Lyra Therapeutics, Inc. (LYRA): Business Model Canvas [Dec-2025 Updated]

You're looking to size up a late-stage biotech making a critical pivot, and honestly, Lyra Therapeutics is right at that inflection point with their LYR-210 program for chronic rhinosinusitis (CRS). As an analyst who's seen countless decks, what stands out here is their proprietary XTreo platform promising six months of localized, continuous anti-inflammatory therapy from a single, minimally invasive implant-a real value proposition for the ~4 million US CRS patients failing current meds. To fund this final push toward the New Drug Application (NDA), they are relying on their $22.1 million in cash and equivalents as of September 30, 2025, plus potential milestone payments up to $135 million from their LianBio partnership in Asia. Dive into the full Business Model Canvas below to see exactly how their key activities, resources, and cost structure are aligned to hit that regulatory goal.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Lyra Therapeutics, Inc. relies on to move LYR-210 from late-stage trials toward commercialization. These aren't just friendly agreements; they represent critical financial and operational dependencies for the company, especially given their cash position of $29.8 million as of June 30, 2025.

LianBio for exclusive development and commercialization in Greater China and Asia

The agreement with LianBio covers the exclusive license for LYR-210 in Greater China (mainland China, Hong Kong, Taiwan, and Macau), Singapore, and South Korea. This partnership is structured with immediate and contingent payments, which are key to Lyra Therapeutics' non-dilutive funding potential.

Here are the financial structures tied to this specific regional partnership:

Financial Component	Amount/Rate	Status/Basis
Upfront Cash Payment	$12.0 million	Received upon execution (2021)
Total Potential Milestone Payments	Up to $135 million	Based on development, regulatory, and commercialization achievements
Collaboration Revenue Recognized (as of March 31, 2025)	$4.9 million	Recognized revenue from the agreement
Net Sales Royalties	Low double-digit royalties	Based on net sales in the licensed territories

This deal means LianBio funds all development, regulatory, and commercialization expenses within that Territory, which helps Lyra Therapeutics manage its own burn rate. Honestly, that external funding for Asian development is a big deal when your cash runway is guided into the third quarter of 2026.

Clinical research organizations (CROs) for managing Phase 3 trials

While the search results don't detail specific CRO contracts, they confirm the scale of the clinical work that necessitates external management. Lyra Therapeutics' ENLIGHTEN program involved two pivotal Phase 3 trials, ENLIGHTEN 1 and ENLIGHTEN 2, each enrolling approximately 180 CRS patients. Following the positive ENLIGHTEN 2 results, Lyra Therapeutics is now planning a third clinical trial for CRS without nasal polyps.

The financial commitment for future large-scale trials is significant, impacting near-term capital needs:

• Estimated R&D cost guidance for another Phase 3 trial: around $20 million.
• Q1 2025 R&D Expense: $4.9 million.
• Q2 2025 R&D Expense: $5.1 million.

Managing these complex, multi-site trials effectively requires experienced CRO partners, so you can bet those contracts are substantial line items in the budget.

Key Opinion Leaders (KOLs) and principal investigators for clinical validation

Clinical validation in late 2025 is being driven by presentations of the ENLIGHTEN 2 data, which is where KOL engagement becomes visible. The positive results from the ENLIGHTEN 2 Phase 3 trial, which met its primary endpoint with a 3CS score improvement of -1.13 (p=0.0078) at week 24 in non-polyp patients, are being shared with the medical community.

Key academic partners presenting this data in late 2025 include:

• Zachary M. Soler, M.D., M.Sc., Medical University of South Carolina.
• Jivianne T. Lee, M.D., Professor, UCLA School of Medicine.

These individuals lend credibility to the data, which is crucial when seeking alignment with regulators and future commercial adoption by prescribers.

US Food and Drug Administration (FDA) for regulatory pathway alignment

The partnership with the FDA is purely procedural but dictates the entire development timeline. Lyra Therapeutics reengaged with the FDA following the June 2025 ENLIGHTEN 2 results.

Key regulatory milestones and requirements as of late 2025:

Regulatory Event	Timing/Outcome	Impact on LYR-210
Type C Meeting with FDA	Scheduled for the second half of 2025	To align on a path forward for an NDA submission for CRS patients without nasal polyps.
September 2025 FDA Meeting Outcome	Confirmed requirement for an additional clinical trial	Necessary for NDA submission for CRS without nasal polyps; Lyra plans to advance a third trial.
ENLIGHTEN 2 Primary Endpoint Result	Statistically significant improvement at week 24	Enabled reengagement with the FDA.

The FDA's feedback, specifically the September 2025 confirmation, directly sets the requirement for that next clinical trial, which is a major driver for the capital Lyra Therapeutics raised in June 2025 (approximately $5.0 million gross proceeds) to extend its runway into Q3 2026.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Key Activities

You're looking at the core actions Lyra Therapeutics, Inc. (LYRA) is taking right now to push LYR-210 toward market. It's all about execution following positive data, and the numbers tell a clear story about where the focus-and the cash-is going.

Conducting the new confirmatory Phase 3 clinical trial for LYR-210

The primary focus is setting up the next step for LYR-210, which is an investigational product candidate for chronic rhinosinusitis (CRS). This involves planning a new, confirmatory Phase 3 clinical trial for CRS patients without nasal polyps, based on feedback from the U.S. Food and Drug Administration (FDA) following a September 2025 meeting. This activity follows the positive results from the ENLIGHTEN 2 Phase 3 trial, which met its primary endpoint by showing a statistically significant improvement in a composite of the three cardinal symptoms (3CS) at week 24, specifically a change of -1.13 ($\text{p=0.0078}$) in patients without nasal polyps. The trial also met key secondary endpoints, including the SNOT-22 score improvement at 24 weeks ($\text{p=0.0101}$). The ENLIGHTEN 2 findings were presented as a Late-Breaking Scientific Oral Presentation at the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) meeting in October 2025.

Research and development (R&D) of the XTreo™ drug delivery platform

While the immediate push is on LYR-210, the underlying technology, the XTreo™ platform, is central to the value proposition. R&D spending reflects the shift from late-stage trial completion to pre-commercialization planning. Here's a look at the recent quarterly R&D spend:

Period Ended	R&D Expenses (Millions USD)
March 31, 2025	$4.9
June 30, 2025	$5.1
September 30, 2025	$4.0

The decrease in R&D expenses for the three months ended September 30, 2025, was primarily driven by a $2.1 million decrease in clinical related costs because the ENLIGHTEN 2 trial for LYR-210 was completed.

Preparing the New Drug Application (NDA) submission package for LYR-210

The company is actively working toward an NDA submission for LYR-210 as a six-month treatment for CRS. This preparation was informed by a Type C meeting with the FDA in September 2025, which confirmed that an additional clinical trial is required before the NDA can be submitted. The plan is to refine the design of this new trial based on learnings from ENLIGHTEN 1 and ENLIGHTEN 2, plus FDA feedback.

Resuming in-house Chemistry, Manufacturing and Controls (CMC) activities

To support future clinical trials and regulatory compliance, Lyra Therapeutics, Inc. has resumed in-house CMC activities. This is critical for ensuring a consistent supply of LYR-210, which is a bioabsorbable nasal implant designed to deliver 7500µg mometasone furoate over six months.

Securing additional capital through equity financing and warrant exercises

Funding operations into the third quarter of 2026 requires continuous capital management. A key recent activity was a registered direct offering and concurrent private placement announced on June 27, 2025, which brought in gross proceeds of approximately $5.0 million.

The structure of this financing involved several components:

• Selling 423,372 shares of common stock (or pre-funded warrants).
• Issuing private placement warrants to purchase up to 846,744 shares.
• The combined purchase price for a share and its associated warrant was $11.81.
• The exercise price for the private warrants is $11.56 per share.

If all private warrants are exercised for cash, Lyra Therapeutics, Inc. could receive an additional gross proceeds of approximately $9.8 million. As of June 30, 2025, the company reported stockholders' equity of approximately $1.6 million, which was below the Nasdaq minimum requirement of $2.5 million. Cash and cash equivalents stood at $22.1 million as of September 30, 2025.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Key Resources

You're looking at the core assets Lyra Therapeutics, Inc. (LYRA) is relying on right now to move LYR-210 toward a New Drug Application (NDA). Honestly, in this space, the IP and the cash to fund the next steps are everything.

Proprietary XTreo™ bioabsorbable sinonasal implant technology

The XTreo™ platform is the engine here, integrating a proven anti-inflammatory drug with advanced materials engineering for localized, long-acting delivery. This isn't just a concept; the in vitro and in vivo data back up the sustained release profile. The matrices were formulated to consistently elute Mometasone Furoate (MF) for up to 6 months in preclinical models. Furthermore, in a rabbit study, plasma MF concentrations showed steady drug release that persisted through day 56 after matrix placement. This technology is designed to conform to the irregular geometry of the maxillary sinuses in a single, in-office procedure.

Cash and equivalents of $22.1 million as of September 30, 2025

Financially, the balance sheet as of the end of the third quarter of 2025 shows the immediate runway. Lyra Therapeutics, Inc. reported $22.1 million in cash and cash equivalents on September 30, 2025. This capital position is projected to be sufficient to fund operating expenses and capital expenditures into the third quarter of 2026. That's the immediate fuel for the next regulatory steps.

Robust patent portfolio, with one lineage potentially extending to 2042

Intellectual property is a massive asset, especially for a platform technology. While the specific 2042 extension date isn't explicitly confirmed in the latest reports, the depth of innovation is clear through the inventors. For instance, Dr. Maria Palasis, the President and CEO, is an inventor on more than 120 issued and pending patents related to drug-eluting medical implants and drug delivery systems. This portfolio protects the core delivery mechanism.

Positive Phase 3 ENLIGHTEN 2 clinical data for LYR-210

The clinical validation is a non-negotiable key resource. Lyra Therapeutics, Inc. presented the positive ENLIGHTEN 2 Phase 3 results in October 2025 following the announcement of positive results in June 2025. The trial met its primary endpoint in patients without nasal polyps, demonstrating statistically significant improvement in a composite of the three cardinal symptoms (3CS) of Chronic Rhinosinusitis (CRS) at week 24 ($p=0.0078$). The trial also met key secondary endpoints:

• Composite 3CS at 24 weeks in the full population ($p=0.0209$).
• Clinically-validated SNOT-22 score at 24 weeks ($-8.7$; $p=0.0101$).

This data supports the path toward an NDA submission for CRS patients without nasal polyps, following a September 2025 meeting with the FDA.

Experienced drug development and regulatory affairs team

The team's experience translates directly into navigating the FDA process. Key personnel bring decades of relevant industry knowledge:

Role/Individual	Key Experience Metric	Context
Maria Palasis, Ph.D. (President and CEO)	Inventor on over 120 patents	Pioneer of drug-eluting stents, which is a ~$6B annual commercial market.
Pamela Nelson (SVP of Regulatory Affairs)	Over 25 years of experience	Regulatory expertise in drugs and drug/device combination products.
Allison Nance (Joined 2023)	Over 30 years of experience	Strategic regulatory affairs head for immuno-oncology programs at Jounce Therapeutics.
Vineeta Belanger (SVP, Clinical Affairs)	20 years of clinical experience	Previously VP of Clinical Affairs for Avedro, Inc.
Robert Kern (Chief Medical Officer)	Experienced drug developer	Part of the team focused on changing CRS treatment.

This team is now focused on executing the plan for a new, confirmatory Phase 3 clinical trial.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Value Propositions

You're looking at the core reason Lyra Therapeutics, Inc. (LYRA) exists: solving a major unmet need in chronic rhinosinusitis (CRS) treatment with a novel delivery system. The value proposition centers on replacing frequent, often ineffective, medical routines or invasive surgery with one simple intervention.

The primary value is the duration of effect. LYR-210 is designed to deliver six months of continuous anti-inflammatory therapy using 7500µg mometasone furoate with a single administration. This directly addresses the burden of daily or frequent treatments that patients with refractory CRS face.

The delivery method is key to its value. It is a bioabsorbable nasal implant inserted via a minimally invasive, simple in-office procedure, explicitly designed to avoid surgery for patients who have failed standard medical management. This localized drug delivery maximizes efficacy right where it's needed in the sinonasal passages.

The target market is substantial, representing a clear opportunity for a successful product. Lyra Therapeutics, Inc. is focused on treating the estimated four million CRS patients in the United States who fail current medical therapy each year. Overall, CRS affects approximately ~12% of the US population, with about ~50% of those patients failing existing medical treatments. The annual healthcare expenditure for CRS is estimated at ~$60B.

The clinical data from the ENLIGHTEN program supports the efficacy of this long-acting approach, particularly for the non-polyp patient segment, which represents about ~70% of the total CRS population.

Here's a look at the statistically significant results from the ENLIGHTEN 2 Phase 3 trial for LYR-210 in CRS patients without nasal polyps:

Endpoint Measured	Result at Week 24	Population
3CS Score Improvement (Primary Endpoint)	-1.13 (p=0.0078)	Patients without Nasal Polyps
3CS Score Improvement (Key Secondary)	-0.90 (p=0.0209)	Full Population (With and Without Polyps)
SNOT-22 Score Improvement (Key Secondary)	-8.7 (p=0.0101)	Full Population (With and Without Polyps)

Symptom improvement was observed quickly, starting as early as week 4. Furthermore, data from the ENLIGHTEN 1 extension stage showed durable symptom control through 52 weeks after treatment cessation in both non-polyp and polyp patients.

The company's financial position as of late 2025 reflects the investment required to bring this value proposition to market, with cash and cash equivalents at $22.1 million as of September 30, 2025. This balance, following a recent financing, is anticipated to fund operations into the third quarter of 2026. Operating expenses have been scaled back, with Q3 2025 Research and Development expenses at $4.0 million and General and Administrative expenses at $2.2 million.

• Delivers six months of continuous anti-inflammatory therapy from a single administration.
• Treatment involves a simple, in-office procedure.
• Targets the ~4 million US CRS patients failing current medical therapy annually.
• Achieved -1.13 improvement in 3CS score at 24 weeks in non-polyp patients (p=0.0078).
• Observed symptom improvement starting as early as week 4.

Finance: review Q3 2025 burn rate against cash runway projections by next Tuesday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Customer Relationships

You're looking at how Lyra Therapeutics, Inc. (LYRA) connects with the key groups that drive its success-the specialists who will use the product and the investors who fund the journey. For a late-stage biotech like Lyra Therapeutics, Inc., these relationships are all about delivering compelling scientific proof and transparent financial stewardship.

Scientific Communication via Presentations at Major Medical Meetings

The primary way Lyra Therapeutics, Inc. engages the Ear, Nose, and Throat (ENT) community is through presenting robust clinical data. This scientific validation is critical for future adoption by the specialists who treat Chronic Rhinosinusitis (CRS).

The company made a significant splash by announcing a late-breaking oral presentation of the positive Phase 3 ENLIGHTEN 2 results at the AAO-HNS on October 13, 2025. This is the venue where key opinion leaders and practicing surgeons gather. Also, Lyra Therapeutics, Inc. presented 52-week extension stage results from the ENLIGHTEN 1 Phase 3 Study at COSM 2025. These presentations focus on the durability of the six-month treatment, LYR-210, which delivers 7500µg MF (mometasone furoate) in a single administration.

• ENLIGHTEN 2: Positive Phase 3 results presented at AAO-HNS 2025.
• ENLIGHTEN 1 Extension: 52-week durability data presented at COSM 2025.
• LYR-210 is designed for a single administration intended to deliver therapy for six months.

Investor Relations and Corporate Updates

Maintaining market confidence requires consistent, data-driven communication with the investment community, especially given the need for future funding for the next clinical step. Lyra Therapeutics, Inc. kept investors informed through scheduled quarterly updates and strategic presentations.

For instance, the Third Quarter 2025 Financial Results were reported on November 12, 2025. At that time, the cash and cash equivalents balance stood at $22.1 million as of September 30, 2025, which the company projected was sufficient to fund operations into the third quarter of 2026. Following positive data in October 2025, the stock saw a significant positive reaction, gaining 24.97% and closing at $8.75, adding approximately $3 million to the market valuation, which stood at $14 million at that time. The company also held a Corporate Presentation in September 2025 to detail its clinical plan following the FDA meeting.

Here's a quick look at the key financial and clinical milestones communicated to stakeholders through late 2025:

Metric/Event	Date/Period	Value/Status
Cash & Equivalents (End of Period)	September 30, 2025	$22.1 million
Net Loss (Q3 2025)	Three Months Ended Sept 30, 2025	$6.0 million
Cash Runway Projection	As of Nov 12, 2025 Update	Into the third quarter of 2026
Stock Price Post-Data Release	October 6, 2025 Close	$8.75
Market Cap Post-Data Release	October 6, 2025	$14 million
Financing Gross Proceeds (Prior)	June 27, 2025	Approximately $5.0 million

High-touch Engagement with ENT Specialists for Adoption and Training

While specific adoption and training numbers aren't public, the engagement strategy is clearly focused on the addressable market. Lyra Therapeutics, Inc.'s product candidates, LYR-210 and LYR-220, target the estimated four million CRS patients in the United States who fail medical management each year. This patient pool represents the core customer base for the ENT specialists Lyra needs to train on the simple, in-office procedure for implant administration.

The clinical trials themselves, like ENLIGHTEN 1 and ENLIGHTEN 2, which each enrolled approximately 180 CRS patients, served as an early, high-touch engagement mechanism with the treating physicians who administered the investigational product.

• Total US Population CRS Prevalence: ~12%.
• Patients Failing Medical Therapy Annually: ~4 million.
• CRSsNP Patient Subset: ~70% of total CRS patients.

Patient Advocacy Group Outreach

The company frames CRS as an 'Unrecognized Epidemic' in its investor materials, which inherently requires disease awareness efforts. Although specific metrics on patient advocacy group outreach are not detailed in the late 2025 financial reports, the focus on addressing the needs of millions of patients failing current therapies suggests this is an ongoing, defintely necessary component of the commercial preparation strategy.

Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Channels

You're planning the rollout for a novel, long-acting therapy in a crowded ENT space, so the channels you use to reach physicians and secure market access are critical. Here's the current state of Lyra Therapeutics, Inc.'s (LYRA) approach to getting LYR-210 to the right hands.

Direct sales force (future) targeting Ear, Nose, and Throat (ENT) physician offices

Lyra Therapeutics, Inc. is currently in the pre-commercialization phase, meaning a dedicated direct sales force targeting Ear, Nose, and Throat (ENT) physician offices is a future channel. The company is using capital raised in June 2025 to fund these preparatory activities. Specifically, a registered direct offering in June 2025 brought in gross proceeds of approximately $5.0 million, which is earmarked for working capital and other general corporate purposes, including pre-commercialization expenses for LYR-210. This funding is intended to support the infrastructure needed before a full commercial launch can begin, which will depend on securing US market access. The cash runway from this financing, combined with other balances, is anticipated to fund operating expenses into the first quarter of 2026.

Medical conferences and peer-reviewed publications for data dissemination

Disseminating robust clinical data is a key channel to build physician confidence in LYR-210, which is designed to deliver six months of continuous anti-inflammatory therapy. Lyra Therapeutics, Inc. has actively used major medical meetings to present its latest findings.

• Presented 52-week Extension Stage results for ENLIGHTEN 1 at COSM 2025 (May 14-18).
• Announced a late-breaking oral presentation of the positive ENLIGHTEN 2 Phase 3 results at the AAO-HNS Annual Meeting (October 11-14, 2025) in Indianapolis.
• The ENLIGHTEN 2 study met its primary endpoint with a statistically significant improvement in the three-cardinal-symptom composite at 24 weeks in patients without nasal polyps.

Regulatory submission pathway (FDA) for US market access

The primary channel for US market access is the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). Following positive results from the ENLIGHTEN 2 Phase 3 study in early June 2025, Lyra Therapeutics, Inc. has reengaged with the FDA. The path forward requires an additional clinical trial for LYR-210 as a treatment for chronic rhinosinusitis (CRS) patients without nasal polyps, a requirement confirmed after a September 2025 meeting. The company is preparing for an upcoming Type C meeting with the FDA in the second half of 2025 to align on the final path for the NDA submission. Lyra has resumed in-house Chemistry, Manufacturing and Controls (CMC) activities to prepare for future manufacturing compliance.

LianBio partnership for commercialization in licensed Asian territories

Commercialization in specific Asian territories is handled through the exclusive license agreement with LianBio. This partnership covers Greater China (mainland China, Hong Kong, Taiwan, and Macau), South Korea, Singapore, and Thailand. Lyra Therapeutics, Inc. retains all rights outside these territories. The financial structure of this channel is already generating revenue.

Here are the key terms of the LianBio License Agreement:

Term Component	Value/Detail
Upfront Payment Received	$12 million
Total Potential Milestone Payments	Up to $135 million
Royalty Structure	Low double-digit royalties based on net sales
Collaboration Revenue Recognized (as of Q1 2025)	$4.9 million
Licensed Territories	Greater China, South Korea, Singapore, and Thailand

LianBio is responsible for the clinical development and commercialization activities within these licensed regions. The agreement will expire on a region-by-region basis upon the latest of patent expiration, regulatory exclusivity expiration, or a specified number of years from the first commercial sale in that region.

Finance: review Q4 2025 cash burn against runway projection into Q1 2026 by next Tuesday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Customer Segments

You're looking at the core patient and provider base for Lyra Therapeutics, Inc. as they push LYR-210 toward final regulatory steps. The numbers tell a clear story about the size of the unmet need they are targeting.

Adult Chronic Rhinosinusitis (CRS) patients who have failed medical management

The addressable population here is substantial. Lyra Therapeutics, Inc. is focused on the estimated four million CRS patients in the United States who fail medical management each year. Overall CRS affects ~12% of the US population, with approximately ~8M patients treated annually. The total annual healthcare expenditure related to CRS is pegged at ~$60B. This segment represents patients who require further intervention beyond standard therapies.

CRS patients without nasal polyps (CRSsNP), the current primary focus

This is where the near-term regulatory focus lies, following the positive ENLIGHTEN 2 Phase 3 trial results announced in June 2025. The CRSsNP subtype is the larger group within the CRS spectrum, accounting for approximately ~70% of all CRS patients. The ENLIGHTEN 2 trial specifically met its primary endpoint in this non-polyp patient group at week 24. However, the path to market for this indication requires an additional confirmatory Phase 3 clinical trial, as confirmed after the September 2025 FDA meeting.

Here's a quick look at the CRS breakdown based on available data:

CRS Subtype	Approximate Percentage of Total CRS Patients	Key Product Focus/Data Point
CRS without Nasal Polyps (CRSsNP)	~70%	Primary focus of ENLIGHTEN 2 trial success
CRS with Nasal Polyps (CRSwNP)	~30%	Pooled data from ENLIGHTEN 1 and 2 showed positive trends

ENT specialists and Rhinologists who perform in-office procedures

The delivery mechanism for LYR-210 dictates a key customer segment: the physicians who perform the administration. LYR-210 is a bioabsorbable nasal implant designed to be inserted in a simple, in-office procedure, delivering 6 months of continuous anti-inflammatory therapy (7500µg mometasone furoate). This procedure-based delivery targets specialists comfortable with in-office sinus interventions. Lyra Therapeutics, Inc.'s operations manage its business as a single operating segment focused on Ear, Nose, and Throat (ENT) diseases, meaning the entire commercial effort is geared toward this provider base.

The treatment profile for the two main product candidates targets different procedural settings:

• LYR-210: Designed for surgically naïve patients.
• LYR-220: An enlarged implant being evaluated in the BEACON Phase 2 trial for patients with recurrent symptoms despite prior ethmoid sinus surgery.

Healthcare payers and insurance providers for reimbursement coverage

Payers are critical gatekeepers for access, especially given the high unmet need and the estimated ~$60B annual healthcare expenditure for CRS. The company's financial standing provides context for their near-term focus on securing coverage. As of September 30, 2025, Lyra Therapeutics, Inc. reported cash and cash equivalents of $22.1 million, with an anticipation that this balance will fund operations into the third quarter of 2026. The net loss for Q3 2025 was $6.0 million, and the trailing twelve-month revenue as of September 30, 2025, was $600K. Securing favorable coverage policies from third-party payors, including Medicare and Medicaid, will be essential to realizing the value from the targeted patient population.

Key financial metrics influencing payer negotiations as of late 2025:

• Cash on Hand (Sep 30, 2025): $22.1 million.
• Projected Cash Runway: Into Q3 2026.
• Q3 2025 Net Loss: $6.0 million.
• Market Capitalization (Nov 7, 2025): $7.58M.

Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Lyra Therapeutics, Inc.'s (LYRA) operations as of late 2025, which clearly shows a company streamlining after major clinical milestones and workforce adjustments. The focus is tight, centered on advancing the next critical step for LYR-210.

The most recent reported quarterly figures from the third quarter of 2025 give you a clear picture of the current cost base. You can see the impact of wrapping up the ENLIGHTEN 2 trial and the lingering effect of the 2024 workforce changes.

Cost Category	Amount (Q3 2025)	Context
Research and development expenses	$4.0 million	For the three months ended September 30, 2025.
General and administrative expenses	$2.2 million	For the three months ended September 30, 2025.
Net Loss	$6.0 million	For the third quarter of 2025.
Cash and cash equivalents	$22.1 million	As of September 30, 2025.

The Research and Development (R&D) spend for Q3 2025 was $4.0 million, a significant drop from $5.9 million in the same period in 2024. This reduction is directly tied to the completion of prior studies and ongoing lean operations.

Here's how the R&D costs broke down for the three months ended September 30, 2025:

• Decrease in clinical related costs of $2.1 million due to the completion of the ENLIGHTEN 2 trial for LYR-210.
• Increase in product development and manufacturing costs of $0.1 million.
• Decrease in employee related costs of $0.1 million, reflecting the May 2024 reduction in force.
• Increase in professional and consulting fees of $0.2 million.

Clinical trial expenses for the new confirmatory Phase 3 study are the next major planned outlay, though the specific Q3 2025 charge related to starting this new trial isn't itemized; the reported R&D decrease was largely due to the completion of the ENLIGHTEN 2 trial. Lyra Therapeutics is now focused on putting the components in place for this next trial to support a New Drug Application (NDA) submission.

General and administrative (G&A) expenses were $2.2 million for Q3 2025, down from $3.9 million year-over-year. This reduction was primarily driven by lower personnel costs following the 2024 workforce reduction, specifically a decrease in employee related costs of $1.6 million within G&A. The company also incurred a restructuring credit of $21 thousand in Q3 2025, compared to a restructuring charge of $2.8 million in Q3 2024 related to those earlier workforce adjustments.

Regarding manufacturing and quality control costs for LYR-210 supply, the most recent data shows a slight increase within R&D. Specifically, product development and manufacturing costs rose by $0.1 million in Q3 2025. This contrasts with the prior year, where product development and manufacturing costs had decreased by $1.0 million year-over-year for the full year 2024 as part of earlier cost-cutting measures, which included halting manufacturing efforts.

Personnel costs are definitely lower, as the May 2024 reduction in force continues to impact the expense base. You saw a $0.1 million reduction in R&D employee costs and a $1.6 million reduction in G&A employee costs for Q3 2025 alone compared to the prior year. Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Lyra Therapeutics, Inc. (LYRA) as of late 2025, and honestly, it's a picture of pre-commercial potential, heavily reliant on partnerships and financing to keep the lights on while LYR-210 moves through its final stages. Right now, the actual cash coming in from operations is minimal, which is typical for a clinical-stage biotech focused on a single asset.

The immediate, realized revenue is sparse, stemming almost entirely from existing agreements. You see this clearly in the latest quarterly filing.

• Collaboration revenue for the three months ended September 30, 2025, was reported at $25 thousand.
• For the nine months ended September 30, 2025, total collaboration revenue reached $391 thousand.

The company's cash position is being supplemented by capital markets activity. The June 2025 financing event provided a necessary cash infusion to support the path toward the New Drug Application (NDA) submission for LYR-210.

Here's a look at that recent equity raise:

Financing Event	Date	Gross Proceeds (Expected)	Estimated Net Proceeds
Registered Direct Offering & Concurrent Private Placement	June 2025	$5.0 million	Approximately $4.4 million

Future revenue is entirely contingent on the success of LYR-210, particularly the progress of the LianBio collaboration for Greater China and other Asian markets. Product sales revenue is currently zero, as the product is still investigational and awaiting regulatory approval.

The LianBio agreement is the primary driver of potential future non-dilutive funding. This partnership, which covers development and commercialization in key Asian territories, is structured around performance-based payments and ongoing sales participation. You should definitely track these milestones closely.

• Total potential milestone payments from LianBio are capped at up to $135 million, contingent on specified development, regulatory, and commercialization achievements.
• The initial upfront payment received upon execution of the agreement was $12.0 million.
• The company is also eligible for low double-digit royalties on net sales of LYR-210 achieved by LianBio in the licensed territories.

To be fair, the path to realizing those milestone payments and royalties is long, as it depends on regulatory success in multiple jurisdictions following the confirmatory Phase 3 trial for LYR-210. Finance: draft 13-week cash view by Friday.