Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union




Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union

• The Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenzelt^® (aflibercept), Stoboclo^® and Osenvelt^® (denosumab), and Avtozma^® (tocilizumab)
• Celltrion is committed to expanding access to biologic treatments in skeletal-related disorders, ophthalmology, and immunology

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions and recommended marketing authorisations for three biosimilar candidates: Eydenzelt^® (CT-P42, aflibercept), Stoboclo^® and Osenvelt^® (CT-P41, denosumab), and Avtozma^® (CT-P47, tocilizumab). This significant milestone reflects the company’s leadership in biosimilar innovation and commitment to expanding access to biologic treatments across Europe.

Eydenzelt (40 mg/mL solution for injection in vial and pre-filled syringe), a biosimilar to Eylea^® (aflibercept), is recommended for approval to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV). In a Phase III study of Eydenzelt, the efficacy, safety, pharmacokinetics and immunogenicity of Eydenzelt was compared to Eylea in patients with diabetic macular edema (DME), demonstrating therapeutic equivalence to Eylea by meeting the predefined equivalence criteria.¹ If marketing authorisation is granted by the European Commission (EC), Eydenzelt would be one of the first-wave aflibercept biosimilars in Europe.

Stoboclo (60 mg solution for injection in pre-filled syringe) and Osenvelt (120 mg solution for injection in vial) have been recommended for approval for all indications of the reference products Prolia^® and Xgeva^®, respectively. The positive CHMP opinion was based on the totality of evidence including results from a Phase III clinical trial in postmenopausal osteoporosis (PMO), and the results showed that CT-P41 had equivalent efficacy and pharmacodynamics (PD) to reference denosumab, with similar pharmacokinetics (PK) and comparable safety and immunogenicity profiles.²

Avtozma, a biosimilar referencing RoActemra^® (tocilizumab), has been recommended for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA) and giant cell arteritis (GCA). The positive CHMP opinion for Avtozma was supported by a comprehensive data package and totality of evidence demonstrating Avtozma’s biosimilarity to RoActemra, with no clinically meaningful differences in efficacy, PK equivalence, safety or immunogenicity.^3,4

“With CHMP approvals for Eydenzelt, Avtozma, and Prolia/Xgeva biosimilars, Celltrion solidifies its leadership in the European biosimilar market, offering one of the most extensive antibody biosimilar portfolios. Our vertically integrated model ensures supply chain stability while addressing the specific challenges faced by European healthcare professionals and patients. These approvals underscore our commitment to supporting European healthcare systems by improving access to high-quality, affordable treatments,” said Taehun Ha, Vice President and Head of Europe. “Our focus remains on empowering clinicians with the tools and solutions they need, as we aim to transition from a pioneer to a frontier leader in European healthcare.”

The CHMP’s recommendations will now be referred to the EC, which will decide whether to grant a marketing authorisation for Eydenzelt, Stoboclo and Osenvelt, and Avtozma. If marketing authorisations are granted, the three biosimilars will be made available across EU member states, furthering Celltrion’s commitment to delivering innovative and accessible healthcare solutions.

About CT-P41 Phase III Clinical Trial

The Phase III study randomised 479 patients to receive 60 mg of CT-P41 or reference product every six months (Weeks 0 and 26; treatment period [TP] I). Before dosing at Week 52, patients initially assigned to reference product in TP I were re-randomised in a 1:1 ratio to continue with the reference product or switch to CT-P41 in TP. All patients initially randomly assigned to CT-P41 in TP I continued their treatment with CT-P41 in TP II. In TP II, 422 patients were randomised in Week 52 (CT-P41 maintenance group: 221, reference product maintenance group: 100, switched to CT-P41 group: 101). The primary efficacy endpoint was met in terms of percent change from baseline in bone mineral density (BMD) for lumbar spine (L1-L4) by dual-energy X-ray absorptiometry (DXA) at Week 52, and the primary pharmacodynamics (PD) endpoint was met in terms of area under the effect curve (AUEC) of serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) over the initial six months. Results of the study showed that CT-P41 had equivalent efficacy and PD to reference denosumab, with similar PK and comparable safety and immunogenicity profiles.²

About CT-P42 Phase III Clinical Trial

In a randomised, double-masked, parallel-group, multi-centre Phase III study of Eydenzelt^® (CT-P42), the efficacy, safety, pharmacokinetics, usability and immunogenicity of Eydenzelt was compared to Eylea^® (aflibercept) in patients with diabetic macular edema (DME). The primary endpoint was the change from baseline in best corrected visual acuity (BCVA) measured at Week 8, comparing Eydenzelt and Eylea. Results of the study showed that Eydenzelt met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea.^1,5

About CT-P47 Phase III Clinical Trial

This was a Phase III, randomised, active-controlled, double-blind trial to compare the efficacy and safety of Avtozma^® (CT-P47) and RoAtemra^® (tocilizumab) in patients with moderate to severely active rheumatoid arthritis (RA). The Phase III study randomised 479 patients to receive 8mg/kg of CT-P47 or reference tocilizumab every 4 weeks (Week 0 and 24; treatment period [TP] I). Before dosing at Week 24, patients initially assigned to tocilizumab in TP I were re-randomised in a 1:1 ratio to continue with tocilizumab or switch to CT-P47 in TP II up to Week 52. In TP II, 444 patients were randomised in Week 24 (CT-P47 maintenance group: 225, tocilizumab maintenance group: 109, switched to CT-P47 group: 110). The primary endpoint was mean change from baseline in Disease Activity score in 28 joints (DAS28; erythrocyte sedimentation rate [ESR]) at week 12. Efficacy equivalence was determined if confidence intervals (CIs) for the treatment difference was within the predefined equivalence margin: (95% CI: -0.6, +0.6 (analysis of covariance [ANCOVA]) at week 12). Therapeutic equivalence of CT-P47 and reference tocilizumab in treating RA was demonstrated and supported by comparable and sustained efficacy results up to Week 52. CT-P47 was also well tolerated with a safety profile comparable to reference tocilizumab, and no notable safety issue was identified following the single transition from reference tocilizumab to CT-P47 compared with maintenance groups up to Week 52. ^3,4

About Stoboclo^® (CT-P41, biosimilar candidate of denosumab)

Stoboclo^® (denosumab), a receptor activator of NF-κb ligand (RANKL) inhibitor, is a treatment developed as a biosimilar to reference product Prolia^® (denosumab). In Europe, Stoboclo has been recommended for approval to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

About Osenvelt^® (CT-P41, biosimilar candidate of denosumab)

Osenvelt^® (denosumab) is a receptor activator of NF-κb ligand (RANKL) inhibitor developed as a biosimilar referencing Xgeva^® (denosumab). Osenvelt has been recommended for approval in Europe to prevent skeletal-related events in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

About Eydenzelt^® (CT-P42, biosimilar candidate of aflibercept)

Eydenzelt^® (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea^®. Based on comprehensive data from a Phase III clinical trial confirming therapeutic equivalence to Eylea¹, Eydenzelt was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in June and November 2023, respectively.

About Avtozma^® (CT-P47, biosimilar candidate of tocilizumab)

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial, designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to the reference product RoActemra^®4, CT-P47 was filed for regulatory approval with the U.S. FDA and EMA in January and February 2024, respectively.

About Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima^®, Truxima^® and Herzuma^®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma^® and Yuflyma^®, FDA approval for Zymfentra^®, and EC approval for Remsima^® SC, Omlyclo^®, SteQeyma^®. To learn more, please visit www.celltrion.com/en-us.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business, and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares,” “hopes to,” “upcoming,” ”plans to,” “aims to,” “to be launched,” “is preparing,” “once gained,” “could,” “with the aim of,” “may,” “once identified,” “will,” “working towards,” “is due,” “become available,” “has potential to,” the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries’ management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.

Trademark

Stoboclo^® and Osenvelt^® are registered trademarks of Celltrion Inc. 

Prolia^® and Xgeva^® are registered trademarks of Amgen Inc.

Eydenzelt^® is a registered trademark of Celltrion Inc. 

Eylea^® is a registered trademark of Bayer AG.

Avtozma^® is a registered trademark of Celltrion, Inc., used under license. 

RoActemra^® is a registered trademark of Chugai Pharmaceutical Co., Ltd.

References

¹ Sebastian Wolf et al., Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 3.1. [EURETINA 2024, Abstract #CA24-2257-8397]. Available at: https://abstracts.euretina.org/2024/ca24-2257-8397/r/recxUD7DqYfFfjC7s [Last accessed December 2024]. 

² Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed December 2024]. 

³ Smolen JS et al., Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10(4), e004514. Available at: https://rmdopen.bmj.com/content/10/4/e004514.abstract [Last accessed December 2024]. 

⁴ Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. Available at: https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ [Last accessed December 2024]. 

⁵ Sebastian Wolf et al., Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study. Available at: https://www.sciencedirect.com/science/article/pii/S2468653024003063 [Last accessed December 2024].

Contacts

Donna Gandhi

dgandhi@hanovercomms.com
+44 (0) 203 817 6591

Catalent and Novo Holdings Fulfill All Regulatory Closing Conditions for Pending Transaction




Catalent and Novo Holdings Fulfill All Regulatory Closing Conditions for Pending Transaction

Transaction Expected to Close in the Coming Days

SOMERSET, N.J. & COPENHAGEN, Denmark–(BUSINESS WIRE)–Catalent, Inc. (“Catalent,” NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings A/S (“Novo Holdings”), a global life sciences investment firm, today announced that the companies have fulfilled all regulatory closing conditions for their pending transaction. The companies now expect to close the transaction in the coming days.

“Today represents an important step in our transition to private ownership under Novo Holdings, a leading life sciences investment firm,” said Alessandro Maselli, President and Chief Executive Officer of Catalent. “As we approach transaction close, I want to thank the Catalent team for all their hard work and share my excitement for our company’s bright future. With the support of Novo Holdings and access to additional resources, Catalent will be well-positioned to drive innovation and enhance offerings for the benefit of customers and the patients they serve, ultimately accelerating our strategy to create value for stakeholders.”

“We are pleased to have achieved this latest milestone, which we believe reflects the significant benefits the proposed transaction is expected to deliver,” said Jonathan Levy, Senior Partner, Novo Holdings. “As we near close, we are enthusiastic about partnering with and supporting the Catalent team in its mission to drive innovation in the healthcare system and improve patient outcomes.”

For additional information associated with the transaction, please visit transaction.catalent.com.

Advisors

Citi and J.P. Morgan served as financial advisors to Catalent. Skadden, Arps, Slate, Meagher & Flom LLP served as legal advisor to Catalent and Jones Day served as legal advisor to the Catalent Board of Directors. Morgan Stanley & Co. LLC served as financial advisor to Novo Holdings. Goodwin Procter LLP and Linklaters LLP served as legal advisors to Novo Holdings. Arnold & Porter Kaye Scholer LLP and Davis Polk & Wardwell LLP served as legal advisors to Novo Nordisk.

About Novo Holdings A/S

Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S (formerly Novozymes A/S) and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Asia, Planetary Health and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. www.novoholdings.dk

About Catalent, Inc.

Catalent, Inc. (NYSE: CTLT), is a global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,500 partner development programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply nearly 70 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 17,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated approximately $4.4 billion in revenue in its 2024 fiscal year. For more information, visit www.catalent.com.

Forward-Looking Statements

This press release, and any related oral statements, may include both historical and forward-looking statements and guidance. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “predict,” “hope,” “foresee,” “likely,” “may,” “could,” “target,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations, projections, and guidance. Some of the factors that could cause actual results to differ materially from forward-looking statements include, but are not limited to, the pending merger of Catalent with an affiliate of Novo Holdings (the “Merger”), the completion of the Merger on anticipated terms and timing, including obtaining antitrust and other regulatory approvals and clearances, the satisfaction of other conditions to the completion of the Merger, potential litigation relating to the Merger that could be instituted by or against Catalent, Novo Holdings or their respective affiliates, directors or officers, including the effects of any outcomes related thereto, the risk that disruptions from the Merger will harm Catalent’s relationships, and certain restrictions during the pendency of the Merger that may impact Catalent’s ability to pursue attractive business opportunities or strategic transactions.

These forward-looking statements speak only as of the date of this press release or as of the date they are made, and Catalent does not undertake to and specifically disclaims any obligation to publicly release the results of any updates or revisions to these forward-looking statements that may be made to reflect future events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

Contacts

Catalent
Investor:
Paul Surdez

+1 (732) 537-6325

investors@catalent.com

Media:
Laura Hortas

+1(609) 240-7025

media@catalent.com

Novo Holdings
(Global inquiries) Marie-Louise Jersin, Senior Communications Partner

(US inquiries) Dora Gonzalez, Public Relations Specialist

novoholdingsmedia@novo.dk

Viridian Therapeutics to Webcast Veligrotug Phase 3 THRIVE-2 Topline Results on December 16, 2024




Viridian Therapeutics to Webcast Veligrotug Phase 3 THRIVE-2 Topline Results on December 16, 2024

– THRIVE-2 global phase 3 clinical trial evaluated efficacy and safety of veligrotug in patients with chronic thyroid eye disease (TED) –

– Conference call and webcast to be held Monday, December 16, at 8:00 a.m. ET –

WALTHAM, Mass.–(BUSINESS WIRE)–Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced plans to host a conference call and webcast to report topline data for the THRIVE-2 phase 3 clinical trial, evaluating veligrotug in chronic TED, on Monday, December 16, 2024 at 8:00am ET.

Conference call and webcast information

The webcast can be accessed under “Events and Presentations” on the Investors section of the Viridian website at viridiantherapeutics.com. To participate in the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference code 9934051. A replay of the webcast will be available following the completion of the event.

About Viridian Therapeutics

Viridian is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED.

In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases.

Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “design,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical and clinical development of Viridian’s product candidates veligrotug (formerly VRDN-001), VRDN-003, VRDN-006 and VRDN-008; Viridian’s product candidates potentially being best-in-class; and the potential for Viridian’s product candidates to be developed in multiple autoimmune diseases.

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to the potential utility, efficacy, potency, safety, clinical benefits, clinical response and convenience of Viridian’s product candidates and those risks set forth under the caption “Risk Factors” in our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

Contacts

Anabel Chan, 617-458-8725

Vice President, Investor Relations & Communications

IR@viridiantherapeutics.com

Louisa Stone, 617-272-4604

Manager, Investor Relations

IR@viridiantherapeutics.com

Viridian Therapeutics to Webcast Veligrotug Phase 3 THRIVE-2 Topline Results on December 16, 2024




Viridian Therapeutics to Webcast Veligrotug Phase 3 THRIVE-2 Topline Results on December 16, 2024

– THRIVE-2 global phase 3 clinical trial evaluated efficacy and safety of veligrotug in patients with chronic thyroid eye disease (TED) –

– Conference call and webcast to be held Monday, December 16, at 8:00 a.m. ET –

WALTHAM, Mass.–(BUSINESS WIRE)–Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced plans to host a conference call and webcast to report topline data for the THRIVE-2 phase 3 clinical trial, evaluating veligrotug in chronic TED, on Monday, December 16, 2024 at 8:00am ET.

Conference call and webcast information

The webcast can be accessed under “Events and Presentations” on the Investors section of the Viridian website at viridiantherapeutics.com. To participate in the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference code 9934051. A replay of the webcast will be available following the completion of the event.

About Viridian Therapeutics

Viridian is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED.

In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases.

Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “design,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical and clinical development of Viridian’s product candidates veligrotug (formerly VRDN-001), VRDN-003, VRDN-006 and VRDN-008; Viridian’s product candidates potentially being best-in-class; and the potential for Viridian’s product candidates to be developed in multiple autoimmune diseases.

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to the potential utility, efficacy, potency, safety, clinical benefits, clinical response and convenience of Viridian’s product candidates and those risks set forth under the caption “Risk Factors” in our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

Contacts

Anabel Chan, 617-458-8725

Vice President, Investor Relations & Communications

IR@viridiantherapeutics.com

Louisa Stone, 617-272-4604

Manager, Investor Relations

IR@viridiantherapeutics.com

Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis




Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis

Ad hoc announcement pursuant to Art. 53 LR

• Approximately 7% of people in the United States (U.S.) have atopic dermatitis – a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions^1-4
• While currently available treatments may improve some signs and symptoms of the disease, many patients do not respond optimally to approved therapies and do not experience itch relief and clear skin to the same degree^2,5-7
• Nemluvio^® (nemolizumab) is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis^2,9-11
• This approval follows Nemluvio’s recent approval for the treatment of adults with prurigo nodularis from the U.S. Food and Drug Administration earlier in August 2024¹²

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SWX:GALD) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nemluvio^® (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. This follows the recent U.S. FDA approval of Nemluvio for subcutaneous injection for the treatment of adults with prurigo nodularis in August 2024.¹²

Atopic dermatitis affects more than 230 million people worldwide, impacting approximately 7% of people in the U.S.^2-4 Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.^13-16 Atopic dermatitis is also a highly heterogenous disease and can be associated with several comorbid conditions, namely mental health disorders and other autoimmune- or immune-mediated diseases.^2,13,17-19 For this reason, there remains a need for more novel, effective treatment options, as while currently available treatments for atopic dermatitis may improve some signs and symptoms, many patients do not respond optimally to approved therapies and do not experience itch relief and clear skin to the same degree.^2,5-7

Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.⁸ IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis.^2,9-11

This approval is based on positive results from the phase III ARCADIA clinical trial program which evaluated the efficacy and safety of Nemluvio in combination with background TCS, with or without TCI, versus placebo in combination with TCS, with or without TCI, in 1,728 patients aged 12 years or older with moderate-to-severe atopic dermatitis.²⁰

Results demonstrated that patients treated with Nemluvio, administered subcutaneously every four weeks in combination with TCS, with or without TCI, showed statistically significant improvements on skin clearance in both co-primary endpoints. These were clearance (0) or almost-clearance (1) of skin lesions when assessed using the investigator’s global assessment (IGA) score, and achieving a 75% reduction in the Eczema Area and Severity Index (EASI) – when compared to placebo in combination with TCS, with or without TCI, after 16 weeks of treatment.²⁰

The trials also met all key secondary endpoints confirming significant responses on itch as early as Week 1, and statistically significant improvements in sleep disturbance with Nemluvio in combination with TCS, with or without TCI, when compared to placebo in combination with TCS, with or without TCI.²⁰

Overall, Nemluvio was well tolerated, and the safety profile was generally consistent between Nemluvio and placebo groups.²⁰

The FDA also approved Nemluvio as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis in August 2024.¹²

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on December 12, 2024, recommending the approval of nemolizumab in the European Union (EU) for the treatment of both atopic dermatitis and prurigo nodularis.²¹ The positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.

Galderma also has marketing authorization applications for nemolizumab in both atopic dermatitis and prurigo nodularis under review by multiple additional regulatory authorities, including via the Access Consortium framework in countries such as Australia, Singapore, and Switzerland, as well as in Canada, Brazil, and South Korea.²² Further submissions to other regulatory authorities will continue in 2025.

As previously communicated, peak sales of nemolizumab are expected to reach more than 2 billion USD (expected beyond the 2023-2027 mid-term guidance period). Galderma anticipates nemolizumab to approach ‘blockbuster’ net sales run-rate by the end of 2027.

Media can find more information about atopic dermatitis in this media toolkit.

About Nemluvio^® (nemolizumab-ilto)

Nemluvio^® (nemolizumab-ilto) was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga^® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.^23,24

Important Safety Information

Indications: NEMLUVIO^® (nemolizumab-ilto) is a prescription medicine used:

• to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.
• to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.

Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO.
• are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

• Breathing problems or wheezing
• Swelling of the face, lips, mouth, tongue, or throat
• Fainting, dizziness, feeling lightheaded
• Fast pulse
• Swollen lymph nodes
• Joint pain
• Fever
• Skin rash (red or rough skin)
• Nausea or vomiting
• General ill feeling
• Cramps in your stomach area

The most common side effects of NEMLUVIO include:

• Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches
• Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088.

Please see full Prescribing Information including Patient Information.

About the ARCADIA clinical trial program^20,25,26

The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.

These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials, evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroids with or without topical calcineurin inhibitors).

The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator’s global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks.

About atopic dermatitis

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.^1-3 It affects more than 230 million people worldwide and is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.^2,27 While currently available treatments for atopic dermatitis show some improvements of signs and symptoms, not all patients experience itch relief and clear skin to the same degree, and many do not respond optimally to approved therapies.^2,5-7

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

1. Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8): 2867. doi: https://doi.org/10.3390/ijms21082867
2. Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi:10.1016/S0140- 6736(20)31286- 1
3. Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911
4. Silverberg JI, et al. Sleep Disturbances in Adults with Eczema Are Associated with Impaired Overall Health: A US Population-Based Study. J Invest Derm. 2015; 135, 56–66; doi:10.1038/jid.2014.325
5. Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927. doi:10.3390/biomedicines10112927
6. Katoh N, Ohya Y, Ikeda M, et al. Clinical practice guidelines for the management of atopic dermatitis 2018. J Dermatol. 2019;46(12): 1053-1101. doi:10.1111/1346-8138.15090
7. Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi:10.1002/cti2.1390
8. Silverberg J, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi:10.1016/j.jaci.2019.08.013
9. Bağci IS and Ruzicka T. IL-31: A new key player in dermatology and beyond. J Allergy Clin Immunol. 2018;141(3): P858-866. doi: 10.1016/j.jaci.2017.10.045
10. Dillon SR, et al. Interleukin 31, a cytokine produced by activated T cells, induces dermatitis in mice [published correction appears in Nat Immunol. 2005;6(1):114.] Nat Immunol. 2004;5(7):752-760. doi: 10.1038/ni1084
11. Datsi A, et al. Interleukin-31: The “itchy” cytokine in inflammation and therapy. Allergy. 2021;76:2982-2997. doi: 10.1111/all.14791
12. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024
13. Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7: 102:adv00830. doi: 10.2340/actadv.v102.3932
14. Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966
15. Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3
16. Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi:10.1016/j.anai.2018.07.006
17. Halvorsen J, et al. Suicidal Ideation, Mental Health Problems, and Social Function in Adolescents with Eczema: A Population-Based Study. J Invest Derm. 2014;134: 1847-1854. doi: https://doi.org/10.1038/jid.2014.70
18. Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017;23(8 suppl):S115-S123. PMID:28978208
19. Hahn EL, Bacharier LB. The atopic march: the pattern of allergic disease development in childhood. Immunol Allergy Clin North Am. 2005;25(2):231-246. doi:10.1016/j.iac.2005.02.004
20. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024. doi: 10.1016/S0140-6736(24)01203-0
21. Galderma. CHMP recommends approval of Galderma’s nemolizumab for moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union. Available online. Accessed December 2024
22. Galderma. Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries. Available online. Accessed December 2024
23. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed December 2024
24. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed December 2024
25. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed December 2024
26. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03989349). Available online. Accessed December 2024
27. Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257

Contacts

For further information:


Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

sebastien.cros@galderma.com
+41 79 529 59 85

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

MIAMI–(BUSINESS WIRE)–$SMMT–Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced the grant of inducement awards of options to purchase a collective total of up to 98,000 shares of common stock. Awards were made to six new employees of the Company. The awards were granted as an inducement material to the new employees becoming employees of the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and have been approved by the Company’s Compensation Committee. The inducement awards were granted on December 10, 2024. The options have a ten (10) year term and an exercise price of $17.97 per share, the closing price per share of the Company’s common stock as reported by Nasdaq on December 10, 2024. The options were granted from a pool of equity incentives reserved by the Compensation Committee on May 3, 2024 for issuance as inducements to new employees in accordance with Nasdaq Listing Rule 5635(c)(4).

The options awarded to the recipients are subject to vesting in equal annual installments over a four-year period. The options awarded are subject to the terms of a stock option agreement to be executed by the recipient of the grant.

About Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol “SMMT”). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX.

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the intended use of the net proceeds from the private placements, the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Summit Therapeutics and the Summit Therapeutics logo are trademarks of Summit Therapeutics Inc. Copyright 2024, Summit Therapeutics Inc. All Rights Reserved.

Contacts

Contact Summit Investor Relations:
Dave Gancarz

Chief Business & Strategy Officer

Nathan LiaBraaten

Senior Director, Investor Relations

investors@smmttx.com

Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Scholar Rock (NASDAQ: SRRK; the “Company”), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 208,800 shares of its common stock to twelve newly hired employees, consisting of inducement stock options to purchase an aggregate of 119,312 shares of common stock and inducement restricted stock units, covering an aggregate of 89,488 shares of its common stock.

The awards are subject to all terms and conditions and other provisions set forth in the Company’s 2022 Inducement Equity Plan (the “Plan”) and the award agreements thereunder.

The Plan, initially adopted by the Company’s board of directors on June 16, 2022, and as amended from time to time, is used exclusively for the grant of equity awards to individuals who were not previously employees of Scholar Rock, or following a bona fide period of non-employment, as an inducement material to such individuals entering into employment with Scholar Rock, pursuant to Nasdaq Listing Rule 5635(c)(4).

The inducement stock options have an exercise price of $45.48, which is equal to the closing price of Scholar Rock’s common stock on December 9, 2024. The inducement stock options will vest with respect to 25% of the shares of common stock underlying the award on the first anniversary of each employee’s start date, and the remaining 75% of the shares of common stock underlying the inducement stock options will vest in 12 equal quarterly installments thereafter. Vesting for the inducement restricted stock units will be in four equal annual installments. All vesting related to inducement awards is subject to the employees’ continuing service at the Company through the applicable vesting date.

About Scholar Rock

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, Scholar Rock has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof-of-concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about our approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Scholar Rock^® is a registered trademark of Scholar Rock, Inc.

Availability of Other Information About Scholar Rock

Investors and others should note that we communicate with our investors and the public using our company website www.scholarrock.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on Twitter and LinkedIn. The information that we post on our website or on Twitter or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Contacts

Scholar Rock:

Investors

Rushmie Nofsinger

Scholar Rock

rnofsinger@scholarrock.com
ir@scholarrock.com
857-259-5573

Media

Molly MacLeod

Scholar Rock

mmacleod@scholarrock.com
media@scholarrock.com
802-579-5995

Evolus Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Evolus Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today reported the grant in November non-qualified stock options to purchase an aggregate of 9,872 shares of Evolus and an aggregate of 16,596 restricted stock units (RSUs) of the company’s common stock to 9 newly hired non-executive employees of the company (the “November Grants”). The Company also is reporting the grant in December non-qualified stock options to purchase an aggregate of 6,034 shares of Evolus and an aggregate of 22,295 RSUs of the company’s common stock to 11 newly hired non-executive employees of the company (the “December Grants”). The awards were approved by the compensation committee of the company’s board of directors under the Evolus’ 2023 Inducement Incentive Plan, with a grant date and vesting commencement date of November 7, 2024 for the November Grants and December 7, 2024 for the December Grants, as an inducement material to the new employees entering into employment with Evolus in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options under the November Grants have an exercise price of $14.29 per share, the closing price of Evolus’ common stock on the date of grant. The stock options under the December Grants have an exercise price of $12.66 per share, the closing price of Evolus’ common stock on the trading day preceding the date of grant. The stock options have a 10-year term and vest over 4 years, with 25% of the number of shares subject to the option vesting on each annual anniversary of the vesting commencement date. The RSUs vest 25% on each annual anniversary of the vesting commencement date. The awards are subject to the terms and conditions of the 2023 Inducement Incentive Plan and the terms and conditions of the stock option agreement or RSU agreement, as applicable, covering the grant, including requirements to remain continuously employed on each vesting date.

About Evolus, Inc.

Evolus (NASDAQ: EOLS) is a global performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau^® (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Evolus is expanding its product portfolio having entered into a definitive agreement to be the exclusive U.S. distributor of Evolysse^™, and the exclusive distributor in Europe of Estyme^®, a line of unique injectable hyaluronic acid (HA) gels. These injectable HA gels are currently in the late stages of the regulatory approval process, with plans, upon approval, for a launch starting in 2025.

Visit us at www.evolus.com, and follow us on LinkedIn, X, Instagram or Facebook.

Jeuveau^® and Nuceiva^®, are registered trademarks and Evolysse^™ is a trademark of Evolus, Inc.

Hi-Pure^™ is a trademark of Daewoong Pharmaceutical Co, Ltd.

Estyme^® is a trademark of Symatese Aesthetics S.A.S.

Contacts

Evolus Contacts:
Investors:
Nareg Sagherian

Vice President, Head of Global Investor Relations and Corporate Communications

Tel: 248-202-9267

Email: ir@evolus.com

Media:

Email: media@evolus.com

Aseptic Processing of Pharmaceutical and Biotech Products Course: Fundamental Principles, Advanced Techniques, and Regulatory Insights Training (ON-DEMAND) – ResearchAndMarkets.com




Aseptic Processing of Pharmaceutical and Biotech Products Course: Fundamental Principles, Advanced Techniques, and Regulatory Insights Training (ON-DEMAND) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Aseptic Processing of Pharmaceutical and Biotech Products Course” training has been added to ResearchAndMarkets.com’s offering.

This comprehensive course covers fundamental principles, advanced techniques, and regulatory insights necessary for success in aseptic processing. Explore the critical practices and regulatory requirements essential for maintaining sterility and ensuring product quality in pharmaceutical and biotech manufacturing.

To adhere to this demand and raise the benchmark of aseptic manufacturing, we have curated a 2-day long virtual course for esteemed professionals like you. Thus, if you are associated with any department of biological and pharmaceutical manufacturing, this course will upskill your knowledge about every step.

This course equips you with the knowledge to evaluate the risks and failures in the unit. Moreover, you will be able to identify the repetitive penalties being imposed on the organization due to disappointing manufacturing practices. By the end of this seminar, your products will be ready to pass sterility tests and FDA audits without any hiccups.

Course Overview

While current GMPs are detailed enough to meet FDA guidelines, many manufacturing units suffer production delays, product losses, and health risks. What is the point of working with high-end facilities and setups when you are still facing common issues?

To tackle these, World Compliance Seminar has curated a course to guide you about handling manufacturing facilities effectively. The core benefits of the aseptic processing course include:

• Managing the complexity of working with highly potent ingredients and executing fill-finish effectively
• Identifying and overcoming issues with single-use system
• Exploring the latest technologies available in aseptic filling
• Best practices to eliminate contamination risk through barrier technology
• Deeper insights from regulatory panels across the leading countries in the world
• Understanding the role of robotics in aseptic processing
• Examining strong trends in small-scale and ready-to-use products

Who Should Attend:

Aseptic sterile technique training will benefit plenty of individuals such as:

• Manufacturing professionals: Get the right knowledge of basic principles and develop skills to control procedure setting
• Project Manager: Understand critical factors required to maintain compliance
• Quality Control Professionals: Decrease the inspections failures, cautionary letters, and agreement rulings
• Reformulation and Formulation Developer: Determine how to develop media fill simulations and work on the worst-case scenarios
• Process Chemistry Specialists: Learn the best repetition techniques for decisive media fill sizes

Apart from these professionals, the course is also useful for analytical chemists, in-house regulatory compliance officials, scale-up and technology transfer professionals, and validation experts.

Key Topics Covered:

Aseptic Processing – Introduction

• The Disinfected Quantity Form
• Conservation and control of serious surroundings
• Expansion of procedures for process, standardization, Preventive Maintenance, CAPA, etc.
• Exercise of workers to include gowning
• Certification and assessment of variations
• Adulteration Sources in Sterile Manufacturing
• Subdivision Content Controls
• Cross Pollution Hazards
• Cleaning Process and Agents for Sterile Production

Developing Media Fill Requirements in An Aseptic Environment

• Form FDA 483s
• Equipment set up
• Sterilization process
• Media fills
• Smoke studies and their emphasis in Aseptic Production (ISO Class 5 facilities)
• Endotoxin sources

Speakers:

Barry A. Friedman, Ph.D

Consultant

Cambrex Bio Sciences

Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

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AI Compliance Breakthrough Wins Klick Prize; Results Signal Industry Trends




AI Compliance Breakthrough Wins Klick Prize; Results Signal Industry Trends

Klick Health announces idea for AI-enhanced pharma marketing compliance tool ‘Guardrail’ as big winner in $1,000,000 AI contest for employees; turns concept into industry’s first fit-for-purpose regulatory solution

TORONTO & NEW YORK–(BUSINESS WIRE)–#AI–After receiving several hundred employee-generated AI ideas for life sciences clients, Klick Health today announced the Grand Prize winner of the $1,000,000 Klick Prize — sharing both key learnings from its year-long, internal contest and the implications they hold for the industry.

“The Klick Prize is about solving real problems and delivering measurable results. AI is a tool for transformation that can reshape what’s possible for our clients as we set the pace for life sciences innovation in 2025 and beyond,” said Klick Co-Founder and Chairman Leerom Segal. “Kudos to all of our Klicksters who submitted AI ideas, congrats to our prize winners, and special thanks to our executive client judging panel for their foresight and desire to elevate industry standards.”

Key Takeaways

The winning Klick Prize ideas showcase a future where AI tools take on dynamic roles, exhibit enhanced complex reasoning, and expand beyond chat to enable seamless interactions across multiple interfaces — all trends that are expected to accelerate in 2025.

Guardrail, the Grand-Prize-winning idea for an AI-enhanced pharma marketing compliance tool, for example, doesn’t just offer simple predictive suggestions. It applies complex reasoning and a decision engine to ensure compliance in pharma marketing, helping teams navigate regulatory frameworks more intelligently and efficiently.

Klick has already turned the idea into reality — building the first fit-for-purpose regulatory solution in life sciences — already using the tool internally to help enhance asset authoring, review, and Medical Legal and Regulatory (MLR) processes, and putting it into pilots with multiple clients.

An immersive AI/human interaction platform for simulating healthcare interactions and delivering actionable industry insights, which was a round-two-winning concept, features AI ‘agents’ that act as patients and healthcare professionals. The concept is poised to lead to enriched market research and simulated user experiences that go far beyond basic chatbot exchanges.

The program also brought to light how AI models are expanding beyond the chat interface, enabling voice-based interactions, as well as multimedia production that incorporates text, images, code, and more.

According to Segal, as these trends advance, more AI solutions that think, learn, and operate with increasing autonomy will be introduced, ultimately driving more meaningful engagement and more effective commercialization within the life sciences industry.

The Guardrail concept was conceived by two members of Klick’s Medical team (known as the Mediverse), along with a tech developer and a project manager. They are splitting the final purse in addition to their winnings from the first round in May.

Other winning ideas from the three rounds of the contest included a personalized AI training concept that enables pharma sales reps to leverage a synthetic personas/digital twinning tool for healthcare professionals; an AI-powered approach to developing high-quality branded messaging; a patient experience panel that uses a gaming engine to identify new ways to make meaningful, positive impact in-market; and an AI tool that utilizes in-market solutions to help pharma companies modernize their standard operating procedures and good clinical practice updates within the regulatory landscape.

Entries were reviewed and evaluated by an industry judging panel, comprised of senior executives from BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Lilly, NewAmsterdam Pharma, Novartis, Novocure, Otsuka, Pfizer, Sobi, and Teva. Entries were judged on impact, pragmatism, market differentiation, and desirability.

Encouraging Employees to Get Comfortable Using AI

Beyond coming up with game-changing AI ideas for healthcare clients, Segal said the Klick Prize program was designed to make Klicksters from across the company more comfortable using AI. “We encouraged our people to give generative AI a try and have fun experimenting with it. We gave them free access to tools, AI coaches, and the opportunity to see their ideas turned into solutions that can make a difference to our clients and be rewarded in the process.”

The unique program also underscores Klick’s people-first workplace culture, exemplifying its commitment to diversity of thought and the belief that great ideas can come from anywhere.

Today’s news is the latest in the company’s ongoing AI and machine-learning innovations created to help Klick clients and team members achieve even greater success. Earlier this year, Klick Labs unveiled important new research on using AI and vocal biomarkers to detect chronic high blood pressure (hypertension) — following its groundbreaking research last year around the AI model it created to detect Type 2 diabetes using 10 seconds of voice. In the spring, Klick also launched KCM+AI™, the first AI social media comment moderator for the life sciences industry.

Last year, it unveiled LOVENet™, an AI framework that rapidly identifies new uses for existing drugs at the prestigious NeurIPS conference; it introduced Genome Perspective, the first AI tool to be developed by an advertising agency to expedite project planning and increase the efficiency and velocity of delivery to clients; and it debuted KlickRx, the first ChatGPT plugin for the life sciences industry in the U.S.

About Klick Health

Klick Health is the world’s largest independent commercialization partner for life sciences, focused on hacking the boundaries of health by developing, launching, and supporting life sciences brands to achieve their full potential. The agency provides best-in-class marketing and advertising, media strategy and purchasing, medical affairs and medical communications, value and market access services, as well as enterprise omnichannel enablement among its specialized offerings. Klick’s client service is rooted in deep medical and scientific understanding, enabled by over 185 post-graduate, in-house medical experts; unrivaled decision sciences capabilities; and innovative, results-driven creative.

One of the most-awarded advertising agencies on the planet, Klick was named 2024 Clio Health Independent Agency of the Year, London International Awards Global (and Regional) Independent Health & Pharma Agency of the Year, as well as Cannes Lions #2 Healthcare Agency and #2 Healthcare Network for the second year running. Cannes Lions also recognized Klick as the 2024 #3 Independent Agency of the Year. In 2024, Klick won over 140 top creative honors, including the coveted Cannes Lions Innovation Grand Prix, and eight agency distinctions from the most respected advertising awards shows. Klick has also been ranked a Best Managed Company, Great Place to Work, Best Workplace for Women, Best Workplace for Inclusion, Best Workplace for Professional Services, Most Admired Corporate Culture, and a FORTUNE Best Workplace in Advertising.

Established in 1997, Klick Health (including Klick Katalyst and btwelve) has offices in New York, Philadelphia, Toronto, London, São Paulo, and Singapore. It is part of the Klick Group of companies, which also includes Klick Media Group, Klick Applied Sciences (including Klick Labs), Klick Consulting, Klick Ventures, and Sensei Labs. Follow Klick Health on LinkedIn and for more information on joining Klick, go to careers.klick.com.

Contacts

For more information, please contact Klick PR at pr@klick.com or (416) 214-4977.