...
Equillium (EQ) Upgraded to Buy: Here's What You Should Know
ZACKS· 2025-02-10 18:01
Equillium, Inc. (EQ) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.The power of a ...
Equillium (EQ) Shows Fast-paced Momentum But Is Still a Bargain Stock
ZACKS· 2025-02-10 14:51
Group 1: Momentum Investing Overview - Momentum investing deviates from the traditional "buy low and sell high" strategy, focusing instead on "buying high and selling higher" to maximize returns in a shorter time frame [1] - Fast-moving trending stocks can be appealing, but determining the right entry point is challenging, as these stocks may lose momentum if their valuations exceed future growth potential [2] Group 2: Investment Strategy and Stock Selection - Investing in bargain stocks that have recently shown price momentum can be a safer approach. The Zacks Momentum Style Score is useful for identifying strong momentum stocks, while the 'Fast-Paced Momentum at a Bargain' screen helps find attractively priced fast-moving stocks [3] - Equillium, Inc. (EQ) is highlighted as a strong candidate, with a four-week price change of 22.3%, indicating growing investor interest [4] - EQ has demonstrated positive returns over a longer time frame, gaining 20.7% over the past 12 weeks, and has a beta of 1.79, suggesting it moves significantly more than the market [5] Group 3: Performance Metrics and Valuation - EQ has a Momentum Score of B, indicating a favorable time to invest, and an upward trend in earnings estimate revisions has earned it a Zacks Rank 2 (Buy) [6][7] - The stock is trading at a Price-to-Sales ratio of 0.66, suggesting it is undervalued, as investors pay only 66 cents for each dollar of sales [7] Group 4: Additional Investment Opportunities - Besides EQ, there are other stocks that meet the criteria of the 'Fast-Paced Momentum at a Bargain' screen, presenting further investment opportunities [8] - The Zacks Premium Screens offer over 45 different strategies tailored to various investing styles, aiding in stock selection [9]
Equillium(EQ) - 2024 Q3 - Quarterly Report
2024-11-13 21:10
Financial Performance - For the nine months ended September 30, 2024, the company reported net losses of $2.3 million compared to $11.0 million for the same period in 2023, with an accumulated deficit of $188.0 million as of September 30, 2024[134]. - The company expects to continue incurring significant expenses and operating losses into the foreseeable future, with a focus on advancing research and development activities[134]. - The company had an accumulated deficit of $188.0 million as of September 30, 2024, and anticipates continuing to incur net losses for the foreseeable future[162]. - Cash used in operating activities for the nine months ended September 30, 2024, was $15.7 million, a slight decrease from $16.1 million in the same period of 2023[177]. - The company expects its cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2025, based on certain operational changes[168]. - The company reported a net loss of $2.3 million for the nine months ended, with an accumulated deficit of $188.0 million[194]. - The company expects to incur significant operating losses for the foreseeable future as it continues research and development activities and seeks regulatory approvals[196]. Revenue Generation - The company has not generated any revenue from therapeutic product sales, developmental milestones, or royalties to date, relying on development funding from Ono and recognition of deferred revenue from an upfront payment under the Asset Purchase Agreement[137]. - The company recognized revenue of $12.2 million and $36.7 million for the three and nine months ended September 30, 2024, respectively, compared to $8.9 million and $26.9 million for the same periods in 2023, reflecting a year-over-year increase of 37% and 36%[140][152]. - The company recognized $2.1 million in aggregate deferred revenue related to the Asset Purchase Agreement with Ono as of September 30, 2024[140]. Research and Development - The ongoing Phase 3 EQUATOR study for itolizumab (EQ001) is expected to accelerate its timeline to topline data by the first quarter of 2025, with reduced enrollment to approximately 150 patients[125]. - A positive recommendation was received from the Independent Data Safety Monitoring Committee to continue the EQUATOR study based on interim analysis of the first approximately 100 subjects[125]. - The company has completed a Phase 1b proof-of-concept clinical study of itolizumab in patients with systemic lupus erythematosus, announcing positive topline data in April 2024[127]. - The company anticipates that expenses may increase substantially as it advances research and development activities, including ongoing and future clinical development of itolizumab[145]. - The company has paused further development activities related to EQ101 and EQ302 due to financial constraints, pending the availability of additional funding[129]. - The company has initiated multiple clinical studies for itolizumab (EQ001), including a Phase 3 study for aGVHD, which is currently paused to save costs[218]. - The company has two active INDs with the FDA for itolizumab (EQ001) targeting aGVHD and LN, and additional INDs for EQ101 and EQ102 following the acquisition of Bioniz[218]. Funding and Capital Requirements - The company plans to finance its cash needs through a combination of equity offerings, debt financings, and collaboration agreements, but may face challenges in securing additional financing[136]. - The company entered into a 2023 ATM Facility with Jefferies LLC, allowing for the sale of shares up to $21.95 million, but no shares have been sold as of the report date[164]. - The company plans to pursue additional capital sources, including the 2023 ATM Facility, to address funding requirements following Ono's decision to let its option lapse[169]. - The company will require substantial additional funding to continue the development and commercialization of itolizumab (EQ001) and other product candidates[198]. - Future capital requirements will depend on various factors, including the progress and costs of ongoing clinical studies and the ability to implement significant expense reductions[204]. - The company may need to raise substantial additional capital to complete the development and commercialization of its product candidates, which could lead to dilution for existing shareholders[203]. Regulatory and Market Risks - The company is highly dependent on the successful development of itolizumab (EQ001) and may not obtain regulatory approval for its product candidates[189]. - The company has not yet obtained approval from the FDA or any other regulatory authority for any product, which may impede future approvals[243]. - Delays in obtaining regulatory approval could materially impair the company's ability to generate revenues and adversely affect its financial condition[244]. - The company faces challenges in enrolling patients for clinical studies, which could delay necessary regulatory approvals[252]. - The FDA may not accept data from clinical studies conducted outside the United States, which could delay development plans[269]. - Regulatory authorities may require additional studies or impose delays based on the safety and efficacy data submitted, affecting the approval timeline[241]. Competitive Landscape - The competitive landscape includes significant players like Pfizer Inc. and Eli Lilly and Company, which possess greater financial resources and expertise in R&D, manufacturing, and marketing[289]. - The company faces substantial competition in the biopharmaceutical market, which may result in competitors developing and commercializing products more quickly or effectively[286]. - The market acceptance of any approved product candidates will depend on factors such as efficacy, pricing, convenience, and marketing support[282]. Manufacturing and Supply Chain - The company relies on Biocon for the manufacturing of itolizumab (EQ001), and any disruptions in Biocon's operations could adversely affect the company's development and commercialization efforts[310]. - The company is dependent on contract research organizations (CROs) for clinical studies, and any failure by these third parties to meet obligations could delay regulatory approvals[311]. - Manufacturing of pharmaceutical products, especially biologics, is complex and dependent on third-party contract manufacturing organizations (CMOs), which poses risks to supply and approval timelines[306]. Intellectual Property - The company's success significantly depends on its ability to establish, maintain, and protect patents related to its proprietary technologies and product candidates, including itolizumab (EQ001) and others[319]. - The patent prosecution process is noted to be expensive and time-consuming, which may hinder the timely filing of necessary patent applications[320]. - There is a risk that the company or its partners may fail to identify patentable aspects of their research before it is too late to secure patent protection[320].
Equillium(EQ) - 2024 Q3 - Quarterly Results
2024-11-13 21:05
Exhibit 99.1 Equillium Reports Third Quarter 2024 Financial Results and Provides Corporate and Clinical Updates Equillium retains rights to itolizumab following substantial funding from Ono partnership Evaluating accelerating Phase 3 EQUATOR study in aGVHD to completion in Q1 2025 Phase 2 ulcerative colitis study recently completed; topline data expected Q1 2025 LA JOLLA, California, November 13, 2024 – Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of i ...