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

You're looking at a biotech right at the inflection point, and frankly, the story of Akero Therapeutics, Inc. is about to change chapters; they are no longer just a clinical-stage player, but an acquisition target for Novo Nordisk as of October 2025, all hinged on their lead drug, efruxifermin (EFX). Honestly, it's a classic story: a company with a potential first-in-class MASH therapy showing real cirrhosis reversal data, sitting on a war chest of over $1.086 billion in cash and marketable securities as of Q2 2025, just before the deal closes. We've mapped out the entire nine-block Business Model Canvas for you-from their key R&D costs nearing $69.3 million in Q2 to the specific customer segments they target-so you can see exactly how this value was built and what the new owner inherits. Dive in below to see the full strategic blueprint.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Key Partnerships

You're looking at the critical external relationships that underpin Akero Therapeutics, Inc.'s strategy as of late 2025. These aren't just names on a slide; they represent significant financial commitments and future value drivers.

Imminent acquisition by Novo Nordisk (announced Oct 2025)

The definitive agreement for Novo Nordisk A/S to acquire Akero Therapeutics, Inc. was announced on October 9, 2025. The total potential transaction value is up to $5.2 billion in cash.

• Upfront cash payment per share: $54.00.
• Total upfront equity value: approximately $4.7 billion.
• Contingent Value Right (CVR) per share: $6.00.
• Aggregate potential CVR payment: $500 million.
• CVR payout contingent on U.S. regulatory approval of efruxifermin (EFX) for compensated cirrhosis due to MASH by June 30, 2031.
• The transaction was expected to close around year-end 2025.

Exclusive intellectual property license agreement with Amgen

Akero Therapeutics, Inc. entered into an exclusive license agreement with Amgen Inc. in June 2018. This grants Akero Therapeutics, Inc. exclusive, royalty-bearing license rights to certain intellectual property, including patents covering the composition of EFX.

The initial consideration paid to Amgen included:

• Upfront payment of $5.0 million.
• Issuance of 2,653,333 shares of Series A preferred stock.
• Total consideration transferred, recorded as R&D expense, was $6,353 thousand.

Contract Research Organizations (CROs) for global Phase 3 trial execution

Akero Therapeutics, Inc. relies on third parties to conduct its clinical trials. The Phase 3 SYNCHRONY program involves three ongoing, randomized, placebo-controlled trials.

Phase 3 Trial Name	Patient Population Focus	Enrollment/Status Detail	Data Anticipation
SYNCHRONY Histology	Pre-cirrhotic MASH (F2-F3 fibrosis)	Ongoing evaluation of efficacy and safety	Not explicitly stated as of late 2025
SYNCHRONY Real-World	MASH or MASLD (F1-F4 fibrosis)	Completed enrollment of 601 patients in the double-blind portion as of January 13, 2025	Anticipated in the first half of 2026
SYNCHRONY Outcomes	Compensated cirrhosis (F4) due to MASH	Ongoing evaluation of effectiveness and safety	Not explicitly stated as of late 2025

The Research and development expenses for the three-month period ended June 30, 2025, were $69.3 million, an increase from $55.3 million in the comparable period in 2024, due in part to higher expenses for the ongoing Phase 3 studies.

Established industry partners for clinical and potential commercial manufacturing

The initial license from Amgen included the transfer of know-how related to EFX manufacture and quantities of GMP-manufactured EFX drug substance for clinical use. Financing secured in December 2018 was intended to support the scaling of manufacturing capabilities. The Q2 2025 R&D expenses also reflected costs for the manufacture of clinical supplies for Phase 3 and potential marketing applications.

Key opinion leaders (KOLs) and clinical investigators for MASH trials

Data from the Phase 2b trials were presented at the 76th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 in November 2025.

• Presenter for SYMMETRY data: Vlad Ratziu, M.D., Ph.D., Professor of Hepatology, Sorbonne Université and the Hôpital Pitié-Salpêtrière Medical School.
• Presenter for Baveno VII criteria data: Mazen Noureddin, M.D., M.H.Sc., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research Institute.
• Presenter for HARMONY histology analysis: Jörn M. Schattenberg, M.D., Professor of [unspecified institution].
• Commentary provided by Kitty Yale, chief development officer of Akero Therapeutics, Inc..

The company's cash, cash equivalents, and marketable securities were reported as $1.08 billion as of June 30, 2025, expected to fund operations into 2028.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Key Activities

You're managing the execution of a pivotal late-stage clinical program, so the key activities are laser-focused on generating data to support commercialization for efruxifermin (EFX).

The core activity involves executing three ongoing Phase 3 SYNCHRONY clinical trials for EFX, which is a global program across approximately 3,500 patients.

• SYNCHRONY Histology: For patients with pre-cirrhotic (F2-F3 fibrosis) MASH.
• SYNCHRONY Outcomes: For patients with compensated cirrhosis (F4) due to MASH.
• SYNCHRONY Real-World: For patients with MASH or MASLD (F1-F4), with double-blind enrollment completed in January 2025. Preliminary results are anticipated in the first half of 2026.

A significant activity is Research and Development (R&D) of EFX and next-generation candidates, which is reflected in the operating expenses. Research and development expenses for the three-month period ended June 30, 2025, were \$69.3 million, up from \$55.3 million in the comparable period in 2024. For the first quarter of 2025, R&D expenses were \$69.6 million.

Manufacturing clinical supplies and scaling up for potential commercial launch is a concurrent key activity, as evidenced by the R&D expense increases being attributable to the manufacture of clinical supplies for Phase 3 and potential marketing applications. This preparation supports the market opportunity, which is projected to exceed \$10 billion by 2030.

Engaging with global regulatory bodies (e.g., FDA) has resulted in major milestones. Efruxifermin (EFX) received a Breakthrough Therapy Designation from the FDA in December 2022. More recently, Akero Therapeutics secured FDA approval for efruxifermin (EFX) to treat MASH on June 28, 2025. The company also had a positive End-of-Phase 2 meeting with the FDA regarding the SYNCHRONY Phase 3 program.

The company is actively presenting clinical data at major scientific conferences (e.g., AASLD 2025). Akero Therapeutics presented new analyses from the Phase 2b SYMMETRY and HARMONY trials at the 76th Annual AASLD The Liver Meeting® 2025 in November 2025. These presentations included 96-week data from the SYMMETRY study (compensated cirrhosis, F4c) and AI-powered histology results from the HARMONY study (pre-cirrhotic F2-F3 MASH).

Here's a quick look at the financial position supporting these activities as of mid-2025:

Financial/Operational Metric	Amount/Value	Date/Period
Cash, Cash Equivalents, Marketable Securities	\$1,086.2 million	June 30, 2025
Cash, Cash Equivalents, Marketable Securities	\$1,128.3 million	March 31, 2025
R&D Expenses	\$69.3 million	Three Months Ended June 30, 2025
R&D Expenses	\$69.6 million	Three Months Ended March 31, 2025
Total Operating Expenses	\$80.9 million	Three Months Ended June 30, 2025
Gross Proceeds from January 2025 Offering	Approximately \$402.5 million	January 30, 2025
Cash Runway Projection	Sufficient into 2028	As of Q2 2025

The company is definitely spending heavily to drive these late-stage trials forward.

Finance: draft 13-week cash view by Friday.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Key Resources

You're looking at the core assets Akero Therapeutics, Inc. (AKRO) is using to drive its MASH (metabolic dysfunction-associated steatohepatitis) program forward. These aren't just line items; they are the foundation supporting the next few years of development.

The lead product candidate is Efruxifermin (EFX), which is an Fc-FGF21 fusion protein. This molecule is the entire focus of the company's near-term value creation. The clinical validation for EFX is a massive resource in itself, especially the data from the Phase 2b SYMMETRY trial.

Here's the quick math on the clinical proof points, which are crucial for any potential partnership or future commercialization:

Metric	Value	Context
Cash & Marketable Securities	$1,086.2 million	As of June 30, 2025 (Q2 2025)
Cash Runway Projection	Into 2028	Based on current operating plan
R&D Expenses (3 Months)	$69.3 million	Q2 2025
Total Operating Expenses (3 Months)	$80.9 million	Q2 2025
SYMMETRY 50mg Group Fibrosis Reversal ($\ge$1-stage)	39%	Week 96, Phase 2b
Placebo Group Fibrosis Reversal ($\ge$1-stage)	0%	Week 96, Phase 2b

The proprietary clinical data demonstrating cirrhosis reversal is a defining asset. Specifically, the 96-week results from the Phase 2b SYMMETRY study, published in the New England Journal of Medicine on May 9, 2025, showed statistically significant reversal of compensated cirrhosis (F4) due to MASH. Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group achieved $\ge$1-stage improvement in fibrosis with no worsening of MASH; that's a 24% effect size over the placebo group's 0% rate.

Financially, Akero Therapeutics, Inc. maintains a strong balance sheet. As of the end of Q2 2025, the company held $1,086.2 million in cash, cash equivalents, and short and long-term marketable securities. Management stated this level of capital is sufficient to fund the current operating plan into 2028, which covers the progression through the Phase 3 SYNCHRONY trials.

The intellectual property portfolio is another key resource, specifically protecting EFX and its use in MASH. This legal moat secures the potential market exclusivity for the drug candidate as it moves through the SYNCHRONY Histology, Real-World, and Outcomes studies.

Finally, the human capital is specialized scientific and clinical development personnel. These teams are managing three concurrent Phase 3 trials, which drove Research and Development Expenses up to $69.3 million for the three months ended June 30, 2025, up from $55.3 million in the comparable period of 2024.

You should keep an eye on the R&D spend; it reflects the scale of the ongoing Phase 3 work.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Akero Therapeutics, Inc. believes its lead candidate, efruxifermin (EFX), stands out for patients suffering from Metabolic Dysfunction-associated Steatohepatitis (MASH). The value centers on addressing the severe, life-threatening progression of this disease, especially in later stages where options are nonexistent.

The data supports the potential for EFX to be a first- and best-in-class therapy. For patients with compensated cirrhosis (F4) due to MASH, the Phase 2b SYMMETRY trial showed statistically significant reversal of this advanced scarring. Specifically, in subjects with baseline and week 96 biopsies, 39% treated with the 50mg dosage achieved cirrhosis reversal without worsening of MASH, compared to 15% on placebo. For the Intent to Treat (ITT) population, 29% showed this reversal. This is a major differentiator; patients with cirrhosis due to MASH face a 50 percent chance of dying within five years without a liver transplant.

The therapy addresses a population in urgent need. By 2030, an estimated 3 million Americans are projected to have MASH-related cirrhosis. Furthermore, EFX has shown promise in earlier stages. In the Phase 2b HARMONY trial for pre-cirrhotic MASH (F2-F3), 35% of patients on 50mg EFX met a composite endpoint of MASH resolution and at least a one-stage fibrosis improvement, versus only 7% for placebo. Almost one-third of participants on the 50mg dose saw near complete disease reversal.

Here's a quick look at how the Phase 2b data stacks up for these critical endpoints:

Patient Group/Endpoint	Treatment Group	Response Rate
Compensated Cirrhosis (F4) Reversal (Completers)	EFX 50mg	39%
Compensated Cirrhosis (F4) Reversal (Completers)	Placebo	15%
Pre-cirrhotic MASH (F2-F3) MASH Resolution + $\geq$1 Fibrosis Stage Improvement (mITT)	EFX 50mg	35%
Pre-cirrhotic MASH (F2-F3) MASH Resolution + $\geq$1 Fibrosis Stage Improvement (mITT)	Placebo	7%

The approach is holistic, aiming to treat the multi-system nature of MASH. EFX has been shown to improve liver histology, resolve MASH, reduce non-invasive markers of liver injury, and improve insulin sensitivity and lipoprotein profile. New analyses also reinforced statistically significant improvements in noninvasive measures linked to a lower risk of liver-related events and clinically significant portal hypertension (CSPH) in compensated cirrhosis (F4c).

Convenience is built into the commercial plan. Patients in the ongoing Phase 3 studies self-administer EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use. EFX is designed for convenient once-weekly dosing. This planned delivery mechanism supports long-term use, which the data suggests is important for sustained response. To support this development, Akero Therapeutics reported cash, cash equivalents, and short and long-term marketable securities of $1,086.2 million as of June 30, 2025. That's a solid war chest for a company pushing through Phase 3 trials; defintely a sign of confidence in the path forward.

The value proposition can be summarized by the functional benefits:

• Potential for first- and best-in-class MASH therapy.
• Statistically significant reversal of compensated cirrhosis (F4).
• Addresses high unmet need in advanced-stage MASH.
• Convenient once-weekly subcutaneous self-administration.
• Improves liver histology and multiple metabolic biomarkers.

Finance: draft 13-week cash view by Friday.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Customer Relationships

You're looking at the relationships Akero Therapeutics, Inc. (AKRO) maintained with key stakeholders as of late 2025, which is a critical period following major data releases and a significant corporate event.

High-touch collaboration with clinical investigators and trial sites

The relationship with clinical investigators is centered on advancing the Phase 3 SYNCHRONY program, which builds upon the robust Phase 2 program. This collaboration is essential for gathering the data needed for marketing authorization applications.

The Phase 3 program consists of three trials, all designed in consultation with global regulatory authorities:

• SYNCHRONY Histology, for pre-cirrhotic (F2-F3) MASH.
• SYNCHRONY Real-World, for noninvasively diagnosed MASH or MASLD (F1-F4).
• SYNCHRONY Outcomes, for compensated cirrhosis (F4) due to MASH.

The SYNCHRONY Real-World and SYNCHRONY Histology studies began enrolling patients in the fourth quarter of 2023, while SYNCHRONY Outcomes began enrolling in the third quarter of 2024. The SYMMETRY Phase 2b trial, which informed this Phase 3 design, was a multicenter trial that enrolled 182 patients.

Direct, authoritative communication with regulatory agencies (FDA, EMA)

Akero Therapeutics, Inc. maintains direct engagement with regulatory bodies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding efruxifermin (EFX). The Phase 3 SYNCHRONY studies were specifically designed in consultation with global regulatory authorities. EFX is noted as being under review by the FDA for Non-alcoholic steatohepatitis (NASH). New findings presented on November 7, 2025, showed EFX led to statistically significant reductions in clinically significant portal hypertension risk, as measured by Baveno criteria, which is a key regulatory consideration for advanced liver disease.

Investor Relations (IR) via presentations at major healthcare conferences (e.g., J.P. Morgan 2025)

Investor relationships are managed through frequent, high-profile presentations to the financial community. The company presented at several key 2025 healthcare conferences:

Conference Name	Date of Presentation (2025)	Time/Time Zone
J.P. Morgan Healthcare Conference	January 14	11:15 a.m. Pacific Time
BofA Securities Health Care Conference	May 13	1:40 p.m. P.T.
Jefferies Global Healthcare Conference	June 4	8:45 AM EDT
Goldman Sachs 46th Annual Global Healthcare Conference	June 10	2:40 PM EDT
Morgan Stanley 23rd Annual Global Healthcare Conference	September 8	10:45 a.m. E.T.

The company's cash, cash equivalents, and marketable securities stood at $1,086.2 million as of June 30, 2025. This followed a follow-on public offering in January 2025 that raised gross proceeds of approximately $402.5 million. The stock price on November 25, 2025, was $54.32.

Scientific engagement through peer-reviewed publications (e.g., New England Journal of Medicine in May 2025)

Scientific engagement is validated through top-tier peer-reviewed publications and major medical society presentations. A significant milestone was the publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine on May 9, 2025.

Key efficacy data from the SYMMETRY study (evaluating EFX in compensated cirrhosis F4) included:

• Among patients with baseline and week 96 biopsies (N=134), 39% of the 50mg EFX group showed $\geq$1-stage fibrosis improvement without MASH worsening, versus 15% for placebo.
• Using an intent-to-treat analysis (N=181), 29% of the 50mg EFX group showed reversal of cirrhosis with no worsening of MASH, versus 12% for placebo.

Further data reinforcing the anti-fibrotic activity of EFX across MASH stages were presented at the 76th Annual AASLD The Liver Meeting® 2025 in November 2025.

Future commercial sales force and patient support programs post-approval

Preparation for a potential commercial launch was explicitly stated as a use of proceeds from the January 2025 financing, which generated gross proceeds of approximately $350.0 million. The company has a Senior VP of Commercial Strategy, Patrick Lamy. The cash position as of June 30, 2025, of $1,086.2 million was believed sufficient to fund the current operating plan into 2028, which includes preparing for a potential commercial launch.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Channels

You're looking at how Akero Therapeutics, Inc. gets its science and, eventually, its drug, efruxifermin (EFX), out to the world. For a clinical-stage company, the channels are heavily weighted toward scientific validation and physician education right now, with commercial distribution being a future, planned channel.

Global network of clinical trial sites for patient enrollment

The current channel for patient access is through the ongoing Phase 3 SYNCHRONY clinical trial program. This network is designed to support the progression of EFX toward potential marketing authorization.

• SYNCHRONY Histology and SYNCHRONY Real-World studies began enrolling patients in the fourth quarter of 2023.
• SYNCHRONY Outcomes began enrolling patients in the third quarter of 2024.
• The double-blind portion of SYNCHRONY Real-World completed enrollment with 601 patients as of January 13, 2025.
• The Phase 2b SYMMETRY study, which informed the Phase 3 design, enrolled 182 patients.

Scientific and medical journals for data dissemination to physicians

Dissemination of trial results through peer-reviewed publications is a critical channel for establishing scientific credibility with the broader medical community. The 96-week results from the Phase 2b SYMMETRY study were supported by a peer-reviewed publication in the New England Journal of Medicine.

Medical conferences (AASLD, EASL) for direct physician education

Direct engagement with key opinion leaders and practicing physicians happens at major liver disease congresses. Akero Therapeutics utilized these forums extensively in 2025 to present data on EFX.

Akero Therapeutics presented new analyses from the Phase 2b SYMMETRY and HARMONY trials at the 76th Annual AASLD The Liver Meeting® 2025, held in Washington, D.C., from November 7-11, 2025. This included two oral and two poster presentations. Furthermore, new 96-week SYMMETRY findings were presented at the EASL Congress 2025 in Amsterdam, the Netherlands, from May 7-10, 2025.

Here's a look at the 2025 conference channel activity:

Conference Name	Date(s) in 2025	Presentation Type Count	Key Data Presented
AASLD The Liver Meeting® 2025	November 7-11, 2025	2 Oral, 2 Poster	96-week SYMMETRY and HARMONY results
EASL Congress 2025	May 7-10, 2025	Oral and Poster (Count not specified)	New 96-week SYMMETRY findings

Future specialty pharmacy and distribution networks for drug delivery

While EFX is not yet commercially available, the company is preparing its supply chain, evidenced by activities related to manufacturing clinical supplies for potential marketing applications. The preparation for commercial launch will involve establishing relationships within the specialty distribution ecosystem.

For context on the market Akero Therapeutics is preparing to enter, specialty pharmaceuticals represent nearly 55% of the drug market as of 2025, with an estimated 2,000 unique specialty pharmacy locations in the U.S.. Akero Therapeutics is currently manufacturing clinical supplies for Phase 3 and potential marketing applications.

Investor relations website and SEC filings for financial communication

The Investor Relations website serves as the primary digital channel for communicating financial health and corporate progress to stockholders and analysts. The company provided updates through its quarterly filings and participation in investor conferences throughout 2025.

Key financial and communication data points as of late 2025:

• Cash, cash equivalents, and marketable securities as of June 30, 2025: $1,086.2 million.
• Projected funding sufficiency: Into 2028.
• R&D expenses for the three months ended June 30, 2025: $69.3 million.
• R&D expenses for the three months ended March 31, 2025: $69.6 million.
• Investor conferences attended in 2025 include the Morgan Stanley Global Healthcare Conference on September 8, 2025, and the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Customer Segments

You're looking at the core groups Akero Therapeutics, Inc. (AKRO) needs to satisfy to get efruxifermin (EFX) to market and generate revenue. This isn't just about patients; it's about the entire ecosystem that validates and prescribes the therapy.

Patients with biopsy-confirmed pre-cirrhotic MASH (F2-F3 fibrosis)

This group is targeted by the SYNCHRONY Histology Phase 3 trial, building on the Phase 2b HARMONY study data. The overall US adult population with MASH and clinically significant fibrosis (stage $\geq$F2) was projected to increase to 11.7 million cases by 2050 from 6.7 million in 2020.

Patients with compensated cirrhosis (F4) due to MASH

This is a high-need segment where EFX showed a defining result in the Phase 2b SYMMETRY study. The US adult population with MASH cirrhosis (F4) was projected to increase from 1.147 million in 2020 to 2.192 million by 2050. The 96-week data from SYMMETRY showed 39% of patients on the 50 mg EFX dose achieved $\geq$1 stage improvement in fibrosis with no worsening of MASH, compared to 15% on placebo. This trial is supported by the SYNCHRONY Outcomes Phase 3 study.

Here's a quick look at the patient focus areas for the SYNCHRONY Phase 3 program, which involves approximately N~3,500 patients globally.

Customer Sub-Segment	Fibrosis Stage Target	Key Clinical Trial Support	Observed Efficacy (50mg EFX vs Placebo)
Pre-cirrhotic MASH Patients	F2-F3	HARMONY (Phase 2b), SYNCHRONY Histology (Phase 3)	Corroborated fibrosis improvements via conventional and AI-based pathology analysis
Compensated Cirrhosis Patients	F4	SYMMETRY (Phase 2b), SYNCHRONY Outcomes (Phase 3)	39% vs 15% for $\geq$1 stage fibrosis improvement at 96 weeks

The overall MASH market opportunity is substantial, with estimates suggesting it could reach $16 billion by 2033.

Hepatologists, gastroenterologists, and endocrinologists treating MASH/MASLD

These are the prescribers. Their segment needs compelling data showing meaningful clinical benefit, especially in advanced stages like F4, which was previously managed only by transplant. The data showing statistically significant improvements in clinically significant portal hypertension (CSPH) risk in F4 patients is critical for this group. The company's financial position, with $176.03 million in cash and cash equivalents as of September 30, 2025, allows for the continued execution of the Phase 3 program to generate the necessary data for adoption. Research and development expenses for the three months ended September 30, 2025, were $78.88 million, reflecting the investment needed to deliver this data.

Global regulatory bodies (FDA, EMA) as primary gatekeepers for market access

These bodies require robust safety and efficacy data from the three ongoing Phase 3 SYNCHRONY trials to support marketing applications for both F2-F3 and F4 MASH populations. The company is positioning EFX as a potential first- and best-in-class therapy with disease-modifying activity, especially in advanced-stage MASH. The company's valuation as of November 2025 was $4.32 billion, and a potential transaction mentioned was up to $5.2 billion, indicating market confidence in the regulatory pathway.

• SYNCHRONY Real-World preliminary results expected in the first half of 2026.
• SYNCHRONY Histology readout expected in the first half of 2027.

Akero Therapeutics, Inc. believes its current funding is sufficient to fund its operating plan into 2028.

Finance: finalize the projected peak sales model based on F2-F3 and F4 patient segment sizes by end of Q4 2025.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Cost Structure

You're looking at the major cash outlays for Akero Therapeutics, Inc. (AKRO) as they push efruxifermin (EFX) through late-stage development. The cost structure is heavily weighted toward clinical execution right now, which is typical for a clinical-stage biotech.

Dominant Research and Development (R&D) expenses for Phase 3 trials represent the largest single cost driver. For the three-month period ended June 30, 2025, Research and development expenses totaled $69.3 million. This spending reflects the intensity of the ongoing Phase 3 SYNCHRONY Histology, Real-World, and Outcomes studies.

Manufacturing costs for clinical trial materials and commercial scale-up are embedded within the R&D spend. Specifically, the increase in R&D was attributable to the 'manufacture of clinical supplies for Phase 3 and potential marketing applications.' This shows Akero Therapeutics is already spending to secure supply chains ahead of potential approval.

General and Administrative (G&A) overhead, including personnel and public company costs, is the next significant category. For the same period ending June 30, 2025, General and administrative expenses were $11.6 million. These costs cover personnel increases, professional services, and the general overhead associated with operating as a public company.

The total operating expenses for the second quarter of 2025 reached $80.9 million. This is a clear picture of where the cash is going before any potential revenue generation. Honestly, the burn rate is dictated by the Phase 3 timeline.

Here's a quick look at the recent operating expense trend:

Metric (USD Millions)	Q1 2025	Q2 2025
Research & Development (R&D)	69.6	69.3
General & Administrative (G&A)	11.3	11.6
Total Operating Expenses	80.9	80.9

Intellectual property maintenance and licensing fees are necessary costs to protect the efruxifermin asset. While not broken out separately in the latest public filings, these are ongoing, non-discretionary expenses required to maintain the patent estate surrounding EFX.

Pre-commercialization and market access planning costs are also factored into the current operating expenses, primarily within G&A. As Akero Therapeutics moves closer to potential launch, these costs will likely increase, covering activities like:

• Building out commercial infrastructure planning.
• Engaging with payers for market access strategies.
• Developing medical affairs capabilities.

To be fair, the company's cash position as of June 30, 2025, was $1,086.2 million in cash, cash equivalents, and marketable securities, which they believe funds the current operating plan into 2028. Finance: draft the projected OpEx for Q3 2025 based on current run-rate by next Tuesday.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Akero Therapeutics, Inc. (AKRO) as of late 2025. Since this is a clinical-stage biotech, the revenue picture is entirely focused on financing the pipeline, not product sales yet. It's all about the burn rate versus the runway funded by capital markets and investment returns.

Zero current product revenue; the company is clinical-stage

Honestly, this is the expected reality for a company deep in Phase 3 trials. Akero Therapeutics, Inc. is not selling a commercial product right now. For the third quarter of 2025, GAAP Revenue was reported as $0.0. Similarly, for the second quarter of 2025, GAAP Revenue was also $0.0. The focus remains entirely on advancing efruxifermin (EFX) through the SYNCHRONY program to achieve regulatory approval for MASH.

The current revenue streams are purely financial, supporting the high Research and Development expenses, which hit $69.3 million for the three months ended June 30, 2025.

Capital raised through equity offerings

The primary source of operational funding comes from successful equity financing events. The most significant recent infusion was in the first quarter of 2025. Akero Therapeutics, Inc. closed an underwritten public offering on January 30, 2025, securing substantial non-dilutive funding.

Here's the quick math on that January 2025 raise:

Metric	Amount/Price
Total Gross Proceeds	$402.5 million
Common Stock Price	$48.00 per share
Pre-Funded Warrant Price (Effective)	Approximately $47.9999 per warrant

This capital influx was critical for funding the ongoing Phase 3 SYNCHRONY Histology, Real-World, and Outcomes studies.

Interest income from substantial cash and marketable securities

Holding a large cash balance generates a secondary, passive revenue stream through interest income. You want to see this number high, as it means the company has a long runway without needing to tap the markets again soon. Akero Therapeutics, Inc. maintains a significant war chest from prior financing activities.

• Cash, cash equivalents, and short- and long-term marketable securities as of June 30, 2025: $1,086.2 million.
• Cash, cash equivalents, and short- and long-term marketable securities as of March 31, 2025: $1,128.3 million.

Management has stated that this cash position is expected to fund the current operating plan into at least 2028. The interest earned on this balance is a non-operating revenue component.

Future potential milestone payments or royalties from licensing deals (pre-acquisition)

As of late 2025, this remains a contingent, non-realized revenue stream. Akero Therapeutics, Inc. has not announced any specific, realized milestone payments or royalty income streams tied to EFX or other assets from licensing agreements. This category represents potential upside if the company enters into a partnership before a full commercial launch or acquisition.

Future revenue from commercial sales of EFX post-regulatory approval (projected)

The ultimate revenue stream is the commercial sale of efruxifermin (EFX) following regulatory clearance. This is entirely forward-looking and dependent on clinical success. Preliminary topline results from the SYNCHRONY Real-World study are expected in the first half of 2026, with the SYNCHRONY Histology readout targeted for the first half of 2027. Successful outcomes in these Phase 3 trials are the gate to generating product sales revenue.

The company's strategy is built on EFX potentially becoming a first- and best-in-class therapy for MASH, especially given the published data showing reversal of compensated cirrhosis (F4) due to MASH.

Finance: draft 13-week cash view by Friday.