MALVERN, Pa., Nov. 10, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease, a rare genetically inherited disease that directly affects the retina, often resulting in slow progressive vision loss in children and adults.
“There is a significant unmet medical need for the approximate 35,000 patients in the U.S. living with Stargardt disease,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “It is critical to our mission to develop innovative treatments for inherited retinal diseases and this milestone is an important step in bringing our novel modifier gene therapies to people who desperately need them.”
This Phase 1/2 trial will assess the safety of unilateral subretinal administration of OCU410ST in subjects with Stargardt Disease and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose ranging study. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which adult and pediatric subjects will be randomized in a 1:1:1 ratio to either one of two OCU410ST dose groups or to an untreated control group.
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, compliment formation, inflammation, and cell survival networks.
“It is important and exciting to pursue novel therapies for untreatable blinding diseases,” said Charles Wykoff, MD, PhD, Director of Research, Retina Consultants of Texas. “Initiation of this trial program investigating a new mechanism of action for the treatment of Stargardt disease is inspiring and brings hope to patients and families.”
About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.
Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Third orphan drug designation (ODD) granted to THIO by the FDA; drug also holds ODDs for hepatocellular carcinoma and small cell lung cancer
Benefits include 7 years of U.S. market exclusivity after drug approval and tax credits for qualified clinical testing
Expected glioblastoma market growth from $2.2 billion to $3.2 billion globally in the next three years
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma. This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.
“We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2 billion glioblastoma market, which is expected to reach $3.2 billion globally in the next three years.1 We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy.”
“In the data presented to the FDA, THIO successfully penetrated the blood brain barrier (BBB) in syngeneic and humanized mouse models of telomerase-expressing brain cancers. Treatment with THIO resulted in potent anticancer activity and significant expansion of the animal lifespan for several difficult to treat cell lines and xenograft mouse models,” added Sergei Gryaznov, Ph.D., MAIA’s Chief Scientific Officer. “These results stem from THIO’s remarkable mechanism of action and its BBB penetrating property that allows for direct targeting of brain tumors in vivo and potentially in glioblastoma patients.”
“Glioblastoma is the most aggressive and most common type of cancer that originates in the brain. With very limited treatment options available, glioblastoma patients have exceptionally short survival durations, and only 7% remain alive five years after being diagnosed with the condition,”2 said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. “We are optimistic about our telomere-targeting agent’s ability to provide clinical benefit in patients with glioblastoma, and we look forward to studying THIO for the treatment of this highly unmet medical indication in a future trial.”
Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101, evaluating the drug candidate in patients with advanced non-small cell lung cancer (NSCLC). THIO is the only direct telomere targeting agent currently in clinical development.
About Orphan Drug Designation
The FDA’s Orphan Drug Act of 1983 was designed to incentivize the development of therapies that demonstrate promise for the treatment of rare (orphan) diseases or conditions. A disease is classified as “rare” if it affects fewer than 200,000 people total in the U.S., or if the cost of developing a drug and making it available in the U.S. for such diseases will exceed any potential profits from its sale due to the small target population size. The FDA’s ODD program provides multiple incentives to make orphan drug development more financially possible for companies to pursue, such as up to seven years of market exclusivity for the approved orphan drug, up to 20 years of 25% federal tax credit for expenses incurred in conducting clinical research within the U.S. and waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a value of approximately $2.9 million in 2021.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
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1 Market size and forecast from the Business Research Company
Topline Results from Phase 3 Potentially NDA-Enabling Study of TNX-102 SL in Fibromyalgia Expected Late December 2023: Centrally-Acting Non-Opioid Analgesic
Topline Results from Phase 2 Proof-of-Concept Study ofTNX-1900 in Chronic Migraine Expected Early December 2023: Intranasal Potentiated Oxytocin
Meaningful Progress Made in Obtaining External Support for Clinical Trials from U.S. Government Agencies and Other Institutions
Revenue from Marketed Acute Migraine Products: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) Included in Third Quarter Financial Statements
CHATHAM, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the third quarter ended September 30, 2023, and provided an overview of recent operational highlights.
“Tonix expects topline results from its Phase 3 fibromyalgia study and Phase 2 chronic migraine study before year end,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “The Phase 3 RESILIENT trial in fibromyalgia, if successful, is expected to be the final efficacy trial required for submitting a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets). In the Phase 2 proof-of-concept PREVENTION study in chronic migraine of TNX-1900 (intranasal potentiated oxytocin), all patients have completed their final visit and topline results are expected in early December 2023.”
Dr. Lederman continued, “We are continuing to shift the expense of clinical trials from our operating budget to U.S. government agencies and other institutions through partnerships. The U.S. Department of Defense (DoD) is supporting the upcoming Phase 2 study of TNX-102 SL in acute stress disorder, being conducted and sponsored by University of North Carolina (UNC). The U.S. National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID), through its Project NextGen, will conduct the Phase 1 study of our vaccine candidate TNX-1800 (modified recombinant horsepox virus, live vaccine). The National Institute of Drug Abuse (NIDA) is supporting our Phase 2 study of TNX-1300 (recombinant double mutant cocaine esterase) for cocaine intoxication. Massachusetts General Hospital (MGH) is conducting Phase 2 studies of TNX-1900 in binge eating disorder and pediatric obesity, and the University of Washington is conducting a Phase 2 study of TNX-1900 in social anxiety disorder. Finally, we continue to collaborate with MGH on several preclinical non-human primate studies for TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody), currently in a Phase 1 study being conducted by Tonix. These outside collaborations leverage our internal resources and allow us to progress our clinical programs in a capital efficient manner.”
Partnerships with External Funding – Recent Highlights
NIH/NIAID selected Tonix’s vaccine candidate, TNX-1800, as part of Project NextGen; a Phase 1 study is expected to start in the second half of 2024. NIH/NIAID will cover the full cost of the clinical trial, while Tonix will supply the vaccine candidate.
NIDA is supporting a Phase 2 study on TNX-1300 for cocaine Intoxication; expected to start enrolling patients in the fourth quarter of 2023.
DoD is supporting a Phase 2 investigator-initiated study of TNX-102 SL for acute stress disorder at UNC for motor vehicle accident victims; expected to start enrolling patients in 2024.
MGH/Harvard Medical School is conducting Phase 2 investigator-initiated studies of TNX-1900 in binge eating disorder and adolescent obesity.
The University of Washington is conducting a Phase 2 investigator-initiated study of TNX-1900 in social anxiety disorder.
Marketed Products – Recent Highlights
In September 2023, Tonix announced that it is committed to meeting potential increased demand for Tosymra® (sumatriptan nasal spray) 10 mg after GlaxoSmithKline’s planned discontinuation of Imitrex® (sumatriptan) nasal spray 5 mg and 20 mg products after January 2024. Tonix is preparing for potential increased demand for Tosymra to help avoid possible drug shortages for patients who suffer from migraines. Tosymra nasal spray is approved on the basis of bioequivalence to Imitrex injection 4 mg.
Tonix completed the acquisition of Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra from Upsher-Smith Laboratories, LLC in June 2023. Both products are indicated for the treatment of acute migraine with or without aura in adults.
Key Product Candidates* — Recent Highlights
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual tablets): once-daily at bedtime small molecule for the management of fibromyalgia (FM) – a centrally-acting, non-opioid analgesic.
The Company announced in August 2023 that it completed enrollment of its potentially confirmatory Phase 3 RESILIENT trial of TNX-102 SL 5.6 mg in FM. 457 participants were randomized in the trial, which, if successful, is expected to serve as the final, well-controlled efficacy trial required for submission of NDA for approval by the FDA. RESILIENT is a registration-quality, double-blind, placebo-controlled study. Topline results from the RESILIENT trial are expected in late December of 2023.
TNX-102 SL for the treatment of acute stress reaction (ARS) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)
In September 2023, the Company announced that the UNC Institute for Trauma Recovery has been awarded a $3 million grant from the DoD to investigate the potential of Tonix’s TNX-102 SL to reduce the frequency and severity of adverse effects of acute trauma, which include ASR and ASD, and development of PTSD. The proposed Phase 2, Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) study will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision (MVC). The study will enroll approximately 180 MVC trauma survivors at ED study sites in the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL or placebo.
Initiation of patient enrollment in the proposed investigator-sponsored OASIS study is anticipated in the beginning of 2024, subject to clearance by the FDA of an investigator-initiated Investigational New Drug (IND) application.
TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)
In September 2023, the Company announced topline results from its Phase 2 PREVAIL proof-of-concept study of TNX-102 SL for fibromyalgia-type Long COVID. TNX-102 SL showed a robust Cohen’s d effect size of 0.5 in improving fatigue relative to placebo; and it showed consistent activity across secondary measures of sleep quality, cognitive function, disability and Patient Global Impression of Change, but did not meet the primary endpoint of multi-site pain reduction at week 14. TNX-102 SL was generally well tolerated and no new safety signals were observed.
The Company intends to request an End-of-Phase 2 meeting with the FDA to discuss a potential Phase 3 program based on a proposed primary outcome measure using the PROMIS Fatigue scale. The meeting is expected to take place in the first quarter of 2024.
TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, social anxiety disorder (SAD), insulin resistance and related disorders, and adolescent obesity and binge eating disorder
In October 2023, the Company announced it completed the clinical phase of the PREVENTION study, a Phase 2 proof-of-concept study of TNX-1900 for the prevention of migraine headaches in chronic migraineurs, as the last of 88 enrolled patients completed their final study visit. PREVENTION is a registration-quality, double-blind, placebo-controlled study.
Topline results from the PREVENTION Phase 2 trial are expected in early December 2023.
In September 2023, the Company announced that David C. Yeomans, Ph.D. presented data relevant to the proposed mechanism of TNX-1900 in treating chronic migraine in a poster and an oral presentation at the 2023 International Headache Congress (IHC) in Seoul, South Korea. The poster and oral presentation titled, “Human trigeminal ganglia possess oxytocin receptors on CGRP positive neurons: expression increased by inflammation,” include research sponsored by and licensed to Tonix. The presentations show that oxytocin receptors are co-expressed with calcitonin gene-related peptide (CGRP) on human trigeminal ganglia neurons, which is similar to Professor Yeomans’ previous findings in animal trigeminal ganglia. The inflammatory cytokine IL-6 upregulated expression of oxytocin receptors on human trigeminal neurons, consistent with the previously observed impact of inflammation on the potency of oxytocin on its receptor. In animals, oxytocin has been shown to functionally inhibit the excitability of trigeminal neurons, which is consistent with oxytocin inhibiting the release of CGRP at trigeminal nerve terminals.1
Tonix announced in July 2023 that the first participant was enrolled in the investigator-initiated Phase 2 STROBE Study of TNX-1900 for the treatment of binge-eating disorder at MGH. Tonix is supporting the STROBE study through a clinical trial agreement with MGH.
Tonix announced in July 2023 that the first participant was enrolled in a Phase 2 investigator-initiated, proof-of-concept study of TNX-1900 for enhancing social safety learning in SADSAD. Tonix entered into an agreement with the University of Washington to examine the potential role of TNX-1900 in enhancing vicarious extinction learning in SAD, compared to healthy controls.
Tonix announced in July 2023 that the first participant was enrolled in the Phase 2 POWER study of TNX-1900 for the treatment of pediatric obesity with MGH. MGH is the sponsor of the NIH-funded trial, being conducted under an investigator-initiated IND.
Tonix expects to initiate a Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the fourth quarter of 2023. In 2022, Tonix was awarded a Cooperative Agreement grant from NIDA, part of the NIH, to support development of TNX-1300.
TNX-1300 has been granted Breakthrough Therapy designation by the FDA.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)
In October 2023, Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, provided an overview of Tonix’s TNX-2900 program at the Foundation for Prader-Willi Research (FPWR) Family Conference in Denver, CO. The presentation highlights preclinical data showing the enhancing effects of magnesium (Mg2+) on the activation of oxytocin receptors. The Mg2+ enhanced formulation of intranasal oxytocin is the basis for TNX-2900, in development to treat hyperphagia, or pathological over-eating, in children and adolescents with PWS. In preclinical studies, Mg2+ increases the potency of oxytocin, which is a peptide hormone that reduces appetite and signals fullness, potentially improving receptor binding and resulting in improved therapeutic action.
Immunology Pipeline
TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.
In October 2023, the Company announced data from two oral presentations which were delivered recently at the American College of Surgeons (ACS) Clinical Congress 2023, and The International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress by faculty at the Center for Transplantation Sciences, MGH. The oral presentations titled, “Pilot Evaluation of a Clinical Xeno Heart Transplant Regimen in a Preclinical Model” and “Extended Survival of 9- and 10-Gene Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression” by Dr. Ikechukwu Ileka et al. include data demonstrating the use of TNX-1500 as maintenance therapy after xeno heart transplant in non-human primates. In both studies, genetically engineered (GE) pigs in baboon transplants were treated with cold-perfused ischemia minimization and a novel costimulation-based immunosuppressive regimen that includes TNX-1500.
In October 2023, Tonix announced that a study published in the Journal Nature2 by faculty at the Center for Transplantation Sciences, MGH in collaboration with biotechnology company, eGenesis, utilized TNX-1500 as part of the immune modulating regimen to prevent organ transplant rejection. The Nature article titled, “Design and testing of a humanized porcine donor for xenotransplantation” includes data that provide additional support for TNX-1500’s activity in preventing pig xenograft organ rejection and for its safety and tolerability in non-human primates.
In August 2023, Tonix announced the initiation of a Phase 1 single ascending dose study of TNX-1500 in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous TNX-1500. This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.
The first indication for TNX-1500 will be prophylaxis of organ rejection in adult patients receiving a kidney transplant, but multiple additional indications are possible, including autoimmune diseases. Two peer reviewed publications described the work at the MGH on allogeneic transplants in animals were published.3,4
Infectious Disease Pipeline
TNX-1800 (modified recombinant horsepox virus, live vaccine): potential vaccine to protect against COVID-19 designed to express the SARS-CoV-2 spike protein
In November 2023, Tonix announced that NIAID, a part of the NIH, will conduct a Phase 1 clinical trial with TNX-1800 as part of Project NextGen. The Phase 1 trial of TNX-1800 is expected to start in the second half of 2024. NIAID will cover the full cost of the clinical trial, including operations and related analyses. Tonix will be responsible for providing clinical trial materials, and upon completion will have the right to rely on the findings in regulatory filings with the FDA to support the approval of its COVID-19 vaccine and other vaccines based on the RPV platform.
TNX-801 (recombinant horsepox virus, live vaccine): potential vaccine to protect against mpox disease and smallpox.
In August 2023, Tonix received the official written response from a Type B pre-IND meeting with the FDA to develop TNX-801 as a potential vaccine to protect against mpox disease (formerly known as monkeypox) and smallpox. Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1/2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND.
*All of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.
1Tzabazis A, et al. Cephalalgia. 2016. 36(10):943-50.
2Anand R.P., et al. Nature. 2023. 622, 393–401.
3Lassiter, G., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.022
4Miura, S., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.025
Recent Highlights—Financial
As of September 30, 2023, Tonix had approximately $6.9 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Additionally, Tonix had inventory totaling approximately $13.3 million as of September 30, 2023. In August 2023, Tonix received net proceeds of approximately $6.3 million through a public offering of common stock, after deducting underwriting discount and other offering expenses. Cash used in operations was approximately $79.7 million for the nine months ended September 30, 2023, compared to $75.8 million for the same period in 2022. Cash used by investing activities for the nine months ended September 30, 2023 was approximately $28.6 million.
On September 28, 2023, the Company sold 4,050,000 shares of common stock, pre-funded warrants to purchase up to 4,950,000 shares of common stock, and accompanying common A warrants to purchase 9,000,000 shares of common stock and common B warrants to purchase up to 9,000,000 shares of common stock in a public offering for net proceeds of approximately $4.0 million, after deducting underwriting discount and other offering expenses. This public offering closed on October 3, 2023.
Third Quarter 2023 Financial Results
Net product revenue for the third quarter 2023 was approximately $4.0 million. As a reminder, Tonix completed the acquisition of two currently marketed products from Upsher-Smith Laboratories, LLC on June 30, 2023.
During the three months ended September 30, 2023, Tonix received $0.4 million from NIDA for the TNX-1300 study to treat cocaine intoxication.
R&D expenses for the third quarter 2023 were approximately $21.1 million, compared to $22.2 million for the same period in 2022. This decrease is predominantly due to decreased non-clinical and manufacturing expenses, offset by an increase in clinical, employee-related and professional expenses.
SG&A expenses for the third quarter 2023 were $8.7 million, compared to $7.4 million for the same period in 2022. The increase was primarily due to sales and marketing associated with the Company’s recently acquired marketed products.
Net loss available to common stockholders was $28.0 million, or $1.83 per share, basic and diluted, for the third quarter 2023, compared to net loss available to common stockholders of $29.0 million, or $4.24 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares outstanding for the third quarter 2023 was 15,327,558 compared to 6,843,099 shares for the same period in 2022.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and enrollment has completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of 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, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
REVENUE:
Product revenue, net
$
3,989
$
—
$
3,989
$
—
COSTS AND EXPENSES:
Cost of revenue
$
2,374
$
—
$
2,374
$
—
Research and development
21,050
22,201
69,537
57,202
Selling, general and administrative
8,712
7,390
23,129
22,161
32,136
29,591
95,040
79,363
Operating loss
(28,147
)
(29,591
)
(91,051
)
(79,363
)
Interest income, net
172
610
1,715
825
Net loss
(27,975
)
(28,981
)
(89,336
)
(78,538
)
Preferred stock deemed dividend
—
—
—
4,255
Net loss available to common stockholders
$
(27,975
)
$
(28,981
)
$
(89,336
)
$
(82,793
)
Net loss per common share, basic and diluted
$
(1.83
)
$
(4.24
)
$
(7.40
)
$
(18.58
)
Weighted average common shares outstanding, basic and diluted
15,327,558
6,843,099
12,079,583
4,455,943
See the accompanying notes to the condensed consolidated financial statements
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands)
(Unaudited)
September 30, 2023
December 31, 20221
Assets
Cash and cash equivalents
$
6,914
$
120,229
Inventory
13,317
–
Receivables, net
1,562
–
Prepaid expenses and other
9,544
10,548
Total current assets
31,337
130,777
Other non-current assets
107,945
94,913
Total assets
$
139,282
$
225,690
Liabilities and stockholders’ equity
Total liabilities
$
18,449
$
18,508
Stockholders’ equity
120,833
207,182
Total liabilities and stockholders’ equity
$
139,282
$
225,690
1The condensed consolidated balance sheet for the year ended December 31, 2022 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
Zembrace® SymTouch® (sumatriptan Injection): IMPORTANT SAFETY INFORMATION
Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.
This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATION AND USAGE
Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.
Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.
Do not use Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
severe liver problems
hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any ingredient in Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.
This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATION AND USAGE Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.
Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.
Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.
Third Quarter 2023 Revenue Up 129% Year-Over-Year to $59.5 Million
Company Raises Full-Year 2023 Revenue Guidance to $170 Million – $190 Million
HOUSTON, Nov. 9, 2023 /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”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced financial results for the third quarter ended September 30, 2023.
Mark D. Walker, Chairman and Chief Executive Officer, commented, “In recent quarters, we have made significant investments in our technology stack, advertising platform and operational structure. We initially expected to see the impact of these investments in 2024, however, we are pleased to report that these benefits have arrived much earlier in 2023. Our strong technology partnerships and our overarching business strategy have enabled us to meet a growing number of customers’ demands and further the capabilities of our sell-side technology platform. On both the sell-side and the buy-side, increased spend from our buying partners has resulted in an associated increase in our impression count and organic growth profile with a direct positive impact on net income and adjusted EBITDA(1).”
Keith Smith, President, added, “The growth seen in this quarter, as well as the past year, has been fueled by a combination of our strategic investments and partnerships, our differentiated approach to advertising solutions, as well as a set of market dynamics which have been highly beneficial to our position in the industry. We have capitalized on the shift in ad spend towards digital media on both the sell- and buy-side and will continue to grow our presence in the space through our recent partnerships and advancements of our technology stack. We remain committed to executing on the same growth and investment initiatives that led us to the strong third quarter results we are reporting today.”
Third Quarter 2023 Business Highlights
For the third quarter ended September 30, 2023, Direct Digital Holdings processed over 400 billion monthly impressions through its sell-side advertising segment, an increase of 220% over the same period of 2022.
In addition, the Company’s sell-side advertising platforms received over 34 billion monthly bid responses in the third quarter of 2023, an increase of over 210% over the same period in 2022. Sell-side revenue per advertiser for the third quarter of 2023 increased 241% compared to the same period of 2022.
The Company’s buy-side advertising segment served approximately 228 customers in the third quarter of 2023 and buy-side revenue per customer increased 14% compared to the same period of 2022.
Third Quarter 2023 Financial Highlights:
Revenue was $59.5 million in the third quarter of 2023, an increase of $33.5 million, or 129% over the $26.0 million in the same period of 2022.
Sell-side advertising segment revenue grew to $51.6 million and contributed $32.8 million of the increase, or 174% growth over the $18.9 million of sell-side revenue in the same period of 2022.
Buy-side advertising segment revenue grew to $7.9 million and contributed $0.7 million of the increase, or 10% growth over the $7.1 million of buy-side revenue in the same period of 2022.
Consolidated operating income in the third quarter of 2023 was $4.5 million compared to consolidated operating income of $1.8 million in the same period of 2022, an increase of 144% year-over-year.
Net income was $3.4 million in the third quarter of 2023, compared to net income of $0.8 million in the same period of 2022, an increase of 313% year-over-year.
Adjusted EBITDA(1) was $5.4 million in the third quarter of 2023, compared to $2.4 million in the same period of 2022, an increase of 123% year-over-year.
Financial Outlook
Assuming the U.S. economy does not experience any major economic conditions that deteriorate or otherwise significantly reduce advertiser demand, we are increasing our previously issued estimate as disclosed in our second quarter 2023 update:
For fiscal year 2023, we expect revenue to be in the range of $170 million to $190 million, or 101% year-over-year growth at the mid-point.
“We are thrilled to announce the raising of our fiscal year 2023 revenue guidance to $180 million at the midpoint, a 101% increase over full-year 2022 results. This increase reflects our belief in our ability to execute on our various growth strategies, demonstrates the strength of our operating leverage and highlights the favorable market trends that we expect to continue for the remainder of this year,” commented Diana Diaz, Chief Financial Officer.
Conference Call and Webcast Details
Direct Digital will host a conference call on Thursday, November 9, 2023 at 5:00 p.m. Eastern Time to discuss the Company’s third quarter 2023 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.
Footnotes
(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.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties.
As used below, “we,” “us,” and “our” refer to the Company. 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 statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.
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. Our forward-looking statements 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. Although we believe that these forward-looking statements are based on reasonable assumptions, 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, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics; 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; 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; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; 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; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; our limited operating history, which could result in our past results not being indicative of future operating performance; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, on receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the Securities and Exchange Commission that we make from time to time. 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.
About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, 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 general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver 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. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.
CONSOLIDATED BALANCE SHEETS (unaudited)
September 30, 2023
December 31, 2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
5,481,949
$
4,047,453
Accounts receivable, net
54,637,634
26,354,114
Prepaid expenses and other current assets
1,426,925
883,322
Total current assets
61,546,508
31,284,889
Property, equipment and software, net of accumulated depreciation and amortization of $219,386 and $34,218, respectively
625,028
673,218
Goodwill
6,519,636
6,519,636
Intangible assets, net
12,172,396
13,637,759
Deferred tax asset, net
5,082,424
5,164,776
Operating lease right-of-use assets
674,846
798,774
Other long-term assets
127,492
46,987
Total assets
$
86,748,330
$
58,126,039
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable
$
45,021,034
$
17,695,404
Accrued liabilities
4,071,128
4,777,764
Liability related to tax receivable agreement, current portion
41,141
182,571
Notes payable, current portion
1,146,250
655,000
Deferred revenues
1,044,069
546,710
Operating lease liabilities, current portion
49,977
91,989
Income taxes payable
113,355
174,438
Related party payables
1,428,093
1,448,333
Total current liabilities
52,915,047
25,572,209
Notes payable, net of short-term portion and deferred financing cost of $1,722,716 and $2,115,161, respectively
22,323,534
22,913,589
Economic Injury Disaster Loan
150,000
150,000
Liability related to tax receivable agreement, net of current portion
4,245,234
4,149,619
Operating lease liabilities, net of current portion
717,632
745,340
Total liabilities
80,351,447
53,530,757
COMMITMENTS AND CONTINGENCIES (Note 9)
STOCKHOLDERS’ EQUITY
Class A common stock, $0.001 par value per share, 160,000,000 shares authorized, 2,991,792 and 2,900,000 shares issued and outstanding, respectively
2,992
2,900
Class B common stock, $0.001 par value per share, 20,000,000 shares authorized, 11,278,000 shares issued and outstanding
11,278
11,278
Additional paid-in capital
8,782,092
8,224,365
Accumulated deficit
(2,399,479)
(3,643,261)
Total stockholders’ equity
6,396,883
4,595,282
Total liabilities and stockholders’ equity
$
86,748,330
$
58,126,039
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Revenues
Buy-side advertising
$
7,850,058
$
7,130,736
$
27,092,816
$
22,283,044
Sell-side advertising
51,622,066
18,854,639
89,006,018
36,333,976
Total revenues
59,472,124
25,985,375
116,098,834
58,617,020
Cost of revenues
Buy-side advertising
3,113,491
2,471,170
10,650,541
7,694,987
Sell-side advertising
44,605,815
16,053,461
77,189,787
30,344,670
Total cost of revenues
47,719,306
18,524,631
87,840,328
38,039,657
Gross profit
11,752,818
7,460,744
28,258,506
20,577,363
Operating expenses
Compensation, taxes and benefits
4,747,081
3,845,918
12,934,406
9,895,646
General and administrative
2,512,330
1,770,002
8,717,584
5,187,875
Total operating expenses
7,259,411
5,615,920
21,651,990
15,083,521
Income from operations
4,493,407
1,844,824
6,606,516
5,493,842
Other income (expense)
Other income
83,331
—
175,472
47,982
Forgiveness of Paycheck Protection Program loan
—
—
—
287,143
Loss on redemption of non-participating preferred units
—
—
—
(590,689)
Contingent loss on early termination of line of credit
—
—
(299,770)
—
Interest expense
(1,059,890)
(905,605)
(3,104,684)
(2,269,643)
Total other expense
(976,559)
(905,605)
(3,228,982)
(2,525,207)
Income before taxes
3,516,848
939,219
3,377,534
2,968,635
Tax expense
165,994
128,436
165,658
215,112
Net income
$
3,350,854
$
810,783
$
3,211,876
$
2,753,523
Net income per common share:
Basic
$
0.23
$
0.06
$
0.23
$
0.23
Diluted
$
0.23
$
0.06
$
0.22
$
0.23
Weighted-average number of shares of common stock outstanding:
Basic
14,268,168
14,178,000
14,216,211
11,846,601
Diluted
14,827,165
14,545,241
14,817,770
11,996,969
CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
For the Nine Months Ended September 30,
2023
2022
Cash Flows Provided By Operating Activities:
Net income
$
3,211,876
$
2,753,523
Adjustments to reconcile net income to net cash provided by operating activities:
Amortization of deferred financing costs
434,847
463,008
Amortization of intangible assets
1,465,363
1,465,364
Amortization of right-of-use assets
123,928
94,974
Amortization of capitalized software
159,057
—
Depreciation of property and equipment
26,112
—
Stock-based compensation
545,504
85,437
Forgiveness of Paycheck Protection Program loan
—
(287,143)
Deferred income taxes
82,352
(40,591)
Payment on tax receivable agreement
(45,815)
—
Loss on redemption of non-participating preferred units
—
590,689
Contingent loss on early termination of line of credit
299,770
—
Bad debt expense
97,740
2,717
Changes in operating assets and liabilities:
Accounts receivable
(28,381,260)
(13,520,067)
Prepaid expenses and other assets
(524,098)
482,190
Accounts payable
27,325,629
10,008,327
Accrued liabilities
(513,138)
1,555,037
Income taxes payable
(61,083)
94,440
Deferred revenues
497,359
(201,907)
Operating lease liability
(69,720)
(75,396)
Related party payable
—
(70,801)
Net cash provided by operating activities
4,674,423
3,399,801
Cash Flows Used In Investing Activities:
Cash paid for capitalized software and property and equipment
(136,978)
—
Net cash used in investing activities
(136,978)
—
Cash Flows Used In Financing Activities:
Proceeds from note payable
—
4,260,000
Payments on term loan
(491,250)
(412,500)
Payments of litigation settlement
(193,500)
—
Payments on lines of credit
—
(400,000)
Payment of deferred financing costs
(442,181)
(525,295)
Proceeds from Issuance of Class A common stock, net of transaction costs
—
11,167,043
Redemption of common units
—
(7,200,000)
Redemption of non-participating preferred units
—
(7,046,251)
Proceeds from options exercised
215
—
Proceeds from warrants exercised
12,100
—
Distributions to members
(1,988,333)
(916,433)
Net cash used in financing activities
(3,102,949)
(1,073,436)
Net increase in cash and cash equivalents
1,434,496
2,326,365
Cash and cash equivalents, beginning of the period
4,047,453
4,684,431
Cash and cash equivalents, end of the period
$
5,481,949
$
7,010,796
Supplemental Disclosure of Cash Flow Information:
Cash paid for taxes
$
348,862
$
133,401
Cash paid for interest
$
2,667,283
$
1,744,365
Non-cash Financing Activities:
Transaction costs related to issuances of Class A shares included in accrued liabilities
$
—
$
1,000,000
Outside basis difference in partnership
$
—
$
3,234,000
Tax receivable agreement payable to Direct Digital Management, LLC
$
—
$
278,900
Tax benefit on tax receivable agreement
$
—
$
485,100
Issuance related to vesting of restricted stock units, net of tax withholdings
$
90
$
—
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 stock compensation expense, loss on early termination of line of credit, and loss on early extinguishment of debt, and loss on early redemption of non-participating preferred units (“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, and certain one-time items such as acquisition transaction costs 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:
NON-GAAP FINANCIAL METRICS (unaudited)
For the Three Months Ended September 30,
For the Nine Months Ended September 30,
2023
2022
2023
2022
Net income
$
3,350,854
$
810,783
$
3,211,876
$
2,753,523
Add back (deduct):
Interest expense
1,059,890
905,605
3,104,684
2,269,643
Amortization of intangible assets
488,455
488,455
1,465,364
1,465,364
Stock-based compensation
241,491
70,030
545,504
85,438
Depreciation and amortization of capitalized software, property and equipment
63,689
—
185,169
—
Contingent loss on early termination of line of credit
—
—
299,770
—
Tax expense
165,994
128,436
165,658
215,112
Forgiveness of PPP loan
—
—
—
(287,163)
Loss on early redemption of non-participating preferred units
Reported updated data from ongoing Phase 1b trial further supporting the potential of tegoprubart as a novel kidney transplant immunosuppressive therapy to prevent rejection and better preserve organ function
First participant dosed in Phase 2 BESTOW trial evaluating tegoprubart for the prevention of rejection in kidney transplantation
IRVINE, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its third quarter operating and financial results and reviewed recent business highlights.
“We were thrilled recently to report updated results from our ongoing Phase 1b study that continue to validate tegoprubart’s potential as an immunosuppressive agent that can prevent the rejection of transplanted kidneys,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “Tegoprubart demonstrated not only the potential to preserve, but also to improve graft function in comparison to the current standard of care treatment. Additionally, during the quarter we initiated our Phase 2 BESTOW trial and had the historic opportunity to support the second ever transplant of a genetically modified heart from a pig to a human. We continue to make significant progress toward our mission of bringing a much-needed, new treatment option to the growing number of patients undergoing kidney transplantation,” Dr. Gros continued.
Recent Corporate Developments
Reported data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplantation at the American Society of Nephrology Kidney Week 2023 Annual Meeting that took place in Philadelphia, PA from November 2-5, 2023. Data from 11 participants demonstrated that tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated. Aggregate mean eGFR was above 70 mL/min/1.73m2 at all reported time points after day 90 supporting tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation.
Announced that tegoprubart was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.
Dosed the first participant in the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.
Enrolled the first participant in the Phase 2 open-label extension (OLE) study which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in the ongoing Phase 1b study, or the Phase 2 BESTOW study.
Announced the publication of results from a study evaluating tegoprubart as an immunomodulatory monotherapy in nonhuman primate kidney and islet allotransplants in Science Translational Medicine. Results from the study showed that treatment with tegoprubart as a monotherapy promoted long-term kidney and islet allograft survival and function in nonhuman primates, indicating its potential as an immunomodulatory agent for organ transplantation.
Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer.
Appointed industry veteran James Robinson and renowned transplant surgeon Allan Kirk, M.D., Ph.D., to its Board of Directors.
Upcoming Anticipated 2024 Milestones
First Half 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
Third Quarter Financial Results
The company reported a net loss of $10.3 million, or $0.35 per share, for the three months ended September 30, 2023, compared to a net loss of $10.5 million, or $0.73 per share, for the same period in 2022.
Research and development expenses were $7.9 million for the three months ended September 30, 2023, compared to $7.5 million for the comparable period in 2022, an increase of $0.4 million. The increase in research and development expenses was primarily driven by an increase in expenses related to the production of clinical trial materials of $0.8 million. The increase was partially offset by a decrease in employee compensation and benefits primarily driven by lower non-cash stock-based compensation expenses and a decrease in clinical development expenses with external contract research organizations.
General and administrative expenses were $3.3 million for the three months ended September 30, 2023, compared to $3.1 million for the comparable period in 2022, a decrease of $0.2 million. The increase in general and administrative expenses was primarily driven by an increase in employee compensation and benefits primarily driven by higher non-cash stock-based compensation expenses.
The company had approximately $59.6 million in cash and cash equivalents and short-term investments as of September 30, 2023, compared to $56.4 million in cash and cash equivalents as of December 31, 2022.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
No matter if you are just starting your investing journey or a seasoned professional, making a sound investment decision is always complex. However, one crucial aspect that can separate successful investors from the rest is equity research.
But, what exactly is equity research, and why is it so vital in the world of investing?
Today, we are going to dive deep into this topic to help you understand how equity research can be leveraged to make more informed investment decisions. By shedding light on this intricate process and providing valuable insights from free equity research reports, you can arm yourself with actionable tips and tools to become a smarter investor.
Understanding Equity Research
Equity research is the detailed analysis and evaluation of companies and their equity securities like common and preferred stocks. The core goal is to develop an informed, unbiased opinion on the financial valuation and future prospects of a public company along with its shares. Equity researchers, often referred to as equity analysts, conduct rigorous financial modeling, ratio analysis and due diligence research to provide actionable investment recommendations and targets.
These comprehensive equity research reports become invaluable resources that help all classes of investors make prudent decisions on which stocks to buy, hold or sell. The reports provide a holistic perspective of a company’s financial health, operations, industry dynamics, and management team. By reviewing equity research reports, investors can better assess the inherent risks and growth opportunities of a potential investment.
For example, research reports incorporate detailed financial projections, valuation models, and investment theses that indicate whether a stock may be undervalued or overpriced. Having access to high-quality equity research from Wall Street analysts can provide individual investors with a distinct edge when selecting stocks to build their portfolios.
What are the different types of equities?
Common Stock – This represents ownership in a company. Common stockholders typically get voting rights and a claim on dividends and corporate earnings after other stakeholders are paid.
Preferred Stock – This represents partial ownership in a company. Preferred shareholders have priority over common stockholders when it comes to claims on assets and earnings. They typically receive regular dividend payments before common shareholders. However, preferred stock usually does not come with voting rights.
Blue Chip Stocks – These are stocks of large, reputable companies with a long history of sound financials and steady dividends. Blue chip stocks are generally considered lower risk. Examples include companies like Johnson & Johnson, Procter & Gamble, and Coca-Cola.
Growth Stocks –These are stocks of companies expected to grow at an above-average rate compared to the broader market. Typical growth stocks trade at higher valuations and reinvest profits into expansion rather than pay dividends. Examples include tech companies like Alphabet, Facebook, and Netflix.
Income Stocks – These stocks regularly pay out higher than average dividends to shareholders. They are ideal for investors seeking regular income. Traditional income stocks include utilities, real estate stocks, and consumer staples companies.
Penny Stocks – These are inexpensive stocks that trade for under $5 per share. Penny stocks are generally more volatile and risky since they belong to smaller companies.
Now you may be wondering, who actually conducts all this intensive equity research that gets distilled into reports? Equity research is primarily conducted by financial analysts employed by investment banks, wealth management firms, hedge funds, pension funds, and other institutional investors. These analysts possess deep financial acumen and industry expertise that allows them to build complex financial models and derive reliable stock valuations for public companies.
Top firms like Goldman Sachs, Morgan Stanley and Noble Capital Markets have entire teams of equity analysts covering different sectors, industries, and regions. The lead analyst generally focuses on and specializes in a specific industry they have experience in. For instance, some analysts may focus on just healthcare stocks or technology companies. These specialists leverage their knowledge to provide invaluable insights and analysis.
Why is Equity Research Essential?
Now that we’ve covered the basics of what equity research encompasses, let’s discuss why it is such an indispensable tool for investors:
Identifying Promising Investment Opportunities
One of the biggest benefits of equity research is it can uncover promising investment opportunities that may be flying under the radar. The due diligence conducted by analysts digs much deeper into a company’s fundamentals to determine if its stock is potentially undervalued relative to its growth prospects. This allows analysts to identify stocks poised for upside that the broader market may be mispricing.
Assessing Downside Risks
While finding hidden gems is great, equity research also evaluates potential downside risks and red flags that may not be apparent to an average investor. This cautionary perspective helps mitigate losses from investments that seem enticing but have underlying issues.
Making Informed Investment Decisions
Equity research provides a holistic 360-degree perspective of a company that individual investors typically lack. Investors can leverage these comprehensive insights to prudently decide where to deploy their capital and build conviction around investment choices.
Gaining Expert Industry Knowledge
Seasoned equity analysts also provide key insights into industry trends, competitive dynamics, economic cycles and sector outlooks that most retail investors do not possess. Their expertise helps investors make bets in promising high-growth industries primed for secular tailwinds.
Considering these myriad benefits, equity research can aid all types of investors ranging from novice individuals to large institutions. Even professional fund managers at marquee hedge funds and investment banks routinely utilize equity research to inform multi-million dollar investment decisions. Leveraging expert third-party research analysis levels the playing field.
The Equity Research Process
Now that we’ve covered why equity research is so invaluable, let’s explore how analysts actually conduct this complex and meticulous process:
Step 1 – Data Gathering & Financial Analysis
The first step of equity research involves gathering all available data and information on the target company. Analysts will thoroughly study annual reports, SEC filings, earnings calls, conference presentations, industry publications, news articles, economic data, and management commentary to ensure nothing is overlooked.
Next, they dive into analyzing the company’s financial statements and operating metrics using various techniques:
– Building detailed financial models based on historical financials
– Projecting future income statements, balance sheets, and cash flows
– Calculating financial ratios like P/E, EV/EBITDA, PEG, current and quick ratios
– Benchmarking metrics and multiples against peers through comparable company analysis
This rigorous financial analysis focuses on developing an objective understanding of the company’s financial health and performance.
Step 2 – Industry and Competitive Analysis
Analysts will also conduct in-depth research on the company’s industry, end-markets, competitive landscape and business model. This includes identifying market size, growth trends, industry drivers, pricing dynamics, competitive threats, opportunities, and regulatory issues.
They’ll assess the company’s positioning and advantages versus rivals. The goal is to develop specialized industry expertise and perspective.
Step 3 – Technical Analysis
Equity researchers will analyze the stock’s price patterns, trends, volatility, trading volume and momentum indicators over time to identify optimal entry and exit points. This technical analysis complements the fundamental financial analysis.
Step 4 – Valuation Analysis
Armed with the financial data and industry insights, analysts derive price targets and fair valuation ranges for the stock. Common valuation methodologies include:
– Discounted cash flow (DCF) analysis
– Applying P/E multiples based on industry averages
– Leveraging valuation multiples from past M&A transactions
Each methodology makes certain assumptions that are tested through sensitivity analysis. The end valuations consider both quantitative data and qualitative assessments.
Step 5 – Final Recommendation
Finally, the analyst sums up their buy/sell recommendation and 12-month price target in an equity research report. This final call is based on the upside potential versus downside risks assessed through their rigorous analysis. Top analysts revisit and update their models regularly as new data becomes available.
Tools and Resources for Equity Research
For those looking to leverage equity research, many free resources are available:
Access Free Equity Research Reports
Channelchek is a resource that provide clients with free equity research reports on companies and stocks they cover. New and seasoned investors should take full advantage of these free resources. When reviewing equity research, look for reports that exhibit quality and objectivity. Some hallmarks to seek out: impartial analysis not motivated by investment banking relationships, the right balance of quantitative and qualitative insights, data/assumptions from credible sources, and serious financial modeling.
Additonally, resources like Capital IQ allow you to practice modeling, while reading analyst reports from top firms can provide templates to learn from. Investor education sites like Investopedia also have introductory content to develop core competencies.
Equity research is the fuel that powers informed investing. By properly leveraging analyst insights, both novice and seasoned investors alike can make smarter stock picking decisions. As you embark on your investing journey, be sure to educate yourself on the equity research process and analysis techniques. With quality research in hand, you can invest with conviction and confidence. Check out our free equity research reports to accelerate your investing education today!
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Impressive results. The company posted revenue of $59.5 million and adj. EBITDA of $5.4 million, both well above our expectations. Revenues accelerated sequentially, up 125.5% in the latest quarter, up from 66.5% in Q2. Notably, Sell-side revenue grew a whopping 174% over the prior year period.
Investments paying off. In our view, the especially strong quarter indicates that the company’s growth investments and tech platform are paying off sooner than expected. Importantly, the Sell-side segment processed 400 billion monthly impressions, due to increased capacity.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for approximately 26,800 SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 330 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data, and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 321 local terrestrial radio stations in 67 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com, and NJ101.5.com and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com and Loudwire.com.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
In line quarter. The company reported Q3 revenue of $115.1 million and adj. EBITDA of $27.2 million, both of which were in line with our estimates. Notably, digital advertising revenue grew a solid 5.5% from the prior year period, in spite of net revenue decreasing 3.8% over the same period. Digital revenues accounted for 52% of total revenue in Q3, a development we view favorably.
Q4 outlook on target. We are modestly lowering our Q4 revenue forecast in light of softer than expected Q4 pacings. Q4 total revenue is lowered from $116.3 million to $111.3 million. Notably, our Q4 and full year 2023 adj. EBITDA forecasts of approximately $24.9 million and $100.1 million, respectively, are largely unchanged due to direct operating expense reductions.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Office Depot, Inc., together with its subsidiaries, supplies a range of office products and services. It offers merchandise, such as general office supplies, computer supplies, business machines and related supplies, and office furniture through its chain of office supply stores under the Office Depot, Foray, Ativa, Break Escapes, Worklife, and Christopher Lowell brand names. The company also provides graphic design, printing, reproduction, mailing, shipping, and other services through design, print, and ship centers. It has operations throughout North America, Europe, Asia, and Central America. The company also sells its products and services through direct mail catalogs, contract sales force, Internet sites, and retail stores, through a mix of company-owned operations, joint ventures, licensing and franchise agreements, alliances, and other arrangements. As of December 31, 2008, Office Depot operated 1,267 North American retail division office supply stores and 162 international division retail stores, as well as participated under licensing and merchandise arrangements in 98 stores. The company was founded in 1986 and is based in Boca Raton, Florida.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q23 Results. Revenue came in at $2.009 billion, down from $2.172 billion in 3Q22, driven by store closures, lower comparable sales, and a challenging economic environment. Adjusted net income was flat at $73 million, while adjusted EPS rose to $1.88 from $1.48 as a result of the reduction in outstanding shares. Adjusted EBITDA was $125 million, compared to $131 million last year.
Strategy Is Working. ODP delivered solid operating results in spite of the challenging economic environment, with strong adjusted EPS and adjusted free cash flow. Adjusted FCF in the quarter was $89 million. The Company’s low cost operating model continues to deliver.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Triple Therapy Trial Results Show Much Longer Survival In HPV-Positive Cancer. PDS announced data from the Triple Therapy Combination conducted by the NCI (National Cancer Institute of the National Institutes of Health). This trial tested the combination of PDS0101, the tumor-targeted IL-12 derivative PDS0301, and a checkpoint inhibitor to give three mechanisms of action against HPV-positive cancers. While the patient sample is small, these results far exceed survival seen in published studies.
Results Shows Significant Improvements Over Expectations. Final survival data from the patients that had no previous therapy with immune checkpoint inhibitors (ICI naïve patients) showed 6 out of 8 (75%) of the patients alive at 36 months, compared with published studies with about 30% to 50% alive at 12 months and less than 30% alive at 24 months. Median overall survival for the ICI naïve patients has not been reached.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
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.
Refer to the full report for the price target, fundamental analysis, and rating.
Pipeline Is Set For 2024. Ocugen reported 3Q23 loss of $14.2 million or $(0.06) per share, compared with our estimated loss of $18.2 million or $(0.07) per share. Cash balance at the end of the quarter was $53.5 million. During 3Q23, data was presented for OCU400, INDs were approved for OCU410 and OCU410ST, and OCU500 was selected by the NIAID-NIH (National Allergy and Infectious Disease Institute of the National Institutes of Health) to begin clinical testing. NeoCart is also expected to begin a Phase 3 trial in 2H24. We see these pipeline events as important milestones for the company.
OCU400 is on schedule to finalize the Phase 3 trial design. The Phase 1/2 trial has completed dosing of the RP patients and three LCA patients. The treatment protocols for the Phase 3 trial are expected to be finalized by year-end. Following FDA acceptance, the Phase 3 trial is expected to begin in early 2024 as expected. The final LCA patient data could allow FDA approval to include LCA patients in 2H24.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
InPlay Oil is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.
Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Production increased 6% quarter over quarter despite continued curtailments and unplanned downtime. Curtailments and well pressure issues have hampered production for InPlay and other Canadian producers in recent quarters. InPlay invested $27.5 million during the quarter to drill and make infrastructure improvements. This represents more than half of the year’s capital expenditure budget. During the quarter, the company completed six wells and upgraded a natural gas facility to process 66% more gas.
InPlay reported strong results in the 2023-3Q and 2023-4Q should be better. Management indicated that its investments should lead to the fourth quarter being the highest production quarter of the year. Management did not make any changes to its guidance for 2023, 2024, and 2025 production and fund flow generation. With a drop in capital expenditures in the upcoming quarter, management should have ample cash flow to pay dividends (7% yield), strategically repurchase shares, and explore small add-on acquisitions.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Updating estimates. We have trimmed our fiscal year 2023 EBITDA and EPS estimates to $80.6 million and $3.22 from $81.2 million and $3.25 per share. Our estimates reflect lower gross margins during the September quarter due to the negative impact of raw material fluctuations. Our September EBITDA and EPS estimates were lowered to $23.2 million and $0.97 from $23.7 million and $1.00. We are making no changes to our 2024 estimates and expect Haynes to provide guidance for fiscal 2024 when it reports results for fiscal year 2023. We still expect the September quarter will be Haynes’ strongest of the fiscal year in terms of volumes shipped, net revenues, and earnings.
Strong order backlog. Orders during the June quarter resulted in a record backlog of $468.1 million and represented a 4.8% increase compared to the prior quarter and a 38.4% increase on a year-over-year basis. Backlog pounds increased 3.2% during the third quarter to approximately 14.6 million pounds and increased 20.7% compared to the prior year period driven by strong demand in the aerospace and industrial gas turbine markets. In our view, the strong order book is indicative of the company’s strong competitive position and favorable outlook.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
