fortress biotech corporate presentation

Fortress Biotech, Inc.

Press releases, fortress biotech reports first quarter 2024 financial results and recent corporate highlights.

Fortress‘ late-stage pipeline continues to advance and may generate up to three regulatory approvals on NDAs and BLAs in the next 12 months and potentially a fourth BLA filing as early as 2025

FDA accepted New Drug Application filing for DFD-29 to treat inflammatory lesions and erythema of rosacea in adults; PDUFA goal date of November 4, 2024

MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2024.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “We achieved first quarter year-over-year product revenue growth of 7%, which was driven by greater than 20% year-over-year growth in our flagship products, Qbrexza ® and Accutane ® . In the first quarter of 2024, the U.S. Food and Drug Administration (“FDA”) accepted the New Drug Application (“NDA”) filing for DFD-29 and set a Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024. If approved, DFD-29 has the potential to be the only oral, systemic therapy to address inflammatory lesions and erythema (redness) from rosacea, differentiating it as a potential best-in-class solution for the millions of patients suffering from rosacea. We also dosed the first patient in a multi-center Phase 2 study for Triplex for control of cytomegalovirus (“CMV”) in patients undergoing liver transplantation and received grant funding from the National Institutes of Health (“NIH”) to further advance cell and gene therapy candidates for the potential treatment of adults living with HIV and children with Menkes disease. Looking ahead, our expansive portfolio of development-stage programs across multiple areas, including oncology, dermatology, and rare diseases, holds the potential for up to three NDA and Biologics License Application (“BLA”) regulatory approvals within the next 12 months and potentially a fourth BLA filing as early as 2025. Additionally, we anticipate multiple data readouts this year, including topline data from the Phase 1b/2a clinical trial of AJ201 to treat spinal and bulbar muscular atrophy (“SBMA”), data from the Phase 1b clinical trial of dotinurad for the treatment of gout and hyperuricemia and topline Phase 2 clinical data of Triplex, a CMV vaccine for adults co-infected with HIV and CMV. This sustained progress underscores the strength of Fortress’ business model, centered on acquiring and advancing assets that address unmet medical needs and enhance long-term value for shareholders through product revenues, equity holdings and royalties.”

Recent Corporate Highlights 1 :

Regulatory Milestones and Updates

• In March 2024, the FDA accepted the NDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) and set a PDUFA goal date of November 4, 2024.  We submitted the NDA to the FDA seeking approval for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults in January 2024. Both double blinded, randomized controlled DFD-29 Phase 3 clinical trials achieved their co-primary and all secondary endpoints with subjects completing the 16-week treatment with no significant safety issues. DFD-29 demonstrated statistical superiority compared to both Oracea capsules and placebo for Investigator’s Global Assessment (IGA) treatment success and the reduction in the total inflammatory lesion count in both clinical trials. Additionally, DFD-29 showed significantly superior reduction in Clinicians Erythema Assessment compared to placebo in both of the Phase 3 clinical trials. DFD-29 is currently in development at our partner company, Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”).
• The CUTX-101 rolling NDA submission is ongoing and is expected to be completed by our partner, Sentynl Therapeutics, Inc. in 2024. Cyprium, our subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.
• We submitted a BLA to the FDA for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation, in January 2023. In December 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA. The CRL solely cited findings that arose during a multi-sponsor inspection of a third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety or labeling for the approvability of cosibelimab. We intend to seek to address the feedback in a potential BLA resubmission, which is currently targeted for mid-year. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) (“Checkpoint”).
• Based on its public statements, AstraZeneca plc has estimated that it expects the FDA to accept its BLA submission of CAEL-101 (anselamimab) to treat AL amyloidosis for review as early as 2025.

Clinical Updates

• The Phase 2 clinical trial of Triplex, a CMV vaccine, for adults co-infected with HIV and CMV is now fully enrolled with topline data anticipated in the fourth quarter of 2024. The study aims to show that vaccination with Triplex can safely elicit a CMV-specific immune response and reduce asymptomatic CMV replication in a population of people with HIV on suppressive antiretroviral therapy. The study will also evaluate whether this intervention might reduce chronic inflammation and immune activation, as compared to placebo, and thus, potentially reduce related mortality and morbidity.
• In May 2024, we announced that the first patient was dosed in a multi-center, placebo-controlled, randomized Phase 2 study of Triplex for control of CMV in patients undergoing liver transplantation. The trial is funded by a grant from the NIH’s National Institute of Allergy and Infectious Diseases of the (NIH/NIAID) that could provide over $20 million in non-dilutive funding. Triplex is currently in development at our subsidiary company, Helocyte, Inc.
• A Phase 1b clinical trial in patients with gout and hyperuricemia is ongoing in the U.S. to confirm the comparability of U.S. patients’ response to dotinurad (urate transporter (URAT1) inhibitor) with data generated in Japan, and to assess drug-drug interactions, if any, with allopurinol. We expect to announce data from this trial in mid-2024. Dotinurad is currently in development at our subsidiary company, Urica Therapeutics, Inc. (“Urica”).

Commercial Product Updates

• Journey Medical’s total revenues for the first quarter ended March 31, 2024 were $13.0 million, an increase of $0.8 million, or 7%, compared to total net revenues of $12.2 million for the first quarter ended March 31, 2023.

General Corporate:

• In January 2024, Fortress raised gross proceeds of approximately $11.0 million in a registered direct offering priced at-the-market under Nasdaq rules.
• In January 2024, Checkpoint raised gross proceeds of approximately $14.0 million in a registered direct offering, and Avenue raised approximately $5.0 million gross proceeds from warrant exercise transactions.

Financial Results:

• As of March 31, 2024, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $85.8 million, compared to $83.4 million as of December 31, 2023, an increase of $2.5 million during the quarter.
• Fortress’ consolidated cash, cash equivalents and restricted cash, totaled $83.4 million as of December 31, 2023, which included $42.2 million attributable to Fortress and private subsidiaries, $1.8 million attributable to Avenue, $4.9 million attributable to Checkpoint, $7.0 million attributable to Mustang Bio and $27.4 million attributable to Journey Medical.
• Subsequent to the end of the first quarter, in May 2024, Avenue raised approximately $4.4 million in gross proceeds from warrant exercise transactions and Mustang raised approximately $4.0 million in gross proceeds from a public offering of common stock and warrants.
• Fortress’ consolidated net revenue totaled $13.0 million for the first quarter ended March 31, 2024, all of which was generated from our marketed dermatology products. This compares to consolidated revenue totaling $12.4 million for the first quarter of 2023, which included $12.2 million in revenue generated from our marketed dermatology products.
• Consolidated research and development expenses including license acquisitions totaled $24.8 million for the first quarter ended March 31, 2024, compared to $39.5 million for the first quarter ended March 31, 2023.
• Consolidated selling, general and administrative costs were $17.9 million for the first quarter ended March 31, 2024, compared to $25.3 million for the first quarter ended March 31, 2023.
• Consolidated net loss attributable to common stockholders was $(17.7) million, or $(1.03) per share, for the first quarter ended March 31, 2024, compared to net loss attributable to common stockholders of $(23.5) million, or $(3.47) per share for the first quarter ended March 31, 2023.
• All share and per share information has been retroactively adjusted to give effect to the Company’s October 2023 1-for-15 reverse stock split for all periods presented, unless otherwise indicated.

About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com .

Forward-Looking Statements Statements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to: our growth strategy, financing and strategic agreements and relationships; our need for substantial additional funds and uncertainties relating to financings; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Company Contact: Jaclyn Jaffe Fortress Biotech, Inc. (781) 652-4500 [email protected]

Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 [email protected]   

FORTRESS BIOTECH, INC. AND SUBSIDIARIES Unaudited Condensed Consolidated Balance Sheets ($ in thousands except for share and per share amounts)

FORTRESS BIOTECH, INC. AND SUBSIDIARIES Unaudited Condensed Consolidated Statements of Operations ($ in thousands except for share and per share amounts)

1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as “subsidiaries”), at Fortress’ public subsidiaries (referred to herein as “partner companies”) and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as “partners”). The words “we”, “us” and “our” may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

Released May 15, 2024

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Fortress Biotech, Inc.

Us34960q3074, pharmaceuticals.

• Fortress Biotech : Corporate Presentation

Fortress Biotech

CORPORATE PRESENTATION

December 2019

Forward Looking Statements

This presentation may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this presentation, the words "we", "us" and "our" may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward- looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our

business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently

anticipated include: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our

need for and continued access to additional funds; government regulation; patent and intellectual property matters; competition; as well as other

risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law. The information contained herein is intended to be reviewed in its totality,

and any stipulations, conditions or provisos that apply to a given piece of information in one part of this presentation should be read as applying

mutatis mutandis to every other instance of such information appearing herein.

Fortress Biotech Programs*

*Includes product candidates in development at Fortress, at its majority-owned and majority-controlled subsidiaries and at entities in which it holds minority ownership positions.

Generating Cash Flow & Shareholder Value

Dermatology Product Revenue Growth

Expect to in-license 1 to 3 new products in 2019

$ in millions

Reaching >70%

of market via top 5,000

prescribing dermatologists

To build a pipeline of both development-stage /commercial-stage assets and leverage

the most efficient course to move products forward with our partners.

Identify Develop Monetize

How We Do It

Aim to increase the intrinsic value and decrease the overall risk of Fortress

Development Team

• 10+ Business Development Professionals
• 30+ Manufacturing Professionals 1
• 25+ MDs and PhDs 1
• Current portfolio includes: 5 revenue-generating dermatology products
• 25+ development-stage biotech product candidates 1
• De-risked assets
• High value / need
• Low acquisition cost
• Known buyers

1 Includes employees and product candidates in development at Fortress, at its majority-owned and majority-controlled partners.

Management Profiles

Lindsay Rosenwald, MD

Chairman, President, and CEO

Michael S. Weiss

Co-Vice Chairman of the Board, Strategic Development

Eric K. Rowinsky, MD

Co-Vice Chairman of the Board

Robyn Hunter

Chief Financial Officer

George C. Avgerinos PhD

Senior Vice President, Operations

Near-term Monetization Opportunities

Contingent Acquisition By Cipla

• Upon FDA approval and other conditions 1
• $180 Million aggregate cash purchase; (est. $13.92/share) 1 ; FBIO 29% or eligible to receive ~$48M of the distribution net of fees
• Potential additional payments pursuant to Contingent Value Rights; CVR payout of 10-20% of gross profits 2
• FBIO stands to realize ~$48M in addition to value of CVRs

1 subject to conditions described in Avenue public filings

2 Fortress to receive ~1/3 of CVR royalty

Contingent Exclusive Acquisition Option

Granted To Alexion (Jan. 2019)

• Alexion purchased minority stock position in Caelum for $30M, with additional $30M in funding due upon achievement of development milestones
• Additionally, up to $500M payable to Caelum shareholders in connection with Alexion option exercise:
• $150M - $200M upfront
• Up to $325M in contingent milestone payments
• FBIO owns ~40% of Caelum and is eligible to receive ~43% of upfront and milestone proceeds

Near-term Value Creating Pipeline Assets

IV Tramadol

Gene Therapy

copper histidinate

Mut.-EGFR Inh.

COSIBELIMAB

Anti-PD-L1 mAb

Partnership % /

29% Avenue**

10-20% CVR Royalty on gross profits****

30% Mustang

4.5% Royalty

89% Cyprium

25% Checkpoint

43% Caelum***

Potential Peak Sales Revenue^

$300M - $600M

$300M - $500M (initial indication CSCC)

• Estimated as of 12.1.2019

*Includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners and at entities in which it holds minority ownership positions.

**FBIO is eligible to receive ~29% of the proceeds upon the second-stage closing of the InvaGen transaction net of fees, and currently owns 23% of Avenue's issued and outstanding capital stock.

***FBIO is eligible to receive ~43% of the proceeds from an Alexion acquisition option exercise, and currently owns ~40% of Caelum's issued and outstanding capital stock.

****FBIO receives ~1/3 of the CVR Royalty on gross profits

• Based on internal forecasts

Registration-enabling

XSCID "Bubble Boy" Disease

Fortress Biotech Near-Term Value Creating Pipeline Assets

*Product candidate in development at Mustang Bio, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large ownership position.

**Mamcarz E et al. N Engl J Med. 2019; 380: 1525-1534

• Lentiviral vector gene therapy
• ~1 in 225k newborns per year (U.S.)
• ~400 patients living with XSCID post-transplant in the US and ~650 patients living with XSCID post-transplant in high and mid-incomeex-U.S. countries
• RMAT Designation granted by FDA in August 2019
• Published clinical results demonstrate**:
• Multilineage engraftment of transduced cells
• Reconstitution of functional T cells and B cells
• Normalization of NK-cell counts

Menkes Disease

• FDA granted Orphan Drug and Fast Track designations
• Would be the first FDA approved therapy in this indication
• Eligible for Rare Pediatric Disease Priority Review Voucher (valuation range ~$75M to $110M)

COSIBELIMAB*

*Product candidate in development at Checkpoint Therapeutics, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large ownership position.

• Fully human IgG1 monoclonal antibody
• Potential therapy for lung cancer, endometrial cancer, colorectal cancer and cutaneous squamous cell carcinoma
• Potentially differentiated vs marketed PD-(L)1s
• Interim P1 data showed efficacy in multiple tumor types w/ well tolerated safety profile
• Enrolling cohorts intended to support potential BLA submissions
• Exploring possible partnerships and collaborations

Third-Gen EGFR Inhibitor

• Irreversible inhibitor against selective mutations of EGFR
• Potential to be effective in NSCLC patients with susceptible mutations as a monotherapy or in combination with anti-tumor immune potentiating therapies
• Interim P1 data presented at 2018 World Conference on Lung Cancer
• Potential emerging safety differentiation vs TAGRISSO ®

IV Tramadol*

Post-operative pain management

Est. Market Estimated Peak Sales of $790M**

• Uniquely positioned to address need for new post- operative pain therapies amid opioid crisis
• Potential to replace conventional narcotics in wide range of patients

Announced Positive Topline Data from 2 nd Pivotal Phase 3 Trial

• Two-stage acquisition agreement with Cipla minimizes dilution and provides substantial upside to shareholders; First stage closed in February 2019

Next Steps File NDA by year-end 2019

CVRs worth 10-20% of gross profits**

*Product candidate in development at Avenue Therapeutics, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large minority ownership position

**Based on internal forecasts Fortress to receive ~1/3 of CVR royalty

AL Amyloidosis

*Product candidate in development at Caelum Biosciences, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large minority ownership position.

• Granted Orphan Drug designations in the U.S. and EU
• No FDA, EMEA, or PMDA approved therapies in this indication
• ~30k - 45k patients in U.S. and EU
• ~4.5k newly-diagnosed patients (U.S.) per year
• Potentially understated market size given AL Amyloidosis often misdiagnosed

Top-tier Academic & Commercial Partners

Potential Near-termValue-Creating Events for FBIO Shareholders

IV Tramadol 1 & Cipla

• FBIO eligible to receive up to $48M in contingent acquisition of Avenue
• CVR Payout of 10-20% of gross profits 2
• NDA Filing anticipated by year-end 2019

CAEL-101 1 & Alexion

• Eligible to receive 43% of up to $500M (upfront and sales milestones) in event of Alexion exercise of contingent option
• Initiate pivotal trial in 1H20

Journey Medical

• Generated $23.5M in net revenue in 2018, $5.5M in cash
• Generated $23.8M in net revenue through Q3 of 2019
• Acquisition of Ximino ® Q3 2019
• Initial meeting with FDA Q4 2019
• IND transfer from St. Jude to MBIO expected Q1 2020

Cosibelimab and CK-101 1

• Complete enrollment in cosibelimab registration-enabling expansion cohorts 2020
• CK-101 data read out Q1 2020, Initiate global registration study for treatment of lung cancer

PRVs (Priority Review Vouchers)

• Filing for 3 PRVs anticipated (CUTX- 101, MB-107 and CEVA-101) 1
• Data over last 24 months suggests these PRVs may be worth ~$75M to ~$110M, each

1 IV Tramadol, CAEL-101, Cosibelimab, CK-101,CUTX-101,MB-107, and CEVA-101 are product candidates in development at FBIO partner companies 2 Fortress to receive ~1/3 of CVR royalty

FORTRESS BIOTECH

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• Akero Therapeutics-stock
• News for Akero Therapeutics

Akero Therapeutics Presents Poster and Late-breaking Oral Presentation on EFX at the EASL Congress 2024

SOUTH SAN FRANCISCO, Calif., June 08, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with serious metabolic disorders marked by high unmet medical need, today announced two presentations featuring its lead product candidate efruxifermin (EFX) at the European Association for the Study of the Liver (EASL) Congress 2024, in Milan, Italy. The presentations will also be available on Akero’s website following the meeting.

A late-breaking oral presentation will feature 96-week data from HARMONY, a Phase 2b study evaluating the efficacy and safety of EFX in patients with metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2–F3). The study met its primary endpoint of ≥1-stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50 mg EFX (41%, p<0.05) and 28 mg EFX (39%, p<0.05) dose groups, compared to 20% for the placebo group. At Week 96, response rates for this endpoint increased to 75% (p<0.001) for 50 mg EFX and 46% (p=0.07) for 28 mg EFX, vs 24% for placebo.

The study also met additional histology endpoints at week 96. Notably 36% (p<0.01) and 31% (p<0.01) of patients treated with 50 mg EFX and 28 mg EFX, respectively, had a 2-stage improvement in fibrosis without worsening of MASH, more than 10-fold the placebo rate of 3%.

A comparison of week 96 with week 24 results showed that treatment response among EFX-treated patients was both sustained and expanded with longer treatment, particularly among the 50 mg EFX group. More than 80% of all EFX-treated patients with improved fibrosis at week 24 experienced sustained improvement through week 96, reflecting maintained reductions in markers of liver injury and fibrosis, whereas more than half of placebo responders at week 24 failed to maintain their response. In addition, 63% of patients treated with EFX 50 mg who were non-responders at week 24 experienced an improvement in fibrosis and no worsening of MASH with the benefit of treatment for 96 weeks, three times the placebo rate of 21%. In a subset of patients with baseline F3, treatment with EFX was associated with response on fibrosis improvement similar to the overall study population of F2 and F3 patients treated with EFX, showing the potential for treating more-advanced fibrosis, associated with increased risk of progression to cirrhosis. Results from the HARMONY study indicate EFX was generally well tolerated, with no liver injury or decompensation events, and no deaths. The most frequent adverse events (AEs) were transient Grade 1 or 2 gastrointestinal events, with an overall event profile similar to what was observed during the first 24 weeks.

A poster presentation will present results from a post-hoc analysis of key biomarkers associated with collagen synthesis and degradation. These data improve our understanding of EFX pharmacology and its effects on extracellular matrix (ECM) remodeling in the liver and fibrosis improvement. EFX treatment was associated with significant changes in the ECM toward a potentially beneficial phenotype, with decreased interstitial collagens (fibrils) and regeneration of structural collagens (basement membrane). The observed remodeling of ECM biomarkers after 24 weeks was associated with reductions in markers of liver injury over the same period and with improvements in liver fibrosis after longer treatment.

Together, the data to be presented at EASL suggest that EFX modulates markers of pathological fibrosis consistent with improvements in metabolic health, liver health, and suppression of fibrogenesis.

“We’re looking forward to sharing our Week 96 data from the Phase 2b HARMONY study in patients with pre-cirrhotic MASH (F2–F3) with the scientific community at EASL Congress,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “We are highly encouraged by these results, which are the first reports of histological improvement after more than 48 weeks. We believe the unprecedented response rates of EFX-treated patients who experienced not only 1-, but 2-stage improvement in fibrosis without worsening of MASH observed in the HARMONY study, sustained over 96 weeks, is a key differentiator of EFX from other treatments in the MASH therapeutic landscape.”

Details of the presentations are as follows:

Oral Presentation Title:  Efruxifermin significantly reduced liver fibrosis in MASH patients with F2–F3 fibrosis, with sustained improvement in liver injury and resolution of steatohepatitis over 96 weeks (HARMONY phase 2b study)

• Presenter:  Vlad Ratziu, M.D., Ph.D. Professor of Hepatology, Sorbonne Université and the Hôpital Pitié-Salpêtrière Medical School
• Late Breaker Abstract Number:  LBO-002
• Session Title:  Late Breaker
• Session Date and Time:  Saturday, June 8, 2024, 2:00 PM – 3:30 PM CEST
• Presentation Time:  2:15 PM CEST
• Location:  Gold Room

Poster Presentation Title:  Efruxifermin treatment improved collagen biomarkers consistent with remodeling of the extracellular matrix in patients with F2-F3 fibrosis due to MASH

• Presenter:  Erik Tillman, Ph.D., Associate Director, Translational Biology & Pharmacology
• Late Breaker Abstract Number:  SAT-220-YI
• Session Title: MASLD: Therapy
• Session Date and Time:  Saturday, June 8, 8:30 AM – 5:00 PM CEST
• Location:  Poster Area

About the HARMONY Study The Phase 2b HARMONY study was a multicenter, randomized, double-blind, placebo-controlled trial in biopsy-confirmed adult MASH patients with fibrosis stage 2 or 3. The study enrolled a total of 128 patients who were randomized to receive once-weekly subcutaneous dosing of 28 mg or 50 mg EFX, or placebo for 24 weeks, 126 of whom received at least one study dose. The primary efficacy endpoint for the study was the proportion of subjects who experienced ≥1-stage fibrosis improvement without worsening of MASH. The study continued for up to 96 weeks. Secondary endpoints at Week 96 included proportion of patients with ≥1-stage fibrosis improvement and no worsening of MASH, proportion of patients with 2-stage fibrosis improvement without worsening of MASH, and proportion of patients with ≥1-stage fibrosis improvement and MASH resolution, as well as changes from baseline in noninvasive markers of liver injury and fibrosis, glycemic control, lipoproteins, and change in body weight as well as safety and tolerability measures.

About Efruxifermin Efruxifermin (EFX), Akero’s lead product candidate for MASH, is a long-acting, bivalent Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX appears to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipid and lipoprotein profile. This pleiotropic mechanism offers the potential to address the complex, multi-system disease state of MASH, including improvements in risk factors linked to cardiovascular disease – the leading cause of death in patients with pre-cirrhotic MASH. EFX is designed to offer convenient once-weekly dosing and has been generally well tolerated in clinical trials to date.

About MASH MASH is a serious form of metabolic dysfunction-associated steatotic liver disease (MASLD) that is estimated to affect more than 17 million Americans. MASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. MASH is the fastest-growing cause of liver transplants and liver cancer in the US and Europe.

About Akero Therapeutics Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH. Akero's lead product candidate, EFX, is currently being evaluated in the ongoing SYMMETRY study, a 96-week Phase 2b clinical trial in patients with compensated cirrhosis due to MASH (F4 fibrosis), as well as two ongoing Phase 3 clinical trials: the SYNCHRONY Histology study in patients with pre-cirrhotic MASH (F2-F3 fibrosis) and the SYNCHRONY Real-World study in patients with MASH (F1-F3 fibrosis) or MASLD. A third clinical trial, the SYNCHRONY Outcomes study in patients with compensated cirrhosis due to MASH (F4 fibrosis), is expected to be initiated in the second quarter of 2024. The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the SYMMETRY study in patients with compensated cirrhosis due to MASH (F4). Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and Twitter for more information.

Forward Looking Statements  Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero’s business plans and objectives, including future plans or expectations for EFX; the therapeutic effects of EFX; the timing and initiation of Akero’s Phase 3 SYNCHRONY program and upcoming milestones. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero’s product candidate development activities and planned clinical trials; Akero’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero’s other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Contact: Christina Tartaglia 212.362.1200 [email protected]

Media Contact: Peg Rusconi 617.910.6217 [email protected]

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