Cardiotoxicity

FDA-approved generic provides cost-effective option for treating cancer LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms of cancer. Now available in the U.S., Cyclophosphamide for Injection, USP is the newest addition to Fresenius Kabi’s broad portfolio of generic oncology injectables that help make cancer therapies more affordable and accessible. This press release features multimedia. View the full release here: Cyclophosphamide is now available from Fresenius Kabi. (Photo: Business Wire) “The introduction of Cyclophosphamide for Injection adds another critical treatment to our broad and leading oncology portfolio that offers lower-cost options for treating cancer,” said John Ducker, president and CEO of Fresenius Kabi USA. Supplied as a 500mg, 1g, and 2g single-dose vials of lyophilized powder, the drug can be administered intravenously or orally. Fresenius Kabi offers all lyophilized presentations of cyclophosphamide currently in the market. Cyclophosphamide for Injection, USP is available through distributors or direct from Fresenius Kabi. About Cyclophosphamide for Injection, USP Cyclophosphamide for Injection is an alkylating drug indicated for the treatment of: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. IMPORTANT SAFETY INFORMATION Cyclophosphamide for Injection is contraindicated in patients with hypersensitivity to cyclophosphamide and with urinary outflow obstruction. Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections - Severe immunosuppression may lead to serious and sometimes fatal infections. Close hematological monitoring is required. Urinary Tract and Renal Toxicity - Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria can occur. Exclude or correct any urinary tract obstructions prior to treatment. Cardiotoxicity - Myocarditis, myopericarditis, pericardial effusion, arrhythmias and congestive heart failure, which may be fatal, have been reported. Monitor patients, especially those with risk factors for cardiotoxicity or pre-existing cardiac disease. Pulmonary Toxicity - Pneumonitis, pulmonary fibrosis and pulmonary veno-occlusive disease leading to respiratory failure may occur. Monitor patients for signs and symptoms of pulmonary toxicity. Secondary malignancies have been reported in patients treated with cyclophosphamide-containing regimens. Veno-occlusive Liver Disease - Fatal outcome can occur. Embryo-Fetal Toxicity - Can cause fetal harm. Advise female patients of reproductive potential to avoid pregnancy. Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . Nursing Mothers: Discontinue drug or nursing. Females and males of reproductive potential: Counsel patients on pregnancy prevention and planning. Renal Patients: Monitor for toxicity in patients with moderate and severe renal impairment. This Important Safety Information does not include all the information needed to use Cyclophosphamide for Injection, USP safely and effectively. Please see the full prescribing information for Cyclophosphamide for Injection, USP at . About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in injectable medicines, biosimilars, clinical nutrition and technologies for infusion and transfusion. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn and Facebook.

– MB-106 AML Phase 1B/2 trial (MB-106) preliminary data readout: Reached 67% recruitment – MB-106 preliminary results: Intent to Treat CR rate of 40% plus a CR/ CRi rate of 47% (N=15); Dosed Per Protocol CR rate of 46% plus a CR/CRi rate of 54% (N=13) – First 1st line AML subject treated and resulted in a CR in MB-106 – No CR/CRi's in MB-106 have relapsed to date – MB-107 STS Lung Mets Phase 1B/2 trial preliminary data readout: Phase 1B median extended overall survival of 11 months for heavily pre-treated subjects (N=15); Phase 2 data continues to develop – 100% of Annamycin subjects in multiple studies (N=62) continue to show no signs of cardiotoxicity during study as evidenced by an independent expert's reports – Company provides 2024 business outlook and updates its upcoming milestones HOUSTON, Jan. 24, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced 2023 year-end Annamycin clinical trials preliminary data and 2024 expectations for multiple data readouts and a transition to pivotal Phase 2B/3 clinical studies. The Company also updated its upcoming milestones. "Over the course of 2023, we delivered on our promise for a year of important data from our Annamycin clinical development programs. We are well-positioned to continue building upon our encouraging growing body of preliminary clinical data and transition to pivotal Phase 2B/3 clinical trials by year-end 2024. We believe that Annamycin should be positioned as a 2nd line therapy for acute myeloid leukemia or AML, and for the first time ever, should enable a clear majority of patients to benefit from anthracyclines. Anthracyclines continue to represent one of the most important treatments for AML and advanced soft tissue sarcoma," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. Mr. Klemp continued, "Our progress is accelerating. Last month, we reported strong results from our first 11 patients in our AML clinical trial. Now, just weeks later our evaluable patients have increased to 15 and the results are even stronger. Enrollment continues to be robust, and we expect to announce the completion of enrollment of 2nd line patients by the time we announce financial results at the end of March, if not sooner. We believe that data will present a clear picture of the approvability of Annamycin and will support our discussions with the FDA for developing an accelerated approval pathway as a 2nd line therapy for relapsed and refractory AML, including a pivotal approval clinical trial we expect to begin before the end of 2024. With our recent financing in December 2023, we have extended our runway into the fourth quarter of 2024, as well. We thank our investors and collaborators for their support in 2023 and we look forward to an exciting and prosperous 2024." Preliminary 2023 Year-End Annamycin Clinical Trials Data AML The Company is currently conducting its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587. The Company has also begun recruiting 1st line subjects into this trial. The Company continues to treat subjects in the Phase 2 portion of the study. Below is a summary of the data to date on this trial which is preliminary and subject to change. Among subjects who had an evaluable post treatment bone marrow biopsy, or who dropped out due to an adverse event (AE), there have been 6 complete responses (CR's) and 1 complete response with incomplete recovery of platelets and/or neutrophils or 40% CR and 47% CR/CRi's of the intent to treat (ITT) subjects (N=15) and 46% CR's and 54% CR/CRi's of the subjects treated (dosed with Annamycin) (N=13). Two subjects experienced adverse events and were not dosed per protocol with one having an allergic reaction to Annamycin, the first the Company has seen in over 70 subjects dosed in the Company's multiple Annamycin clinical trials; the second adverse event was due to an allergic reaction to cytarabine. The CR/CRi's have been spread across 3 different sites in two different countries (Poland and Italy) and 7 out of 9 sites participating in the study have recruited subjects to date. The Company has expanded the study protocol to include a cohort of 1st line subject which should provide data to enable the designing of a potential confirmatory Phase 3 post-approval study, however it does not expect the addition of this cohort to delay its End of Phase 2 (EOP2) Meeting with the FDA, which will focus primarily on securing an accelerated approval pathway for the treatment of 2nd line patients (those who were relapsed from or refractory to a 1st line AML therapy). The first 1st line therapy AML subject for Annamycin was recruited, treated, and upon evaluation it was determined that the treatment resulted in a CR. The first CR subject was treated in February of 2023. The Company has not been notified of any relapses to date, indicating significant durability of the CRs being generated in this study. There continues to be no evidence of cardiotoxicity as reported by an independent expert's reports following assessments of ejection fractions, strain analyses, ECGs, and cardiac biomarkers including Troponin-I and T cross all trials (N=62). Most subjects have experienced myelosuppression, febrile neutropenia and/or thrombocytopenia, which are common adverse events with other anthracyclines. Currently, the median age of the 15 intent to treat subjects in MB-106 is 69 years (range of age is 32 to 78 years) with a median number of prior therapies for AML of 1 (range of 0 to 6). The Company has recruited 19 subjects to date with 2 subjects withdrawing from the trial due to adverse events and 4 other subjects not yet having a bone marrow aspirate fully evaluable. The Company may recruit up to 28 subjects in the Phase 1B/2 clinical trial. At the Company's current rate of recruitment for the study, Moleculin expects to complete recruitment and report topline data in 1H 2024, if not by the end of the first quarter. STS Lung Mets On September 21, 2023, Moleculin announced the completion of enrollment in the Phase 2 portion of its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases (MB-107) clinicaltrials.gov: NCT04887298. All subjects had pulmonary metastasis from soft tissue sarcoma (STS Lung Mets or STS) and at least one prior therapy. There was no limit on how many prior therapies a subject could have prior to entering this study. Most subjects were heavily treated with other therapies prior to entering our trial with our treatment representing the 4th median therapy for all subjects in the Phase 1B and Phase 2 portion of the trial (range of 2 to 12). Below is a summary of the data to date on this trial which is preliminary and subject to change. The Company previously announced the preliminary data from the Phase 1B portion of the study showing median progression free survival (PFS) for 67% of the Phase 1B subjects of over 2 months (N=15) and median overall survival (OS) of 11.3 months. Not including the one subject that withdrew from OS follow-up the median OS increased to 13 months. Additionally, the Company noted that Phase 1B subjects with less than or equal to 2 prior treatments and treated at the recommended Phase 2 dose or lower demonstrated a higher percentage of subjects with PFS of 2 months or greater at 78% (N=9). Of the 17 subjects in the Phase 2 portion of the study, all treatments have ceased, and subjects are being followed for PFS and OS. A majority of subjects remain alive at this time. The Company believes that the data will be similar to or better than the Phase 1B portion of the study and will announce the results once the study has substantively concluded. 2024 Expected Upcoming Milestones The Company announces the updated expected upcoming milestones for 2024. Annamycin AML 1H 2024: In-depth data review and presentation of topline data on MB-106 clinical trial. 1H 2024: MB-106 End of Phase 2 (EOP2) Meeting with the FDA and/or its European equivalent. Mid 2024: Identify next phase of development/pivotal program. Late 2024 into 1H 2025: Initiate pivotal program. STS Lung Mets 2H 2024: Final MB-107 data readout. 2024: Identify next phase of development/pivotal program. Late 2024 into 1H 2025: Initiate 1st line STS study with an investigator-initiated trial. Other Drug Candidates Moleculin is in ongoing discussions with multiple academic institutions in separate programs evaluating WP1066 for the treatment of glioblastomas and/or pediatric brain tumors. The Company expects to finalize agreements with Northwestern University for an investigator-initiated and funded trial in early 2024 (clinicaltrials.gov: NCT05879250). Expected Upcoming Milestones Report topline results from investigator-initiated Phase 1 study in pediatric brain tumors. Announce results of formulation efforts for intravenous delivery. Expect the commencement of an externally funded investigator-initiated adult clinical trial to be announced in 1H 2024. Seeking investigator-initiated pediatric cancer clinical trial in 2H 2024. WP1122 was developed as a prodrug of 2 deoxy-D-Glucose (2-DG) to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG monotherapy in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a greater antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells in culture. The improved pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122 compared to 2-DG was noted in mice following oral dosing at equimolar (i.e., equivalent levels of 2-DG) doses. WP1122 successfully completed a Phase 1 clinical trial, which established a recommended safe dose for future potential Phase 1B or Phase 2 clinical trials. The WP1122 Portfolio includes numerous analogs, including WP1096, which has demonstrated the potential for broad antiviral capabilities in a wide range of in vitro models including multiple arenaviruses, filoviruses, Zika virus, and HIV. The Company looks forward to the potential for additional externally funded research to confirm such activity. Expected Upcoming Milestones Report preliminary findings of National Institutes of Health (NIH) funded animal testing of WP1096 in the Tacaribe Arenavirus. Identify investigators interested in initiating a clinical trial to study the safety, pharmacokinetics, and efficacy of oral WP1122 in adult patients with GBM. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of COVID-19 and other viruses, as well as cancer indications including brain tumors, pancreatic and other cancers. For more information about the Company, please visit and connect on Twitter, LinkedIn and Facebook. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Expected Upcoming Milestones set forth above, the pace of enrollment in Moleculin's clinical trials, the timing of Moleculin's ability to report topline data from its studies, the timing of the commencement of investigator-sponsored and/or externally funded clinical trials which are outside the control of Moleculin, and whether the results of Moleculin's preclinical animal models can be replicated in human trials. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact: JTC Team, LLC Jenene Thomas (833) 475-8247 [email protected] SOURCE Moleculin Biotech, Inc.

DLX-001 Shown to Be Safe and Well-Tolerated Without Producing Hallucinogenic, Psychomimetic, or Dissociative Effects Based on Interim Data from Phase 1 Trial Preclinical Findings In Vivo Demonstrate DLX-001 Promotes Rapid and Durable Structural and Functional Neuroplasticity After a Single Dose Phase 2 Trial of DLX-001 Expected to Begin in mid-2024 Dr. Jeff Jonas Appointed to Scientific & Strategic Advisory Board BEDFORD, Mass.--(BUSINESS WIRE)-- Delix Therapeutics, a clinical-stage neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological disorders, today announced interim results from the Phase 1 trial evaluating DLX-001, a novel neuroplastogen, in healthy volunteers, which were presented at the 2023 American College of Neuropsychopharmacology (ACNP) Annual Meeting in Tampa, Florida. Preclinical data characterizing the compound were also presented at the meeting. “While ketamine and serotonergic psychedelics have shown promise for treating certain neuropsychiatric disorders, they are also associated with troublesome side effects and cardiac risks,” said Aaron Koenig, MD, Chief Medical Officer of Delix Therapeutics. “We are encouraged by our preliminary Phase 1 results, which indicate that DLX-001 is safe, well-tolerated, and, as predicted by our preclinical studies, does not produce hallucinogenic, psychotomimetic, or dissociative effects in healthy volunteers. Importantly, preclinical findings confirm DLX-001’s ability to robustly promote structural and functional neuroplasticity in vivo in the prefrontal cortex, which we believe drives the underlying efficacy of this class of fast-acting agents. We look forward to the continued development of DLX-001, as we believe it has the potential to address the significant unmet medical needs of patients suffering from difficult-to-treat neuropsychiatric conditions.” A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of DLX-001, a Novel Neuroplastogen Lead Author: Aaron Koenig, M.D. Session Date: Monday, December 4 Session Time: 5:00pm-7:00pm EST The Phase 1, three-part study is enrolling approximately 100 healthy volunteers with the primary objectives of assessing safety, pharmacokinetics (PK), and markers of brain activity. Part A is a randomized, double-blind, placebo-controlled single ascending dose (SAD) study of DLX-001. Part B is a standard, open-label, crossover design study to investigate the effect of food on the PK of DLX-001. Part C is a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study in which participants receive multiple oral doses of either DLX-001 or placebo over 7 days. Key Findings In the 62 healthy volunteers dosed so far, DLX-001 demonstrated a favorable safety pro was well-tolerated, with no serious adverse events reported to-date. No psychotomimetic, hallucinatory, or dissociative effects were observed, as reflected by no change over time on a robust battery of metrics including the Clinician-Administered Dissociative States Scale (CADSS), Bond & Lader Visual Analogue Scale (B&L VAS), Bowdle Visual Analogue Scale (Bowdle VAS), and Mystical Experience Questionnaire 30 (MEQ-30). DLX-001 is orally bioavailable, achieves plasma exposures within the predicted therapeutic range, and achieves measurable levels within the CSF. The maximum tolerated dose for DLX-001 has not yet been reached; additional cohorts are in progress. In addition to these interim clinical data, Delix presented preclinical data characterizing DLX-001’s neuroplastic and therapeutic effects, including comparative data marking the beneficial efficacy of DLX-001 against ketamine, psilocybin, and DMT and differentiating it from these compounds on hallucinogenic liability. Preclinical Pharmacology of DLX-001, a Novel Non-Hallucinogenic Neuroplastogen With the Potential for Treating Neuropsychiatric Diseases Lead Author: Kurt Rasmussen, Ph.D. Session Date: Tuesday, December 5 Session Time: 5:00pm-7:00pm EST DLX-001 was examined in a series of in vitro, ex vivo, and in vivo assays relevant to neuroplasticity and major depressive disorder. Key Findings In pharmacokinetic (PK) studies, DLX-001 was shown to be orally bioavailable and brain penetrant. In a phenotypic screen of neurite outgrowth in neuronal cell cultures, DLX-001 produced significant increases in both neurite length and complexity. In vivo, DLX-001 demonstrated significant effects on promoting both structural and functional neuroplasticity on par with the 1st generation compounds ketamine and psilocybin after a single dose DLX-001 exhibited both rapid, within 24-hours, and enduring, up to 7 days, antidepressant-like activity after a single dose in behavioral assays In studies relevant to cardiotoxicity and hallucinations, no signal was identified for DLX-001. Importantly, DLX-001 met or exceeded the efficacy and duration of effect of first-generation psychoplastogens, including DMT, psilocybin, and ketamine. “Delix is excited to share these data from DLX-001, the first novel neuroplastogen to enter clinical testing. These data reinforce the potential of our broader neuroplastogen platform to develop therapies that can repair damaged neurons,” said Delix CEO Mark Rus. “We are particularly impressed with DLX-001’s ability to cross the blood-brain barrier and achieve therapeutic exposures, which is a common challenge in CNS drug development, but not produce hallucinogenic effects.” Delix is also announcing today the appointment of Jeff Jonas, M.D., to the company's Strategic & Scientific Advisory Board. Dr. Jonas brings decades of experience in R&D leadership and cutting-edge CNS drug discovery and development across brands that have successfully helped millions of patients, such as Lexapro, Vyvanse, Zulresso, Zurzuvae and Namenda. In addition, across roles such as CEO of Sage Therapeutics, and Board Member of Karuna Therapeutics, Jeff's significant company building and advisory experience has generated considerable shareholder and stakeholder value, particularly when developing novel scientific approaches to CNS. "The Delix team and I are thrilled that Jeff has joined us as a Scientific and Strategic Advisor," said Delix CEO Mark Rus. "Jeff's proven track record and experience will be invaluable to Delix in the future. He and his teams have significantly advanced the CNS treatment landscape throughout his career. I look forward to leveraging his considerable experiences as we progress our novel neuroplastogen platform and build Delix into a leading neuroscience company." "The therapies being developed by Delix and their overall approach to repairing neuronal atrophy have the potential to shift the treatment paradigm for several neuropsychiatric conditions," said Dr. Jonas. "I look forward to working with Delix's talented management and scientific team as they advance a pipeline of non-hallucinatory neuroplasticity-promoting therapeutics to better treat patients struggling with difficult-to-treat disorders.” About Jeffrey Jonas Jeffrey Jonas, M.D., has more than 25 years of experience in drug development and discovery across multiple therapeutic areas in the pharmaceutical and healthcare industries. Dr. Jonas has served as CEO and Chief Innovation Officer of Sage Therapeutics, where he led the development of industry-leading CNS treatments and development pipelines. Before Sage, he was President of the Regenerative Medicine Division at Shire Pharmaceuticals. Earlier on his career, Dr. Jonas served as Executive Vice President of ISIS Pharmaceuticals and held senior positions at Forest Laboratories, Inc. and Upjohn Laboratories. He received his M.D. from Harvard Medical School and a B.A. from Amherst College. About DLX-001 DLX-001 is a novel, non-hallucinogenic, and non-dissociative isotryptamine neuroplastogen currently undergoing initial human testing to treat those diagnosed with major depressive disorder (MDD) and other associated neuropsychiatric conditions. Preclinical data suggests that in efficacious doses, DLX-001 increased dendritic spine density in rat brain layer-V PFC pyramidal neurons and had rapid and enduring antidepressant-like effects after a single dose. Recent phase 1 data found DLX-001 to be safe and well tolerated, with no serious adverse events reported. In addition, researchers did not observe significant abnormalities among crucial safety indicators, including vital signs, electrocardiogram (ECG) readings, and laboratory analysis. About Neuroplastogens Neuroplastogens are a novel class of potentially disease-modifying therapeutics for psychiatric and neurological conditions. These compounds promote rapid and sustained neuroplasticity in select neural circuits resulting in fast-acting therapeutic effects. Neuroplastogens are novel chemical entities inspired by compounds that are proving to be beneficial across a range of therapeutic areas including mood, anxiety, cognitive, and neurodegenerative disorders in addition to other synaptopathies. Generated from our phenotypic drug discovery engine, Delix’s seeks to bring to market a pipeline of neuroplastogens that will be the faster, stronger, and more effective therapies of the future. About Delix Therapeutics Delix Therapeutics is a clinical-stage neuroscience company focused on harnessing the power of novel neuroplasticity-promoting therapeutics to better treat patients struggling with difficult-to-treat neuropsychiatric and neurological disorders. The company's compounds are easily manufactured small molecules capable of rapidly inducing structural and functional neural changes in targeted areas of the brain. Through its novel Neuroplastogen Platform, Delix is pioneering a new class of fast-acting outpatient pharmacotherapies and rapidly advancing through preclinical and clinical development to bring patients FDA-approved, take-home medicines that will serve several unmet needs and enhance the psychiatric treatment paradigm for patients and providers.