Spotlight on September's Small-Cap Catalysts

We've dug deep into filings and press releases to bring you the ultimate small-cap catalyst watchlist for September. Enjoy the insights and remember—staying one step ahead is key in this market!

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NCNA: NuTide:701 and NuTide:303 Studies Continue Unchanged with Encouraging Data on NUC-7738 plus Pembrolizumab to be Presented at the ESMO Annual Conference in September.

VRAX: The Company will be showcasing its portfolio of immune profiling products for research use at Booth C13, and management will be available for discussions with research organizations and potential customers. Announced they will be hosting a booth at the 7th European Congress of Immunology (ECI), which is taking place from September 14, 2024, in Dublin, Ireland.

SNAL: Announce its latest Steam Publisher Sale, offering players exclusive discounts on some of the Company's top titles from August 29, 2024, at 10:00 AM (pst) until September 4, 2024. ARK: Survival Ascended: The much-anticipated Aberration map is expected to launch on September 4th, driving renewed interest and engagement among the ARK community.

SIDU: Announced that they will attend World Satellite Business Week (WSBW) 2024, held in Paris from September 16-20. Sidus Space's CEO, Carol Craig, will join industry leaders as a speaker on the panel Sky's No Limit: The Rise of the Space Infrastructure as a Service Offering, scheduled for September 18th.

NTBL: The Company will present an overview of the Phase 2 program and additional data from preclinical studies evaluating volasertib for acute myeloid leukemia (AML) at the twelfth annual meeting of the Society for Hematologic Oncology (SOHO 2024), being held from September 4th-7th 2024.

GOSS: Announced two oral presentations and a poster presentation with data relevant to seralutinib at the European Respiratory Society (ERS) Congress 2024, which takes place from September 7th through 11th online and onsite in Vienna, Austria.

SMTK: Announced that it will be giving a live in-person keynote presentation at the PlayNitride 2024 MicroLED Technology Forum on Tuesday, September 3rd, 2024. Smartkem will also be exhibiting at SEMICON® Taiwan 2024 from Wednesday, September 4th to Friday, September 6th, 2024.

SYRS: Announced that it will present additional data from the randomized portion of the SELECT-AML-1 Phase 2 clinical trial at the Society of Hematologic Oncology (SOHO) Annual Meeting taking place September 4-7, in Houston, Texas.

ICON: Consistent with our policy to pay quarterly cash dividends on our common shares during the one-year period following our initial public offering in an aggregate amount of approximately $500,000, Icon's Board of Directors has approved a cash dividend of $0.08 per common share ($116,000 in aggregate) for the second quarter of 2024. The cash dividend will be paid on or around September 30, 2024, to all of our common shareholders of record as of September 15, 2024.

ZEPP: Q2 2024 Results Earnings Conference Call August 22, 2024 > Leon Deng : I think you have heard us saying that in the upcoming IFA, which is in September, we're going to launch a new watch. Our most popular outdoor smartwatch, T-Rex, is up for an update. Actually, a lot of new functionalities will be added to that watch.

AMIX: Announced its technology and interim clinical trial findings will be featured in a podium presentation at the 2024 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress being held September 14-18, 2024 in Lisbon, Portugal.

SCNI: Q2 2024 Results Conference Call August 20, 2024 > We will be attending the EADV conference for dermatology in Amsterdam at the end of September.

FLYE: The Company is currently developing the GO FLY app, a mobile application designed for its rental services. As part of FLY-E's growth strategy, the Company plans to expand the rental service to Miami, Toronto, and Los Angeles shortly. The final delivery of GO FLY APP is scheduled for September 5, 2024.

TRIB: Biosensor Developments > We successfully initiated our first pre-pivotal clinical trial and expect this trial to conclude in September.

PPBT: Further evaluation of the data in the second part of the study concluded that unlike in the Nal-IRI/5FU/LV part, the gemcitabine/nab-paclitaxel-based portion of the study was significantly impacted by informative censoring of the control arm that resulted in an imbalance between the control and experimental arms, rendering this part of the study unsuitable for analysis. The study was designed as a two-part study, with each of the Nal-IRI/5FU/LV and the gemcitabine/nab-paclitaxel parts as a standalone, and therefore the analysis of each part is independent. Additional interim data is expected to be presented at a medical conference in September 2024.

ITRM: We continue to work with the U.S. Food and Drug Administration (FDA) during their review of our resubmitted new drug application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) in adult women, including preparing for the Advisory Committee meeting in September where we will address the FDA's discussion topics regarding stewardship and patient population, among other things.

AIM: Q2 2024 Earnings Conference Call August 16, 2024 > I want to update you on the progress of Ampligen for the post-COVID condition of fatigue. We have done a thorough analysis of the data, and we have identified certain inclusion criteria that can help delineate the high responders. We're awaiting the biomarker data necessary to complete our analysis and expect to receive this data in mid-September.

MCRB: Lead SER-155 program remains on track for a clinical data readout from the placebo-controlled study Cohort 2 in patients receiving allogeneic hematopoietic stem cell transplant (allo-HSCT) in September.

BLRX: Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease. The Phase 1 clinical trial is an open-label, multi-center study evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ HSCs in 12 patients (aged 18 and older) with SCD. Anticipate first patient dosed in September 2024.

PSTV: Presentations planned for the following upcoming medical conferences > Congress of Neurological Surgeons (CNS) Annual Conference (September 28-October 2, 2024) Treatment Of Recurrent Glioblastoma (rGBM) Via Convection Enhanced Delivery (CED) With Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 2 Trial Update.

OXBR: These events will provide a platform for Oxbridge Re and Zoniqx to discuss their collaborative efforts in pioneering the issuance of tokenized reinsurance securities. The detailed schedule of events includes > Token 2049 | Singapore | September 18-19th.

MGRM: Q2 2024 Earnings Conference Call August 14, 2024 > wesuccessfully submitted our 510-k application to the FDA for our mBôs TKA System. The application was submitted on July 19th. It has passed administrative review. So the FDA has gone through it and it is a complete application. And now we're in what's called the primary substantial review phase which should last approximately 60 days. So we expect to hear from the FDA on or around September 17th.

CYTH: announced that two abstracts have been accepted for poster presentation at the SSIEM Annual Symposium 2024 being held September 3-6, 2024 in Porto, Portugal > TRANSPORTNPC™: Phase 3 global trial of intravenous hydroxypropyl-beta-cyclodextrin (HPβCD) in patients three years of age or older with Niemann-Pick disease type C1 (NPC1) and TRANSPORTNPC™: Phase 3 global trial of intravenous hydroxypropyl-beta-cyclodextrin (HPβCD) in patients with Niemann-Pick disease type C1 (NPC1)– open label sub-study in patients below 3 years of age.

PRPH: Prepares for commercialization of Equivir in anticipation of receipt of Final Trial Data expected in September.

NXPL: On April 12, 2024, NextPlat announced a proposed merger with Progressive Care in an all-stock transaction that would result in Progressive Care becoming a wholly-owned subsidiary of NextPlat which is expected to provide annual operating cost reductions. On August 6, 2024, the Company filed the definitive proxy statement/prospectus regarding the proposed merger and set September 13, 2024, as the Annual Meeting date for the shareholder vote.

FCUV: As of May 11, 2024, the Company announced board approval for the eventual spin-off of Lusher to better prioritize the development of its SEC Financial Reporting Automation Software while also allowing the management of Focus Universal Inc. to better prioritize its core business. The Company plans to demo the software at the beginning of September 2024, and plans a company roadshow in 3Q of 2024.

CTSO: The Company has completed its pivotal randomized, controlled clinical trial in the U.S. and Canada, called the STAR-T trial, evaluating the use of DrugSorb-ATR during cardiothoracic surgery to prevent or reduce perioperative bleeding complications in pursuit of FDA and Health Canada marketing approval. We believe that the safety and efficacy results of the STAR-T trial will support regulatory submissions expected in the third quarter of 2024 for marketing approval by the FDA and Health Canada.

PDSB: Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "This clinical trial is supported by the maturing data from our VERSATILE-002 Phase 2 trial, including encouraging survival, disease control response rates and safety data. We look forward to the presentation of updated data from the VERSATILE-002 trial at the European Society for Medical Oncology (ESMO) 2024 Congress in September.

IOBT: Updated data for the head and neck cohort of the company's Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic NSCLC or recurrent or metastatic SCCHN was accepted for poster presentation at the European Society of Medical Oncology (ESMO 2024) congress taking place September 13-17 in Barcelona. This presentation will share efficacy and safety data for the full patient cohort, which completed enrollment earlier this year.

BRN: In July 2024, the Company commenced drilling one 100%-owned and operated development oil well in the Twining area. The well is currently cased pending completion. The Company's expectation is to have the well completed and on production in early September 2024.

DPRO: Announce a strategic partnership with The Institute for Drone Technology, a leading drone solution provider for the Australian government and enterprise sectors. As part of the partnership, Draganfly is proud to announce its participation in the Land Forces International Land Defence Exposition in September. This premier event serves as the gateway to the land defence markets of Australia and the region, providing a platform for interaction with major prime contractors.

HBIO: Q2 2024 Earnings Conference Call August 8, 2024 > Late last year, we announced the initial delivery of our groundbreaking VivaMARS neurobehavioral monitoring system to one of our largest CRO customers. This CRO has adopted the system as part of their preclinical testing offering. Weexpect to ship additional VivaMARS products to this customer as they expand their use in these systems to more locations. As an aside, we expect to see posters describing the initial results of testing using the VivaMARS system at this September Safety Pharmacology Society show.

BCAB: Phase 2 Trials of ozuriftamab vedotin, CAB-ROR2-ADC in treatment-refractory SCCHN (NCT05271604) (median 3 prior lines of treatment) In the 29 evaluable patients to date, a total of 11 responses at the combined 2Q3W and Q2W dose regimens Fast Track Designation granted by FDA Data to be presented at the upcoming poster presentation at ESMOin September.

IFRX: Will present two posters for INF904 featuring new preclinical data at EMCHD 2024, which is being held in Lübeck, Germany, September 2– 6, 2024. In addition to two poster presentations, InflaRx representatives will participate in a C5a/C5aR-focused panel discussion as well as speak at a satellite symposium.

GANX: Presentation of late-breaking abstract at International Congress of Parkinson's Disease and Movement Disorders from September 27th through October 1st.

EVAX: Positive and validating Phase 2 immune data on lead asset EVX-01 presented at ASCO, 67% Objective Response Rate from Phase 1 published in leading medical journal. On track for Phase 2 one-year clinical data readout at the ESMO Congress 2024 in September, as we continue the solid progress for this program.

AWH: Announced its poster entitled "Application of Deep Neural Network-Based Algorithm to Provide Additional Information in the Assessment of Adnexal Masses Classified as Indeterminate by Imaging" will be presented on September 12, 2024, at The Menopause Society's 2024 Annual Meeting being held in Chicago, Il.

ADAG: Longer-term data from a phase 1b/2 trial in MSS CRCwill be presented at the ESMO Congress 2024 taking place in Barcelona, September 13–17, including additional patients from expansion cohorts of ADG126 10 mg/kg in combination with pembrolizumab.

HSCS: Announced that the MyoVista® wavECGTM has been selected by the Innovation Value Institute as a technology which can drive the radical transformation of healthcare and has been invited to demonstrate and discuss the MyoVista wavECG at the 4th Digital Health Symposium at the United Nations General Assembly to be held in New York, USA in September 2024.

NUWE: Announce that new clinical evidence demonstrating the efficacy of its Aquadex® system will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, taking place September 27-30, 2024, in Atlanta, Georgia.

ATHA: Topline data from completed Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer's disease targeted for September 2024.

CANF: Announces that company scientists came up with breakthrough findings showing that the anti-cancer and protective effects in the liver are conferred via the signaling protein adiponectin. This very important positive cytokine plays a pivotal role in regulating anti-inflammatory, anti-cancer, metabolic and insulin resistance. Namodenoson increases adiponectin production in pre-clinical studies and in humans. The data will be presented at the 20th Annual Congress of International Drug Discovery Science & Technology, China Branch (IDDST-2024), September 12-14, Shanghai, China.

IINN: Announce plans to exhibit the INSPIRA™ ART100 System, recently cleared by the U.S. Food and Drug Administration ("FDA"), at the Extracorporeal Life Support Organization (ELSO) conference in Detroit, Michigan between September 29 to October 1, 2024.

ENTX: announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting which will be held on September 27-30, 2024 in Toronto, ON, Canada.

CRIS: On September 26, 2024, Curis will be hosting the 3rd Annual Symposium on IRAK-4 in cancer. The symposium will be hosted by Dr. Eric S. Winer and Dr. Grzegorz S. Nowakowski and will focus on IRAK-4 and the promise of IRAK-4 inhibition in both hematologic malignancies and solid tumors.

EFSH: We are advancing with the sale of a division of 1847 Cabinets Inc., which we anticipate closing by mid-September 2024. This proposed sale marks a strategic milestone for 1847, demonstrating our ability to acquire, operate, and enhance the value of assets before divesting them.

CATO: declared a regular quarterly dividend of $0.17 per share. The dividend will be payable on September 30, 2024 to shareholders of record on September 16, 2024.

SCLX: Announced oral, poster presentations, and symposia on ZTlido (lidocaine topical system) at the 2024 Annual PAINWeek conference in Las Vegas, NV on September 3-5, 2024.

RVPH: Announced it will host a virtual key opinion leader (KOL) event on Wednesday, September 4, 2024 at 2:00 PM. The discussion will focus on reviewing results of the vocal biomarker data and their relationship to the primary efficacy endpoint and key efficacy secondary endpoints negative symptoms, social functioning, social cognition and CGI from brilaroxazine Phase 3 RECOVER-1 trial in schizophrenia.

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