Evogene Announces Successful Completion of Phase 1 Clinical Study of BMC128, a Rationally Designed Live Bacterial Product, in Combination with Nivolumab by its Subsidiary Biomica
Rhea-AI Summary
Evogene (Nasdaq: EVGN) reported successful completion of a first-in-human Phase 1 study of BMC128, a rationally designed live bacterial product, in combination with Nivolumab in 11 patients with advanced solid tumors.
The study met its primary safety endpoint, showed preliminary anti-tumor signals, and supports continued development by licensing partner Lishan Biotech.
AI-generated analysis. Not financial advice.
Positive
- Phase 1 first-in-human trial met primary safety and tolerability endpoint
- No dose-limiting toxicities observed in 11 treated patients
- Five of eleven patients achieved stable disease beyond 16-week combo phase
- One patient achieved partial response; two completed two-year follow-up
- Translational data aligned with proposed BMC128 mechanism of action
- Licensing agreement in place for further development and commercialization
Negative
- Phase 1 study enrolled only 11 patients, limiting interpretability
- Preliminary clinical activity signals; no confirmatory efficacy data yet
News Market Reaction – EVGN
On the day this news was published, EVGN declined 13.60%, reflecting a significant negative market reaction. Argus tracked a peak move of +46.6% during that session. Argus tracked a trough of -28.6% from its starting point during tracking. Our momentum scanner triggered 38 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $1M from the company's valuation, bringing the market cap to $7.11M at that time. Trading volume was exceptionally heavy at 369.3x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Biotech peers show mixed moves, with some up and some down (e.g., scanner names moving both directions), indicating stock-specific factors may be more important than a pure sector trend.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 20 | Q1 2026 results | Negative | -7.3% | Revenue fell sharply and net loss widened versus prior year quarter. |
| May 12 | Conference participation | Positive | -2.0% | Announcement of presentation on GenAI molecule design at user group meeting. |
| May 07 | Earnings scheduling | Neutral | -1.3% | Set date and call details for upcoming Q1 2026 results release. |
| Apr 02 | Nasdaq notice | Negative | -0.4% | Noncompliance with Nasdaq $1.00 minimum bid price and start of cure period. |
| Mar 31 | Subsidiary field trials | Positive | +4.8% | Casterra reported successful 74-hectare castor field trials in Brazil. |
Recent news—including weak Q1 results and even neutral/positive items—has often been followed by negative price reactions, with only a subsidiary success update coinciding with a meaningful gain.
Over the past months, Evogene has faced pressure from weak Q1 2026 financials and a Nasdaq minimum bid price notice, with shares frequently declining after both earnings and routine updates. A subsidiary Casterra’s successful Brazilian field trials on Mar 31 did align with a positive +4.79% move, but other items such as conference participation and earnings scheduling saw modest declines. Against this backdrop, today’s positive Phase 1 results from Biomica’s BMC128 add a clinical milestone to a story otherwise dominated by regulatory and financial headwinds.
Regulatory & Risk Context
An effective Form F-3 dated 2026-03-26 registers 5,076,924 ordinary shares issuable upon warrant exercise. The prospectus states Evogene would receive $6.35 million if these warrants are exercised in full for cash, while secondary resales by the selling shareholder do not generate proceeds for the company.
Market Pulse Summary
The stock dropped -13.6% in the session following this news. A negative reaction despite encouraging Phase 1 data would fit a pattern where recent Evogene headlines, including conference updates and earnings, often preceded declines. The BMC128 study showed no dose-limiting toxicities, 5 of 11 patients with durable stable disease and 1 partial response, but the company also reported soft Q1 2026 results and maintains an effective F-3 resale registration, factors that could keep pressure on the shares.
Key Terms
phase 1 medical
first-in-human medical
nivolumab medical
non-small cell lung cancer medical
stable disease medical
partial response medical
microbiome medical
immune checkpoint inhibitors medical
AI-generated analysis. Not financial advice.
Study Results Demonstrated Favorable Safety Profile and Preliminary Signals of Clinical Activity
REHOVOT,
The open-label, single-arm Phase 1 study enrolled 11 patients, with advanced solid tumors who had previously progressed following anti-PD-1 immunotherapy and was designed to evaluate the safety and tolerability of BMC128 in combination with Nivolumab. The treatment regimen included a two-week induction phase with BMC128 monotherapy, followed by 16 weeks of combination treatment with BMC128 and Nivolumab. Patients demonstrating clinical benefit were eligible to continue Nivolumab monotherapy for up to two years or until disease progression.
The study successfully met its primary endpoint, demonstrating favorable safety and tolerability, with no dose-limiting toxicities observed.
Preliminary clinical findings demonstrated early signs of anti-tumor activity. Five of the eleven treated patients achieved stable disease beyond the 16-week combination treatment period. Two patients remained on study through the full two-year follow-up period during Nivolumab maintenance therapy, while one patient achieved a partial response.
In addition to clinical observations, translational analyses demonstrated biological signals consistent with the proposed mechanism of action of BMC128. Responding patients showed increased microbiome diversity, evidence of immune activation, and modulation of immune suppression-associated signatures.
Ofer Haviv, President and CEO of Evogene and Biomica, commented:
"Completion of this first-in-human study represents an important milestone for the BMC128 development program and further supports the potential of microbiome-based approaches in immuno-oncology. We are encouraged not only by the favorable safety and tolerability profile observed in the study, but mainly by the preliminary signals of clinical activity and the translational data supporting the proposed mechanism of action of BMC128. We believe these findings support the continued clinical development of BMC128 by our licensing partner, Lishan Biotech."
Earlier this year, Evogene, through its subsidiary Biomica, entered into a licensing agreement with Lishan Biotech for the continued clinical development and commercialization of BMC128, now designated LS-LBP-002.
Dr. Weijie Chen, President and CEO of Lishan Biotech, added: "We are highly encouraged by the favorable safety profile and preliminary efficacy signals results generated in this Phase 1 study. These results not only provide important support for the continued advancement of LS-LBP-002, formerly BMC128, but also strengthen our confidence in the rationale of rationally designed live bacterial products combined with immune checkpoint inhibitors.
Based on this positive data, we are accelerating our planning for the next-stage clinical development. We look forward to further evaluating the therapeutic potential of this novel microbiome-based approach and bringing this promising candidate closer to patients in need."
About BMC128
BMC128 is a rationally designed live bacterial therapeutic candidate developed to facilitate anti-tumor immune responses in patients receiving immune checkpoint inhibitors. The product consists of a defined consortium of bacterial strains selected based on Evogene's computational microbiome discovery platform and preclinical validation studies.
Under the licensing agreement with Lishan Biotech, BMC128 is being further developed under the designation LS-LBP-002.
About Lishan Biotech:
Lishan Biotech is a biotechnology company focused on the development of live biotherapeutic products (LBPs). We aim to address the substantial unmet clinical needs for complex diseases including inflammatory bowel disease, oncology and neurological disorders. Adopting an "AI + Microbiome" strategy, we combine gut microbiota regulation and host pathway intervention to create synergistic effects and expand the boundaries of microbiome-based therapeutics. Leveraging our proprietary Swarming technology and AI-driven clinical enrollment strategies, Lishan Biotech is evolving into a globally leading innovation platform in microbiome therapeutics.
For more information, please visit www.lishan.ltd/en
About Evogene Ltd.
Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN) is a pioneering company in computational chemistry, specializing in the generative design of small molecules for drug development and agchemical products.
At the core of its technology is ChemPass AI™, a proprietary generative AI designed to explore vast chemical space and generate novel, highly potent small molecules optimized across multiple critical parameters. Built on this powerful technological foundation, and through strategic partnerships alongside internal product development, Evogene is focused on creating breakthrough products for the pharmaceutical and agricultural industries, driven by the integration of scientific innovation with real-world industry needs.
For more information, please visit www.evogene.com.
Forward-Looking Statements
This press release contains "forward-looking statements" relating to future events. These statements may be identified by words such as "may," "could," "expects," "hopes," "intends," "anticipates," "plans," "believes," "scheduled," "estimates," "demonstrates" or words of similar meaning. For example, Evogene is using forward-looking statements in this press release when it discusses BMC128 anti-tumor activity and the preliminary signals of clinical activity and the translational data supporting the proposed mechanism of action of BMC128. Such statements are based on current expectations, estimates, projections and assumptions, describe opinions about future events, involve certain risks and uncertainties which are difficult to predict and are not guarantees of future performance. Therefore, actual future results, performance or achievements of Evogene and its subsidiaries may differ materially from what is expressed or implied by such forward-looking statements due to a variety of factors, many of which are beyond the control of Evogene, including the aftermath of the recent war between Israel and each of (i) the terrorist groups, Hamas and Hezbollah, (ii) Iran, and (iii) other regional terrorist groups supported by Iran, and any destabilizations in Israel, neighboring territories or the Middle East region, as well as those additional risk factors identified in Evogene's reports filed with the applicable securities authority. In addition, Evogene relies, and expects to continue to rely, on third parties to conduct certain activities, such as their field-trials and pre-clinical studies, and if these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, Evogene and its subsidiaries may experience significant delays in the conduct of their activities. Evogene and its subsidiaries disclaim any obligation or commitment to update these forward-looking statements to reflect future events or developments or changes in expectations, estimates, projections and assumptions.
Evogene Investor Relations Contact:
Email: ir@evogene.com
Tel: +972-8-9311901
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