3rd Quarter Small-Cap Catalysts: What's Left?

We've combed through countless filings and press releases to spotlight the remaining 3rd quarter catalysts. Enjoy our research and remember—staying ahead is the name of the game!

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TNXP: The investigator-initiated OASIS trial 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. The trial plans to enroll approximately 180 trauma survivors at ED study sites around the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo. The first participant for the OASIS trial is expected to enroll in the third quarter of 2024.

SGE: In April 2024, announced a transaction to merge Strong/MDI Screen Systems, Inc. ("Strong/MDI") with FG Acquisition Corp., a Canadian special purpose acquisition company, which will be renamed Saltire Holdings, Ltd. ("Saltire") Proposed transaction values Strong/MDI subsidiary at $30 million. Strong Global Entertainment will retain a significant economic stake, participating in the future growth and success of Strong/MDI and Saltire. The transaction is expected to close in the third quarter of 2024.

UNCY: Enrollment in the UNI-494 Phase 1 study is complete, and the Company expects to present the data in Q3 2024.

GWAV: We operate an automotive shredder at our Kelford, North Carolina location and a second automotive shredder at our Carrollton, Virginia location is expected to come online in the third quarter of 2024. Press release from 8/2/24 > Greenwave has generated hundreds of thousands of dollars in revenue from cars purchased through the Scrap App platform. The Company plans to launch Scrap App in several new markets during the coming weeks as part of its nationwide expansion.

RNAZ: On April 15, 2024, we announced that the FDA had completed its review of our IND application to conduct a Phase I/II clinical trial with our lead therapeutic candidate, TTX-MC138, and concluded that we may proceed with this clinical trial. The trial is a multicenter, open-label, dose-escalation and dose-expansion study in patients with advanced solid tumors. We have entered into agreements with two clinical trial sites and expect patient enrollment to begin at these sites in the third quarter 2024. Wemayenter into agreements with up to three additional trial sites.

KITT: Q2 2024 Earnings Conference Call August 14, 2024 > During the second quarter, we moved our Drix out of held for sale back to PPE as we now have the Drix working on a revenue-generating contract that started in July. Additionally, we have a signed offer on our Hydronaut vessel, which has been in held for sale since December '23. This is expected to close prior to the end of the third quarter of 2024.

ALRN: Topline results from Cohort 2 evaluating high-dose LTI-03 (5 mg BID) expected in the third quarter of 2024

TNON: The second prospective, multi-center, Catamaran study will evaluate 6-to-12-month radiographic outcomes to assess fusion of patients that have already undergone treatment with The Catamaran System. In addition, retrospective and prospective clinical outcomes will be evaluated. We anticipate completing enrollment by the end of the third quarter of 2024.

PLX: Results from the first seven dosing cohorts demonstrated that single administration of PRX-115 induced rapid, long-lasting reduction of plasma uric acid concentrations, a dose-dependent increase in exposure, and a favorable tolerability profile. Dosing of the eighth and highest dose cohort is complete, and topline results from the full trial are expected in the third quarter of 2024.

OKYO: The Company recently completed a phase 2b clinical trial of OK-101 to treat DED and is presently planning to open a trial of OK-101 in the third quarter of 2024 to treat NCP.

GRTS: Preliminary randomized Phase 2 data suggest GRANITE (personalized neoantigen vaccine) could drive meaningful clinical benefit in front-line metastatic microsatellite-stable colorectal cancer (MSS-CRC); mature progression-free survival (PFS) data expected in the third quarter of 2024.

BRTX: In May, the Company revealed the development of a novel exosome-based biologic program targeting obesity. BioRestorative currently anticipates initiating the formal FDA process for this ThermoStem®-based therapeutic candidate by filing a Drug Master File ("DMF") in the third quarter of 2024. The DMF is expected to facilitate the timely initiation of first-in-human clinical studies.

ALBT: Announced that Laboratory Services MSO, LLC ("LSM") has begun manufacturing the GeeWhiz External Condom Catheter, a patented, FDA-registered, in-market, male incontinence device. LSM plans to launch its sales of the GeeWhiz External Condom Catheter in the third quarter of 2024. Avalon owns a 40% interest in LSM.

AWH: To accelerate our progress in securing coverage for OvaWatch, we have initiated a comprehensive analysis of national, regional, and Integrated Delivery Network (IDN) payers with the assistance of an experienced third-party consultant. The objective of the project is to gather specific and direct insights regarding evidence requirements we must meet to support broad coverage and reimbursement for OvaWatch. The first phase of the study, which we expect to complete in the third quarter of 2024, will consist of interviews with senior stakeholders to identify evidentiary or other gaps.

NRBO: DA-1726 in Obesity: Top-line data from the single ascending dose (SAD) Part 1 is expected in the third quarter of 2024.

ACET: Fast Track Designation for ADI-001 in relapsed/refractory class III or class IV LN. In June 2024, the FDA granted ADI-001 Fast Track Designation for the potential treatment of relapsed/refractory class III or class IV LN. The Company has initiated startup activities at multiple clinical sites and plans to commence enrollment in its Phase 1 clinical trial of ADI-001 in lupus nephritis in the third quarter of 2024.

PALI: Complete analysis of ongoing IND/CTA-enabling tox studies by the end of the third quarter 2024; Submit initial IND/CTA prior to the end of the third quarter of 2024.

ONCT: Nodose-limiting toxicities or concerning side effects in our Phase 1/2 study with ONCT-534, our dual-action androgen receptor inhibitor (DAARI), for patients with advanced prostate cancer who are resistant to approved androgen receptor pathway inhibitors; 1200 mg cohort for ONCT-534 given orally once daily enrolled and treated; initial data readout expected in the third quarter of 2024.

INTS: The Company expects that the data from INVINCIBLE-4 Study will provide data to size a follow-on Phase 3 study. The Company is in the process of screening and qualifying sites for the INVINCIBLE-4 Study and plans to initiate the study in the third quarter of 2024.

BRNS: In the third quarter of 2024, the Company expects to: VTP-1000 (Celiac Disease): Dose the first patient in GLU001, a randomized, placebo-controlled Phase 1 trial including a controlled gluten challenge to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease.

CNTX: In May 2024, announced that the FDA cleared the Company's IND for CTIM-76, a Claudin 6 x CD3 bispecific antibody. Dosing of the first patient in the CTIM-76 Phase 1 trial is expected to occur in the third quarter of 2024.

CAPR: Announced the completion of a positive pre-BLA meeting with FDA that occurred in Q3 2024, where we discussed our rolling BLA submission schedule, potential label expansion, plans for commercial manufacturing as well as other topics. Plan to announce the outcome from our pre-BLA meeting in the third quarter of 2024.

CRVS: Corvus anticipates initiating a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL in the third quarter of 2024. There are currently no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma.

TTOO: Completed clinical studies required to launch the T2Lyme Panel as a laboratory developed test (LDT) in the third quarter of 2024.

ABVC: We commenced the ADHD Phase IIb trials at the University of California, San Francisco (UCSF) and five other sites in Taiwan. The trials are heading for the interim report, which we expect to complete by the end of Q3 2024.

LRHC: entered into a non-binding Letter of Intent to acquire Celebration Corporate Center LLC. The Company expects to acquire this entity through its wholly-owned subsidiary, La Rosa Property Management LLC ("LRPM"). The Company anticipates finalizing the transaction in the third quarter of 2024.

SCYX: Clinical study reports for the FURI, CARES and NATURE trials in refractory or resistant invasive fungal infections were delivered to GSK, triggering a $10 million development milestone payment to SCYNEXIS which we expect to receive in Q3 2024.

CLNN: On July 13, 2024, the Company submitted a briefing book to FDA in advance of a granted Type C interaction expected to occur in the third quarter of 2024. The briefing book contains new post-hoc analyses from two independently conducted Phase 2 clinical trials of CNM-Au8 for the treatment for ALS.

AEON: Progressing plans to develop ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX®(onabotulinumtoxinA) as the reference product. Scheduled to hold a biosimilar initial advisory meeting with FDA in 3Q 2024.

OPAL: The Sapphire RNG project is mechanically complete. Commissioning has begun and Commercial operations are expected to begin in the third quarter. This project represents approximately 0.8 million MMBtu for OPAL Fuels' 50% ownership share of annual design capacity.

QURE: AMT-260 for the treatment of refractory mesial temporal lobe epilepsy (mTLE)– Patient screening in a Phase I/II clinical study has been initiated and enrollment is expected to begin in the third quarter of 2024. AMT-162 for the treatment of SOD1 amyotrophic lateral sclerosis (ALS)– Patient screening in a Phase I/II clinical study has been initiated and enrollment is expected to begin in the third quarter of 2024.

VIVK: Provided an update on the closing of its previously announced acquisition of Endeavor Crude, LLC, Meridian Equipment Leasing, LLC, its subsidiary CPE Gathering MidCon, LLC, Equipment Transport, LLC, its subsidiary ET EmployeeCo, LLC, and Silver Fuels Processing, LLC. Vivakor is now targeting the closing of the acquisition of the Endeavor Entities in the third quarter of 2024.

KTRA: As previously announced, TuHURA entered into a definitive agreement for an all-stock transaction with Kintara to form a company combining expertise and resources to advance a risk diversified late-stage oncology pipeline. The transaction is subject to customary closing conditions, including stockholder approval of both companies, and is expected to close in the third quarter of 2024.

BJDX: The SYMONII clinical study has three components: (1) collection, freezing, and biobanking of patient samples, (2) measuring IL-6 concentrations in the biobanked samples near the end of patient enrollment or after the patient enrollment has completed, and (3) analysis of the IL-6 data with the patient outcomes to see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality. We are planning to initiate the SYMON-II pivotal clinical study in the third quarter of 2024.

AEHL: The Company is aiming to launch energy supply business through AEHL US, formerly known as Million Star US Inc. AEHL US has taken preliminary steps in developing this business including engaging a broker to source natural gas from natural gas provider in Texas and the procurement of electricity generators. AEHL US plans to supply power to a data center in Midland, Texas. The Company anticipates that its energy supply business will start operation in the third quarter of 2024.

KTTA: In December 2023, the U.S. Food and Drug Administration (the “FDA”) cleared our Investigational New Drug application (the “IND”) for PAS-004 and the Company received a study may proceed letter from the FDA for the Company’s Phase 1 multicenter, open-label, dose escalation trial of PAS-004 in patients with MAPK pathway-driven advanced tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition. The Company is currently conducting the Phase 1 clinical trial at clinical sites in the United States and plans to open additional sites in Eastern Europe in the third quarter of 2024. announced that members of its management team will deliver a company presentation at the H.C. Wainwright 26th Annual Global Investment Conference. The presentation will be available online for conference participants beginning at 7:00 a.m. Eastern Time on Monday, September 9th.

TLSI: Announces plan to launch the "DELIVER" Program in Q3 2024, clinical trials leveraging the TriNav® Infusion System (TriNav) in complex patient types and aiming to significantly expand the addressable market.

NXL: The Nexalin regulatory team has made a strategic decision to develop strategies for pilot trials and/or pivotal trials in various mental health disease states. In addition, a new PMAapplication in the United States is in strategic development for the treatment of depression utilizing both Gen-2 and Gen-3. We plan to schedule additional pilot trials and/or pivotal trials for the new Gen-3 device for anxiety and insomnia in the United States and China beginning in the late third quarter or early fourth quarter of 2024.

TOVX: VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), is expected to complete enrollment in the third quarter of 2024.

STSS: The Company is currently negotiating its contract with O&M to provide 3PL services for both the Company and Roncadelle products, in North and South America, beginning in the third quarter of 2024. The Company and Nephron continue to maintain the Pharma Services Program (PSP) that focuses on the creation of new business development and growth opportunities for both companies. These opportunities will include the development and sale of next generation drug delivery systems that will be produced by the Company and can be purchased by the healthcare industry, pharmaceutical markets, and Pharma companies such as Nephron and others.

DBVT: On September 21, 2022, the Company announced it received from the FDA a partial clinical hold letter related to certain design elements of VITESSE. The Company announced on December 23, 2022 that the FDA lifted the partial clinical hold. The FDA confirmed the Company satisfactorily addressed all clinical hold issues and the VITESSE phase 3 clinical study could proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of the last subject is anticipated by the end of the third quarter of 2024.

PTPI: The Company is currently conducting non-clinical consumer studies in connection with the pursuit of potential FDA approval for Stendra® Non-Prescription OTCuse in treating ED. The Company has contracted with a leading Contract Research Organization (“CRO”) in the conduct of Rx-to-OTC Switch development including self-selection studies, human factors studies and various web app studies. The Company has committed approximately $1.4 million through multiple task orders/statements of work with the CRO to perform these studies. As of June 30, 2024, these projects are approximately 82% complete. The Company expects the CROto complete these studies during the third quarter of 2024.

CHRO: While we currently do not have strategy and development plans for the Spray Formulations licensed from Benuvia, beginning in the third quarter of 2024, we plan to develop clinical programs for each of the Spray Formulations, determine the labeling strategy that would be obtained from completion of these programs and discuss with the FDA the requirements for bringing each of the Spray Formulations to market. Neuropathic Pain: CC8464 is being developed to address certain types of neuropathic pain. We anticipate that the dose escalation will enroll the first patient dosing in the third quarter of 2024. The dose escalation trial will enroll approximately 20 healthy volunteers who will receive CC8464 over a period of approximately nine weeks, with the dose escalation study expected to take approximately nine months in total.

ALLK: Upcoming Allakos Anticipated Milestones: Report safety, PK, and PD results from the Phase 1 trial of SC AK006 in healthy volunteers in Q3 2024.

AIMD: Ainos is developing the next-gen Ainos Flora, optimized for at-home testing. We are fast-tracking development by utilizing NVIDIA CUDA's accelerated computing, targeting Q3 2024 for design completion.

VINC: During the second quarter, our team focused on execution and the continued enrollment of patients in our ongoing Phase 1 studies for our potentially best-in-class ADC, VIP943, and first-in-class SMDC, VIP236," said Ahmed Hamdy, M.D., Chief Executive Officer. "We look forward to evaluating the results from additional cohorts and sharing data by the end of Q3 for VIP236.

XTIA: Key Expected Milestones: Q3 2024 > Finalize definitive agreement with AVX for further design and development of the TriFan 600 Vertical Lift Crossover Airplane.

RVPH: Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in Q3 2024.

AFMD: Upcoming Milestones: Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK® cells) study in Q3 2024. ORRand PFSdata from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024.

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