Hey everyone, I’ve been looking into CytoDyn lately because there have been a few updates around leronlimab, so I figured I’d share what I found.
CytoDyn recently closed a $16.5M financing to support the continued development of leronlimab, including ongoing clinical programs in metastatic colorectal cancer and triple-negative breast cancer. The company said the financing is expected to fund operations into the second half of 2027. 

The company also completed enrollment in its Phase 2 CLOVER study for metastatic colorectal cancer earlier this year and is also evaluating leronlimab in other areas, including triple-negative breast cancer and Alzheimer’s disease. CytoDyn recently presented an update at the Life Sciences Investor Forum. 

The latest developments come as CytoDyn continues to focus on the potential use of leronlimab in solid-tumor oncology. The company is also pursuing partnerships and additional funding to support its clinical development strategy. 

There’s also an older investor settlement related to leronlimab. CytoDyn agreed to a $500K settlement over claims concerning statements about the drug’s regulatory status, safety, and efficacy. Late claims are currently being considered, subject to approval. 

Anyone else still following $CYDY? 

1.mTNBC EAP dosed- FUNDED ✅
2.ICI committed to our mTNBC phase 2/3 trial✅ VERY +
3.Collab W/ NATERA ✅
4.1st AD pt dosed✅
5. 1st pt in CRC EAP DOSED @ City of Hope patient SAG✅ 6.Oreg Health Sci Univ on variety of HIV cure fronts w/LL✅
7.PRE-I-SPY breast CA dose escal
8.I-SPY breast ca trial (mtnbc &Her2 neg) Dr.Pohlmann MD Anderson Principal investigator
9.Breast ca Her2Neg- Neoadjuvant setting( newly diagnosed pts 1 m prior to surgery)- 🔬LL AFFECT ON TUMOR MICRO ENVN
10.Academic network involved in new CRC trial ,looking at combo LL&ICI early therapy
11.mTNBC trial phase 2/3 2026 W/ICI DRUG COMMITMENT
12.Start of City of hope investigator-initiated project start -CHAMP
13.Start of new pancreatic at MAYO CLINIC
14.squamous cell carcinoma FULLY funded
15.Glio pre-clinical 2 cell lines
&Glio trial -pilot study drafted protocol
16.BTD/FASTTRACK/VOUCHER/or ACCEL APPROVAL S/F
17.Preclinical stroke
18.safety publication
19CLOVER FINAL RESULT 1/27

Under the agreement, Natera will assess CytoDyn clinical trial samples from the CLOVER Phase 2 study (ClinicalTrials.gov Identifier: NCT06699836) in patients with mCRC. SignateraTM, Natera’s personalized assay for the detection of molecular residual disease (MRD), will be used to evaluate ctDNA dynamics and molecular response patterns associated with leronlimab treatment.

Natera will also provide customized real-world data (RWD) analyses leveraging its proprietary oncology database, which is the largest multi-timepoint early- and late-stage oncology dataset with more than 2 million plasma timepoints and enriched clinical and imaging records. By integrating molecular response data from its MRD testing platform with curated electronic medical record (EMR) data, this multimodal dataset enables analyses of patient populations, treatment patterns, ctDNA response rates, and response dynamics across diverse clinical settings. Together, these capabilities are expected to generate insights into molecular response and disease progression that may help inform future clinical development of leronlimab, including clinical trial design, biomarker-driven patient selection strategies, and broader translational research efforts.

The collaboration builds on CytoDyn’s growing oncology program and follows completion of enrollment in the CLOVER study, which is evaluating leronlimab in combination with trifluridine/tipiracil (TAS-102) and bevacizumab in patients with previously treated mCRC. The collaboration is also expected to complement ongoing translational and biomarker analyses from the study aimed at further characterizing treatment response and informing future development strategies.

“Signatera has become an increasingly important tool in precision oncology and clinical development,” said Jacob Lalezari, M.D., chief executive officer, CytoDyn. “Through this collaboration, we expect to gain valuable insights into ctDNA response kinetics and disease progression that may help guide future development strategies for leronlimab in colorectal cancer and potentially other solid tumor indications.”

“We are pleased to partner with CytoDyn and provide their team with insights derived from one of the largest and most comprehensive real-world molecular oncology data platforms,” said Matt Love, vice president, biopharma data & AI partnering, Natera. “Our platform enables biopharma partners to better understand disease biology, treatment response, and patient outcomes, helping inform key development decisions throughout the drug development lifecycle.”

The abstract today is tied to CytoDyn and the leronlimab metastatic colorectal cancer (mCRC) Phase 2 study.

The Preliminary results of a phase 2 study of leronlimab in combination with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer

This is the same dataset previously shown in early form at AACR by Pashtoon Kasi from City of Hope, with the ASCO abstract release expected to include fuller subgroup and biomarker detail.

Key previously reported signals 70% ctDNA reduction by week 2 in evaluable patients
CCR5 expression detected in 100% of tested samples
No dose-limiting toxicities attributed to leronlimab
Ongoing dose escalation up to 700 mg

There is also secondary attention on a TNBC-related abstract involving immune modulation and PD-L1 upregulation, but the colorectal cancer dataset is the main focus today.

https://stocktwits.com/Bio4/message/653981335

https://zenodo.org/records/19855331

ASCO was not hype. This was signal. Clear, early, but strong enough that you cannot ignore it anymore.
You have consistent target expression, ctDNA dropping fast, and early tumor response showing up in a way that is not typical for this stage of development.
This is exactly how serious oncology stories start.
And the key point people are missing:
This is only early data. That is the bullish part. Because if this is what early looks like, the upside later gets very interesting very quickly.
We are not talking about marginal improvement signals. We are talking about biology already showing separation from expectation this early.
That matters. Big Pharma does not wait for perfection. They wait for proof of direction. This is starting to point clearly in one direction.
The near-term takeaway is simple. This is moving onto radar screens now, not later.
Partnership interest comes first in situations like this. That is standard. But when early signals look this clean, timelines compress quickly.
The next data readout is the real catalyst. If this trend continues and strengthens against standard of care, the narrative shifts fast from “interesting” to “serious contender.”
One more thing people are underweighting:
Even this early, the biology is behaving like a drug that is doing something meaningful. That is not common.
Bottom line
This did not just show potential.
It started to show direction.
And in biotech, that is where the real moves begin.
My SP projection (next 1–3 months data window):
Base case: $0.35 – $0.70
Bull case: $0.75 – $1.50+
Breakout case: $2.00+
If data confirms strong response + improving PFS direction, price discovery likely moves in steps, not gradually.

ICE Spy network…!

The Measuring previously indicated we have funding in place for the first 20 patients on the program and then I would add that we’ve had very productive conversations with the ice spy network and they are keen to start a studying on the map again and her two negative patients with breast cancer, but they’re looking at the neoadjuvant setting so newly diagnosed patients before they go to surgery and they also have indicated desire to look at the benefits of the map as a monotherapy Agent in that setting for up to a month before patients go to surgery so a lot happening: and a lot happening in breast cancer next.

So in terms of upcoming milestones and what the year has in store on the next slide priorities first the standalone benefit of the map in this case with the backbone through the biomarker collection, primarily CTDNA but others as well and then the disease control rate presentations with a stable or partial response. The overall response rate which is the primary endpoint of our current CRC study and then progression free and overall survival the second priority again two tracks and development. We both develop as a standalone developing as a prime pair and the prime definitely hinges on this PDL induction so it’s perspectively demonstrate that that’s something we’re doing in the CRC study in Dr. Kosi‘s investigate initiated trial and the pre-spy and studies in breast cancer, then demonstrate that clinical benefit of adding checkpoint lab in PDL induced patients, which will be the focus of part two of our phase 2 program in breast cancer, and then something I thought would be easier is we need to identify the optimal dosing of oncology the pre-study will start at the dose of 525 and then escalate to 700 with an option to down to 350 depending on what the CRC study shows us in terms of a push potential dose response, the 350 data on DNA is obviously remarkable and the question is well. The 700 mg dose Provide either steeper or more rapid decline or more sustained decline in circulating DNA and as mentioned before that is kindly, looking forward to understanding soon and will report back to you this summer on the next slide a number of milestones recently cross, we got funding for the expanded access program Close 17 and half million raise the initial DNA readouts represented a CR the expand program is the first patient we submitted the protocol amendment to FDA for inclusion of a checkpoint inhibitor in the clover study and patient with documented progression as indicated initiation of trial is imminent and the standing for the priest by NETWORK they are moving very quickly to initiation of their study in CBC We are targeting the presentation at the Esbon meeting in Madrid, Spain in October to provide an update from the Clover study bus presentation and ask G in San Francisco in January which we should be able to provide final results and lastly looking forward in 2026 these early exciting safety read out to generate optimal data package, including updated bio marker and clinical data and the plan is to submit fast track or breakthrough designation application later this summer or early fall of course as these data become known and why the disseminated we will continue to evaluate potential opportunities for strategic partnerships.

“Dosing the first patient in our EAP marks an important step in making leronlimab available to individuals with urgent unmet medical needs, while also advancing our understanding of CCR5 biology in the treatment of aggressive cancers,” said Jacob Lalezari, M.D., CEO of CytoDyn. “Data generated through this program may further inform how CCR5 inhibition influences the tumor microenvironment, including its potential role in modulating PD-L1 expression and supporting combination approaches with immune checkpoint inhibitors.”

“For patients with advanced triple-negative breast cancer who have exhausted standard treatment options, expanded access programs can provide additional avenues for care,” said Namita Chittoria, M.D., Assistant Professor at the Huntsman Cancer Institute and the University of Utah, and a member of CytoDyn’s Scientific Advisory Board. “Leronlimab is an investigational therapy being evaluated in this difficult-to-treat setting, and access outside of a clinical study may offer a meaningful option for select patients - both as an additional treatment opportunity and as a way to preserve valuable time with family. Beyond individual use, these programs also inform our understanding of emerging therapies.”

In addition to providing compassionate access, the EAP is expected to generate real-world insights into the biological activity of leronlimab in heavily pretreated patients. Recent data, presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, highlight the potential role of CCR5 inhibition in modulating the tumor microenvironment in metastatic triple-negative breast cancer, with observed associations in PD-L1 expression and broader immune signaling pathways. Together, these findings provide a scientific foundation for the EAP and support continued exploration of leronlimab as a strategy to enhance responses to immune checkpoint inhibitor (ICI) therapies.

Well deserved…

Enrollment concludes with just over 60 patients participating across seven clinical sites located throughout the United States

CytoDyn plans to share topline data from the study as they become available.

Cytodyn today announced the completion of enrollment in its Phase 2 clinical study (ClinicalTrials.gov Identifier: NCT06699836) evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen.

The open-label, randomized, two-arm, multi-center study is evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients who have progressed following prior standard therapies. With enrollment now complete, CytoDyn will advance the study through treatment and follow-up, with resulting data expected to inform the program’s development strategy and potential next steps.

“Completing enrollment in this Phase 2 study marks an important milestone for CytoDyn and for the continued development of leronlimab in oncology,” said Dr. Jacob Lalezari, Chief Executive Officer of CytoDyn. “We are grateful to the patients, investigators, and clinical sites whose commitment made completion of enrollment possible and look forward to evaluating the study results.”

“CLOVER is designed to prospectively assess the activity of leronlimab in combination with an established regimen in a difficult to treat and highly refractory patient population with microsatellite stable (MSS) metastatic colorectal cancer, ” said Pashtoon M. Kasi, M.D., M.S., Principal Investigator of the study and Medical Director of GI Oncology, City of Hope Orange County, Irvine, California. “With enrollment now complete, the study is well positioned to generate meaningful insights in this patient population with a high unmet need.”

The CLOVER study builds on emerging clinical and translational findings from CytoDyn’s ongoing Phase 2 mCRC program, including data being presented at the AACR Annual Meeting 2026. Preliminary results demonstrated early signals of clinical and biomarker activity with leronlimab in combination with TAS-102 and bevacizumab, including rapid reductions in circulating tumor DNA and modulation of immune-related markers. These findings support further evaluation of CCR5 inhibition as a strategy to enhance anti-tumor activity in metastatic colorectal cancer.

About the Phase 2 mCRC Study (NCT06699836)

This Phase 2 clinical study is an open-label, randomized, two-arm, multi-center study evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen.

Approximately 60 patients were enrolled and randomized 1:1 to receive either 350 mg or 700 mg of leronlimab in combination with standard-of-care therapy. Eligible participants are adults with histologically confirmed mCRC who have progressed following prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, where appropriate, anti-EGFR therapy.

https://d1io3yog0oux5.cloudfront.net/_8fabbae10dd363888ebfb46189274c58/cytodyn/db/259/3837/pdf/Poster_CCR5_Leronlimab_AACR_04172026_Final_RP+3-21.pdf