Caribou Biosciences: CB-010, chRDNA Technology Continue To Show Promise In Gene Editing

seekingalpha09-30

Caribou Biosciences focuses on allogeneic CAR-T therapies for hematological cancers and autoimmune diseases, leveraging its unique chRDNA genome-editing technology.In my view, CRBU's chRDNA platform ...

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Thus, I rate it a \"buy\" after appreciating by over 20% since my previous article.   PhonlamaiPhotoSince my previous article, Caribou Biosciences (NASDAQ:CRBU) has progressed its gene editing research. It’s developing allogeneic therapies against hematological cancers and autoimmune diseases. Currently, CRBU has decided to concentrate on CAR-T therapies and discontinued its CAR-NK platform to optimize resources and extend its cash runway into 2H2026. Additionally, I think CRBU may be well-positioned to advance its promising CAR-T IP, supported by its in-house manufacturing. It also has a cutting-edge chRDNA genome-editing technology that I believe sets it apart from competitors such as Allogene Therapeutics (ALLO). CRBU’s leading candidate is CB-010. This drug can potentially become a safer and more effective therapy for relapsed patients with large B cell lymphoma [LBCL]. Moreover, CRBU’s valuation remains exceedingly cheap compared to its peers. Thus, I reiterate a speculative “buy” rating for the company. CB-010: Business Overview Caribou Biosciences is focused on innovative gene editing to develop allogeneic therapies to treat hematological cancers and autoimmune conditions. Since my initial analysis in July 2024, CRBU has seen its stock rise by over 20%. At the time, I rated CRBU a strong buy, and I still believe the company has promising long-term prospects. Moreover, CRBU has made strides in its investigational pipeline in recent months.   Source: CRBU’s website.As I previously noted, the potential of its allogeneic (donor-derived), off-the-shelf CAR-T treatments is considerable. CRBU’s IP could lead to higher efficacy and safety, justifying a higher price to offset its potentially higher COGS. In my previous analysis, I noted that CRBU’s approach requires maintaining different stock products, which could be costlier than its competitors. Fortunately, CRBU is streamlining production processes to reduce costs and ensure efficient scalability. Moreover, one of CRBU’s main advantages is its in-house development, which guarantees high-quality products and manufacturing expansion. Furthermore, CRBU’s CAR-T products may have superior characteristics due to its chRDNA precision genome editing platform. I believe this could provide better specificity with reduced risk for unintended edits. You can think of this technology as a hybrid between RNA and DNA editing. In other words, it could essentially become an advanced version of CRISPR. This approach theoretically allows for concurrent multiple gene edits without compromising the integrity of the genome.   Source: Corporate Presentation. September 2024.Currently, CRBU’s flagship candidate is CB-010. It’s worth mentioning that CRBU plans to announce partial human leukocyte antigen [HLA] matching results for relapsed patients with large B cell lymphoma [LBCL] in 1H2025. Partial HLA matching uses donor cells from allogeneic CAR-T therapies when they share a patient’s HLA alleles. This approach potentially leads to a decreased risk of rejection. Thus, CRBU’s HLA method could prevent complications such as graft-versus-host disease [GvHS]. This is why their upcoming ANTLER study results are key, as that will give us a clearer picture of CRBU’s benefits for this cancer niche population. It’s also important to mention that in November 2024, CRBU will present preclinical data for lupus nephritis [LN] and extrarenal lupus [ERL] at the American College of Rheumatology Convergence 2024. This data previously supported CB-010's IND clearance for its extended indication for autoimmune diseases. Since the FDA granted the drug additional Fast Track Designation for the LN and ERL indications, that data could be a potential positive upcoming catalyst for CRBU’s shares.   Source: Corporate Presentation. September 2024.Aside from CB-010, CRBU’s pipeline includes CB-011 and CB-012. These are indicated for relapsed or refractory multiple myeloma [r/r MM] and relapsed or refractory acute myeloid leukemia [r/r AML], respectively. Currently, they’re progressing as planned in their respective Phase 1 studies. Management intends to disclose initial dose escalation trial data for CB-011 by year-end 2024 from its CaMMouflage trial. On the other hand, CB-012 received the FDA’s Fast Track designation for r/r AML in September 2024. CB-010 HLA Matching: Tumor Responses and Durability In my opinion, CRBU’s CB-010 ANTLER Phase 1 study for second-line [2L] large B cell lymphoma [LBCL] remains its main value driver at this stage. This study’s results suggested dosing 80x10^6 CAR-T cells to evaluate tumor response with HLA matching. This could lead to higher safety and efficacy for this subpopulation. Therefore, with its HLA matching approach, the ANTLER trial enrolled 20 patients to assess more than four alleles. So far, the trial’s cutoff data showed four diffuse large B cell lymphoma [DLBCL] patients in complete response [CR]. Also, five out of six patients reached CR as of June 20, 2023. More importantly, they remain in CR as of April 1, 2024, showing that CB-010 has long-term effectiveness after a single dose. Two patients remain in CR after 24 months of follow-up. The median CR duration also suggests some patients may stay in remission beyond the follow-up time. Furthermore, CRBU is still collecting data from this trial to corroborate CB-010’s potential as a durable therapy. If these outcomes persist, CB-010 may become a valuable treatment for aggressive previously treated lymphoma compared to existing autologous therapies.   Source: Corporate Presentation. September 2024.One of CB-010’s most promising aspects is its high progression-free survival [PFS] with HLA matching, corroborating its unique approach to allogeneic CAR-T therapies. CB-010’s research is also advancing for 2L LBCL and LN patients as it moves into broader Phase 1 studies. CRBU uses PD-1 knockout features to prevent CAR-T cell exhaustion, offering possible longer-lasting remission than similar medicines. For comparison, CB-010’s HLA matching reduces rejection risks versus Allogene Therapeutics' ALLO-501 and ALLO-501A. Allogene uses a gene-edited T cell receptor [TCR] knockout approach to reduce graft-versus-host disease (GvHD) and immune rejection risks. However, CRBU’s therapy could be a more effective approach, placing it among the best therapeutic alternatives for hematologic malignancies and autoimmune diseases. Alternatively, it could at least have a competitive profile to secure a substantial market share. Worth Speculating: Valuation Analysis From a valuation perspective, CRBU trades at a $178.9 million market cap, making it a microcap in its sector. Its balance sheet holds $37.9 million in cash and equivalents and $223.8 million in marketable debt securities. This amounts to $261.7 million in available short term. On top of that, it has $50.1 million in long-term marketable securities, raising its available liquidity to $311.8 million against no financial debt. Its shareholder’s equity stands at $310.5 million, implying CRBU actually trades well below its book value. Its 0.6 P/B is substantially lower than its sector’s median P/B of 2.5, so CRBU seems cheap relative to its peers.   Source: CRBU’s Investor Presentation. Q2 2024.Moreover, I estimate CRBU’s latest quarterly cash burn was $35.2 million by adding its CFOs and Net CAPEX. This suggests a cash runway of 2.2 years, which is healthy. After all, its upcoming Phase 3 pivotal trial for second-line large B-cell lymphoma could be a game changer, and it’s planned for 2H2025. Since we should get its initial data in 1H2025, I believe its current cash runway seems sufficient for these key upcoming catalysts. Lastly, it’s worth mentioning that CRBU discontinued its allogeneic CAR-NK platform to concentrate on its allogeneic CAR-T therapies. Management is also optimizing its resources to extend its cash runway, reducing its workforce by 12%.   Source: CRBU’s Investor Presentation. Q2 2024.In my view, CB-010’s Phase 1 ANTLER trial and its positive early results for complete response rates warrant optimism. Thus, I lean bullish on the shares and rate them a “Buy” for investors who understand CRBU’s IP remains relatively speculative until we get Phase 3 data. This is especially valid after considering CRBU’s exceedingly low valuation multiples. Additionally, the company believes it has enough resources until 2H2026, so it seems like CRBU has the ingredients to deliver good news over time and support its stock price. Investment Caveats: Risk Analysis Naturally, the main risk for CRBU is that its IP remains in its early stages. This means until we get more definitive Phase 3 data, we can’t discount the possibility of its CB-010, CB-011, or CB-012 failing to corroborate its effectiveness under more stringent conditions. On top of that, if any safety issues arise, they could severely hamper its approval odds since the FDA also significantly focuses on that aspect. This means investors could face significant losses if future trial data suggests its IP is unsafe or has substantial adverse effects. Likewise, if its IP fails to show superior efficacy compared to the standard of care, its TAM and competitive prospects might be considerably reduced.   Source: TradingView.Nevertheless, I do think the FDA's Fast Track Designation for CB-010 and CB-012 is an important green flag. This suggests its IP is particularly promising, so that’s why I lean bullish on CRBU despite the aforementioned risks. But, I remain somewhat skeptical about its novel chRDNA gene-editing technology, which still hasn’t reached FDA approval for any of its product candidates. Conversely, once CRBU secures FDA approval with its chRDNA gene-editing approach, it will significantly de-risk its IP across its remaining research programs. Speculative “Buy”: Conclusion  Overall, CRBU seems to be a promising biotech company in its sector. I particularly like its unique and novel chRDNA technology. However, we can’t ignore that even its leading candidate, CB-010, remains in Phase 1 clinical trials. This means CRBU is an inherently speculative bet until we get more definitive Phase 3 trial data for its IP. Since my last CRBU article, the shares have appreciated over 20%, so I now taper my rating to a “Buy” instead of a “Strong Buy.” Nevertheless, I still believe that the early trial data from its ANTLER study and its below-book-value valuation make CRBU a viable speculative “buy” for investors who understand its inherent biotech risks.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"analysis","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.2","shortVersion":"4.29.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2471878487"}