On September 20, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending approval of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for two indications in gynecologic cancers (Press release, Merck & Co, SEP 20, 2024, View Source [SID1234646767]). The first opinion recommends the approval of KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy. The second positive opinion recommends the approval of KEYTRUDA in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and final decisions are expected in the fourth quarter of 2024.

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"At Merck, we are deeply committed to expanding the role of KEYTRUDA to improve outcomes for more patients facing difficult-to-treat gynecologic cancers as we work to address the impact of women’s cancers around the world," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "These positive CHMP opinions bring us one step closer to providing new immunotherapy-based regimens to more patients with endometrial and cervical cancer in the European Union who may benefit. We look forward to the European Commission’s decisions."

The recommendation in primary advanced or recurrent endometrial carcinoma is based on the NRG-GY018 trial, also known as KEYNOTE-868, evaluating KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent. In this study, the KEYTRUDA-based regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus carboplatin and paclitaxel. If approved, this would mark the third indication for KEYTRUDA in endometrial cancer in Europe. KEYTRUDA plus LENVIMA (lenvatinib) was approved in November 2021 for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation, and KEYTRUDA monotherapy was approved in April 2022 for these patients who have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors. In June 2024, KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, was approved in the U.S. for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

The recommendation in newly diagnosed patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer is based on the KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, in which KEYTRUDA in combination with concurrent CRT demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and PFS versus CRT alone. If approved, this would mark the second indication for KEYTRUDA in cervical cancer in Europe. KEYTRUDA plus chemotherapy, with or without bevacizumab, was approved in April 2022 for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). In January 2024, KEYTRUDA in combination with CRT was approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.

About endometrial carcinoma

Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. Globally, endometrial cancer is the sixth most common cancer in women and 15th most common cancer overall. Worldwide, it is estimated there were approximately 420,368 patients diagnosed with endometrial cancer and 97,723 patient deaths from the disease in 2022. In Europe, it is estimated there were approximately 124,874 patients diagnosed with endometrial cancer and 30,272 patient deaths from the disease in 2022.

About cervical cancer

Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. All women are at risk for cervical cancer, and it is most frequently diagnosed between the ages of 35 and 44. While screenings and prevention have resulted in declining cervical cancer rates, the disease continues to affect many people in the U.S. and around the world. Cervical cancer is the fourth most common cancer in women globally. Worldwide, it is estimated there were approximately 662,301 patients diagnosed with cervical cancer and 348,874 patient deaths from the disease in 2022. In Europe, it is estimated there were approximately 58,219 new cases of cervical cancer diagnosed and 26,950 patient deaths from the disease in 2022.

On September 20, 2024 iBio, Inc. (NYSEA:IBIO), an AI-driven innovator of precision antibody immunotherapies, reported its financial results for the fiscal year ended June 30, 2024, and provided a corporate update (Press release, iBioPharma, SEP 20, 2024, View Source [SID1234646766]).

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"Our fiscal year 2024 was a transformational year for iBio, as we’ve solidified our business and financial position as a next-generation antibody company with a machine-learning-enabled platform for designing and developing difficult-to-drug therapeutics," said CEO and Chief Scientific Officer Martin Brenner, Ph.D., DVM. "We made significant progress entering the fast-growing cardiometabolic and obesity space with our collaboration with AstralBio and strengthened our financial position by eliminating our debt associated with the facility and closing a fully subscribed financing including participation from Ikarian Capital, Lynx1 Capital Management, ADAR1 Capital Management, and other institutional and accredited investors. We continued to build our drug discovery platform, adding innovative technologies that are helping to advance our pipeline and provide critical support to our biopharma partners with best-in-class antibody discovery and development projects."

Business Developments:

Expanded the AI-powered technology stack with the launch of ShieldTx, a patent-pending antibody masking technology designed to enable specific, highly targeted antibody delivery to diseased tissue without harming healthy tissue.

In February, iBio closed the sale of its early-stage PD-1 asset to Otsuka Pharmaceutical Co., Ltd. for $1MM in upfront cash with contingent downstream payments of up to $52.5MM, a pivotal moment that showcased the power of iBio’s platform to discover best-in-class assets.

Added bispecific capabilities with its EngageTx technology. We advanced a Trop2 x CD3 molecule to clinical candidate selection stage by demonstrating in a humanized mouse model of squamous cell carcinoma, a significant 36 percent reduction in tumor size 14 days after tumor implantation and after a single dose. Additionally, we leveraged our EngageTx technology and Epitope Steering technology to successfully develop multiple MUC16 x CD3 molecules, which show potent cell killing against ovarian cancer cells.

Entered into a collaboration with AstralBio, Inc. to provide an exclusive license in the cardiometabolic and obesity space. iBio will develop four targets of interest with rights to license up to three of these targets prior to entering the clinic.
Corporate Developments:

At the Company’s Special Meeting of Stockholders held on November 27, 2023, iBio’s stockholders authorized a reverse stock split, with a ratio ranging from 1-for-5 to 1-for-20 (the "Range"), with the ratio within such Range to be determined at the discretion of the Board of Directors (the "Board"), and thereafter the Board approved a one for twenty (1-for-20) reverse stock split of the Company’s shares of common stock. The reverse stock split was effective November 29, 2023.

Entered into a best-efforts public offering with investors in the fiscal second quarter for gross proceeds of approximately $4.5MM before deducting placement agent fees and offering expenses

Entered into a securities purchase agreement for a private investment in public equity financing with several institutional investors and an accredited investor in the fiscal third quarter and consummated the financing in the fiscal fourth quarter for gross proceeds of approximately $15.0MM before deducting placement agent fees and offering expenses.

During the third and fourth quarters, strengthened the Company’s cash position after previously issued warrants were exercised for proceeds of approximately $4.5MM.

The Company closed the sale of its manufacturing facility located in Bryan, Texas (the "Property") to the Board of Regents of the Texas A&M University System for $8.5MM. Following the issuance of pre-funded warrants having a value of $4.5MM to the lender, Woodforest National Bank, iBio and its wholly owned subsidiary, iBio CDMO LLC, satisfied all of the conditions of the settlement agreement releasing the Company and its subsidiary of all obligations with respect to the debt secured by the Property, which coupled with the release of approximately $915K in restricted cash previously held by Woodforest, eliminated approximately $13.2MM in secured debt from the Company’s balance sheet.

Strengthened its Board of Directors and executive leadership team through the appointments of Dr. Brenner to the Board of Directors, effective June 1, 2024, and Kristi Sarno as Senior Vice President, Business Development, effective August 8, 2024.
"We ended this fiscal year well-positioned to advance our technology to drive value for patients and shareholders," said Chief Financial Officer Felipe Duran. "We strengthened our balance sheet through capital raises and debt extinguishment. In fiscal year 2024, we executed transactions which brought in non-dilutive funding, and we continue to pursue business development projects to strengthen our financial position."

Financial Results:

Revenues for the fiscal year ended June 30, 2024, were approximately $0.2 million, an increase of 100% over fiscal 2023.

R&D and G&A expenses for fiscal 2024 decreased $5.1 million and $7.3 million, respectively, over the comparable period in fiscal 2023. The decrease in R&D and G&A reflects the Company’s cost savings implemented to support its growing investments in its pipeline, platform technologies, employees, and related infrastructure.

iBio’s consolidated net loss for the fiscal year ended June 30, 2024, was $24.9 million, a decreased loss of $40.1 million compared to 2023 primarily because of the decrease in expenses related to the Company’s discontinued operations and cost saving initiatives.

iBio held cash, cash equivalents and restricted cash of $14.4 million as of June 30, 2024.

As disclosed in its Annual Report on Form 10-K for the fiscal year ended June 30, 2024, which was filed on September 20, 2024 with the Securities and Exchange Commission, the audited financial statements contained an audit opinion from its registered public accounting firm that includes an explanatory paragraph related to the Company’s ability to continue as a going concern. See further discussion in footnote 2 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K. This announcement is made pursuant to NYSE American LLC Company Guide Sections 401(h) and 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph.

On September 20, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the European Commission (EC) has approved VYLOY (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive (Press release, Astellas, SEP 20, 2024, View Source [SID1234646764]). The European Medicines Agency has recommended that zolbetuximab’s designation as an orphan medicinal product be maintained in recognition of the poor survival outcomes associated with gastric and GEJ cancers.

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Zolbetuximab is currently the first and only approved monoclonal antibody specifically designed to target gastric tumor cells that express the biomarker CLDN18.2, offering a more personalized approach to cancer treatment. In the zolbetuximab Phase 3 clinical trials, approximately 38% of adult patients with advanced and metastatic gastric and GEJ cancers had tumors that were CLDN18.2 positive.1,2 By binding to CLDN18.2 expressed on tumor cell membranes, zolbetuximab results in antibody-dependent cellular cytotoxicity, complement dependent cytotoxicity and tumor growth inhibition.3

Zorana Maravic, Chief Executive Officer of Digestive Cancers Europe (DiCE):
"Sadly, due to similar symptoms to more common stomach conditions, gastric and gastroesophageal junction cancers are often diagnosed at the advanced or metastatic stage when treatment options have traditionally been relatively limited. Ensuring timely diagnosis, followed by personalized treatment and care, will be essential to better survival and quality of life for patients."

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas:
"We are delighted to bring zolbetuximab, a first-in-class targeted treatment option, to patients in Europe where gastric and gastroesophageal cancers are the sixth leading cause of cancer-related death. With zolbetuximab, we’re entering a new era in precision medicine for these advanced cancers, underpinning our ongoing commitment to pioneering scientific discovery that can advance patient outcomes."

Data from the Phase 3 SPOTLIGHT and GLOW clinical trials, which supported the European Marketing Authorization, showed that treatment with zolbetuximab provided statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers.1,2 In the SPOTLIGHT trial, a median PFS of 10.61 months was achieved with zolbetuximab plus mFOLFOX6 as first-line treatment, versus 8.67 months with placebo plus mFOLFOX6. The median OS was 18.23 months versus 15.54 months in the respective treatment groups.1 Similar efficacy findings were seen in the GLOW trial where median PFS was 8.21 months versus 6.80 months, and median OS 14.39 months versus 12.16 months, with zolbetuximab plus CAPOX, compared to placebo plus CAPOX, respectively.2 In both the SPOTLIGHT and GLOW trials, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared to the controls. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite.1,2

The European Marketing Authorization for zolbetuximab is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway, and is aligned to the recently updated ESMO (Free ESMO Whitepaper) Gastric Cancer Living Guidelines which state that the addition of zolbetuximab to chemotherapy can be considered for patients with CLDN18.2 positive, HER-2 negative tumors in the first-line metastatic disease setting.4 Astellas is working closely with local regulatory authorities and health technology assessment bodies across the EU to ensure that patients who may gain benefit from zolbetuximab are able to access the novel treatment as soon as possible.

This regulatory approval for zolbetuximab follows the August 2024 approval by the UK Medicines and Healthcare products Regulatory Agency and the March 2024 approval by Japan’s Ministry of Health, Labour and Welfare.5,6 Astellas has submitted further applications for zolbetuximab to other regulatory agencies around the world with reviews ongoing.

Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025.

About Zolbetuximab
Zolbetuximab is a claudin 18.2-directed cytolytic antibody investigated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. In both the SPOTLIGHT and GLOW Phase 3 clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive, defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed and confirmed using an in-vitro companion diagnostic test or medical device.1,2 Astellas collaborated with Roche on the VENTANA CLDN18 (43-14A) RxDx Assay that, upon approval, is intended to be used by a pathologist or laboratory to identify patients eligible for targeted treatment with zolbetuximab.7 This immunohistochemistry based companion diagnostic test is currently under review by the notified body.

As an investigational first-in-class monoclonal antibody (mAb), zolbetuximab targets and binds to CLDN18.2, a transmembrane protein expressed on cancer cells. In pre-clinical studies, zolbetuximab reduced the number of CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to tumor growth inhibition.3

About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer
Gastric and gastroesophageal junction (G/GEJ) cancers are known to be histologically similar, are recommended to be managed in the same way in treatment guidelines, and frequently display aligned responses to treatment.2,8 Across Europe, over 135,000 new cases of G/GEJ cancer were diagnosed in 2022.9 G/GEJ cancer is the sixth most common cause of cancer-related mortality in Europe, responsible for 95,431 deaths in 2022.9,10 GEJ adenocarcinomas start in the first two inches (5 cm) where the esophagus joins the stomach.11 The average five-year survival rate for patients in Europe with G/GEJ cancer is 26% across all stages of the disease, driving the need for new therapeutic options that can slow disease progression and extend lives.12

Because early-stage cancer symptoms frequently overlap with more common stomach-related conditions, G/GEJ cancers are often diagnosed in the advanced or metastatic stage, or once they have spread from the tumor’s origin to other body tissues or organs.13

Early signs and symptoms can include indigestion or heartburn, pain or discomfort in the abdomen, nausea and vomiting, bloating of the stomach after meals, and loss of appetite.13,14 Signs of more advanced G/GEJ cancer can include unexplained weight loss, weakness and fatigue, sensation of food getting stuck in the throat while eating, vomiting blood or having blood in the stool.13,14,15 Risk factors associated with G/GEJ cancer can include older age, male gender, family history, H. pylori infection, smoking, and gastroesophageal reflux disease (GERD).16,17

INVESTIGATIONAL STUDIES

About the SPOTLIGHT Phase 3 Clinical Trial
SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 565 patients at 215 study locations in the U.S., Canada, United Kingdom, Australia, Europe, South America, and Asia. The primary endpoint is progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters.1

Data from the SPOTLIGHT clinical trial were presented during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium in an oral presentation on January 19, 2023, and were subsequently published in The Lancet on April 14, 2023.1

For more information, please visit clinicaltrials.gov under Identifier NCT03504397.

About the GLOW Phase 3 Clinical Trial
GLOW is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 507 patients at 166 study locations in the U.S., Canada, United Kingdom, Europe, South America, and Asia, including Japan. The primary endpoint is PFS in participants treated with the combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints include OS, ORR, DOR, safety and tolerability, and quality-of-life parameters.2

Data from the GLOW study were initially presented at the March 2023 ASCO (Free ASCO Whitepaper) Plenary Series with an updated oral presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting on June 3, 2023, and were subsequently published in Nature Medicine on July 31, 2023.2

For more information, please visit clinicaltrials.gov under Identifier NCT03653507.

Investigational Pipeline in CLDN18.2
An expanded Phase 2 trial of zolbetuximab in metastatic pancreatic adenocarcinoma is in progress and recruiting patients. The trial is a randomized, multi-center, open-label study, evaluating the safety and efficacy of investigational zolbetuximab in combination with gemcitabine plus nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic adenocarcinoma with CLDN18.2 positive tumors (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining based on a validated immunohistochemistry assay). For more information, please visit clinicaltrials.gov under Identifier NCT03816163.

In addition to zolbetuximab, ASP2138 is under development in our Primary Focus Immuno-Oncology area and is currently recruiting patients. ASP2138 is a bispecific monoclonal antibody that binds to CD3 and CLDN18.2, and it is currently in a Phase 1/1b study in participants with metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma or metastatic pancreatic adenocarcinoma whose tumors have CLDN18.2 expression. The safety and efficacy of the agent under investigation have not been established for the uses being considered. For more information, please visit clinicaltrials.gov under Identifier NCT05365581.

There is no guarantee that the agent(s) will receive regulatory approval and become commercially available for the uses being investigated.

On September 20, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT (Press release, Alpha Tau Medical, SEP 20, 2024, View Source [SID1234646763]).

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The clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of Emory University in Atlanta, has been approved to enroll up to 28 U.S. patients at up to 8 institutions in the U.S., and will focus on patients with recurrent cSCC who have a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes. The primary efficacy objective of the study is the objective response rate (ORR) to the treatment, as measured by best overall response. Secondary efficacy objectives include progression-free survival, overall survival and local control up to twelve months after treatment, and the safety objective is the measurement of any related adverse events.

A 2015 article in Journal of Clinical Medicine noted that non-melanoma skin cancers represent a major cause of morbidity for patients after organ transplantation, and cSCC is the most common skin cancer seen in this population, with a 65–100 fold greater incidence in organ transplant recipients compared to the general population. For example, a 2003 article in the New England Journal of Medicine cited a number of sources indicating that 50% or more of Caucasian transplant recipients will ultimately develop cutaneous carcinomas.

In addition, a 2019 article in JAMA Otolaryngology – Head & Neck Surgery found that immunosuppression is independently associated with a worse outcome in cSCC, with a 2.32-times increased risk of disease-specific death, after adjusting for assorted demographic factors.

"As we continue to progress in our ReSTART multi-center pivotal trial for recurrent cutaneous SCC, a number of investigators asked about the ability to treat immunocompromised patients, who are ineligible for the ReSTART trial," commented Alpha Tau CEO Uzi Sofer. "Emory University is an important partner of ours and we are proud to work with them in initiating a trial for this population. Given the continued requests we receive from clinicians to help them treat immunocompromised patients, we are confident that a successful clinical trial can help deliver an important new potential alternative for these patients."

Zachary Buchwald, MD, PhD, an Assistant Professor of Radiation Oncology at Winship Cancer Institute of Emory University and Principal Investigator of the trial, noted, "We are thrilled to be able to initiate this trial and pioneer the use of the Alpha DaRT in immunocompromised patients. As we continue to see the promise of the Alpha DaRT through our participation in the ReSTART trial, it is obvious to us that we need to use this treatment elsewhere, particularly in populations at risk such as this."

Dr. Robert B. Den, Alpha Tau Chief Medical Officer, added, "This trial targets a particularly vulnerable population for whom treatment options are limited, which affords the ability to provide even more potential value to these patients. We are looking forward to treating patients in this trial soon."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On September 19, 2024 Ascendis Pharma A/S (Nasdaq: ASND) reported the pricing of its underwritten public offering of 2,000,000 American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis, at a price to the public of $150.00 per ADS (Press release, Ascendis Pharma, SEP 20, 2024, View Source [SID1234646743]). All of the ADSs are being offered by Ascendis. The offering is expected to close on or about September 23, 2024, subject to the satisfaction of customary closing conditions. In addition, Ascendis has granted the underwriters a 30-day option to purchase up to an additional 300,000 ADSs at the public offering price, less the underwriting commissions.

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Ascendis estimates the net proceeds from the offering will be approximately $281.3 million (assuming no exercise of the underwriters’ option to purchase additional ADSs), after deducting the underwriting commissions and estimated offering expenses. Ascendis intends to use the net proceeds of the offering to support the commercial preparations, launch and commercial activities, clinical development and regulatory approvals for its products and product candidates, and for working capital and general corporate purposes.

J.P. Morgan, Morgan Stanley, Evercore ISI and Goldman Sachs & Co. LLC are acting as joint book-running managers for the offering. BofA Securities, Wells Fargo Securities and Citigroup are acting as lead managers for the offering and Oppenheimer & Co. is acting as co-manager for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on September 18, 2024, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.