DNLI

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Investor Relations - Laura Hansen Chief Executive Officer - Ryan Watts Chief Commercial Officer - Katie Peng Chief Operating and Financial Officer - Alexander Schuth Chief Medical Officer, Head of Development - Peter Chin Operator: Good day and thank you for standing by. Welcome to the second quarter 2026 financial results and business highlights. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Laura Hansen. Please go ahead. Laura Hansen: Good afternoon, everyone, and thank you for joining us today to discuss Denali Therapeutics' second quarter 2026 financial results and business highlights. Earlier today, we issued our earnings press release and filed our quarterly report. The press release, financial tables, and today's presentation are available in the Investor Relations section of our website. Before we begin, I would like to remind everyone that today's discussion will include forward-looking statements. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Please refer to our SEC filings and the cautionary language in today's press release and presentation for a discussion of these risks. Denali undertakes no obligation to update these forward-looking statements, except as required by law. Joining me today are Ryan Watts, our Chief Executive Officer; Katie Peng, our Chief Commercial Officer; Alexander Schuth, our Chief Operating and Financial Officer; and Peter Chin, our Chief Medical Officer, Head of Development. Ryan will begin with opening remarks. Katie will then provide an update on the U.S. launch of AVLAYAH. Ryan will return to discuss pipeline highlights, and Alex will review our financial results. Peter will join the team for the question-and-answer session. Ryan? Ryan Watts: Thanks, Laura, and thank you, everyone, for joining us today. We will begin on Slide 5. This was a transformative quarter for Denali. We completed the first full quarter of the AVLAYAH launch, advanced two transport vehicle-enabled Alzheimer's disease programs into clinical development, and further strengthened our financial position. Before I discuss those highlights, I want to begin with why we are here. At Denali, our purpose is to transform life for people living with serious diseases. That includes children and adults with rare genetic diseases such as Hunter syndrome, Sanfilippo syndrome, FTD-GRN, and Pompe disease, as well as the millions of people living with common neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. Across both groups, our mission is the same: to bring the power of biologic medicine to the brain. Slide 6. The common challenge across many of these diseases is the blood-brain barrier. For over a decade, we have built the transport vehicle platform to address that challenge by engineering biologic medicines to cross the blood-brain barrier through receptor-mediated transport. Earlier this year, that work reached an important milestone. Slide 7. With FDA approval of AVLAYAH, Denali became a commercial company and began delivering our first medicine to patients. In the Hunter syndrome community, AVLAYAH is the first new FDA-approved therapy in nearly 20 years and a new treatment option designed to reach both the body and the brain. Importantly, AVLAYAH became the first approved medicine developed using our transport vehicle platform and the first FDA-approved biologic specifically designed to cross the blood-brain barrier. For Denali, AVLAYAH is much more than a product. It is the first proof that our platform can progress from scientific concept to an approved medicine for patients. Slide 8. We believe Denali today represents a powerful and differentiated combination to create significant value for patients, the healthcare system, and investors in the near and long term. We have a commercial product in AVLAYAH and an encouraging early launch. We have a broad clinical pipeline spanning rare genetic diseases and common neurodegenerative diseases, each with substantial market potential. We have a validated and scalable transport vehicle platform and scientific leadership in the field of BBB transport. We have the operational capabilities and financial strength to execute from discovery through development, manufacturing, and commercialization. Together, these attributes position Denali to create near-term growth and sustainable long-term value. Slide 9. Turning to the quarter, AVLAYAH generated $3.6 million in net product revenue in its first full commercial quarter. The positive response from the Hunter syndrome community and the physicians caring for these individuals reflects years of partnership with patients, families, advocacy organizations, and clinicians. We could not have achieved this milestone without their unwavering commitment to advancing new treatment options. I also want to recognize the outstanding execution by our commercial team in the early stages of this launch. In the pipeline, DNL628 targeting tau and DNL921 targeting Abeta both advanced into clinical development for Alzheimer's disease, with initial clinical data expected in 2027. And following the sale of our priority review voucher in July, our pro forma cash, cash equivalents, and marketable securities exceeded $1.1 billion. Slide 10. A key focus of today's call will be the AVLAYAH launch. Katie will walk through the early commercial indicators, what we are learning, and how we are building the foundation for continued growth. Katie Peng: Thank you, Ryan. On Slide 12, I'd like to start by reinforcing why we believe AVLAYAH is setting a new bar for the treatment of MPS II. For the first time, a therapy is designed to reach the whole body, including the brain, and can normalize key disease biomarkers, both in the CNS and peripherally. These data continue to reinforce physician confidence and resonance with families, supporting the strong momentum we are seeing in the launch. Slide 12. Hunter syndrome represents one of the more prevalent mucopolysaccharidoses and affects a meaningful patient population within the rare disease community. The U.S. opportunity is highly concentrated, with most eligible patients already identified and receiving conventional IDS enzyme replacement therapy at a relatively small number of specialized treatment centers. These are pediatric patients with pre-symptomatic or symptomatic neurologic manifestations who have not progressed to advanced neurologic impairment. We estimate that there are approximately 2,000 patients worldwide in the addressable market, including approximately 500 prevalent patients with Hunter syndrome in the United States. Based on the FDA-approved indication, approximately 75% of the U.S. prevalent population, or roughly 375 patients, are currently eligible for AVLAYAH. In addition, about 30 children are born each year with Hunter syndrome, providing an ongoing opportunity to initiate treatment early. Our ongoing Phase III COMPASS study is an important next step in advancing AVLAYAH, with the goal of supporting full approval and expansion of the label to include adults. Ultimately, our goal is to reach all eligible patients worldwide. Slide 13. Our launch is being executed against four core strategies. First, partnering closely with the Hunter syndrome community through a high-touch, community-centered approach. In rare diseases, families often learn from and support one another. We believe that positive experience with both AVLAYAH and the Denali team helps build trust, increase awareness, and encourage additional families to seek treatment. Second, helping physicians evaluate AVLAYAH and supporting treatment centers as they prepare to initiate therapy. Strong clinical conviction is creating urgency amongst physicians to switch eligible patients and engage payers to accelerate access. Third, helping each patient and family navigate the steps from prescription through their first infusion. And fourth, driving fast label-aligned coverage decisions that help remove payer roadblocks. After our first full quarter of launch, what has been particularly encouraging is how these four strategies have reinforced one another. Strong clinical conviction has driven physician and patient demand. That demand has accelerated payer coverage, and together, these dynamics are enabling more patients to begin therapy. Slide 14. Beginning with physicians, we entered the launch with a strong foundation. Before approval, more than 80% of physicians surveyed were already aware of AVLAYAH. 90% viewed the biomarker and clinical data as motivating to prescribe. Since approval, we have reached approximately 80% of targeted healthcare organizations with AVLAYAH's launch information through our field engagements, scientific exchange, educational webinars, and treatment center support. These activities have been highly impactful and are driving strong engagement across a significant number of treating physicians. Physicians consistently tell us that the ability to address neurologic manifestations is highly meaningful and that most patients experience neurologic symptoms at some point during the course of their disease. That belief is translating into action, as many treatment centers with eligible patients are working with families to navigate reimbursement and transition patients to AVLAYAH. Slide 15. We have seen equally strong engagement from patients and caregivers. Through our launch webinars focused on clinical data and access, as well as with Denali Patient Services, we reached more than 100 families. That represents greater than one quarter of the eligible U.S. patients. This high level of engagement reflects both the unmet need in Hunter syndrome and the extent to which families have followed the development of AVLAYAH. We are also seeing families share their experiences through advocacy networks and local media, helping other members of the community learn about the availability of a new treatment option. Slide 16. One of the most powerful aspects of launch has been hearing directly from families and advocates about their experience with AVLAYAH and Denali. They have described the opportunity to begin AVLAYAH as a source of hope and, in some cases, as the possibility of gaining more meaningful time with their children. They are careful not to draw clinical conclusions from individual experiences. However, these stories illustrate how much the approval of AVLAYAH means to this community that has waited many years for a therapy designed to reach both the brain and the body. We are also hearing very positive feedback about the way the Denali team is supporting families and healthcare organizations. For many patients, initiating a new therapy involves coordinating physicians, infusion centers, insurers, specialty distributors, and patient services. Our team works closely with each family and treatment center to help them navigate those steps. The feedback from families and advocacy organizations has consistently highlighted the responsiveness, compassion, and partnership of the Denali team. That experience matters. It builds confidence in treatment, helps patients move through the access process, and supports continuity once treatment begins. Slide 17. Now turning to payer access. We have made exceptional progress during the first quarter of launch. Commercial policies covering more than 50% of lives have already been established. As with many rare diseases, a significant portion of MPS II patients is covered by Medicaid. Recognizing that not every state will publish a product-specific policy, 14 state Medicaid programs publicly listed AVLAYAH as covered. Separately, we are also seeing managed Medicaid policies align their coverage with commercial plans. These results compare favorably with early coverage achieved by analogous rare disease launches. Importantly, the absence of published policy does not mean a patient cannot obtain access. To date, physicians and families have successfully used prior authorizations, appeals, and medical exceptions while formal policies are being developed. The willingness of physicians to initiate these requests reflects their conviction in AVLAYAH, and our payer and patient access teams are working closely with them to move eligible patients towards treatment. Slide 18. We are extremely pleased with the trajectory of the U.S. launch. In our first full commercial quarter, we generated $3.6 million in net product revenue and secured commercial coverage for more than 50% of covered lives. Before discussing the outlook, I want to briefly address our approach to communicating launch dynamics and metrics. We understand that visibility is important to our investors, and we are committed to maintaining an open dialogue. There are many factors that influence the trajectory of AVLAYAH adoption, and every patient journey is unique, from the initial expression of interest through reimbursement approval and ultimately dosing. In addition, because AVLAYAH is weight-based, the number of vials used can vary meaningfully between a newly-diagnosed infant and a 16-year-old adolescent. For the first two quarters of launch, we therefore plan to provide guidance on expected net product revenue for the following quarter. We believe that this approach, together with the prior quarter's reported net product revenue, will provide the clearest view of the launch trajectory during this early period. Before launch, we described an adoption curve that would build over time. We expected the earliest patients to be highly engaged families who were waiting for AVLAYAH and were prepared to move quickly through the medical exceptions process. That initial demand has been stronger than we anticipated, reflecting both the high awareness of AVLAYAH and the significant unmet need in the Hunter syndrome community. While many patients have already started therapies, others continue to move through the reimbursement and treatment journey. As payer coverage expands and treatment centers gain experience with AVLAYAH, we expect the patient journey from prescription to infusion to become increasingly efficient, enabling more eligible patients to begin treatment. Given the pace of adoption, expanding access, and continued strong execution, we expect Q3 net product revenue to be in the range of $10 million to $12 million. Most importantly, families continue to tell us that AVLAYAH and the support they receive from the Denali team is making a meaningful difference in their lives. Slide 19. The AVLAYAH launch also has significance beyond a single product. It establishes the first commercial foundation for our enzyme transport vehicle franchise across lysosomal storage disorders. The ETV platform is designed to reach the whole body, including the brain, and it provides opportunities across Hunter syndrome, Sanfilippo syndrome, FTD-GRN, Pompe disease, Gaucher disease, and Hurler syndrome. The ERT market alone represents more than a $9 billion opportunity. Across these diseases, we expect to benefit from shared scientific expertise, established relationships with treatment centers and advocacy organizations, and commercial capabilities that could be leveraged across future launches. Each patient we support and each treatment center we activate strengthens the infrastructure that can serve the broader ETV franchise. AVLAYAH is therefore both an important medicine for the Hunter syndrome community and an early demonstration of our ability to discover, develop, manufacture, and commercialize innovative therapies efficiently and successfully. We are proud of the start while recognizing that this is still the beginning of the launch. Our priorities remain expanding access, supporting a positive treatment experience, reaching additional eligible patients, and preparing for international expansion. With that, I'll turn it back to you, Ryan, to discuss the broader pipeline. Ryan Watts: Thanks, Katie. Slide 21. Earlier I described AVLAYAH as the commercial foundation for Denali and the first proof that the transport vehicle platform can enable medicines for patients. I would now like to provide an update on the broader pipeline and then spend most of my time on our Alzheimer's disease programs. Our D3x3 strategy remains unchanged: deliver, develop, and discover. Over the 2026 to 2028 period, our goals are to build two growing commercial brands, generate five clinical proofs of concept, and advance four to six additional programs into the clinic through continued leadership and invention in blood-brain barrier technologies. Slide 22. Next, I would like to briefly update you on DNL593. DNL593 is a direct progranulin replacement therapy designed to deliver progranulin across the blood-brain barrier and restore the missing protein to key cell types in the brain, including the lysosome, where progranulin normally functions. Earlier this year, we regained full ownership and control of the program from Takeda. That provides us with greater flexibility over the development strategy and timing of the data analysis. We have decided to allow for a longer period of observation in the open-label extension portion of the ongoing Phase I/II study. We now expect data in the first half of 2027, updated from our prior expectation of results by the end of the year. The additional follow-up will allow us to better characterize treatment effects across multiple biomarkers, including neurofilament light chain, or NfL, which may change gradually following treatment. Pending the totality of the data, we also plan to explore whether a biomarker-driven accelerated approval path may be appropriate. NfL has regulatory precedent in the related neurodegenerative disease, ALS, although any potential path for DNL593 would require discussion and alignment with regulators. We are excited about DNL593 because it directly addresses the genetic cause of FTD-GRN by replacing progranulin. This week, the FDA granted orphan drug designation to DNL593 for FTD-GRN, underscoring the significant unmet need facing individuals affected by this disease and the potentially promising rationale of our approach with PTV:progranulin. Earlier, healthy volunteer data demonstrated dose-dependent increases in cerebrospinal fluid progranulin following intravenous administration, providing evidence of brain delivery and further validation of the transport vehicle platform. Slide 23. I will now turn to what we believe is one of the most exciting areas of our pipeline, Alzheimer's disease. A few weeks ago, I had the privilege of delivering a plenary presentation at the Alzheimer's Association International Conference in London. After working in Alzheimer's disease for more than 20 years, I believe the field has entered a transformative period because of extraordinary progress in three historically challenging areas: biology, biomarkers, and the blood-brain barrier. Human genetics and pharmacology are sharpening our understanding of the multifaceted biology of disease. Imaging and blood-based biomarkers are enabling earlier diagnosis and increasingly precise measurements of disease progression and treatment response. And brain transport technologies are creating the potential to deliver biologic medicines broadly throughout the brain. Together, these advances create new opportunities for the next generation of Alzheimer's therapies. Slide 24. We believe the next advances in Alzheimer's disease may depend on delivering therapies more effectively throughout the brain. Amyloid plaque clearance is now clinically validated, but currently available antibodies are limited by modest efficacy and the risk of amyloid-related imaging abnormalities, or ARIA. Tau reduction has also shown encouraging clinical signals, but current antisense approaches rely on intrathecal administration and may not achieve uniform distribution throughout the brain and have other limitations. Our two clinical programs are designed to address these limitations through better brain delivery. DNL921 is a potential best-in-class BBB-crossing anti-amyloid antibody designed to improve plaque engagement while reducing ARIA potential and peripheral immune activation. DNL628 is a potential first-in-class BBB-crossing tau antisense oligonucleotide designed for intravenous administration and broad uniform distribution throughout the capillary network. Slide 25. Starting with DNL921, one of the important features of transport vehicle-enabled delivery is the route of entry into the brain. When conventional anti-amyloid antibodies enter the brain, they concentrate around larger arteries and arterioles where vascular amyloid is present. We believe that localization contributes to ARIA risk. By engaging the transferrin receptor, antibody transport vehicle-enabled antibodies enter the brain through the extensive capillary network and distribute more evenly throughout the brain. In preclinical models, this route of entry was associated with substantially fewer MRI lesions than a conventional anti-amyloid antibody, including at dose levels that achieved strong target engagement. These data support our hypothesis that improved brain delivery and biodistribution may enhance plaque engagement while reducing ARIA potential. Slide 26. We've also engineered DNL921 to address the broader attributes required for a successful medicine. Unlike fusion approaches that append a transferrin receptor binding arm to an antibody, our transport vehicle binding is embedded directly into the Fc. DNL921 is designed to achieve robust brain concentrations while remaining intact and minimizing effects on immature reticulocytes. With the goal of preserving activity at amyloid plaques while reducing peripheral immune activation, DNL921 incorporates conditional effector function through our cisLALA design. Slide 29. Turning to DNL628, the central opportunity is to improve both distribution and convenience for antisense therapy. Intrathecally administered antisense oligonucleotides distribute from cerebrospinal fluid and can produce uneven exposure across brain regions with greater treatment burden for patients. By contrast, intravenous oligonucleotide transport vehicle, OTV delivery, uses the capillary network to distribute the antisense oligo broadly across the brain and spinal cord. This distribution includes key cell types involved in neurodegeneration, including neurons, astrocytes, and microglia. Slide 28. In mice expressing human tau and the human transferrin receptor, DNL628 produced robust reductions in MAPT RNA and tau protein. Importantly, tau protein reduction persisted for more than 12 weeks after dosing, supporting the potential for a practical dosing interval. These data support the design of the ongoing Phase Ib study where we are evaluating safety, dose selection, effects on tau levels, and imaging measures in people with biomarker-confirmed early Alzheimer's disease. Slide 29. Both Alzheimer's disease programs are now in clinical development. DNL628 Phase Ib study is ongoing, and we expect initial clinical biomarker data in the first half of 2027. For DNL921, the clinical trial application was submitted in the first half of this year, and we expect initial safety and clinical proof of concept data in 2027. These readouts will be important not only for individual programs but also for the broad validation of our oligonucleotide and antibody transport vehicle platforms in common neurodegenerative disease. Taken together, our progress this quarter demonstrates the breadth of Denali: a growing commercial business, broad clinical pipeline, and a repeatable platform capable of supporting multiple therapeutic modalities, all focused on delivering meaningful medicines to patients and families. Slide 30. With that, I will turn the call over to Alex to review our financial results. Alexander Schuth: Thank you, Ryan. Slide 31. I will close our prepared remarks today with a look at our portfolio, capital allocation priorities, and second quarter financial results. We have built a broad portfolio based on the transport vehicle platform, which is now clinically and commercially validated through AVLAYAH. This portfolio has the potential to create significant value in the near and long term, with each program designed to offer first- or best-in-class potential in its respective indication. And we are well capitalized to execute against it. Our portfolio has two key components. First, we have a pipeline of next-generation enzyme and protein replacement therapies designed to treat the whole body, including the brain. Across these programs, we can apply the clinical and regulatory learnings from AVLAYAH and leverage our existing capabilities in development, manufacturing, and commercialization. We estimate that each program represents a potential market opportunity ranging from approximately $500 million to more than $1 billion, creating a multi-billion-dollar opportunity across the franchise. These programs benefit from a well-established therapeutic modality, measurable biomarkers, and in certain diseases, the potential for biomarker-based accelerated development path. In addition, and shown on the right, is our portfolio targeting common neurodegenerative diseases. This includes two clinical-stage blood-brain barrier-enabled molecules targeting tau and amyloid beta for Alzheimer's disease with first- and/or best-in-class potential. If successful, these programs could reach millions of patients and represent substantial multi-billion-dollar market opportunities. Slide 32. Turning to the financials and capital allocation. We ended the second quarter with approximately $940 million in cash, cash equivalents, and marketable securities. In July, we received $195 million in proceeds from the sale of the rare pediatric disease priority review voucher awarded following the approval of AVLAYAH. Together, this brings our pro forma cash, cash equivalents, and marketable securities to more than $1.1 billion. This gives us flexibility to pursue three priorities with discipline. First, it allows us to invest in the execution of our portfolio, including the commercial activities for AVLAYAH as outlined by Katie, preparations for the potential launch of DNL126, or zafinofusp alfa, in 2027, and advancement of clinical programs. Second, we can continue to build capabilities and infrastructure for efficiency. In particular, our internal manufacturing facility in Salt Lake City provides opportunities for speed in development and attractive COGS as we bring additional products forward. Third, our balance sheet provides strategic flexibility with respect to potential future partnerships and diversified sources of capital. Slide 33. The complete details of our financial results are included in today's press release and Form 10-Q, so I will focus only on the key items. AVLAYAH generated $3.6 million in net product revenues during the first full quarter of commercial availability. Research and development expenses were $97 million compared with $102.7 million for the same period in 2025. The decrease primarily reflected the timing of AVLAYAH commercial supply manufacturing in the prior year period and lower external spending on small molecule programs. Selling, general, and administrative expenses were $36.3 million compared to $32.3 million in the second quarter of 2025. The increase primarily reflected investments to support the AVLAYAH commercial launch. As noted, we ended the quarter with approximately $940 million in cash, cash equivalents, and marketable securities before receipt of the $195 million in PRV proceeds in July. In closing, we believe Denali is entering this exciting next phase from a position of strength, with a commercial product, a broad pipeline, a validated platform, and the capabilities and capital to deliver value for patients and investors. With that, I will turn the call back to the operator to begin the Q&A session. Thank you. Operator: We will now begin the question-and-answer session. [Operator Instructions] We will take our first question, and the question comes from the line of Jessica Fye from JPMorgan. Adam Ferrari: Hello, this is Adam on for Jess. I just was curious, what in the launch so far has helped you come up with the next quarter's guidance? Can we assume that growth trajectory to continue through the end of the year? And could we see maybe OpEx guidance in the future? Katie Peng: Thanks, Adam. So, what's giving us confidence is all of the leading indicators are moving in a very positive direction. As you saw from the presentation, physician awareness is extremely high of the AVLAYAH data, and they're highly motivated to switch patients. In addition, we've seen tremendous engagement from families as well. And we've also had great success moving patients through reimbursement with the medical exceptions process. And as you can see, also we've had success with payer access, and we have now greater than 50% of commercial lives covered as of the end of Q2. So given all the dynamics are moving in the right direction, we feel very confident that the momentum will continue. Alexander Schuth: I can take the second part. This is Alex. I can take the second part on OpEx. So capital efficiency is very important to us, and we are pleased that we're able to keep OpEx flat in Q2 '26 versus Q2 '25 and actually slightly lower on a six-month basis, while at the same time preparing for the launch and advancing important new programs into the clinic. With respect to an outlook, we generally provide an outlook for the full year at the beginning of the year, so please stay tuned for that. Operator: We will take our next question. And the question comes from Salveen Richter from Goldman Sachs. Lydia Erdman: Good afternoon. This is Lydia on for Salveen. Congrats on the progress and on your first earnings call. Could you just speak to the patient profile of the initial patients on therapy and kind of the breakdown between the newly diagnosed versus switched patients? Katie Peng: Great, thanks for that question, Lydia. So as you know, with this patient population, the majority of the patients are already treated on idursulfase. So we expect 90% of patients, prevalent patients, would be then switching. So the majority of that -- of course, we are seeing as well newly diagnosed patients being put on AVLAYAH, but the majority will come from patients that are switching. In terms of patient profiles, we initially believed that patients may skew to the younger population because those are the families that were most engaged and have been following the development of AVLAYAH. But we've been really pleased to see that what we can gather today is that it's very broad. In fact, patients across the different age groups within the pediatric population have demonstrated interest in being prescribed AVLAYAH. Operator: We will take our next question. And the question comes from Andrew Tsai from Jefferies. Lin Tsai: So maybe one more on Hunter. You're guiding to a strong sales number for Q3. And then I think in your prepared remarks, the original guidance for an S-shaped curve still seems to hold. So, to me, that would mean that come next year, could we be talking about a quarterly revenue number that's significantly larger than $10 million? Is that the right way to think about it? And then secondly, Biogen just shared their Phase II tau dataset. So I'd be curious to gauge your thoughts on the degree of efficacy they're seeing. How much do you think that is attributed to too much tau lowering, or is it the mode of administration or something else? It would be nice to gauge your views on these possibilities or variables around efficacy. Katie Peng: Thanks, Andrew. I'll start with the first part of your question. And yes, we still believe that this year is a foundational year. We talked about getting as many patients on therapy as possible. And we are definitely at the beginning stages of that S-curve. But of course, our goal is to tighten that S-shaped curve and bring in the inflection point as soon as possible. And that's why our focus on driving awareness, making sure the experience on AVLAYAH is very positive so that the community can further share that and drive the momentum. That will drive, as well as with payer access, that will drive that inflection point. Ryan Watts: I'm happy to take the second question, Andrew. As you know, we spoke before the data was shared at AAIC in London, and then, of course, a lot came out after the data presentation, and I think our response is that, in general, it's the first dataset to show that tau lowering may lead to a clinical benefit. And I think what's probably the most compelling is you look across not just ADAS-Cog -- or sorry, CDR Sum of Boxes but also ADAS-Cog and MMSE, and you're seeing consistency in potential clinical benefit. I think the challenge is, as you have highlighted, is a question around why was there not a dose response? Why did the higher doses not lead to more efficacy? And I think just a couple of points without going into too much detail. Obviously, there were more discontinuations and adverse events in the higher doses. I think it's well understood with intrathecal administration that this is not uncommonly seen, including transient confusion. So I think we, like others, look forward to seeing more details and the differences between the doses and that may this actually be masking some of the efficacy. But in general, first dataset showing tau lowering and potential clinical benefit. Operator: We will take our next question, and the question comes from Tazeen Ahmad from Bank of America. Tazeen Ahmad: I wanted to just focus on DNL593 for a second. I'm sorry if I missed this in your prepared remarks, but can you share any color on what level of data you plan to share when you release it? And what, in your view, would be good data? And then can you just clarify why you want to wait for NfL data? I think in the past you mentioned the focus was going to be on lysosomal function. Ryan Watts: Thanks, Tazeen. I'm happy to take that. I think the most important point here is that as we've regained full rights to this program, we're now in a position where we can essentially drive the strategy on this program. And I think in our experience, I think point number one is that longer-term data is often needed when looking at biomarkers like NfL. And I think what's unique about FTD-GRN from, let's say, some of our other lysosomal storage disease programs, is that this is a haploinsufficiency in terms of the underlying disease. And as a result, as we look at some of the lysosomal biomarkers historically, there's elevation, but it's modest, not like what you see with heparan sulfate in Hunter syndrome. So what we've decided to do is we're trying to find an accelerated path. As you may have also noted, we received orphan disease designation for this program just recently as well. And so we think we have the best chance of seeing robust data specifically on the distal biomarkers such as NfL and more broadly, just looking at the entire biomarker set, including lysosomal biomarkers as well. So I think the key here is just giving this program the best chance of a potential accelerated path. Obviously, with data in hand, then we'd have to address that with regulators. Operator: We will take our next question, and the question comes from Michael Yee from UBS. Unknown Analyst: Hi, this is [indiscernible] on for Michael. I just wanted to ask a couple more on the launch. Congratulations on such a strong number right out of the gate. Just wondering, given your comments around stronger than expected early demand and the fact that we sort of know the number of Hunter patients that are out there, do we expect a sort of bolus effect in the U.S. of these patients who are covered on the label now coming on? And then for these patients that are having to go through sort of medical exceptions and prior auth, do you have any sense of what the time is from like getting the scripts to actually getting infused? Katie Peng: Thank you for that question. So, in terms of what we expected, we definitely expected that pool of patients who've been following AVLAYAH's development very closely. And that pool of highly interested families is bigger than we initially had expected. But we are working through -- with the early experience, with these early families, though, we are seeing expansion into the broader patient population, as I described earlier. And so we're very excited about the fact that it's going beyond just those early families, and we're going to expect to see continued growth into the broader population. And as you stated, the total eligible population is around 375 that are considered pediatric patients in the U.S. In terms of -- I think your question was starting the interest to infusion and what's the timeline for that. As you know this early in launch and without payer coverage initially, although of course that's expanding now, there is huge variability in the time between patients expressing interest to when they actually get infused. So it's really hard to comment on that this early in launch. However, with payer coverage improving over time, that timeline should get more straightforward, more efficient. Operator: We will take our next question. And the question comes from Sean Laaman from Morgan Stanley. Michael Riad: Hi, this is Mike Riad on for Sean. Congratulations on the strong start. Can you remind us how is progress going on for the adult confirmatory study? And given what you've learned so far, acknowledging it's only one quarter into the launch, is there anything that has changed your excitement or views as to how that adult study could influence launch trajectory or pricing? Katie Peng: So, what we're hearing today, certainly there are adult patients that are very much interested in getting treated with AVLAYAH. I think that's your question. I don't think launch price will change since we've already gone into market, even when we hopefully will get the label expansion. And I'll let Peter comment on the study. Peter Chin: Yes, and in terms of the COMPASS Phase II/III study, we're excited about reading out the study, which is set to end at the end of next year. It is going to be the basis for expanding the label both in the U.S. as a confirmatory study and for global -- potential global launches. Michael Riad: Thank you. That's very helpful. And then just thinking about the Q2 to Q3 revenue guidance and ramp, can you walk us through any key drivers of that acceleration? How much of it is coming from new patient starts versus patients converting to reimbursement? Katie Peng: So I think it's a combination of all those factors. So we're seeing, as I stated earlier, all of the leading indicators, the high level of engagement from physicians and families, the conviction that physicians have in going for a medical exceptions process, and then the fact that our payer coverage is getting better every day. I think all of those things are going to be contributing to the growth over the next quarter. Operator: We will take our next question. And the question comes from the line of Paul Matteis from Stifel. Paul Matteis: Great, thanks very much. I guess taking a step back, given everything you kind of understand around this patient population, the degree to which families are plugged in and were waiting for AVLAYAH, do you think you're seeing a bolus right now? And might we see some attenuation in the add rate later this year, or do you feel like this is actually potentially sustainable? And then as it relates to tau and the upcoming data next year, Ryan, I think you've talked about CSF tau data being an interesting early biomarker, given that PET changes can take some time. I'm wondering, though, do you think your CSF tau data for the shuttle will be comparable to the CSF tau data for an intrathecal drug, given that IT-administered drugs can maybe bias CSF biomarkers, given sort of the site of administration? Katie Peng: Thanks. I will take the bolus question first. And certainly you're correct, that we expected this bolus. The bolus is bigger than we expected. But I think the key thing that we're seeing is that this early experience from this initial patient population is translating to the broader population. And over time, especially as physicians gain more experience and the stories are shared more broadly through the patient community, we expect the growth to continue into the full eligible population. Ryan Watts: Thanks, Katie. Paul, fantastic question. Obviously very mechanistic. Obviously, my kind of question. I think you're exactly right. It's really difficult to compare CSF tau in an intrathecally delivered molecule versus one that's delivered through capillaries through the transport vehicle through transferrin receptor. And the experience we have related to this is actually with early days of ETV:IDS, now AVLAYAH, and its comparison with intrathecal delivery of iduronate-2-sulfatase, where there's a regional very high concentration of enzyme. In this case, it would be high concentration of the antisense oligo, and so I think it's really apples to oranges in terms of like percent reduction and what we would correlate ultimately with clinical benefit. But what we can say is that our biodistribution is even and robust. So when we look at different cell types throughout the brain and brain regions, we get basically roughly the same knockdown of gene expression across these various cell types. So when we measure CSF levels of tau, we're confident that, that's the level of knockdown we're getting throughout the brain. And I think if you then relate that to maybe some disappointment in the maximal efficacy seen with intrathecal delivery, that may be simply because you're not penetrating deeper brain regions that may be impacted by tau and tau pathology. And then to the sort of first half of your question around CSF tau and tau PET, I think what's really remarkable, and I just -- we mentioned this at AAIC, intrathecal data has essentially proven that tau PET can be reversed. That was actually a fundamental question, and many mouse models actually had never really necessarily shown that. So in other words, if you reduce the expression of MAPT, which codes for tau, and then you reduce the expression of tau protein, over time you start to see a reduction in the tau PET signal. And if you look at the totality of the data, including the new data that's been presented, it seems like the shortest window is about a year from when they see tau PET reduction. The early dataset didn't really show much reduction at six months, and then they looked later. It was either 18 months or two years, this dataset shows that a year they're seeing, albeit variable from patient to patient. And actually, if you look at the datasets carefully, they've been published. Some patients get no tau reduction by PET and others get robust. We think this is actually heterogeneity in intrathecal delivery. And so the take-home is biodistribution is going to be critically important and different with the transport vehicle technology. And CSF tau will still be very informative, just like heparan sulfate CSF was informative for our Hunter program. But we're not comparing percent reductions because of exactly the point you made. These are fundamentally different delivery approaches. Operator: We will take our next question, and the question comes from the line of Mayank Mamtani from B. Riley Securities. Please go ahead. Your line is open. Mayank Mamtani: Congrats on a strong AVLAYAH launch. Maybe, Ryan, on the prior point on the OTV:MAPT strategy, are there any genetic tauopathies you could potentially look at? And just taking the logic that you're applying to the GRN program, so there are FTD MAPT tauopathies also that could be looked at. And then maybe just a higher-level question, there's a lot still we need to see from a biomarker standpoint in the CELIA study. What are sort of the right things to kind of look out for as you obviously think about the biomarkers you want to look at in your 628 cohort reading out next year? Ryan Watts: Thanks, Mayank. Again, great questions. My take is -- I think with MAPT, the key point here is really focusing on tau reduction, showing that the OTV works, that you can deliver medicine systemically and get tau reduction. We're definitely interested in these genetic cell populations, but our experience actually with FTD-GRN is that initially it was very, very difficult to enroll, these more rare cases. And the tauopathies are not unlike FTD. And in fact, there are FTD sort of tauopathies. So sort of rare, hard to diagnose initially, and then you have to genetically diagnose them. So we're interested in that. I just don't think that it's the fastest path to really proving the platform and then subsequently driving for the first approval. In terms of what to look for, we're essentially looking for tau reduction in CSF, not really hitting a target. The genetic data in mice suggests that the haploinsufficiency loss of one copy of tau is highly protective in the Alzheimer's models. And so you could imagine somewhere between 25% and 70% reduction. But I think that fundamentally, what's actually very interesting about the dataset that has recently been presented is that there was a non-dose proportional reduction in tau. So as you go up 2x in dose and 4x in dose, there's only really about a 20% difference in overall tau reduction in that range. And yet there is sort of a different, obviously, AE profile for those higher doses. And so we feel like the CSF data for intrathecal is apples to oranges, but we look at our own data and our own preclinical data and what's sort of been published to set the tone that we really need to see CSF tau reduction as really a proof of the platform. I don't know, Peter, if you want to add anything there. Peter Chin: No, I think you covered it well. I think we're really focused on executing the program, generating the data that Ryan alluded to, and I think other potential indications is something that we can consider in the future. Operator: We will take our next question. The question comes from the line of Ananda Ghosh from H.C. Wainwright & Co. Ananda Ghosh: Congrats on the great quarter. I have actually two questions. In 2025 CTAD, Biogen presented some data using this zirconium dye where they tried to show their intrathecal, the tau modality, how well they distribute throughout the CNS. And you would see that it's a very poor distribution. Now, the question is that despite such a poor distribution, they do see, as you rightly mentioned, that they can move the clinical endpoints at least in a trend way. And so just wanted to get your thoughts on that aspect of it, that how did -- even with such a poor distribution, how can they see some efficacy with respect to both as a biomarker as well as from clinical endpoints? The second question is, there are also these ideas that, and especially from the donanemab trial, that in patients where you have low tau, there you can see those patients are much more amenable to either both anti-Abeta therapy or anti-tau therapy. So as you are thinking about your Phase Ib, is there a way to enrich patients with low tau in your Phase Ib trial population? Ryan Watts: Yes, good questions. I'll try to be brief because we have a number of other questions. I think let's look at additional data that hopefully will be presented on BIIB080 to really understand that dynamic. But you're right. There's enormous heterogeneity. There is. And we've published this already in monkey. And so I think that the positive clinical signal across three different endpoints, ADAS-Cog, CDR Sum of Boxes, and MMSE, is really encouraging. And there are some patients that get really decent biodistribution in the particular study that you're referencing. And so I think that -- that's, I think, the main point. Operator: We will take our next question, and the question comes from Joseph Thome from TD Cowen. Jacob Ormes: Hi, this is Jacob on the line for Joe. Kind of going along with patient enrichment or kind of patient selection, I was curious how you're thinking about some of these co-pathologies that often come along with AD, like alpha-synuclein and TDP-43 and how those could play a role in patient selection or kind of pre-specified subgroup analyses. And then just additionally, looking farther ahead, how you're thinking about what a bar might look like given some of the currently approved amyloid beta therapies on things like CDR-SB. Ryan Watts: So I'll address the first one on the co-pathologies. And then, Peter, why don't you address the bar on -- I'm assuming what you're asking is the bar for approval or for, like, clear differentiation with the anti-amyloids. So I think with co-pathologies, the two, obviously, the most common co-pathology, which is, actually, in some ways, defines Alzheimer's, is Abeta plaque or amyloid plaque and tau neurofibrillary tangles. I think what you're referencing is also, it's been shown like, you see Lewy bodies and other sort of vascular pathologies. The challenge with those type of co-pathologies, there aren't imaging biomarkers yet that allow you to look at the level of, let's say, Lewy bodies that can also be observed with amyloid plaque or tau, and so at this point, our focus is on the two most common and prevalent. I'll add that there's, by the way, a fourth one, TDP-43 pathology, which I think represents roughly 30% of Alzheimer's. All of this being said, amyloid appears to be at the top of the cascade. So amyloid eventually drives the formation of tau pathology, and then tau pathology correlates with cognitive decline. And so we're keen on targeting both amyloid and tau. And I think as biomarkers improve, you'll be able to see -- hopefully we'll be able to identify patients that have other pathologies, which, in some ways, is probably complicating the clinical picture. With that in mind, I'll hand it to Peter to talk about what the bar might be for anti-amyloid approvals. Peter Chin: Yes, thank you, Ryan, and thanks for the question. I mean, I think I'll start by saying this is a very exciting time for Alzheimer's, and coming off the vast amount of data that was presented at AAIC, there's a lot that's being learned about different aspects of the patient populations. I think it's premature to say exactly where we're headed, but I do think that with all the data that's being generated and understanding both progression rates and response to different types of therapies, this is something that we'll definitely pay attention to both with targeting tau as well as with amyloid. I think from an amyloid perspective, we're very excited about the differentiating potential of DNL921. I think our goal is really to generate proof of concept with that first. Operator: We will take our next question. The question comes from the line of Laura Chico from Wedbush. Laura Chico: Congrats, guys, on the quarter. Maybe one for Katie. I'm wondering if you could expand a little bit further, what capacity do the centers have for switch patients? Just wondering if there's any additional considerations that the physicians need to work through for a switch patient versus perhaps somebody that's new to treatment. You indicated in the webinars that you encompassed or encountered over 100 families or about greater than 25% of the eligible patient pool. So I guess I'm just trying to understand if there's any capacity considerations that we should be making as you're progressing here. Katie Peng: Thank you, Laura. That's a great question, and you're exactly right. There are definitely dynamics, both for the newly diagnosed patients and for the switchers. As you remember, the majority of the idursulfase patients are treated at home. And so these are patients coming back to the clinic. And definitely, infusion scheduling is one of the steps that families have to work through. And so with all the families coming back, there is a sequencing depending on the center, depending on if you're at a center that has specialized centers of care, they are going to have a little bit more capacity than other centers. So that is the dynamic that has significant variability that we're going to be working through. But what we've seen is the sense of urgency and the motivation from families have been very strong. Operator: We will take our next question. And the question comes from Marc Goodman from Leerink Partners. Alyssa Larios: Hi, good evening, everyone. This is Alyssa on for Marc. I was wondering if you could help us think about the average price per patient for AVLAYAH, given the weight-based dosing and titration schedule? Since many patients will initially be up-titrating over the course of the first few months, when should we expect pricing to reach a steady-state run rate? And then secondly, on the manufacturing facility in Salt Lake City, do you have any plans to use that facility to manufacture commercial batches of AVLAYAH, or will that be used only for clinical manufacturing? Katie Peng: Great, thanks. I'll address the pricing question. So at maintenance for a 10-kilogram patient, it's roughly around $270,000 per year, and up to a 30-kg patient, which is about $800,000 per year. And as you described, there is a dose escalation described in our label. And what's been provided to physicians, and this is ultimately a physician's decision on how quickly to do the escalation, is that we expected the escalation to be about four weeks at each step before they get to maintenance dose. And there may be variability as patients dose escalate, depending, and it'll be very individualized and physician-guided. Ryan Watts: And then I'll answer the second question. We do not have plans to manufacture in Salt Lake City for AVLAYAH. In fact, our plans are to go to larger scale with Lonza and onshore to Portsmouth to go to 6,000 liter. Operator: We will take our next question. The question comes from Michael DiFiore from Evercore ISI. Michael DiFiore: Congrats on the progress so far. Two from me. Now that you have a full commercial quarter under your belt at this juncture, could you give us the number of patients on drug as well as the number of cumulative start forms, and if not, when might you be able to share this information? And the second question is, as patients switch off of ELAPRASE, have you seen any competitive response from Takeda, either on contracting pricing or account-level pushback for that matter? Katie Peng: Okay, let me see if I can address all the questions. So your first question was on start forms and patient numbers. So at this stage, we intentionally focused on communicating the overall trajectory rather than providing individual operational metrics. So I shared earlier why we have confidence, is we're seeing all of the progress with the various stakeholders within the ecosystems, with physicians being highly aware and engaged, families highly engaged and driving towards switching, as well as centers working through reimbursement and payer access. With regard to start forms, we also feel that at this point, start forms are not predictive of revenue, and it's because each individual patient journey is very unique. And the time, depending on what their insurance plan is, which centers they're getting treatment at, that is highly variable at this point. And we haven't provided guidance as to when in the future we may provide patient or start form information. For now, we really want our investors to rely on the revenue guidance because we feel like it's the most clear quantitative indicator of how our launch is progressing. Did you have one more question? Michael DiFiore: I did. Just regarding the switch off from ELAPRASE. Any competitive response from Takeda that you've seen? Katie Peng: So in terms of competitive response, you know, we've been very much focused on making sure that the clinical value and the biomarker data is well recognized. So I think we haven't seen a ton of pushback because it's very well recognized that ELAPRASE does not address neurologic manifestations. And we haven't seen the other activities that you've described, which is contracting, and I think you've described another one, but we haven't seen any activity related to that. Operator: We will take our next question. The next question comes from Myles Minter from William Blair. Unknown Analyst: Hey, team, this is John on for Myles. Congrats on a strong first launch quarter. So for AVLAYAH, wondering if any of your commercial patients have previously been clinical trial participants, and wondering if you can give us any color on the cadence you expect for clinical trial participants to transition over to commercial therapy? Katie Peng: So the majority of patients that have started today are not actually our clinical trial patients. We expect all of our clinical trial patients to be able to convert to commercial patients by the end of this year. Operator: We will take our next question. And the question comes from David Hoang from Deutsche Bank. Unknown Analyst: Hi, this is Rosemary on for David. Congrats on the quarter. I was just wondering how you might be thinking about the competitive landscape evolution for AVLAYAH, as there's some competitor resubmission happening this year and JCR Pharma's IZCARGO maybe having a global Phase III readout next year. Katie Peng: Thanks for that question. Of course, we're always very encouraged to see continued innovation in Hunter syndrome, but we are very confident in our biomarker and clinical evidence. As you know, we've shown normalization for the first time in this disease area for key disease biomarkers, and our focus is on executing on our launch and driving the momentum that we're seeing today. Operator: Your next question comes from the line of Charles Moore from Baird. Charles Moore: Congrats on a great quarter. Just kind of following up on the last question, I recall your analogous trial for AVLAYAH included patients who had been treated with gene therapy. So looking toward the DNL126 trial, are there any patients there who have been treated with the gene therapy previously, considering that there's the possibility for a Sanfilippo gene therapy to be approved ahead of DNL126? Ryan Watts: Peter, maybe I'll have you take that. I'll just make one comment. We haven't gone into great detail on the DNL126 patient population, but, obviously, presented new data earlier this year at WORLD and very excited about that program, but great question around the competitive landscape. Peter, do you want to add anything to that? I just don't think we've gone into much detail on the nature of those patients. Peter Chin: Yes, thanks, Ryan. I would just say we haven't presented the baseline characteristics of the full cohort yet, but we do intend to present the data early next year at the WORLDSymposium. Ryan Watts: And I'll just add, great memory. We did have both gene therapy and cell therapy patients in the Hunter dataset, and where we saw robust normalization in those patients' data in terms of CSF heparan sulfate. But I think the key here is really focused on the sustained biomarker response across our ETV franchise. Operator: This concludes today's question-and-answer session. I'll now hand the call back to Ryan Watts for closing remarks. Ryan Watts: We thank everyone for joining the call today. We're very excited about where we are and look forward to continued momentum. Thanks, everyone. Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Before you buy stock in Denali Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Denali Therapeutics wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved $3.6 million in net product revenue during the first full commercial quarter of AVLAYAH, marking Denali's transition to a commercial-stage company. The AVLAYAH launch serves as a commercial proof-of-concept for the Transport Vehicle (TV) platform, demonstrating the ability to deliver biologics across the blood-brain barrier. Early launch momentum is driven by high physician awareness and clinical conviction regarding AVLAYAH's ability to address both peripheral and neurologic manifestations of Hunter syndrome. Strengthened the financial position to over $1.1 billion in pro forma cash following the $195 million sale of a priority review voucher, providing a multi-year runway for pipeline execution. Strategic focus remains on the 'D3x3' strategy: delivering commercial brands, developing clinical proofs of concept, and discovering new blood-brain barrier technologies. Regained full ownership of DNL593 (FTD-GRN) from Takeda, allowing for a more flexible, biomarker-driven development strategy focused on long-term neurofilament light chain (NfL) data. Projected Q3 2026 net product revenue for AVLAYAH is between $10 million and $12 million, reflecting accelerated patient adoption and expanding payer coverage. Anticipate initial clinical biomarker data for DNL628 (tau) and safety/proof-of-concept data for DNL921 (Abeta) in Alzheimer's disease during 2027. Expect to report data from the DNL593 Phase I/II study in the first half of 2027, allowing for longer observation of NfL and lysosomal biomarkers to support a potential accelerated approval path. The Phase III COMPASS study for AVLAYAH is expected to conclude by the end of 2027, aiming to support full approval and label expansion to include adult patients. Preparing for the potential 2027 launch of DNL126 for Sanfilippo syndrome, leveraging the commercial infrastructure established by the AVLAYAH launch. Secured commercial insurance coverage for more than 50% of U.S. lives within the first full quarter of the AVLAYAH launch. Received FDA orphan drug designation for DNL593 in FTD-GRN, highlighting the unmet need and the potential of the PTV:progranulin approach. Transitioning AVLAYAH manufacturing to a 6,000-liter scale at Lonza's Portsmouth facility to optimize long-term cost of goods and supply capacity. Management noted that while an initial 'bolus' of highly engaged families drove early demand, interest is now expanding into the broader prevalent patient population. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed the launch is in the early stages of an S-shaped adoption curve but aims to reach the inflection point sooner through high physician motivation and medical exception successes. The initial pool of interested families was larger than anticipated, and this early positive experience is now translating to the broader eligible population of approximately 375 pediatric patients. Ryan Watts emphasized that intravenous delivery via the TV platform provides uniform distribution across the brain's capillary network, unlike the uneven distribution seen with intrathecal administration. Management argued that uniform distribution may avoid the 'masking' of efficacy seen in other trials where high doses led to increased adverse events without proportional clinical benefit. The delay from late 2026 to H1 2027 is intended to capture longer-term NfL data, which changes gradually and is critical for a potential accelerated approval path. Since FTD-GRN is a haploinsufficiency disease, distal biomarkers like NfL are expected to be more robust indicators of treatment effect than proximal lysosomal biomarkers. While formal policies are still being established, physicians are successfully using medical exceptions and prior authorizations to secure access, reflecting strong clinical conviction. The time from interest to infusion remains variable due to the need for centers to coordinate home-care patients returning to clinics for weight-based dosing.

Interested in Denali Therapeutics Inc.? Here are five stocks we like better. AVLAYAH generated $3.6 million in its first full commercial quarter for Hunter syndrome, with payer policies covering more than 50% of covered lives. Denali guided to $10 million–$12 million in third-quarter revenue as access and treatment starts expand. Denali advanced two Alzheimer’s programs, DNL628 and DNL921, into clinical development, with initial data expected in 2027. The company also delayed DNL593 data to the first half of 2027 to gather additional biomarker observations. Following the $195 million sale of its Priority Review Voucher, Denali’s pro forma cash, cash equivalents and marketable securities exceeded $1.1 billion, supporting commercialization, clinical programs and manufacturing expansion. Analysts Say These 2 Mid-Cap Biotechs Have 2x Potential Denali Therapeutics (NASDAQ:DNLI) reported $3.6 million in net product revenue from AVLAYAH during the second quarter of 2026, its first full quarter of commercial availability, as the company expanded payer access and advanced two Alzheimer’s disease programs into clinical development. Chief Executive Officer Ryan Watts described the period as “a transformative quarter” for Denali, citing the early AVLAYAH launch, progress across the Transport Vehicle platform and a strengthened cash position following the July sale of a rare pediatric disease Priority Review Voucher. → 3 Drone Stocks That Should Soar After the Summer Slump 3 Mid-Cap Biotechs Analysts Think Can Double AVLAYAH, approved by the FDA earlier this year for Hunter syndrome, is Denali’s first commercial product and the first approved medicine developed using its Transport Vehicle platform, which is designed to help biologic medicines cross the blood-brain barrier. The therapy is intended to reach both peripheral tissues and the brain. Chief Commercial Officer Katie Peng said the U.S. addressable market includes roughly 375 currently eligible prevalent pediatric patients, based on Denali’s estimate of approximately 500 prevalent Hunter syndrome patients in the country and the FDA-approved label. The company estimates about 2,000 patients are addressable globally. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Denali said commercial policies covering more than 50% of covered lives had been established by the end of the second quarter. Fourteen state Medicaid programs publicly listed AVLAYAH as covered, while other patients have obtained access through prior authorizations, appeals and medical exceptions, according to the company. Peng said Denali reached about 80% of targeted healthcare organizations through field engagements, scientific exchanges, webinars and treatment-center support. The company also said it had engaged with more than 100 families through launch webinars and patient services, representing more than one-quarter of the eligible U.S. population. → Jersey Mike's Serves Fresh Gains After IPO Stumble The company expects third-quarter AVLAYAH net product revenue of $10 million to $12 million. Peng said the forecast reflects growing physician and family engagement, improving payer coverage and progress moving patients through reimbursement and infusion processes. Denali did not disclose patient-start or prescription-form figures, saying revenue guidance provides a clearer indicator of launch progress because individual treatment journeys vary and dosing is weight-based. Peng said the majority of patients starting treatment so far were not former clinical-trial participants, though Denali expects clinical-trial participants to transition to commercial treatment by the end of the year. For a 10-kilogram patient at maintenance dosing, AVLAYAH costs roughly $270,000 annually, Peng said. For a 30-kilogram patient, the annual cost is about $800,000. The label includes dose escalation, with the company indicating physicians have been provided an expected four-week escalation period at each step, although treatment decisions are individualized. Denali said DNL628, an investigational tau-targeting antisense oligonucleotide, and DNL921, an investigational anti-amyloid beta antibody, have entered clinical development for Alzheimer’s disease. The company expects initial clinical biomarker data from the DNL628 Phase I-B study in the first half of 2027, while initial safety and clinical proof-of-concept data for DNL921 are expected in 2027. Watts said the programs are designed to use the company’s blood-brain barrier delivery technology to improve distribution of therapies throughout the brain. DNL628 is being evaluated in people with biomarker-confirmed early Alzheimer’s disease for safety, dose selection, tau effects and imaging measures. Denali submitted a clinical trial application for DNL921 during the first half of 2026. The company also pushed back its expected data timing for DNL593, a progranulin replacement therapy for frontotemporal dementia caused by progranulin mutations, or FTD-GRN. Denali now expects data from the ongoing Phase I/II study in the first half of 2027, rather than by the end of 2026. Watts said the company chose to allow additional observation time in the study’s open-label extension to better characterize effects across biomarkers, including neurofilament light chain. The FDA granted orphan drug designation to DNL593 for FTD-GRN during the week of the earnings call. Denali also said its Phase II/III COMPASS study of AVLAYAH is scheduled to conclude at the end of 2027. The company expects the study to support full approval and potentially expand the product label to include adults in the United States, as well as support potential global launches. Denali ended the second quarter with approximately $940 million in cash equivalents and marketable securities. In July, it received $195 million from the sale of the Priority Review Voucher awarded after AVLAYAH’s approval, bringing pro forma cash equivalents and marketable securities to more than $1.1 billion. Research and development expense declined to $97 million from $102.7 million a year earlier, primarily reflecting the timing of AVLAYAH commercial-supply manufacturing in the prior-year period and lower external spending on small-molecule programs. Selling, general and administrative expense rose to $36.3 million from $32.3 million, driven primarily by investments supporting the AVLAYAH launch. Chief Operating and Financial Officer Alexander Schuth said the company plans to allocate capital toward AVLAYAH commercialization, preparations for a potential 2027 launch of DNL126, clinical development programs, manufacturing capabilities and potential partnerships. Denali does not plan to manufacture AVLAYAH at its Salt Lake City facility and instead intends to expand production with Lonza in Portsmouth, including a move to 6,000-liter scale. Denali Therapeutics is a clinical‐stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases. The company's research leverages a proprietary Blood–Brain Barrier Transport Vehicle (TV) platform designed to enable large molecules, including antibodies and enzymes, to penetrate the central nervous system. Denali's approach includes small molecules, monoclonal antibodies and gene therapy candidates aimed at key drivers of disorders such as Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis (ALS) and frontotemporal dementia. Among Denali's lead programs is an orally delivered leucine‐rich repeat kinase 2 (LRRK2) inhibitor for Parkinson's disease, and an anti‐TREM2 antibody designed to modulate microglial activity in Alzheimer's patients. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Denali Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Strong first full quarter of AVLAYAH™ (tividenofusp alfa-eknm) launch generated $3.6 million in net product revenue Advanced TransportVehicle™ portfolio with two Alzheimer’s disease programs now in clinical development $195 million in gross proceeds received in July 2026 from sale of a Priority Review Voucher, bringing pro forma cash, cash equivalents and marketable securities to more than $1.1 billion Conference call and webcast today at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the second quarter ended June 30, 2026, and provided business highlights. "We are excited by the positive response to our AVLAYAH launch from the Hunter syndrome community and the physicians caring for these patients. It reflects years of partnership with patients, families, advocacy organizations and investigators, together with the outstanding execution of our commercial team," said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. "This quarter marks an important step in Denali's growth. AVLAYAH establishes our commercial foundation, validates our TransportVehicle platform and supports the continued expansion of our portfolio of medicines. During the quarter, we also advanced two TransportVehicle-enabled programs into clinical development, expanding our Alzheimer's disease pipeline. We believe this combination of a commercial business, a broad clinical pipeline and a scalable platform uniquely positions Denali to deliver sustainable value." Second Quarter 2026 and Recent Program Updates COMMERCIAL PRODUCT AVLAYAH for Hunter syndrome (MPS II) AVLAYAH (tividenofusp alfa-eknm) is the first and only FDA-approved medicine in the emerging class of biotherapeutics that leverage the transferrin receptor to cross the blood-brain barrier. Enabled by Denali's Enzyme TransportVehicle™ (ETV), AVLAYAH is an enzyme replacement therapy designed to systemically deliver iduronate 2-sulfatase (IDS) throughout the body, including the brain. AVLAYAH received U.S. Food and Drug Administration (FDA) accelerated approval for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. The U.S. launch of AVLAYAH demonstrated strong momentum during its first full quarter of commercial availability, supported by positive engagement from patients, caregivers and physicians, the experiences of families beginning treatment, and the rapid expansion of payer coverage. In its first full quarter of commercial availability, AVLAYAH generated $3.6 million in net product revenue. Projected third-quarter 2026 AVLAYAH net product revenue is $10.0 million to $12.0 million. Initial interest in starting treatment with AVLAYAH has tracked ahead of Denali’s internal expectations. Approximately 80% of healthcare organizations that treat eligible MPS II patients have been reached through AVLAYAH launch webinars and engagement with Denali's field team. Commercial access to AVLAYAH expanded rapidly. Published commercial policies now represent more than 50% of covered lives, and 14 state Medicaid programs have published coverage of AVLAYAH. Denali continues to advance U.S. launch execution across patient access services, physician engagement and payer access, supported by a fully established commercial infrastructure. The ongoing global Phase 2/3 COMPASS study is intended to support generation of confirmatory evidence, expansion of the U.S. label to adult patients and future global regulatory submissions. CLINICAL PROGRAMS Lysosomal Storage Diseases Zafinofusp alfa (DNL126; ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA) Zafinofusp alfa is an investigational ETV-enabled enzyme replacement therapy designed to systemically deliver N-sulfoglucosamine sulfohydrolase (SGSH) throughout the body, including the brain, for the treatment of Sanfilippo syndrome type A. There are currently no approved therapies for Sanfilippo syndrome type A. Preliminary data from the ongoing Phase 1/2 study demonstrated that treatment with zafinofusp alfa resulted in substantial reductions in both cerebrospinal fluid (CSF) and urine heparan sulfate (HS), including normalization of CSF HS, with a safety profile generally consistent with established enzyme replacement therapies. Start-up activities are underway for a global Phase 3 confirmatory study. Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for zafinofusp alfa for Sanfilippo syndrome type A in 2027. DNL593 (PTV:PGRN) for FTD-GRN DNL593 is an investigational Protein TransportVehicle™ (PTV)-enabled protein replacement therapy designed to systemically deliver progranulin (PGRN) across the blood-brain barrier for the treatment of granulin (GRN)-related frontotemporal dementia (FTD-GRN). In August 2026, the FDA granted Orphan Drug Designation to DNL593 for FTD-GRN, underscoring the significant unmet need facing individuals affected by this disease. Enrollment in the Phase 1/2 study of DNL593 is complete with a total of 40 participants with FTD-GRN. Denali now expects results from the study in 2027, updated from its prior expectation of results by the end of 2026. The revised timing allows for a longer observation period to assess the treatment effect on biomarkers including neurofilament light chain (NfL), a biomarker of neuroaxonal injury that may decline gradually following treatment, as observed in other neurodegenerative diseases. DNL952 (ETV:GAA) for Pompe disease DNL952 is an investigational ETV-enabled enzyme replacement therapy designed to systemically deliver acid alpha-glucosidase (GAA) to muscle tissue and the brain by crossing the blood-brain barrier for the treatment of Pompe disease. The current standard of care is enzyme replacement therapy. Progressive motor weakness, respiratory failure and neurologic symptoms remain unmet needs. Dosing of participants with late-onset Pompe disease began in the Phase 1 study of DNL952 in the second quarter of 2026, and initial clinical data are expected in 2027. Alzheimer's Disease In July 2026, Dr. Watts delivered the opening plenary address, "Accelerating the Discovery and Development of Medicines for Neurodegeneration," at the Alzheimer's Association International Conference® in London. The presentation highlighted advances in disease biology, biomarkers and blood-brain barrier delivery, as well as progress across Denali's two clinical-stage Alzheimer's disease programs, DNL628 (OTV:MAPT) and DNL921 (ATV:Abeta). DNL628 (OTV:MAPT) for Alzheimer's disease DNL628 is an investigational Oligonucleotide TransportVehicle™ (OTV)-enabled antisense oligonucleotide designed for systemic delivery across the blood-brain barrier to reduce tau by targeting the MAPT gene for the treatment of Alzheimer’s disease. Initial clinical biomarker data from the ongoing Phase 1b study of DNL628 in participants with Alzheimer’s disease are expected in the first half of 2027. DNL921 (ATV:Abeta) for Alzheimer's disease DNL921 is an investigational Antibody TransportVehicle™ (ATV)-enabled antibody designed for systemic delivery across the blood-brain barrier to target amyloid plaques in Alzheimer's disease. Safety and clinical proof-of-concept data from the ongoing Phase 1/1b study of DNL921 in healthy volunteers and participants with Alzheimer's disease are expected in in 2027. Parkinson’s Disease DNL151 (LRRK2 inhibitor) for Parkinson's disease DNL151 is an investigational small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2) for the treatment of Parkinson's disease. In May 2026, Denali and Biogen announced that the global Phase 2b LUMA study of DNL151 did not meet its primary or secondary endpoints in early-stage Parkinson's disease. Based on these results, Denali and Biogen decided to discontinue further development of DNL151 in idiopathic Parkinson's disease. Denali continues to independently conduct the Phase 2a BEACON study evaluating DNL151 in individuals with Parkinson's disease who are confirmed by genetic testing to be carriers of a pathogenic LRRK2 variant. Data from BEACON are expected in the first half of 2027. IND-ENABLING STAGE PROGRAMS Denali has multiple additional programs in the investigational new drug (IND)-enabling stage, including DNL111 (ETV:GCase) for Parkinson's disease and Gaucher disease; DNL622 (ETV:IDUA) for MPS I; and DNL422 (OTV:SNCA) for Parkinson's disease. Corporate Updates In April 2026, Denali announced that it had received notification of Takeda’s decision to terminate the companies’ collaboration agreement to co-develop and co-commercialize DNL593. Takeda’s decision was driven by strategic considerations and was not related to efficacy or safety data. Denali continues to advance DNL593 in the ongoing Phase 1/2 study in patients with FTD-GRN and now expects results in 2027 as described above. In June 2026, Denali entered into an agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV), awarded following the FDA approval of AVLAYAH, for gross proceeds of $195 million. The transaction closed and Denali received the funds in July 2026. Participation in Upcoming Investor Conferences Cantor Global Healthcare Conference 2026, September 9-11 (New York) Morgan Stanley 24th Annual Global Healthcare Conference, September 14-16 (New York) H.C. Wainwright 28th Annual Global Investment Conference, September 14-16 (New York) Baird Global Healthcare Conference, September 15 (New York) Deutsche Bank’s 2026 Healthcare Summit, September 16-17 (New York) Second Quarter 2026 Financial Results Net product revenue was $3.6 million for the quarter ended June 30, 2026, reflecting the commencement of commercial sales of AVLAYAH in the United States following FDA approval in March 2026. Cost of goods sold was $0.1 million for the quarter ended June 30, 2026. Because manufacturing costs incurred prior to FDA approval of AVLAYAH were expensed to research and development, cost of goods sold during the initial commercialization period reflects a lower average per-unit cost as previously expensed inventory is sold. Total research and development expenses were $97.0 million for the quarter ended June 30, 2026, compared to $102.7 million for the quarter ended June 30, 2025. The decrease of approximately $5.7 million was primarily attributable to lower costs related to small molecule programs as well as lower clinical expenses for tividenofusp alfa. Selling, general and administrative expenses were $36.3 million for the quarter ended June 30, 2026, compared to $32.3 million for the quarter ended June 30, 2025. The increase of approximately $4.0 million was primarily driven by higher personnel-related costs due to increased headcount to support the commercial launch of AVLAYAH. Intangible asset amortization was $0.7 million for the quarter ended June 30, 2026, compared to zero for the quarter ended June 30, 2025, reflecting amortization of the developed technology intangible asset recognized upon FDA approval of AVLAYAH in March 2026. Net loss was $127.6 million for the quarter ended June 30, 2026, compared to net loss of $124.1 million for the quarter ended June 30, 2025. Cash, cash equivalents and marketable securities were approximately $940.0 million as of June 30, 2026. Following the receipt of $195.0 million in gross proceeds from the sale of a Priority Review Voucher in July 2026, pro forma cash, cash equivalents and marketable securities exceeded $1.1 billion. Conference Call and Webcast InformationDenali will host a conference call today, Thursday, August 6, 2026, at 4:30 p.m. Eastern Time to discuss the second quarter financial results and provide a corporate update. The live and replayed webcast of the call will be available through Denali’s website at https://investors.denalitherapeutics.com/events. The replay of the call will be available for 90 days. About the Denali TransportVehicle™ Platform The blood-brain barrier (BBB) is essential in maintaining the brain’s microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for central nervous system diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali’s TransportVehicle™ (TV) platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes and oligonucleotides throughout the whole body, including the brain, by crossing the BBB after intravenous administration. The TV platform is based on engineered Fc domains that bind to specific natural transport receptors, such as transferrin receptor and CD98 heavy chain amino acid transporter, which are expressed at the BBB and deliver the TV and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered with the TV platform demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Oligonucleotides engineered with the TV platform demonstrate more than a 1,000-fold greater brain exposure in primates than systemically delivered oligonucleotides without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates. The TV platform has been clinically validated, with AVLAYAH™ (tividenofusp alfa-eknm) as the first FDA-approved medicine leveraging transferrin receptor to cross the BBB. About Denali Therapeutics Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform life for people with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. For more information, please visit www.denalitherapeutics.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations for Denali’s TransportVehicle™ (TV) platform, including the Enzyme TransportVehicle™ (ETV) franchise, and its therapeutic and commercial potential; plans, timelines and expectations relating to AVLAYAH™ (tividenofusp alfa-eknm); expectations related to the ongoing Phase 2/3 COMPASS study of tividenofusp alfa, including the timing and availability of data and the likelihood that it will generate confirmatory evidence to support continued approval, U.S. label expansion and global regulatory submissions; plans, timelines and expectations related to zafinofusp alfa, including with respect to the ongoing Phase 1/2 study and the planned Phase 3 confirmatory study, the timing and occurrence of a planned BLA submission, and the likelihood and timing of accelerated approval; plans, timelines and expectations related to DNL593, including the ongoing Phase 1/2 study, the timing and availability of data, and the potential benefits of the extended data period; plans, timelines and expectations related to DNL952 and the timing and availability of data from the ongoing Phase 1 study; plans, timelines and expectations related to DNL628, including the ongoing Phase 1b study and the timing and availability of clinical biomarker data; plans, timelines and expectations related to DNL921, including the Phase 1/1b study and the timing and availability of data; plans, timelines and expectations related to DNL151, including the timing and availability of data from the ongoing Phase 2a BEACON study; plans, timelines and expectations for IND-enabling stage programs; plans regarding participation in upcoming investor conferences; forecasts of future revenues and operating expenses; and statements by Denali's Chief Executive Officer. Actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of risks and uncertainties. These include, but are not limited to, risks arising from adverse economic conditions and their impact on Denali’s business and operations; the possibility of events or changes that could lead to the termination of Denali’s collaboration agreements; the ability of Denali to complete the development and, if approved, the commercialization of product candidates; reliance on third-party manufacturers and suppliers for clinical trial and commercial materials; difficulties in patient enrollment for ongoing and future clinical trials; potential delays or failures in meeting expected clinical trial timelines; discrepancies between preclinical, early-stage or preliminary clinical results and outcomes from later-stage trials; the risk that interim or topline clinical results may not be predictive of final study results or longer term outcomes; the occurrence of significant adverse events or other undesirable side effects; the uncertainty surrounding regulatory approvals required for commercialization in the U.S., Europe or other international jurisdictions, including uncertainties related to the FDA’s policies; developments relating to Denali's competitors and competing product candidates; Denali’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; the implementation and success of Denali’s strategic plans for its business, product candidates and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future revenues and operating expenses in the current environment; and other risks and uncertainties, including those described in Denali's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2026, its Quarterly Report on Form 10-Q filed with the SEC on May 7, 2026, and Denali’s future reports to be filed with the SEC. Except for AVLAYAH, Denali's product candidates are investigational, and their safety and efficacy profiles have not yet been established. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali’s expectations, except as required by law. Investor Contact:Laura Hansen, [email protected] Media Contact:Erin [email protected]

Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below. On Wednesday, Nancy Pelosi Stock Tracker drew attention to an AI-powered portfolio's latest biotech wager after Claude AI opened a new position in Denali Therapeutics ahead of its earnings report. The AI-run portfolio, known as The Claude Portfolio, allocated roughly 4.82% of its $50,000 fund to Denali, framing the move as a high-risk earnings play centered on the commercial launch of AVLAYAH, the company's treatment for neurological Hunter syndrome. Claude argued Denali's first-quarter report could offer key insights into "patient starts, payer coverage penetration, and manufacturing run-rate," while suggesting Wall Street may be undervaluing the stock. "The orphan-disease commercial ramp cadence is the question the market is pricing uncertainly," Claude said, adding that the uncertainty may create an attractive entry point. Don't Miss: A single bad hire can set a startup back years. Here are the 5 hires founders most often misjudge — and why Still Learning the Market? These 50 Must-Know Terms Can Help You Catch Up Fast Claude's thesis also pointed to Denali's competitive advantage after REGENXBIO's rival gene therapy received an FDA Complete Response Letter earlier this year, effectively leaving AVLAYAH without an approved competitor in the U.S. market. The AI model projected a $24.75 price target for Denali, implying more than 32% upside over 12 months. Claude acknowledged substantial risks, including Denali's annual cash burn, manufacturing scale-up challenges and the limited patient population for its ultra-rare disease treatment. "The sizing at 4.82% reflects those risks," the AI noted. Trending: Avoid the #1 Investing Mistake: How Your ‘Safe' Holdings Could Be Costing You Big Time Nancy Pelosi Stock Tracker summarized the move by posting, "We now have Claude doing Pharma earnings plays. Will be interesting to see how this one plays out." DNLI is set to release its first-quarter 2026 earnings on May 19, with Wall Street projecting a loss of 71 cents per share on revenue of $3.82 million. In the prior quarter, the company posted a loss of 73 cents per share, outperforming analyst expectations of 75 cents, though revenue fell short at zero versus the projected $8.99 million. Photo courtesy: Shutterstock Read Next: Skip the Regrets: The Essential Retirement Tips Experts Wish Everyone Knew Earlier. Thinking about ETFs? See what investment risks you should be aware of before you buy. Building a resilient portfolio means thinking beyond a single asset or market trend. Economic cycles shift, sectors rise and fall, and no one investment performs well in every environment. That's why many investors look to diversify with platforms that provide access to real estate, fixed-income opportunities, professional financial guidance, precious metals, and even self-directed retirement accounts. By spreading exposure across multiple asset classes, it becomes easier to manage risk, capture steady returns, and create long-term wealth that isn't tied to the fortunes of just one company or industry. Connect Invest is a real estate investment platform that allows investors to access short-term, fixed-income opportunities backed by a diversified portfolio of residential and commercial real estate loans. Through its Short Notes structure, investors can choose defined terms (6, 12, or 24 months) and earn monthly interest payments while gaining exposure to real estate as an asset class. For investors focused on diversification, Connect Invest may serve as one component within a broader portfolio that also includes traditional equities, fixed income, and other alternative assets—helping balance exposure across different risk and return profiles. Mode Mobile is changing the way people interact with their phones by letting users earn money from the same apps and activities they already use every day. Instead of platforms keeping all the advertising revenue, Mode Mobile shares a portion back with users who engage with content, play games, and scroll on their devices. Named one of Deloitte's fastest-growing software companies in North America, the company has built a large beta user base and is scaling a model that turns everyday smartphone usage into a potential income stream. For investors, Mode Mobile offers exposure to the expanding mobile advertising and attention economy through a pre-IPO opportunity tied to a new approach to user monetization. rHealth is building a space-tested diagnostics platform designed to bring lab-quality blood testing closer to patients in minutes rather than weeks. Originally validated in collaboration with NASA for use aboard the International Space Station, the technology is now being adapted for at-home and point-of-care settings to address widespread delays in diagnostic access. Backed by institutions including NASA and the NIH, rHealth is targeting the large global diagnostics market with a multi-test platform and a model built around devices, consumables, and software. With FDA registration in progress, the company is positioning itself as a potential shift toward faster, more decentralized healthcare testing. Direxion specializes in leveraged and inverse ETFs designed to help active traders express short-term market views during periods of volatility and major market events. Rather than long-term investing, these products are built for tactical use—allowing investors to take magnified bullish or bearish positions across indices, sectors, and single stocks. For experienced traders, Direxion offers a way to respond quickly to changing market conditions and act on high-conviction views with greater flexibility. Immersed is a spatial computing company building immersive productivity software that enables users to work across multiple virtual screens inside VR and mixed-reality environments. Its platform is used by remote workers and enterprises to create virtual workspaces that reduce reliance on traditional physical hardware while improving focus and collaboration. The company is also developing its own lightweight VR headset and AI productivity tools, positioning itself in the future-of-work and spatial computing space. Through its pre-IPO offering, Immersed is opening access to early-stage investors looking to diversify beyond traditional assets and gain exposure to emerging technologies shaping how people work. Backed by Jeff Bezos, Arrived Homes makes real estate investing accessible with a low barrier to entry. Investors can buy fractional shares of single-family rentals and vacation homes starting with as little as $100. This allows everyday investors to diversify into real estate, collect rental income, and build long-term wealth without needing to manage properties directly. Masterworks enables investors to diversify into blue-chip art, an alternative asset class with historically low correlation to stocks and bonds. Through fractional ownership of museum-quality works by artists like Banksy, Basquiat, and Picasso, investors gain access without the high costs or complexities of owning art outright. With hundreds of offerings and strong historical exits on select works, Masterworks adds a scarce, globally traded asset to portfolios seeking long-term diversification. Public is a multi-asset investing platform built for long-term investors who want more control, transparency, and innovation in how they grow wealth. Founded in 2019 as the first broker-dealer to offer commission-free, real-time fractional investing, Public now lets users invest in stocks, bonds, options, crypto, and more—all in one place. Its latest feature, Generated Assets, uses AI to turn a single idea into a fully customized, investable index that can be explained and backtested before committing capital. Combined with AI-powered research tools, clear explanations of market moves, and an uncapped 1% match for transferring an existing portfolio, Public positions itself as a modern platform designed to help serious investors make more informed decisions with context. AdviserMatch is a free online tool that helps individuals connect with financial advisors based on their goals, financial situation, and investment needs. Instead of spending hours researching advisors on your own, the platform asks a few quick questions and matches you with professionals who can assist with areas like retirement planning, investment strategy, and overall financial guidance. Consultations are no-obligation, and services vary by advisor, giving investors a chance to explore whether professional advice could help improve their long-term financial plan. Accredited Debt Relief is a debt consolidation company focused on helping consumers reduce and manage unsecured debt through structured programs and personalized solutions. Having supported more than 1 million clients and helped resolve over $3 billion in debt, the company operates within the growing consumer debt relief industry, where demand continues to rise alongside record household debt levels. Its process includes a quick qualification survey, personalized program matching, and ongoing support, with eligible clients potentially reducing monthly payments by 40% or more. With industry recognition, an A+ BBB rating, and multiple customer service awards, Accredited Debt Relief positions itself as a data-driven, client-focused option for individuals seeking a more manageable path toward becoming debt-free. Finance Advisors helps Americans approach retirement with greater clarity by connecting them to vetted, fiduciary financial advisors who specialize in tax-aware retirement planning. Rather than focusing on products or investment performance alone, the platform emphasizes strategies that account for after-tax income, withdrawal sequencing, and long-term tax efficiency—factors that can materially impact retirement outcomes. 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FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting in April Broad clinical pipeline progressing for lysosomal storage and neurodegenerative diseases, including first patient dosed with Oligonucleotide TransportVehicle™ (OTV)-enabled DNL628 (OTV:MAPT) targeting tau for Alzheimer's disease Advancing DNL593 (PTV:PGRN) in Phase 1/2 study for GRN-related frontotemporal dementia after regaining full rights, with data expected by end of 2026 SOUTH SAN FRANCISCO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2026, and provided business highlights, including the recent U.S. Food and Drug Administration (FDA) approval of AVLAYAH™ (tividenofusp alfa-eknm). “The FDA approval of AVLAYAH is a major milestone for Denali, for the Hunter syndrome community, and for the field of biotherapeutics enabled to cross the blood-brain barrier. We are thrilled by the strong engagement with the community, seamless execution by our commercial team, and achievement of our first patient dosed in less than one month from approval,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “AVLAYAH provides validation for our TransportVehicle™ (TV) platform enabling our broad clinical portfolio for lysosomal storage and neurodegenerative diseases. We are excited about progress achieved across the portfolio, including dosing of the first patients with our Oligonucleotide TV-enabled investigational therapy DNL628 (OTV:MAPT) targeting tau for Alzheimer’s disease and advancing DNL593 (PTV:PGRN) for FTD-GRN after regaining full rights." First Quarter 2026 and Recent Program Updates COMMERCIAL PRODUCT AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome (mucopolysaccharidosis type II [MPS II]) On March 25, 2026, Denali announced AVLAYAH (tividenofusp alfa-eknm) received accelerated approval for the treatment of neurologic manifestations of Hunter syndrome (MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. The U.S. commercial launch of AVLAYAH is underway and the first patients have received therapy. All key operational launch components are in place, including availability of commercial product through an established distribution channel and fully operational patient support hub. The major health systems and key national and regional payers have been engaged. The ongoing global Phase 2/3 COMPASS study is designed to generate confirmatory evidence and support global regulatory submissions for AVLAYAH. CLINICAL PROGRAMS DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA) DNL126 is an investigational, intravenously administered, Enzyme TransportVehicle™ (ETV)-enabled N-sulfoglucosamine sulfohydrolase (SGSH) replacement therapy designed to deliver SGSH into the brain and body, with the goal of addressing the behavioral, cognitive and physical manifestations of Sanfilippo syndrome type A. The Phase 1/2 trial of DNL126 is ongoing, and start-up activities are underway for a global Phase 3 confirmatory study. Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for DNL126 for Sanfilippo syndrome type A in 2027. DNL593 (PTV:PGRN) for GRN-related frontotemporal dementia (FTD-GRN) Denali is conducting a Phase 1/2 study of DNL593, an investigational, intravenously administered progranulin replacement therapy utilizing Denali’s Protein TransportVehicle™ (PTV) to deliver progranulin across the blood-brain barrier (BBB) and into the brain for individuals with FTD-GRN. Enrollment in the study is complete with a total of 40 participants with FTD-GRN, and results are expected by the end of 2026. DNL628 (OTV:MAPT) for Alzheimer's disease In March 2026, the first patient was dosed in the Phase 1b study of DNL628, which is an investigational therapy for Alzheimer’s disease and enabled by Denali’s Oligonucleotide TransportVehicle™ (OTV). DNL628 is designed to cross the BBB and reduce the tau protein by targeting the MAPT gene that encodes for tau. Denali expects data from this study in 1H 2027. DNL952 (ETV:GAA) for Pompe disease DNL952 is enabled by Denali’s ETV and designed to enhance delivery of the missing enzyme, GAA, into muscle tissues and across the BBB into the brain. Phase 1 study start-up activities are underway. BIIB122/DNL151 (small molecule LRRK2 inhibitor) for Parkinson’s disease A clinical data readout of the global Phase 2b LUMA study of BIIB122 for early-stage Parkinson’s disease is expected in mid-2026. Denali’s Phase 2a BEACON study in individuals with Parkinson’s disease who are confirmed by genetic testing to be carriers of a pathogenic LRRK2 variant is ongoing. The LRRK2 program is being developed in collaboration with Biogen. IND-ENABLING STAGE PROGRAMS Denali has multiple additional programs in the IND-enabling stage including DNL921 (ATV:Abeta) for Alzheimer’s disease; DNL111 (ETV:GCase) for Parkinson’s disease and Gaucher disease; DNL622 (ETV:IDUA) for MPS I; and DNL422 (OTV:SNCA) for Parkinson’s disease. Denali is on track to submit a regulatory filing for DNL921 in the first half of 2026 to begin clinical development of this TV-enabled anti-amyloid program for Alzheimer’s disease. Corporate Updates As previously announced in connection with the approval of AVLAYAH, the FDA granted Denali Therapeutics a Rare Pediatric Disease Priority Review Voucher (PRV). This voucher may be used to obtain priority review for a future marketing application and can be transferred to another sponsor. On March 27, 2026, Denali received $200 million in gross proceeds in connection with the closing of the transactions under a synthetic royalty funding agreement signed in December 2025 with Royalty Pharma Investments 2023 ICAV. On April 3, 2026, Denali announced it received notification from Takeda of its decision to terminate the collaboration agreement between the two companies to co-develop and co-commercialize DNL593. Takeda’s decision was driven by strategic considerations and was not related to efficacy or safety data. Denali continues to advance DNL593 in the ongoing Phase 1/2 study in patients with FTD-GRN and expects results by the end of 2026 as described above. Participation in Upcoming Investor Conferences Bank of America Healthcare Conference 2026, May 12-14 (Las Vegas) Jefferies Global Healthcare Conference, June 2-4 (New York City) Goldman Sachs 47th Annual Global Healthcare Conference, June 8-10 (Miami) BTIG Virtual Biotechnology Conference, July 28-29 First Quarter 2026 Financial Results Net loss was $128.4 million for the quarter ended March 31, 2026, compared to net loss of $133.0 million for the quarter ended March 31, 2025. Total research and development expenses were $103.8 million for the quarter ended March 31, 2026, compared to $116.2 million for the quarter ended March 31, 2025. The decrease of approximately $12.4 million was primarily attributable to the timing of manufacturing of AVLAYAH commercial supply in the first quarter of 2025, as well as lower external expenses related to small molecule programs. General and administrative expenses were $33.5 million for the quarter ended March 31, 2026, compared to $29.4 million for the quarter ended March 31, 2025. The increase of $4.1 million was primarily driven by higher personnel-related costs due to increased headcount in the first quarter of 2026, reflecting headcount additions made throughout 2025 to support post-launch activities for AVLAYAH. Cash, cash equivalents and marketable securities were approximately $1.05 billion as of March 31, 2026. About the Denali TransportVehicle™ Platform The blood-brain barrier (BBB) is essential in maintaining the brain’s microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for central nervous system diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali’s TransportVehicle™ (TV) platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes and oligonucleotides throughout the whole body, including the brain, by crossing the BBB after intravenous administration. The TV platform is based on engineered Fc domains that bind to specific natural transport receptors, such as transferrin receptor and CD98 heavy chain amino acid transporter, which are expressed at the BBB and deliver the TV and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered with the TV platform demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Oligonucleotides engineered with the TV platform demonstrate more than a 1,000-fold greater brain exposure in primates than systemically delivered oligonucleotides without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates. The TV platform has been clinically validated, with AVLAYAH™ (tividenofusp alfa-eknm) as the first FDA-approved medicine leveraging transferrin receptor to cross the BBB. About Denali Therapeutics Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform, and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform life for people with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. For more information, please visit www.denalitherapeutics.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations for Denali’s TransportVehicle™ (TV) platform, including the Enzyme TransportVehicle™ (ETV) franchise, and its therapeutic and commercial potential; plans, timelines, and expectations relating to the commercial launch of AVLAYAH™ (tividenofusp alfa-eknm) and related activities; expectations related to the ongoing Phase 2/3 COMPASS study of tividenofusp alfa, including the timing and availability of data and its ability to generate confirmatory evidence and support global regulatory submissions; plans, timelines and expectations related to DNL126, including the ongoing Phase 1/2 study, the planned Phase 3 confirmatory study, the planned BLA submission, and the likelihood and timing of accelerated approval; plans, timelines and expectations related to DNL593, including the ongoing Phase 1/2 study, the timing and availability of data, and Denali’s ability to independently advance the program; plans, timelines and expectations related to DNL628, including the ongoing Phase 1b study and the timing and availability of data; plans, timelines and expectations related to DNL952 and the planned Phase 1 study; plans, timelines and expectations related to DNL151, including the ongoing Phase 2a BEACON study, and the timing and availability of data from the Phase 2b LUMA study; plans, timelines and expectations related to DNL921, including the expected timing of a regulatory filing and initiation of clinical development; plans, timelines, and expectations for IND-enabling stage programs; plans and expectations regarding Denali's Rare Pediatric Disease Priority Review Voucher; expectations regarding the Royalty Pharma funding agreement, including royalty payment obligations and milestones; plans regarding participation in upcoming investor conferences; and statements by Denali's Chief Executive Officer. Actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of risks and uncertainties. These include, but are not limited to, uncertainties related to the FDA’s policies and accelerated approval program; risks arising from adverse economic conditions and their impact on Denali’s business and operations; the possibility of events or changes that could lead to the termination of Denali’s collaboration agreements; challenges associated with Denali’s transition to a commercial company; the ability of Denali and its collaborators to complete the development and, if approved, the commercialization of product candidates; difficulties in patient enrollment for ongoing and future clinical trials; whether the current ongoing trials have been powered sufficiently to demonstrate approvability to regulatory agencies; reliance on third-party manufacturers and suppliers for clinical trial materials; dependence on the successful development of Denali’s blood-brain barrier platform technology and related programs; potential delays or failures in meeting expected clinical trial timelines; discrepancies between preclinical, early-stage or preliminary clinical results and outcomes from later-stage trials; the risk that interim or topline clinical results may not be predictive of final study results or longer‑term outcomes; the occurrence of significant adverse events or other undesirable side effects; the uncertainty surrounding regulatory approvals required for commercialization in the U.S., Europe or other international jurisdictions; Denali’s ability to advance a pipeline of product candidates or develop commercially successful products; developments relating to Denali's competitors and competing product candidates; Denali’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; the implementation and success of Denali’s strategic plans for its business, product candidates and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future financial results in the current environment; and other risks and uncertainties, including those described in Denali's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2026, and Denali’s future reports to be filed with the SEC. Except for AVLAYAH, Denali's product candidates are investigational, and their safety and efficacy profiles have not yet been established. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali’s expectations, except as required by law. Investor Contact: Laura Hansen, Ph.D. [email protected] Media Contact: Erin Patton [email protected]

Tividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndrome DNL126 (ETV:SGSH) Phase 1/2 preliminary data presented at 2026 WORLDSymposium™, supporting plans to pursue an accelerated approval path in Sanfilippo syndrome type A Start-up activities underway for DNL628 (OTV:MAPT) Phase 1b study for Alzheimer's disease and DNL952 (ETV:GAA) Phase 1 study for late-onset Pompe disease TransportVehicle™ platform and clinical pipeline progressing across lysosomal storage disorders and neurodegenerative diseases SOUTH SAN FRANCISCO, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business highlights. “In 2025, we made meaningful progress toward delivering urgently needed treatment options for people living with neurodegenerative diseases and lysosomal storage disorders, building on the strong scientific foundation that defines Denali,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “We established commercial readiness for the anticipated launch of tividenofusp alfa for individuals and families affected by Hunter syndrome and continued advancing our TransportVehicle platform across serious neurologic and systemic diseases that impact millions worldwide. "In 2026, we are focused on launching tividenofusp alfa and transforming life for individuals living with other serious diseases. Data presented at WORLDSymposium support our plans to pursue an accelerated approval path for DNL126 in Sanfilippo syndrome type A. We are also initiating clinical studies of DNL628 (OTV:MAPT) in Alzheimer’s disease and DNL952 (ETV:GAA) in late-onset Pompe disease. Over the next three years, we expect to advance four to six additional programs into the clinic, guided by our commitment to the patients we serve.” Fourth Quarter 2025 and Recent Program Updates CLINICAL PROGRAMS Tividenofusp alfa (DNL310; ETV:IDS) for Hunter syndrome (mucopolysaccharidosis type II [MPS II]) Denali has established commercial launch readiness in anticipation of a regulatory decision on the Biologics License Application (BLA) for tividenofusp alfa under the U.S. Food and Drug Administration (FDA) accelerated approval pathway with a Prescription Drug User Fee Act (PDUFA) target action date of April 5, 2026. Results from the open-label Phase 1/2 clinical trial of tividenofusp alfa were published in the January 1, 2026 issue of The New England Journal of Medicine. The ongoing global Phase 2/3 COMPASS study is expected to generate confirmatory evidence and support global regulatory submissions; enrollment in Cohort A (neuronopathic participants) was completed in December 2025. DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA) In February 2026, Denali presented preliminary Phase 1/2 data at WORLDSymposium demonstrating treatment with DNL126 resulted in substantial reductions in disease biomarkers in cerebrospinal fluid (CSF heparan sulfate and GM3) and the periphery (urinary heparan sulfate) with a safety profile generally consistent with established enzyme replacement therapies. These preliminary data support an accelerated approval path in Sanfilippo syndrome type A. Planning for a global Phase 3 confirmatory study is ongoing. TAK-594/DNL593 (PTV:PGRN) for GRN-related frontotemporal dementia (FTD-GRN) TAK-594/DNL593 is an intravenously administered progranulin replacement therapy utilizing Denali’s Protein TransportVehicle™ (PTV) technology to deliver progranulin across the blood-brain barrier (BBB) and into the brain for individuals with FTD-GRN. Enrollment in the ongoing Phase 1/2 study is complete with a total of 40 participants with FTD-GRN enrolled. Initial FTD-GRN patient data are expected in 2026. The program is being developed in collaboration with Takeda. DNL952 (ETV:GAA) for Pompe disease DNL952 is enabled by Denali’s Enzyme TransportVehicle™ (ETV) and designed to enhance delivery of the missing enzyme, GAA, into muscle tissues and across the BBB into the brain. In January 2026, Denali announced that the FDA had lifted the clinical hold on the Investigational New Drug (IND) application for DNL952. Phase 1 study start-up activities are underway. DNL628 (OTV:MAPT) for Alzheimer's disease DNL628 is enabled by Denali’s Oligonucleotide TransportVehicle™ (OTV) and is designed to cross the BBB and reduce the tau protein by targeting the MAPT gene that encodes for tau. In January 2026, Denali announced that the Clinical Trial Application (CTA) for the Phase 1b study of DNL628 had been approved and study start-up activities are underway. BIIB122/DNL151 (small molecule LRRK2 inhibitor) for Parkinson’s disease A clinical data readout of the global Phase 2b LUMA study of BIIB122 for early-stage Parkinson’s disease is expected in mid-2026. Denali’s Phase 2a BEACON study in LRRK2-associated Parkinson’s disease remains ongoing. The LRRK2 program is being developed in collaboration with Biogen. SAR443122/DNL758 (eclitasertib; small molecule RIPK1 inhibitor) for ulcerative colitis The Phase 2 study of eclitasertib in participants with moderate to severe ulcerative colitis is expected to have results in the first half of 2026. The program is being developed by Sanofi. IND-ENABLING STAGE PROGRAMS Denali has multiple additional programs in the IND-enabling stage including DNL921 (ATV:Abeta) for Alzheimer’s disease; DNL111 (ETV:GCase) for Parkinson’s disease and Gaucher disease; DNL622 (ETV:IDUA) for MPS I; and DNL422 (OTV:SNCA) for Parkinson’s disease. Corporate Updates In December, Denali announced two funding events. The first was a $275.0 million synthetic royalty funding agreement with Royalty Pharma plc based on future net sales of tividenofusp alfa. The second was a successful public offering of common stock and pre-funded warrants totaling approximately $200.0 million in net proceeds. Participation in Upcoming Investor Conferences TD Cowen 46th Annual Healthcare Conference, March 2-4, 2026, Boston UBS Biotech Summit Miami - Catalyst for Change, March 8-10, 2026, Miami Leerink Global Healthcare Conference, March 8-11, 2026, Miami Jefferies 2026 Biotech on the Beach Summit, March 10-11, 2026, Miami Fourth Quarter and Full Year 2025 Financial Results Net losses were $128.5 million and $512.5 million for the quarter and year ended December 31, 2025, respectively, compared to net losses of $114.8 million and $422.8 million for the quarter and year ended December 31, 2024, respectively. Total research and development expenses were $97.9 million and $418.8 million for the quarter and year ended December 31, 2025, respectively, compared to $99.8 million and $396.4 million for the quarter and year ended December 31, 2024, respectively. The increase of approximately $22.4 million for the year ended December 31, 2025, compared to the comparative period in the prior year was primarily attributable to higher external research and development costs related to multiple preclinical and clinical TransportVehicle programs, as well as increased personnel and other operating expenses associated with our large molecule manufacturing facility in Salt Lake City, Utah. These increases were partially offset by lower external expenses related to small molecule programs, which also contributed to the $1.9 million decrease in research and development expenses for the quarter ended December 31, 2025, compared to the same period in the prior year. General and administrative expenses were $39.5 million and $136.6 million for the quarter and year ended December 31, 2025, respectively, compared to $30.1 million and $105.4 million for the quarter and year ended December 31, 2024, respectively. The increases of $9.4 million and $31.1 million for the quarter and year ended December 31, 2025, compared to the comparative period in the prior year were primarily driven by headcount increases and other activities associated with preparing for the potential commercial launch for tividenofusp alfa. Cash, cash equivalents and marketable securities were approximately $966.2 million as of December 31, 2025. About Denali Therapeutics Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using its proprietary TransportVehicle™ platform. With a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. For more information, please visit www.denalitherapeutics.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations for Denali’s TransportVehicle™ (TV) platform and its therapeutics and commercial potential; statements regarding Denali's business strategy and business plans, including expected key milestones for Denali's therapeutic portfolio in 2026 and beyond and Denali’s ability to execute on its commercial strategies; plans, timelines and expectations related to Denali's Enzyme TransportVehicle™ (ETV) franchise and its therapeutic and commercial potential; plans, timelines and expectations relating to tividenofusp alfa (DNL310), including the timing, likelihood and scope of regulatory approvals and commercial launch, the therapeutic potential of tividenofusp alfa, and the likelihood of the Phase 2/3 COMPASS data to support confirmatory evidence for global regulatory submissions and approval; plans, timelines and expectations related to DNL126, including the timing and availability of data from the Phase 1/2 study, the therapeutic potential of DNL126, the likelihood and pathway of regulatory approval, and the plans to initiate a Phase 3 study; plans and expectations regarding DNL593 and the timing and availability of data from the ongoing Phase 1/2 study; plans and expectations regarding DNL628, including the planned Phase 1b study; plans and expectations regarding DNL952, including the Phase 1 study and the program's therapeutic potential; plans, timelines and expectations regarding DNL151, including the ongoing Phase 2a BEACON study, and timing and expectations for availability of data from the Phase 2b LUMA study; expectations regarding DNL758 and the timing and availability of data from the Phase 2 study; the timing and occurrence of potential milestone payments, including from Royalty Pharma plc; Denali's future operating expenses and anticipated cash runway; plans regarding participation in upcoming investor conferences; and statements by Denali's Chief Executive Officer. All drugs currently being developed by Denali are investigational and have not received regulatory approval for any indication. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: the impact of adverse economic conditions, tariffs and inflation on Denali’s business and operations; the occurrence of any event, change or other circumstance that could give rise to the termination of Denali’s agreements with Sanofi, Takeda, Biogen or other collaborators; Denali’s transition to a late-stage clinical drug development company; Denali’s and its collaborators’ ability to complete the development and, if approved, commercialization of its product candidates; Denali’s and its collaborators’ ability to enroll patients in its ongoing and future clinical trials; Denali’s reliance on third parties for the manufacture and supply of its product candidates for clinical trials; Denali’s dependence on successful development of its blood-brain barrier platform technology and its programs and product candidates; Denali’s and its collaborators' ability to conduct or complete clinical trials on expected timelines; the risk that preclinical profiles of Denali’s product candidates may not translate in clinical trials; the potential for clinical trials to differ from preclinical, early clinical, preliminary or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; the uncertainty that product candidates will receive regulatory approval necessary to be commercialized; Denali’s ability to continue to create a pipeline of product candidates or commercialize products; developments relating to Denali's competitors and its industry, including competing product candidates and therapies; Denali’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Denali’s strategic plans for its business, product candidates and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future financial results and hedge against financial risk in the current environment; and other risks and uncertainties, including those described in Denali's most recent Annual Report and Quarterly Reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 27, 2025 and November 6, 2025, and Denali’s future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali’s expectations, except as required by law. Denali Therapeutics Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) Denali Therapeutics Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) Investor Contact: Laura Hansen, Ph.D. [email protected] Media Contact: Erin Patton [email protected]

Denali Therapeutics Inc. (NASDAQ:DNLI) is one of the 15 stocks set to explode in 2026. On November 7, 2025, H.C. Wainwright’s Andrew Fein reiterated his “Buy” rating on Denali Therapeutics Inc. (NASDAQ:DNLI) with a $32 price target. Fein’s bullish stance followed Denali Therapeutics Inc. (NASDAQ:DNLI)’s Q3 results. He highlighted the upcoming launch of tividenofusp, which is the first transferrin receptor (TfR)-enabled medicine. Fein believes this launch will establish a commercial framework capable of supporting future enzyme replacement programs. He also discussed the recent acquisition of Avidity, which reflects the industry’s increasing recognition of TfR-based delivery as an efficient method for tissue penetration. Moreover, with tividenofusp getting closer to its PDUFA date and DNL126 completing Phase 1/2 enrollment, the analyst believes Denali’s pipeline is advancing strongly. Furthermore, with its innovative Transport Vehicle (TV) platform seen as both clinically and commercially viable, investor confidence in the company’s ability to bank on its technological progress is bolstered. At the same time, Denali Therapeutics Inc. (NASDAQ:DNLI) is filing new Investigational New Drug applications (INDs) for programs targeting Alzheimer’s and Pompe disease, which the analyst believes will expand its market reach. The analyst’s note followed the company’s earnings release on the previous day, where it reported a net loss of $126.9 million. Denali Therapeutics Inc. (NASDAQ:DNLI) reported slightly increased R&D expenses of $102 million, driven by operational start at its large molecule manufacturing facility in Salt Lake City, Utah. The company ended the quarter with $872.9 million in cash balance. Denali Therapeutics Inc. (NASDAQ:DNLI), a South San Francisco-based biopharmaceutical company, is focused on the development of therapies for neurodegenerative and lysosomal storage diseases, improving drug delivery across the blood-brain barrier. While we acknowledge the potential of DNLI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 13 Best Fortune 500 Stocks to Invest in Now and 13 Best Fortune 500 Stocks to Invest in Now. Disclosure: None.

Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on track DNL126 Phase 1/2 study enrollment completed, supporting an accelerated approval path in MPS IIIA Two new regulatory applications submitted to initiate clinical studies with DNL628 (OTV:MAPT) for Alzheimer’s disease and DNL952 (ETV:GAA) for Pompe disease Tim Van Hauwermeiren, CEO of argenx, to join Denali's Board of Directors Carole Ho, M.D., Chief Medical Officer, departing company; Peter Chin, M.D., assuming role of Acting CMO and Head of Development Denali to host Investor Day on December 4, 2025 SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2025, and provided business highlights. “Momentum is building across Denali as we prepare for the anticipated launch of tividenofusp alfa with an experienced and focused commercial team in place,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “We are also excited to have submitted regulatory applications to initiate clinical studies with two additional programs representing new opportunities to expand the TransportVehicle™ platform to Alzheimer's disease and Pompe disease. Our robust pipeline continues to lead the way in the emerging class of transferrin receptor (TfR)-enabled medicines designed to deliver the power of biotherapeutics throughout the body, including the brain.” Third Quarter 2025 and Recent Program Updates CLINICAL PROGRAMS Tividenofusp alfa (DNL310, ETV:IDS) for Hunter syndrome (MPS II) In October, Denali announced that the FDA extended its review timeline of the Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) target date was extended from January 5, 2026, to April 5, 2026. The extension follows Denali’s submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to efficacy, safety or biomarkers. The FDA classified the submission as a Major Amendment (MA) to the BLA, which, per FDA regulations, extends the review by three months. No additional data were requested by the FDA in the MA letter. Denali believes that the updated information submitted in the amendment does not affect the clinical pharmacology or benefit-risk conclusions of the BLA. Denali continues to have productive engagement with the FDA on the review process while preparing for commercial launch. DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA) In September, Denali completed enrollment in the ongoing Phase 1/2 study of DNL126 to support an accelerated approval path in MPS IIIA, also known as Sanfilippo syndrome type A. Previously announced data demonstrated a significant reduction in cerebrospinal fluid (CSF) heparan sulfate (HS) from baseline, including normalization, and a safety profile that supports continued development. A global Phase 3 confirmatory study is being planned. Phase 1/2 data will be presented in a platform presentation at the 2026 WORLDSymposium™. TAK-594/DNL593 (PTV:PGRN) for GRN-related frontotemporal dementia Denali and Takeda continue their collaboration to develop DNL593, an investigational therapeutic designed to deliver progranulin across the blood-brain barrier for the treatment of granulin (GRN) mutation-associated frontotemporal dementia (FTD-GRN). A Phase 1/2 study is ongoing. DNL628 (OTV:MAPT) for the treatment of Alzheimer's disease In October, the company submitted a Clinical Trial Application (CTA) for DNL628 (OTV:MAPT) to initiate clinical studies in Alzheimer’s disease, marking a significant milestone in advancing the Oligonucleotide TransportVehicle™ (OTV) platform. DNL952 (ETV:GAA) for the treatment of Pompe disease In October, Denali submitted an Investigational New Drug (IND) application for DNL952 (ETV:GAA) to begin clinical studies in Pompe disease, expanding the reach of the Enzyme TransportVehicle™ (ETV) platform into muscle disease. BIIB122/DNL151 (small molecule LRRK2 inhibitor) for the treatment of Parkinson’s disease Denali and Biogen continue co-development of BIIB122. The Phase 2b LUMA study completed enrollment earlier this year with a data readout expected in 2026, while Denali’s Phase 2a BEACON study in LRRK2-associated Parkinson's disease remains ongoing. IND-ENABLING STAGE PROGRAMS Denali expects to continue expanding its TV-enabled pipeline across enzyme, antibody, and oligonucleotide franchises, bringing forward one to two new programs annually. The next most advanced programs include: DNL921 (ATV:Abeta) for Alzheimer’s disease; DNL111 (ETV:GCase) for Parkinson’s/Gaucher disease; DNL622 (ETV:IDUA) for MPS I; and DNL422 (OTV:SNCA) for Parkinson’s disease. CORPORATE UPDATES Today, in a separate press release, Denali announced that Tim Van Hauwermeiren has been appointed to its Board of Directors. Mr. Van Hauwermeiren is co-founder and Chief Executive Officer of argenx. Carole Ho, M.D., who has served as Denali’s Chief Medical Officer and Head of Development since 2015, will be departing to join Eli Lilly and Company as Executive Vice President, and President of Lilly Neuroscience. Peter Chin, M.D., is assuming the role of Acting Chief Medical Officer and Head of Development at Denali. Dr. Chin is a neurologist and joined Denali in 2019, most recently serving as Senior Vice President of the ETV Franchise and Late-Stage Clinical Development. Participation in Upcoming Investor Conferences Stifel 2025 Healthcare Conference, November 11 - 13 (New York City) Jefferies Global Healthcare Conference, November 17 - 20 (London) Denali's 2025 Investor Day on December 4, 2025, in New York City Denali’s leadership team will host an in-person and virtual Investor Day on December 4, 2025, in New York City to provide an update on the company’s progress and strategic priorities, including its transition to a fully integrated organization and preparations for the planned launch of tividenofusp alfa for Hunter syndrome (MPS II). The discussion will also highlight continued advancement of Denali’s TransportVehicle platform, pipeline execution across multiple programs, and the company’s near- and long-term strategy to drive sustainable growth and create shareholder value through the development of transformative treatments for people living with serious diseases. The event is scheduled to begin at 8:30 a.m. EST and will continue until approximately 11:30 a.m. EST. In-person attendance is intended for institutional investors and financial analysts. Denali is also offering a live webcast of the event, which will be accessible from the Events page of the Investor section on Denali's corporate website: www.denalitherapeutics.com. Third Quarter 2025 Financial Results Net loss was $126.9 million for the quarter ended September 30, 2025, compared to a net loss of $107.2 million for the quarter ended September 30, 2024. Total research and development expenses were $102.0 million for the quarter ended September 30, 2025, compared to $98.2 million for the quarter ended September 30, 2024. The increase of approximately $3.8 million was attributable to increases of $7.8 million and $6.4 million in other research and development expenses and personnel-related expenses, respectively, both driven by the commencement of operations at Denali's large molecule manufacturing facility in Salt Lake City, Utah. These increases were partially offset by a decrease of $10.2 million in external expenses for small molecule programs. General and administrative expenses were $35.5 million for the quarter ended September 30, 2025, compared to $24.9 million for the quarter ended September 30, 2024. The increase of $10.6 million was primarily driven by preparatory activities for a potential commercial launch for tividenofusp alfa. Cash, cash equivalents, and marketable securities were approximately $872.9 million as of September 30, 2025. About Denali Therapeutics Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB, and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations for Denali’s TV platform and its therapeutics and commercial potential; statements made by Denali’s Chief Executive Officer; plans, timelines, and expectations relating to DNL310, including the PDUFA target action date and plans for commercial launch; plans, timelines, and expectations related to DNL126, including the global confirmatory Phase 3 study; plans regarding DNL593 and the ongoing Phase 1/2 study and the timing and availability of initial patient data; plans, timelines, and expectations regarding DNL628 and the initiation of clinical studies; plans, timelines, and expectations regarding DNL952 and the initiation of clinical studies; plans, timelines, and expectations regarding DNL151, including with respect to the ongoing Phase 2a BEACON study and the timing and likelihood of readout of the Phase 2b LUMA study; plans and expectations for Denali's preclinical programs, including the timing of advancement to clinical studies; plans and timelines regarding corporate changes; Denali's participation in upcoming investor conferences; expectations for Denali's 2025 Investor Day, including with respect to the planned content and availability of updates; Denali's future operating expenses and anticipated cash runway; and statements by Denali's Chief Executive Officer. All drugs currently being developed by Denali are investigational and have not received regulatory approval for any indication. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: the impact of adverse economic conditions, tariffs, and inflation on Denali’s business and operations; the occurrence of any event, change, or other circumstance that could give rise to the termination of Denali’s agreements with Sanofi, Takeda, Biogen, or other collaborators; Denali’s transition to a late-stage clinical drug development company; Denali’s and its collaborators’ ability to complete the development and, if approved, commercialization of its product candidates; Denali’s and its collaborators’ ability to enroll patients in its ongoing and future clinical trials; Denali’s reliance on third parties for the manufacture and supply of its product candidates for clinical trials; Denali’s dependence on successful development of its blood-brain barrier platform technology and its programs and product candidates; Denali’s and its collaborators' ability to conduct or complete clinical trials on expected timelines; the risk that preclinical profiles of Denali’s product candidates may not translate in clinical trials; the potential for clinical trials to differ from preclinical, early clinical, preliminary or expected results; the risk of significant adverse events, toxicities, or other undesirable side effects; the uncertainty that product candidates will receive regulatory approval necessary to be commercialized; Denali’s ability to continue to create a pipeline of product candidates or commercialize products; developments relating to Denali's competitors and its industry, including competing product candidates and therapies; Denali’s ability to obtain, maintain, or protect intellectual property rights related to its product candidates; implementation of Denali’s strategic plans for its business, product candidates, and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future financial results and hedge against financial risk in the current environment; and other risks and uncertainties, including those described in Denali's most recent Annual Report and Quarterly Reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 27, 2025 and November 6, 2025, and Denali’s future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results, or to make changes in Denali’s expectations, except as required by law. Denali Therapeutics Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) Denali Therapeutics Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) Investor Contact: Laura Hansen, Ph.D. [email protected] Media Contact: Erin Patton [email protected]

A month has gone by since the last earnings report for Denali Therapeutics Inc. (DNLI). Shares have added about 16.2% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Denali Therapeutics due for a pullback? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent drivers for Denali Therapeutics Inc. before we dive into how investors and analysts have reacted as of late. Denali reported a second-quarter 2025 loss of 72 cents per share, narrower than the Zacks Consensus Estimate of a loss of 74 cents. The company reported a loss of 59 cents in the year-ago quarter. The loss per share deteriorated year over year due to an increase in total operating expenses. In the absence of a marketed product, the company only recognizes revenues from ongoing collaborations. Denali did not generate collaboration revenues in the reported quarter. The Zacks Consensus Estimate for revenues was pegged at $25 million. Research and development expenses increased 12.4% to $102.7 million. The increase was primarily due to increased spending on multiple preclinical programs. An increase in other research and development expenses, consultants and general facilities costs also contributed to the surge. General and administrative expenses increased 28% to $32.3 million due to activities related to the preparations for a potential launch of tividenofuspalfa. As of June 30, 2025, cash, cash equivalents, and marketable securities amounted to approximately $977.4 million. In July 2025, Denali announced that the FDA accepted its biologics license application (BLA) for pipeline candidate tividenofuspalfa for priority review. The regulatory body assigned a target action date of Jan. 5, 2026. The BLA seeks accelerated approval based on a data package, including results from the phase I/II study in individuals with Hunter syndrome. The FDA had previously granted tividenofusp alfa Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Tividenofusp alfa is an investigational, next-generation enzyme replacement therapy designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain. Denali continues to prepare for commercial launch and is conducting the phase II/III COMPASS study to support global regulatory submissions. Denali is also evaluating DNL126 for the treatment of Sanfilippo syndrome type A (MPS IIIA). Concurrent with the quarterly results, Denali announced that it has reached alignment with the FDA’s Center for Drug Evaluation and Research that cerebrospinal fluid heparan sulfate (CSF HS) may be considered a reasonably likely surrogate endpoint to predict clinical benefit and may therefore be used to support accelerated approval of DNL126 for MPS IIIA. Data from the ongoing open-label phase I/II study at week 49 is consistent with previously announced 25-week data, demonstrating a significant reduction in CSF HS from baseline, including normalization, and a safety profile that supports continued development. Denali has almost completed enrollment in the phase I/II study, and planning is underway for a confirmatory global phase III study. Another candidate in DNLI’s pipeline is TAK-594/DNL593. Denali has collaborated with Takeda for the co-development and co-commercialization of DNL593, a therapeutic candidate engineered for the delivery of progranulin (PGRN) across the BBB and into lysosomes for the treatment of frontotemporal dementia (FTD) associated with a mutation in the granulin (GRN) gene. Denali is conducting the ongoing phase I/II study of DNL593 in FTD-GRN. Denali and Biogen are jointly evaluating an LRRK2 inhibitor, BIIB122/DNL151, in development to treat Parkinson’s disease (PD). Biogen is leading the global phase IIb LUMA study, evaluating BIIB122's impact on disease progression in early-stage PD. In May 2025, Biogen announced that the LUMA study was fully enrolled with a readout expected in 2026. Meanwhile, Denali is conducting the phase IIaBEACON study, specifically enrolling participants with LRRK2-associated PD to assess how LRRK2 inhibition may impact this disease. Denali expects to submit regulatory applications to begin clinical testing of one to two TV-enabled programs each year over the next three years across its Enzyme TV (ETV), Antibody TV (ATV), and Oligonucleotide TV (OTV) franchises. The most advanced programs include: DNL952 (ETV: GAA) for Pompedisease; DNL111 (ETV:GCase) for Parkinson’s/Gaucher disease; DNL622 (ETV:IDUA) for MPS I; DNL921 (ATV:Abeta) for Alzheimer’s disease; DNL628 (OTV:MAPT) for Alzheimer’s disease; and DNL422 (OTV:SNCA) for Parkinson’s disease. In the past month, investors have witnessed a upward trend in estimates review. Currently, Denali Therapeutics has a subpar Growth Score of D, however its Momentum Score is doing a lot better with an A. However, the stock has a score of F on the value side, putting it in the fifth quintile for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Denali Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Denali Therapeutics belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, MannKind (MNKD), has gained 50.6% over the past month. More than a month has passed since the company reported results for the quarter ended June 2025. MannKind reported revenues of $76.53 million in the last reported quarter, representing a year-over-year change of +5.7%. EPS of $0.00 for the same period compares with $0.05 a year ago. MannKind is expected to post earnings of $0.01 per share for the current quarter, representing a year-over-year change of -75%. Over the last 30 days, the Zacks Consensus Estimate has changed -25%. MannKind has a Zacks Rank #4 (Sell) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Denali Therapeutics Inc. (DNLI) : Free Stock Analysis Report MannKind Corporation (MNKD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research