– OLC New Drug Application (NDA) Accepted by the FDA with a PDUFA Target Action Date of June 28, 2025–
– Commercial Planning in Progress for 2025 Launch –
– Late Breaker Poster Presentation on OLC at ASN Kidney Week –
– Successful Completion of UNI-494 Phase 1 Trial –
LOS ALTOS, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended September 30, 2024, and provided a business update.
“We are pleased with the tremendous progress we have made over the last several months highlighted by the acceptance of our New Drug Application for oxylanthanum carbonate (OLC) which may result in the potential approval of our first drug in 2025,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “If approved, we believe OLC’s high potency and low pill burden would provide a best-in-class option for patients with chronic kidney disease (CKD) on dialysis who have hyperphosphatemia and face adherence challenges with current treatment regimens. With the NDA acceptance now behind us, we are actively preparing to commercialize OLC with the goal of bringing this innovative new treatment to market in the second half of 2025.”
“We have also made progress on our second asset, UNI-494, as we announced the successful completion of our Phase 1 clinical trial providing the necessary data to potentially advance to Phase 2 clinical development. UNI-494 is targeting acute kidney injury (AKI), a challenging and often under-treated disease. We plan to request a meeting with the FDA by the end of this year to continue advancing our clinical development program for UNI-494,” concluded Dr. Gupta.
Key Highlights
Announced the acceptance of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.
Announced initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. In the survey, OLC consistently outperformed the other phosphate binders in all categories: 79% of patients preferred OLC compared to 18% of patients who preferred their prior therapy; 98% of patients said that OLC was easy to take compared to 55% for their prior therapy; and 89% of patients said they were satisfied with OLC while only 49% were satisfied with their prior therapy.
Announced the successful completion of the UNI-494 Phase 1 study in healthy volunteers. The Phase 1 study was a single center, double-blind, placebo-controlled, randomized single ascending dose (Part 1) and multiple ascending dose (Part 2) study in healthy volunteers conducted in the United Kingdom. UNI-494 was well-tolerated as a single dose up to 160 mg and in multiple doses at 40 mg twice-a-day. The absorption of UNI-494 was fast, and UNI-494 was rapidly metabolized to release nicorandil. Collectively, the results will help determine the dose and schedule of UNI-494 in a potential Phase 2 clinical trial in patients with acute kidney injury.
Granted a patent on UNI-494 to treat AKI by the United States Patent and Trademark Office (USPTO). The patent, valid until 2040, secures protection of a method of treating a disease or a condition (“method of use”) related to AKI or contrast-induced-nephropathy by administering the UNI-494 compound.
Delivered four presentations on OLC and UNI-494 at the American Society of Nephrology (ASN) Kidney Week 2024 including a late-breaker poster presentation highlighting favorable safety and tolerability data of OLC. The presentation highlighted the positive pivotal clinical trial data demonstrating that OLC was able to achieve serum phosphate control in more than 90% of patients with CKD on dialysis who entered the maintenance phase of the trial. A poster presentation also described the results from the UNI-494 Phase 1 study results, and two preclinical posters were presented.
Two preclinical studies for both OLC and UNI-494 were featured in two publications: “Systemic Absorption of Oxylanthanum Carbonate is Minimal in Preclinical Models” was published in the Pharmaceutical Chemistry Journal; “Evaluation of UNI-494 in Acute Kidney Injury Treatment Efficacy When Administered After Ischemia-Reperfusion in a Rat Model” was published in EC Pharmacology and Toxicology.
UNCY was added to the Russell Microcap® Index effective July 1, 2024. Membership in the Russell Microcap® Index, which remains in place for one year is accompanied by automatic inclusion in the appropriate growth and value style indexes.
Financial Results for the Quarter Ended September 30, 2024
Research and Development (R&D) expenses were $3.0 million for the three months ended September 30, 2024, compared to $3.4 million for the three months ended September 30, 2023. The decrease in research and development expenses was primarily due to decreased drug development costs.
General and Administrative (G&A) expenses were $3.2 million for the three months ended September 30, 2024, compared to $2.6 million for the three months ended September 30, 2023. The increase was primarily due to increased non-cash stock compensation expense.
Other Income was $2.2 million for the three months ended September 30, 2024 compared to $1.6 million in the three months ended September 30, 2023, due primarily to a decrease in the fair value of our warrant liability.
Net loss attributable to common stockholders for the three months ended September 30, 2024 was $4.1 million, compared to a net loss attributable to common stockholders of $4.4 million, for the three months ended September 30, 2023. The decreased net loss for the three-month period ended September 30, 2024 was attributable to a decrease in the fair value of our warrant liability.
As of September 30, 2024, cash and cash equivalents totaled $32.3 million. The Company believes that it has sufficient resources to fund planned operations into 2026.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
For more than 70 years, Vectrus has provided critical mission support for our customers’ toughest operational challenges. As a high-performing organization with exceptional talent, deep domain knowledge, a history of long-term customer relationships, and groundbreaking technical expertise, we deliver innovative, mission-matched solutions for our military and government customers worldwide. Whether it’s base operations support, supply chain and logistics, IT mission support, engineering and digital integration, security, or maintenance, repair and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on Facebook, Twitter, and LinkedIn.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
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Round 2. American Industrial Partners (AIP) is selling another trance of VVX shares, this time 2.5 million shares with up to an additional 375,000 shares to be sold. As we noted in AIP September’s stock sale, we had expected AIP eventually to begin to sell off its stake, so we are not surprised with this additional sale. V2X will not receive any proceeds from the sale. The additional float is a positive for investors, in our view.
Ownership. Upon the completion of this offering, investment funds affiliated with AIP will beneficially own approximately 44.9% of V2X’s outstanding common stock, or 14,167,286 shares (or approximately 43.7% if the underwriters exercise their option to purchase additional shares in full).
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Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
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Q3 results. The company reported Q3 revenue of $22.2 million and an adj. EBITDA loss of $2.6 million. While the revenue was slightly below our estimate of $24.1 million, the adj. EBITDA loss was milder than our estimate of $3.4 million.
Gaining traction with Home Depot. Since announcing the partnership in July, the company’s presence in Home Depot locations has expanded to 100 stores. Additionally, SKYX products are available on Home Depot’s website. We anticipate more SKUs to become available both online and in stores soon, as a wide variety of SKYX products are expected to arrive from the company’s manufacturing partner, Ruee Appliances.
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Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
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Third quarter financial results. FreightCar America generated third quarter adjusted net income to common stockholders of $2.455 million or $0.08 per share compared to $3.953 million or $0.13 per share during the prior year period. We had anticipated adjusted net income to common stockholders of $2.465 million or $0.07 per share. Average shares outstanding of 31.4 million were lower than our estimate of 34.5 million. Revenue and rail car deliveries increased to $113.3 million and 961, respectively, compared to $61.9 million and 503 during the third quarter of 2023. On a year-over-year basis, adjusted EBITDA increased to $10.9 million compared to $3.5 million during the prior year period and our estimate of $9.8 million. Free cash flow amounted to $5.7 million.
Full year 2024 corporate guidance. While guidance for revenue and rail car deliveries is unchanged, management narrowed its guidance range for EBITDA to $37.0 million to $39.0 million compared to previous expectations of $35.0 million to $39.0 million.
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Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
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New assay results. Aurania received preliminary results from studies conducted by SGS Laboratories on a sample of magnetic sand taken from Nonza Beach, Corsica. The nickel-bearing mineral in the black magnetic sand is indeed awaruite, a natural nickel-iron alloy. SGS was able to isolate a nearly pure awaruite concentrate from the magnetic sand using a combination of grinding and flotation. New assays of awaruite flotation concentrate yielded 71.4% nickel, 0.98% cobalt, 0.65% copper, 0.58 grams of gold per tonne, 0.09 grams of platinum per tonne, and 0.39 grams of palladium per tonne. The flotation method recovered 83.8% of the nickel contained in the magnetic sand, which had a head grade of 6% nickel. Studies of identical sands at nearby Albo Beach are underway.
Extraction and processing. Aurania hired IHC Mining Advisory Services (IMAS) to identify the best means to extract and recover the black beach sands at Albo-Nonza. IHC proposed two different scenarios focused on the extraction of heavy minerals containing nickel and iron. The preferred scenario uses a floating suction and cutter-head dredge on floating pontoons. IMAS estimated the capital cost of the cutter suction dredger scenario to be €13 million, including €7.8 million for the dredging equipment and €5.2 million for a processing plant.
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Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Ocugen Held A Meeting With Scientists, Doctors, and Patients. On November 12, Ocugen held a Clinical Showcase meeting to present the scientific basis of its Gene Modifier technology, interim data updates from its clinical trials, and allow patients to discuss their experiences with the treatments.
First OCU410 Data Shows Efficacy. The Phase 2 ArMaDa trial is testing OCU410 in Geographic Atrophy (GA), a lesion in patients with dry age-related macular degeneration that leads to blindness. The presentations included its four mechanisms of action and the clinical outcomes from the initial patient cohorts in the dose-escalation stage of the trial. These data at 6 months compare favorably to approved complement inhibitors for GA.
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GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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3Q24 Report Reviews Progress During The Quarter. GeoVax reported a loss of $5.8 million or $(0.91) per share. The quarter included first revenues from its BARDA contract for the Project NextGen Phase 2b trial testing CM04S1 as a preventive vaccine for COVID-19. The company gave updates and data timeframes for clinical trials with CM04S1, MVA, and Gedeptin. During the quarter, it raised $13.5 million and ended with a cash balance of $8.6 million on September 30, 2024.
Gedeptin Trial Design Announced. GeoVax announced that the Phase 2 trial in head and neck squamous cell carcinoma (HNSCC) will test Gedeptin in combination with an immune checkpoint inhibitor (ICI) in recurrent patients before surgery. A single-cycle of Gedeptin will be given with a standard dose of Keytruda (pembrolizumab), followed by a second cycle of Keytruda alone, then surgery. Endpoints will include standard measures of response, tumor shrinkage, and survival that would make the data comparable to other treatments. The trial is expected to begin in 1H25.
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Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
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Weak Q3 Results, likely the trough. Q3 revenues declined 85% to $9.1 million, with a decline in both its Buy-side and Sell-side businesses, down 12% and 96%, respectively. Adj. EBITDA was a negative $2.8 million. Management blamed the weak fundamentals on a business disruption caused by a “false and disproven” blog post by Adalytics, which it sued for defamation. Notably, the Q3 results puts the company back on track on its financial reporting under its new auditor BDO.
Guidance anticipates a strong revenue rebuild. Management anticipates rebound in revenues as one of its largest clients rebuilds volume. We expect strong sequential Q4 revenue to $14.5 million, up from $9.1 million in Q3. Full year 2024 revenue is expected to be $67.7 million, with full year 2024 adj. EBITDA loss of $8.6 million. Management anticipates strong full year 2025 revenue growth to a range of $90 million to $110 million.
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Key Points: – US stocks rise as inflation data meets forecasts, supporting a potential December Fed rate cut. – Consumer Price Index (CPI) shows annual inflation at 2.6% with core inflation at 3.3%, aligning with expectations. – FedWatch tool indicates 80% likelihood of a rate cut in December, reinforcing investor confidence.
US stocks gained in Wednesday afternoon trading as the latest consumer inflation report aligned with expectations, reinforcing the likelihood of a Federal Reserve interest rate cut in December. The Dow Jones Industrial Average (^DJI) rose by approximately 0.4%, recovering from previous session losses, while the S&P 500 (^GSPC) and the tech-heavy Nasdaq Composite (^IXIC) saw increases of about 0.3% and 0.2%, respectively. Bitcoin (BTC-USD) also continued its bullish trend, climbing 5% to over $92,000 per coin as investors maintained optimism in the digital asset market.
The October Consumer Price Index (CPI) reported a 2.6% year-over-year increase, with core inflation — which excludes volatile food and energy prices — rising by 3.3%. Both monthly and annual inflation rates met analyst forecasts, with core inflation edging up 0.3% month-over-month. These figures suggest that inflation may be stabilizing, a welcome development for the Fed as it considers a rate cut to support economic growth.
Minneapolis Fed President Neel Kashkari commented on the importance of inflation data for upcoming Fed policy decisions. He stated that while the numbers are in line with expectations, any unexpected rise in inflation could influence the Fed’s approach. The latest CME FedWatch tool data indicates an 80% chance of a December rate cut, as traders expect the Fed to act cautiously in light of recent economic and inflation trends.
Looking at broader market factors, post-election economic optimism has slowed somewhat as investors consider the potential impact of President-elect Donald Trump’s policy promises on inflation and growth. Concerns over rising borrowing costs due to increased Treasury yields have tempered market enthusiasm, adding some caution to the economic outlook. However, the inflation data provides a clearer backdrop for the Fed, likely keeping it on a path toward reducing rates next month, which could help offset higher yields and bolster economic activity.
Investors continue to keep a close eye on inflation as well as any signals from the Fed. With the markets increasingly expecting rate cuts, the stability of inflation numbers may provide confidence for both consumers and businesses as they plan for 2024. Meanwhile, the growing strength of assets like bitcoin reflects a broader trend of investor confidence across diverse sectors.
As the year winds down, the stock market will closely monitor any changes in inflation, economic data, and Fed commentary, which will likely guide trading activity into 2024.
Key Points: – Elliott Management holds a major stake in Honeywell, urging a split into Aerospace and Automation segments. – Elliott projects a 75% stock price boost within two years if Honeywell proceeds with the split. – Reflecting a broader trend, Elliott argues for simplification to enhance focus and unlock value.
Activist investor Elliott Management has acquired a $5 billion stake in Honeywell International and is calling for the industrial conglomerate to split into two separate companies. Elliott’s proposal would see Honeywell divide along its two main business lines: Aerospace, which supplies critical technology to military and commercial clients, and Automation, a major supplier of sensors and control systems for industrial applications. Elliott’s managing partner, Jesse Cohn, and partner Marc Steinberg believe that a breakup would unlock significant shareholder value, projecting a 75% increase in Honeywell’s stock price within two years if their recommendations are followed.
In a letter addressed to Honeywell’s board, Cohn and Steinberg argue that the company’s current conglomerate structure has become a drag on its growth. They point to underperformance since 2019, attributing it to an unwieldy corporate structure and ineffective investor communication. Elliott, however, did not direct criticism at Honeywell’s CEO, Vimal Kapur, who took the reins in 2023 and has pursued an aggressive M&A strategy to enhance Honeywell’s portfolio. Nevertheless, Elliott contends that Honeywell would achieve better performance by focusing on core areas, which could be achieved more effectively through a separation.
Honeywell’s Aerospace division, which Elliott calls the company’s “crown jewel,” has been a consistent source of revenue, yet has received only 10% of the M&A investment allocated by Honeywell in the past 20 years. Elliott suggests that by reallocating resources and focusing exclusively on high-performing units, both Aerospace and Automation could realize their full potential independently. Additionally, Elliott argues that Honeywell’s back-office operations—such as legal, IT, and HR—are largely divided between the two units, making a split more feasible than in typical conglomerates.
Honeywell responded to Elliott’s recommendations by stating its openness to shareholder perspectives and welcoming further engagement with the activist investor. Despite this, Honeywell’s board was reportedly unaware of Elliott’s involvement prior to the public release of the letter. In keeping with its careful approach to activism, Elliott consulted extensively with industry experts and former employees to understand the company’s operational and strategic options, even enlisting investment bankers and consultants to aid in its analysis.
Elliott’s push for a breakup reflects a growing trend across industrial conglomerates, many of which have embraced separations in recent years. General Electric, for example, completed a long-awaited division into distinct units, which has driven significant stock gains in 2024. Similarly, 3M and Johnson Controls have shed divisions in favor of streamlined operations. Elliott argues that such moves allow companies to focus on core competencies, attract dedicated investor interest, and ultimately improve shareholder value—a transformation it believes Honeywell would benefit from.
Elliott’s recommendation proposes that the split would yield two businesses each valued at over $100 billion if taken public independently. They also suggest that Honeywell divest some additional non-core segments, such as its personal protective equipment and Advanced Materials units, a step Kapur has already considered. Cohn and Steinberg emphasized that their proposed path for Honeywell is not unprecedented, pointing out that investor sentiment has moved away from conglomerates in favor of more focused companies.
As Honeywell’s board weighs Elliott’s recommendations, the company’s future remains uncertain, but Elliott’s pressure may catalyze significant changes to its longstanding structure. With this move, Elliott hopes to add Honeywell to its track record of successful activist campaigns, having previously advocated for similar strategic breakups in companies like Marathon Petroleum and Alcoa.
Progress in GEO-CM04S1 BARDA/Project NextGen Phase 2b trial; multiple data readouts of existing COVID-19 vaccine Phase 2 trials expected during fourth quarter 2024
Gedeptin® on track to advance into Phase 2 clinical trial for first recurrent head and neck cancer in the first half of 2025
GEO-MVA Mpox vaccine advancing with cGMP clinical batch anticipated during fourth quarter 2024
Company to host conference call and webcast today at 4:30 p.m. ET
ATLANTA, GA, November 12, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced financial results for the third quarter ended September 30, 2024, and provided a business update.
David Dodd, GeoVax’s Chairman and CEO, stated, “2024 has shaped up to be a year of steady progress and execution across our development programs. Following the BARDA/RRPV award of nearly $400 million in support of evaluating GEO-CM04S1 in the Project NextGen program, we continue to collaborate closely with the BARDA Project NextGen team and our CRO, Allucent, preparing for the activation of the 10,000-patient Phase 2b clinical study. The necessary sites are confirmed, and we are working closely with Oxford Biomedica (“OXB”), our manufacturing partner, to produce the vaccine product required for study activation. We look forward to sharing further updates related to this exciting Phase 2b study.”
“In the third quarter, we also strengthened our balance sheet with additional funding, enabling us to confirm plans towards initiating a Phase 2 trial of Gedeptin in conjunction with an immune checkpoint inhibitor, as therapy for first recurrent head and neck cancer patients,” Dodd continued. “We anticipate initiating this study during the first half of 2025. We have also made significant progress with GEO-MVA, our vaccine candidate for Mpox, and expect to achieve production of a cGMP clinical batch during the fourth quarter. With GEO-MVA, we intend to create the first U.S.-based source for a Mpox vaccine, an important biodefense goal.”
“Supported by our recent progress, we believe we are well-positioned to advance our priority programs in support of developing innovative solid tumor therapies and infectious disease vaccines. Our commitment to advancing life-changing treatments continues to drive us in our mission to improve patient care worldwide through innovative developments.”
Third Quarter Business Achievements and Updates
GEO-CM04S1
BARDA Project NextGen Phase 2b trial: Target sites are confirmed, and activities are underway in support of initiating the 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA) approved mRNA COVID-19 vaccine.
Existing Phase 2 clinical studies: During the fourth quarter of 2024, GeoVax anticipates reporting interim results from (a) the comparative trial among Immunocompromised/Chronic Lymphocytic Leukemia (CLL) patients and (b) the booster trial among healthy adults. For the Immunocompromised/Stem Cell Transplant patient trial, additional sites have been added and patient enrollment continues.
Gedeptin®
Activities underway in support of Phase 2 study of Gedeptin combined with an immune checkpoint inhibitor as therapy among patients with first recurrent head and neck cancer.
This trial is anticipated to be a single-cycle trial in approximately 36 patients with a pathologic response rate as the primary endpoint. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer.
Mpox and Smallpox Vaccine Platform
GEO-MVA is GeoVax’s vaccine candidate in development for protection against Mpox and Smallpox.
A cGMP Master Seed Virus has been successfully manufactured and released by OXB and a cGMP clinical batch is currently in production, anticipated to be completed during Q4.
MVA is the vaccine recommended by both WHO and the CDC against both Mpox and Smallpox, recognized for its safety and efficacy among all patient populations, including pregnant women, children and immunocompromised individuals. MVA is the vaccine currently used and stockpiled in the United States Strategic National Stockpile for immunization against potential bioterrorism threats based on the smallpox virus.
Continuous Cell-line MVA Manufacturing Process Development
Development activities are underway in support of the AGE.1 continuous MVA manufacturing process. Additional progress is expected to be reported during Q4.
Corporate Updates
GeoVax Scientific Advisory Board: Appointed Teresa Lambe, PhD, OBE, FMedSci, professor of Vaccinology and Immunology at the Oxford Vaccine Group within the University of Oxford, to the Scientific Advisory Board.
Third Quarter 2024 Financial Results
Net Loss: Net loss for the three-month period ended September 30, 2024, was $5,815,468, or $0.91 per share, as compared to $8,408,818, or $4.75 per share, for the comparable period in 2023. For the nine months ended September 30, 2024, the Company’s net loss was $16,729,642, or $4.52 per share, as compared to $18,374,354, or $10.42 per share, in 2023.
Revenue: During the three-month and nine-month periods ending September 30, 2024, the Company reported $2,789,484 and $3,090,161 of government contract revenues associated with the BARDA/RRPV Project NextGen award. There were no revenues reported during the comparable 2023 periods.
R&D Expenses: Research and development expenses were $7,402,884 and $16,105,480 for the three-month and nine-month periods ended September 30, 2024, compared with $6,947,979 and $14,486,896 for the comparable period in 2023, with the changes primarily due to costs of manufacturing materials for use in our clinical trials of GEO-CM04S1 and other costs associated with the BARDA Contract.
G&A Expenses: General and administrative expenses were $1,241,176 and $3,784,559 for the three-month and nine-month periods ended September 30, 2024, compared to $1,651,775 and $4,562,293 for the comparable periods in 2023, with the changes primarily due to lower stock-based compensation expense, consulting costs, legal and patent costs and franchise tax cost.
Cash Position: GeoVax reported cash balances of $8,592,523 at September 30, 2024, as compared to $6,452,589 at December 31, 2023.
Summarized financial information is attached. Further information is included in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.
Conference Call Details
Management will host a conference call and live audio webcast to discuss third quarter 2024 financial results and provide a business update today, November 12, 2024, at 4:30 p.m. ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the GeoVax website at geovax.com/investors. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax’s website approximately two hours after the conference call and will remain available for at least 90 days following the event.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
MIAMI, Nov. 12, 2024 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 97 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today reported its financial and operational results for the third quarter ended September 30, 2024.
Third Quarter 2024 Highlights and Recent Events
Generated record third quarter revenues of $22.2 million compared to $21.6 million for the third quarter of 2023,
Prior to the completion of the $11 million equity raise in October 2024, as of September 30, 2024, Company reported $13.0 + million in cash, cash equivalents, and restricted cash, as compared to $15.6 million as of June 30, 2024.
In October 2024, SKYX Secured $11 million equity preferred stock investment representing $2.00 per share of common stock with NO warrants, led by global Marriott Hotel chain developer/owner (of over 70 hotels) Lance Shaner, and included significant insider investing by SKYX’s President Steve Schmidt, who invested $500,000, Co-CEO Lenny Sokolow, who invested $250,000, and Co-CEO John Campi, who invested $250,000.
Net cash used in operating activities for the third quarter ending September 30, 2024, decreased sequentially by 39% to $2.6 million compared to $4.2 million in net cash used in the second quarter of 2024.
Company’s gross profit for the third quarter ending September 30, 2024, increased sequentially by 4% to $6.8 million compared to the quarter ending June 30, 2024.
As common with companies such as ours when sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, the Company leverages its trades payable to finance its operations, to enhance its cash position and to lower its cost of capital.
Management emphasizes that it has sufficient cash to achieve its goals including being cash flow positive in 2025.
The Company continues to grow its market penetration of its advanced and smart plug & play products and expects its products to be in close to 15,000 U.S. and Canadian homes by the end of 2024.
Company expects its products to be in tens of thousands of homes, incrementally in 2025.
Company strongly believes its products can save insurance companies many billions of dollars annually by reducing fires, ladder falls, and electrocutions among other things. Management expects that once it completes an entire range and variations of its safe plug & play products it will start being recommended by insurance companies.
Product range is currently in production and is expected to arrive by the end of 2024. Products will comprise advance and smart plug & play lighting including recessed lights, down lights, EXIT signs, emergency lights, ceiling fans, chandeliers/pendants, holiday/kids/themes lights, indoor/outdoor wall lights among other.
Company’s plug & play technology enables an installation of lighting, fans, and smart home products in high-rise buildings and hotels within days rather than months. Company expects to start delivering products to buildings and hotels in Q-1 of 2025.
Company’s total addressable market (TAM) in the U.S. is roughly $500 billion with over 4.2 billion ceiling applications in the U.S. alone. Expected revenue streams from retail and professional segments include product sales, royalties, licensing, subscription, monitoring, and sale of global country rights.
Company continues to utilize its e-commerce platform of over 60 websites for lighting and home décor to educate and enhance its market penetration to both retail and professional segments.
Recent Collaborations:
Announced a Collaboration with Home Depot for the retail and professional markets. Company started shipping and products are already in 100 stores. Company has also started to sell product on Home Depot website and ultimately expects to have hundreds of advanced smart plug & play products on Home Depot’s website.
Announced a Collaboration with world leading home décor website, Wayfair, for its advanced and smart plug & play products, and ultimately expects to have hundreds of its advanced smart plug & play products on Wayfair’s website.
Signed with General Electric / GE Licensing a 5-year global licensing agreement to license its advanced and smart technologies with a goal to create an advanced smart global ceiling standard.
Collaboration with a world-leading Chinese Lighting supplier and manufacturer Ruee Appliances. The collaboration with Ruee includes SKYX’s advanced and smart products to both professional and retail markets and provides SKYX substantial backing in several areas including financial, mass production manufacturing capabilities, and distribution to global markets, including China and Europe. The collaboration is expected to substantially enhance gross margins on SKYX’s product sales and favorably impact its cash conversion cycle.
Collaboration with world leading lighting company Kichler for online and builder segments.
Collaboration with U.S. leading lighting company Quoizel including for online and builder segments.
Collaboration with European leading lighting company EGLO for online and builder segments.
Future Collaborations: Management is in the process of working on additional collaborations with leading strategic companies.
Companies collaborating with SKYX are expected to leverage the fast and easy interchangeability capabilities of the technology to enhance sales of smart fixtures and fixture replacements for seasonality, energy savings, holidays, smart capabilities and renovations for both retail and professional segments.
SKYX smart home technology wins 7 CES Awards (Consumer Electronics Show).
Company started production of its new global patented advanced, smart, plug & play recessed light. The global recessed light market is a multi-billion-unit market. SKYX’s new Plug & Play recessed light global patents include the U.S., China, Canada, Hong-Kong and Mexico. As billions of recessed lights are installed globally with hazardous electrical wires, SKYX’s recessed light solution enables an advanced, simple Plug & Play installation that saves time, cost and lives. SKYX’s Plug & Play recessed lights can be controlled through SKYX’s App, Voice Control and Phone and works with Apple’s Siri, Amazon Alexa, Google Home and Samsung.
New Global Smart Home and AI Related Patents. SKYX’s new and existing patents, including the new global patented advanced, smart, plug & play recessed light, enable and enhance performance of smart home and AI sensors in addition to home safety sensors bringing the Company’s intellectual property portfolio to a total of over 97 issued and pending patents, 36 of which are issued patents covering SKYX’s advanced plug and play and smart home platform technologies for the smart home, AI, electrical, and lighting industries in the U.S. and internationally including China, Europe, Mexico and 2 patents in India. This also includes the recent issuance of 6 additional patents in the U.S. andinternationally, in China, India, Europe, Canada, andMexico for its advanced smart Plug & Play Ceiling Fan & Heater. The 6 additional patent issuances cover SKYX’s advanced plug-and-play smart ceiling fan and heater, enabling an all-in-one all-season product providing cool air for summertime and hot air for wintertime.
The Company entered into an agreement to supply approximately 1,000 homes with its advanced smart home platform technologies and is expected to deliver approximately 30,000 units representing a variety of its advanced and smart platform technology products to the developer’s upcoming projects.
Safety Standardization Highlights
Based on the safety aspects of the Company’s ceiling outlet receptacle, in the past 12 years, the Company’s product was voted into 10 segments in the NEC Code Book. Management believes that its standardization process, including it’s the NEC votes and its product specification significant approval voting by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturing Association) meet the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings. Voting decisions are at the discretion of the NEC voting members.
The Company’s code team is led by Mark Earley – former head of the National Electrical Code (NEC) and former Chief Electrical Engineer of the National Fire Protection Association (NFPA) – as well as Eric Jacobson, former President and CEO of The American Lighting Association (ALA). Mr. Earley and Mr. Jacobson were instrumental in numerous code and safety changes in both the electrical and lighting industries.
Select Third Quarter 2024 Financial Results
Revenue in the third quarter of 2024 increased sequentially 3% to a record $22.2 million, including E-commerce sales as well as smart and standard plug and play products, as compared to $21.6 million in the third quarter of 2023.
The gross profit for the third quarter ending September 30, 2024, increased sequentially by 4% to $6.8 million compared to the quarter ending June 30, 2024.
Net cash used in operating activities for the third quarter ending September 30, 2024, decreased sequentially by 39% to $2.6 million compared to $4.2 million in net cash used in the second quarter of 2024.
Prior to the completion of the $11 million equity raise in October 2024, we reported $13.0 million in cash, cash equivalents, and restricted cash, as of September 30, 2024, as compared to $15.5 million as of June 30, 2024. As common with companies such as ours when their sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, we leverage our trades payable to finance our operations to enhance our cash position and lower our cost of capital.
Loss before interest, taxes, depreciation, and amortization, as adjusted for share-based payments (“adjusted EBITDA”), a non-GAAP measure, to $2.6 million, in the third quarter of 2024, as compared to $2.1 million, in the second quarter of 2024.
Adjusted EBITDA loss, a non-GAAP measure, amounted to $2.6 million, or $(0.03) per share, as compared to $2.9 million, or $(0.03) per share, in the third quarter of 2023.
The Company’s financial statements for the quarter ended September 30, 2024, will be filed with the SEC and are available on the Company’s investor relations website. https://ir.skyplug.com/sec-filings/
Management Commentary
Company’s Management, Board members, and Senior Advisors include former CEO’s and executives from Fortune 100 companies including Nielsen, Microsoft, Disney, GE, Home Depot, Office Depot, Chrysler, among others.
The third quarter of 2024 was highlighted by our continued market penetration and positioning that includes our announced collaboration with Home Depot and Wayfair which we believe can be significant for our growth to both retail and professional markets. Additionally, the Ruee Appliances collaboration will assist us with product variety, gross margins, future distribution channels, and sales and marketing programs with key stakeholders in such channels. We believe we have accelerated our cadence of sales, notably managing our cash burn, while our e-commerce platform with over 60 websites is providing additional cash flow to the Company, which, when combined with our existing cash enhanced by our $11 Million equity raise in October 2024, enhances our cash position to continue executing our business plan. We believe we will be cash flow positive during 2025.
We are encouraged by our path to the builder/commercial segments, large online and brick-and-mortar retail partners as well as our future potential to realize incremental licensing, subscription, and AI/data aggregation revenues.
Furthermore, our e-commerce website platform with 60 websites enhances the acceleration of marketing, distribution channels, collaborations, licensing and sales to both professional and retail segments. Our websites include banners, videos, and educational materials regarding the simplicity, cost savings, timesaving, and lifesaving aspects of the Company’s patented technologies.
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
Non-GAAP Financial Measures
Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense and amortization expense associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business.
Company Launches Colossus Connections to Accelerate Direct Integration Efforts with Leading Demand-Side Platforms
New Unified Buy-Side Operating Structure Creates Additional Business Lines and Revenue Opportunities
Company to Host Conference Call at 5:00 PM ET Today
HOUSTON, Nov. 12, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced financial results for the third quarter ended September 30, 2024.
Mark D. Walker, Chairman and Chief Executive Officer, commented, “The past few quarters have presented significant challenges for our company due to a targeted and defamatory disinformation campaign. We describe this as disinformation not only because it contained factual inaccuracies, but also because it omitted key insights and context that would have clarified our business practices. As a result, Direct Digital Holdings experienced an unexpected business disruption among our partners, advertisers, and clients, including a major customer who paused its connection with our supply-side platform, Colossus SSP, which led to a temporary reduction in our revenues.”
Walker continued, “We moved swiftly to address these claims, working closely with all of our partners to ensure they understood the truth of our practices and taking legal action against the author of the defamatory claims. Our paused customer has since restored its connection, with volumes through our sell-side platform steadily increasing, though not yet fully returned to previous levels. Throughout this, we have been working diligently with our multi-national HoldCo agencies, our Fortune 500 brand partners, and demand-side partners, to resume business, which many already have. While we are confident we will return the Company to normalcy, it will take time to rebuild. We are grateful for the resiliency and focus of our employees as they work to position us to rebound from these challenges.”
Revenues for the third quarter of 2024 were $9.1 million, consisting of $2.2 million in our sell-side advertising segment and $6.9 million in our buy-side advertising segment. The key driver for the reduction of our revenue from prior periods was the pause by our customer as described above.
Keith Smith, President, commented, “Our recently announced $20 million Equity Reserve Facility with New Circle Principal Investments provides us with enhanced financial flexibility to execute on our strategic initiatives while also strengthening our balance sheet. This new financing source will support both our technology investments and growth objectives as we continue to evolve our platform capabilities and position Direct Digital Holdings for sustainable, long-term growth.”
Walker added, “Over these past few months, we have innovated and optimized our business and are now in a position of strength, well-situated to capitalize on several of our key growth initiatives. Direct Digital Holdings’ technology platform, diversified client base, optimized cost structure and new financing sources allow us to expand into new industry verticals, accelerate our direct integrations with leading demand-side platforms, advance our technological capabilities across our business and maintain our commitment to bringing underrepresented publishers into the programmatic ecosystem.”
Advancing Innovation for Colossus SSP
The Company expects to make investments to drive technological advancements for Direct Digital Holdings’ supply-side platform, Colossus SSP, including the launch of Colossus Connections, an aggressive initiative the Company is already executing to accelerate direct integrations with leading demand platforms. This initiative will aim to unlock direct access to more demand partners and revenue, while optimizing transaction costs and efficiency for Colossus SSP and its clients. As a result of Colossus Connections, the Company has already signed two of the leading demand-side partners, with those direct connections expected to go live in 2025.
Additionally, for Colossus SSP, the Company is developing new curation and segment-based products in areas such as carbon, attention, and media quality, which are in high-demand among advertisers. The Company is also expanding efforts to bring underrepresented publishers and creators into the programmatic ecosystem, with their unique and premium inventory available through Colossus SSP.
Enhancing Growth on the Demand Side
On the demand-side, the Company expects that funding will support the recently announced unification of Direct Digital Holdings’ buy-side divisions, Orange 142 and Huddled Masses. This will enable the delivery of new capabilities, particularly in helping clients navigate emerging technologies, such as artificial intelligence and machine learning, as well as emerging, high-growth channels such as marketing-enabled services, connected TV, social media and retail media. Small- and mid-sized clients will be a key focus for the combined entity, as these clients are increasingly shifting advertising budgets to digital and require support to navigate its complexities and optimize their ad spend. Currently, the Company serves hundreds of small- and mid-sized clients, enabling over 2,000 campaigns each year.
Third Quarter 2024 Financial Highlights:
For the third quarter of 2024, revenue was $9.1 million, a decrease of $50.4 million, or an 85% decline compared to the $59.5 million in the same period of 2023.
Sell-side advertising segment revenue fell to $2.2 million compared to $51.6 million in the same period of 2023, 96% decrease year-over-year. As described above, the key driver for this reduction was the suspension by one of our large customers following the defamatory article against the Company, and this customer has since restored its connection.
Buy-side advertising segment revenue fell to $6.9 million compared to $7.9 million in the same period of 2023, a 12% year-over-year decline.
Gross profit was $3.5 million, or 39% of revenue, in the third quarter of 2024 compared to $11.8 million, or 20% of revenue, in the same period of 2023.
Operating expenses were $7.2 million in the third quarter of 2024, a decrease of $0.1 million, or 1%, over $7.3 million in the same period of 2023.
Consolidated operating loss was $3.7 million, compared to operating income of $4.5 million in the same period of 2023, a decrease of $8.2 million or 181%.
Net loss was $6.4 million in the third quarter, compared to net income of $3.4 million in the same period of 2023.
Adjusted EBITDA(1) was a loss of $2.9 million in the third quarter of 2024, compared to positive Adjusted EBITDA of $5.4 million in the same period of 2023.
As of September 30, 2024, the Company held cash and cash equivalents of $4.1 million compared to $5.1 million as of December 31, 2023.
(1) “Adjusted EBITDA” is a non-GAAP financial measure. The section titled “Non-GAAP Financial Measures” below describes our usage of non-GAAP financial measures and provides reconciliations between historical GAAP and non-GAAP information contained in this press release.
Financial Outlook
Assuming the U.S. economy does not experience any major economic conditions that deteriorate or otherwise significantly reduce advertiser demand, and subject to certain uncertainties related to the ramp-up of our businesses and general market conditions, Direct Digital Holdings is providing full-year revenue guidance of $60 million to $70 million for FY 2024 and full-year revenue guidance of $90 million to $110 million for FY 2025 as the Company rebuilds to previous levels.
Diana Diaz, Chief Financial Officer, stated, “As we move forward, we are pleased to return to a normal cadence of reporting our financial results which will provide our investors with the timely and accurate information they deserve. We’re committed to delivering sustainable growth for our investors while offering our partners industry-leading marketing and advertising capabilities.”
Smith added, “While Direct Digital Holdings is working to overcome these recent challenges, defamatory disinformation attacks go far beyond the advertising technology industry, distorting public perception, manipulating stock prices, often to the disadvantage of everyday investors, and stifling innovation. The weaponization of disinformation is posing a profound risk to small and up-and-coming businesses such as ours, and calls for a deeper dive into this pernicious and increasingly ubiquitous issue and an appropriate systemic response.”
Conference Call and Webcast Details
Direct Digital will host a conference call on Tuesday, November 12, 2024 at 5:00 p.m. Eastern Time to discuss the Company’s third quarter 2024 financial results. The live webcast and replay can be accessed at https://ir.directdigitalholdings.com/. Please access the website at least fifteen minutes prior to the call to register, download and install any necessary audio software. For those who cannot access the webcast, a replay will be available at https://ir.directdigitalholdings.com/ for a period of twelve months.
This press release contains forward-looking statements within the meaning of federal securities laws that are subject to certain risks, trends and uncertainties. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in our most recent Annual Report on Form 10 K (the “Form 10-K”) and subsequent periodic and or current reports filed with the Securities and Exchange Commission (the “SEC”).
The forward-looking statements contained in this press release are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this press release, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control) and assumptions.
Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements. We believe these factors include, but are not limited to, the following: conditions to our ability to sell Class A common stock under our equity reserve facility; the restrictions and covenants imposed upon us by our credit facilities; the substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing; our ability to secure additional financing to meet our capital needs; our ineligibility to file short-form registration statements on Form S-3, which may impair our ability to raise capital; our failure to satisfy applicable listing standards of the Nasdaq Capital Market resulting in a potential delisting of our common stock; failure to remedy any listing deficiencies noted in the deficiency letters from the Listing Qualifications Department of The Nasdaq Stock Market LLC; the risk that the Listing Qualifications Department of The Nasdaq Stock Market LLC does not accept the Company’s plan to regain compliance with applicable rules to maintain its listing on The Nasdaq Capital Market; costs, risks and uncertainties related to the restatement of certain prior period financial statements; any significant fluctuations caused by our high customer concentration; risks related to non-payment by our clients; reputational and other harms caused by our failure to detect advertising fraud; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; our failure to manage our growth effectively; the difficulty in identifying and integrating any future acquisitions or strategic investments; any changes or developments in legislative, judicial, regulatory or cultural environments related to information collection, use and processing; challenges related to our buy-side clients that are destination marketing organizations and that operate as public/private partnerships; any strain on our resources or diversion of our management’s attention as a result of being a public company; the intense competition of the digital advertising industry and our ability to effectively compete against current and future competitors; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; as a holding company, we depend on distributions from Direct Digital Holdings, LLC (“DDH LLC”) to pay our taxes, expenses (including payments under the Tax Receivable Agreement) and any amount of any dividends we may pay to the holders of our common stock; the fact that DDH LLC is controlled by DDM, whose interest may differ from those of our public stockholders; any failure by us to maintain or implement effective internal controls or to detect fraud; and other factors and assumptions discussed in our Form 10-K and subsequent periodic and current reports we may file with the SEC.
Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT) brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within the general market and multicultural media properties. The Company’s buy-side platform, Orange 142, delivers significant ROI for middle-market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Combined, Direct Digital Holdings’ sell- and buy-side solutions generate billions of impressions per month across display, CTV, in-app and other media channels.
NON-GAAP FINANCIAL MEASURES
In addition to our results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), including, in particular operating income, net cash provided by operating activities, and net income, we believe that earnings before interest, taxes, depreciation and amortization (“EBITDA”), as adjusted for loss on early termination of line of credit, revaluation of tax receivable agreement liability and stock-based compensation (“Adjusted EBITDA”), a non-GAAP financial measure, is useful in evaluating our operating performance. The most directly comparable GAAP measure to Adjusted EBITDA is net income (loss).
In addition to operating income and net income, we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-GAAP financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:
Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as depreciation and amortization, interest expense, provision for income taxes, stock-based compensation, revaluation of tax receivable agreement liability and certain one-time items such as acquisition costs, losses from early termination or redemption of credit agreements or preferred units and gains from settlements or loan forgiveness that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired;
Our management uses Adjusted EBITDA in conjunction with GAAP financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and
Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-GAAP financial measures to supplement their GAAP results.
Our use of this non-GAAP financial measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under GAAP. The following table presents a reconciliation of Adjusted EBITDA to net income (loss) for each of the periods presented:
