On November 8, 2021 ATP, a leader in life sciences venture capital, reported the launch of Marengo Therapeutics, Inc. to develop novel antibodies that target V T cell receptor (TCR) variants, selectively boosting anti-tumor T cells and promoting longterm protection against cancer. $80 million in launch financing from ATP will help advance Marengo’s proprietary Selective T Cell Activation Repertoire (STAR) platform and progress the company’s lead candidate into the clinic in 2022 (Press release, Marengo Therapeutics, NOV 8, 2021, View Source [SID1234594707]).

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Marengo is based in Cambridge, Massachusetts, and led by Chief Executive Officer Zhen Su, M.D., MBA, who joined from Merck KGaA, where he was Senior Vice President and Head of Global Oncology following a successful tenure as Chief Medical Officer for EMD Serono. During his time at Merck KGaA, Dr. Su was instrumental in delivering multiple drug approvals and double-digit growth of the oncology business in addition to building a robust pipeline of assets and establishing key partnerships in the immuno-oncology field.

"Existing immuno-oncology therapies have transformed cancer care, yet they are often unable to overcome dysfunctional T cell responses that develop in patients with cancer and that result in less than a third of patients achieving a durable response," Dr. Su said. "Marengo’s deep understanding of T cell biology and TCR signaling has driven our discovery of a new mode of T cell activation that promises to more effectively attack tumors and provide long-term protection against cancer. We believe this discovery represents a remarkable departure in the field of immuno-oncology, and our team is working to translate it into a great leap forward for patients."

From its proprietary antibody library targeting diverse germline-encoded TCR Vβ variants, Marengo can deploy therapeutic antibodies to prime the activation of clonally diverse T cells within both CD8+ and CD4+ effector pools that drive both near-term effector responses to tumors and long-term tumor immunity-promoting memory T cell responses. The activation of T 2 cells using this approach also comes with reduced pro-inflammatory cytokine release that may translate into a better safety and tolerability profile.

"ATP created Marengo Therapeutics to realize the potential of an exciting scientific discovery we have been incubating for several years," said Seth Harrison, M.D., founder and Managing Partner at ATP. "Priming specific T cells to fight cancer could pave the way to an entirely new class of much-needed effective and durable immunotherapies. We have been and continue to be incredibly energized by the promise of Marengo’s science, and I have great confidence that Zhen and the Marengo leadership team, with their experience and expertise, will deliver on our ambitions to transform cancer care for patients."

Lead Program
Marengo’s first-in-class lead candidate, STAR0602, is an antibody fusion molecule that binds and activates a specific Vβ TCR variant T cell subset while also delivering additional signals to the same T cell (known as cis-targeting) to further re-program the T cell to enhance anti-tumor activity. STAR0602 is expected to enter the clinic in late 2022 for the treatment of advanced and metastatic solid tumor cancers. Marengo is developing a broad pipeline of additional STAR programs that engage other immune cell types.

"Marengo’s STAR platform is highly flexible; it can turbo-charge cancer patients’ T cells, but with an inherent selectivity and flexibility that enables the engineering of more robust adaptive immune responses to tumors," said Andrew Bayliffe, Ph.D., Chief Scientific Officer of Marengo and Venture Partner at ATP.

Raj Chopra, FRCP, FRCPath, FRSB, Ph.D., Chief Medical Officer of Marengo and Head of Oncology and Venture Partner at ATP, added: "The platform has far-reaching applications, with the potential to ’tune’ a patient’s T cell responses on a personalized basis and in a way that could be integrated into different therapeutic regimens to treat a wide variety of advanced cancers."

On November 8, 2021 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported recent business and pipeline updates, as well as third quarter 2021 financial results (Press release, Beam Therapeutics, NOV 8, 2021, View Source [SID1234594706]).

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As part of today’s update, Beam announced that its Investigational New Drug (IND) application for BEAM-101 for the treatment of sickle cell disease was cleared by the U.S. Food and Drug Administration (FDA). BEAM-101, the company’s lead ex vivo base editing product candidate, is a patient-specific, autologous hematopoietic investigational cell therapy which incorporates base edits that mimic single nucleotide polymorphisms seen in individuals with hereditary persistence of fetal hemoglobin (HPFH) to potentially alleviate the effects of mutations causing sickle cell disease or beta-thalassemia. This is the first open IND for base editing technology, a next-generation form of CRISPR capable of making single base changes without creating double strand breaks in the DNA. Beam is preparing to initiate a Phase 1/2 clinical trial designed to assess the safety and efficacy of BEAM-101 for the treatment of sickle cell disease, which Beam refers to as the BEACON-101 trial.

"We are thrilled to share that the FDA has cleared our first IND. BEAM-101 has the potential to offer a one-time treatment for patients with sickle cell disease, and this clearance enables the important transition from a preclinical to a clinical-stage company, bringing us closer to our ultimate goal of helping patients," said John Evans, chief executive officer of Beam. "As leaders in the field of base editing, this milestone underscores the expertise of our team and the significant potential of our technology. We are grateful to the team members who have dedicated countless hours to this effort, and we look forward to this program’s continued evaluation in the clinic. As we look toward 2022, we believe we are well-positioned both financially and organizationally to execute on our vision."

"In addition to the clearance of our IND for BEAM-101, we are pleased to announce that we have initiated IND-enabling studies for BEAM-102, our Makassar base editing approach for the treatment of sickle cell disease," said Giuseppe Ciaramella, Ph.D., president and chief scientific officer of Beam. "We have also made continued progress on BEAM-201, our multiplexed base editing approach for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia as well as continued advancement across our robust portfolio, as showcased by a number of recent and upcoming data presentations demonstrating our leadership in base editing as well as optimized delivery technologies for our programs. Importantly, we also expect to nominate our first development candidate for in vivo base editing in the liver using LNP delivery for the treatment of patients with glycogen storage disease type Ia (R83C mutation) by the end of the year. We’ve made extraordinary progress as a company this year and remain committed to advancing novel science so that we may reach as many patients as possible."

Upcoming Base Editing Data Presentations

Preclinical data highlighting potential of CAR T multiplex base editing approach targeting CD5 at 2021 SITC (Free SITC Whitepaper) Annual Meeting. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, Beam will present preclinical data from its multiplex edited allogeneic CAR T research targeting CD5-positive hematologic malignancies in a poster titled "CD5 knockout enhances the potency of multiplex base-edited allogeneic anti-CD5 CAR T-cell therapy for the treatment of T-cell malignancies."
Multiple abstracts accepted for presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (ASH) (Free ASH Whitepaper). At this year’s ASH (Free ASH Whitepaper) meeting, Beam will present preclinical data highlighting its base editing approach to address sickle cell disease, including new preclinical data for BEAM-102, and data highlighting Beam’s in vivo high-throughput lipid nanoparticle (LNP) screening approach to identify novel LNPs that can deliver base editors to tissues beyond the liver, such as hematopoietic stem cells. In addition, Beam will present an overview on the application of base editing for the treatment of beta-hemoglobinopathies and other genetic blood disorders during a scientific program session. Details of the presentations can be found here.
Recent Base Editing Progress & Data Updates

BEAM-102 IND-enabling studies initiated. Beam has initiated IND-enabling studies for BEAM-102 for the treatment of sickle cell disease. BEAM-102 aims to directly correct the causative mutation in sickle cell disease by recreating a naturally-occurring normal human hemoglobin variant, HbG Makassar.
Preclinical data highlighting base editing approach to address GSDIa presented at European Society of Gene & Cell Therapy. Beam recently presented preclinical data demonstrating the ability of its liver-targeted base editing approach to directly correct R83C, one of the primary disease-causing mutations of glycogen storage disease type Ia (GSDIa), and the elimination of the disease phenotype in a novel in vivo model.
Optimized LNP delivery approaches for in vivo base editing to the liver and other tissues presented at TIDES 2021. Beam announced new preclinical data highlighting advancements with its approach to developing novel LNP formulations for increased in vivo liver editing potency, with high levels of editing at what Beam believes could be a clinically-relevant dose level of 1.0 mg/kg. Beam remains on track to nominate its first Development Candidate for in vivo base editing using LNP delivery by the end of 2021. Also at TIDES, Beam reported an update on its proprietary approach to developing LNPs to deliver base editors to tissues beyond the liver, including hematopoietic stem and progenitor cells.
Preclinical data highlighting potential of base editors to target disease drivers of chronic hepatitis B infection presented at 2021 International HBV Meeting. Beam recently presented data demonstrating the potential of its cytosine base editors to reduce viral markers, including hepatitis B surface antigen (HBsAg) expression, and prevent viral rebound of hepatitis B virus (HBV) in in vitro models.
Business Highlights

Executed non-exclusive option and license agreement with Sana Biotechnology for Cas12b. Under the agreement, Beam granted Sana non-exclusive commercial rights to utilize its CRISPR Cas12b system with certain allogeneic T-cell and stem cell-derived programs. The agreement excludes any rights to base editing using Beam’s Cas12b system, which rights remain exclusively with Beam. Sana agreed to pay Beam an upfront payment of $50 million, and Beam may also receive certain target option exercise fees, certain milestone payments upon the achievement of certain development and commercial sale milestones, and certain royalties on net sales of royalty-bearing products by Sana.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $933.4 million as of September 30, 2021, compared to $299.7 million as of December 31, 2020.
Research & Development (R&D) Expenses: R&D expenses were $54.6 million for the third quarter of 2021, compared to $29.8 million for the third quarter of 2020.
General & Administrative (G&A) Expenses: G&A expenses were $15.8 million for the third quarter of 2021, compared to $7.5 million for the third quarter of 2020.
Net Loss: Net loss attributable to common stockholders was $28.1 million, or $0.42 per share, for the third quarter of 2021, compared to $34.5 million, or $0.69 per share, for the third quarter of 2020.
About Sickle Cell Disease and Beta-Thalassemia

Sickle cell disease, a severe inherited blood disease, is caused by a single point mutation, E6V, in the beta globin gene. This mutation causes the mutated form of sickle hemoglobin (HbS) to aggregate into long, rigid molecules that bend red blood cells into a sickle shape under conditions of low oxygen. Sickled cells obstruct blood vessels and die prematurely, ultimately resulting in anemia, severe pain (crises), infections, stroke, organ failure, and early death. Sickle cell disease is the most common inherited blood disorder in the United States, affecting an estimated 100,000 individuals, of which a significant proportion are of African-American descent. Beta-thalassemia is another inherited blood disorder characterized by severe anemia caused by reduced production of functional hemoglobin due to insufficient expression of the beta globin protein. Transfusion-dependent beta-thalassemia (TDBT) is the most severe form of this disease, often requiring multiple transfusions per year. Patients with TDBT suffer from failure to thrive, persistent infections, and life-threatening anemia.

About BEAM-101
BEAM-101 is a patient-specific, autologous hematopoietic cell therapy under investigation for the treatment of sickle cell disease. BEAM-101 incorporates ex vivo base edits that mimic single nucleotide polymorphisms seen in individuals with hereditary persistence of fetal hemoglobin (HPFH) to potentially alleviate the effects of mutations causing sickle cell disease or beta-thalassemia by increasing the levels of fetal hemoglobin (HbF).

On November 8, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported financial results for the third quarter ended September 30, 2021 and provided a business update (Press release, AVEO, NOV 8, 2021, View Source [SID1234594705]).

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"During the third quarter, we continued to see strong commercial uptake for FOTIVDA, further underscoring the significant unmet medical need that exists in the indicated treatment population. FOTIVDA has been well received by oncologists treating relapsed or refractory (R/R) renal cell carcinoma (RCC), noting both the durable responses and tolerability profile as attractive for their third-line patients. We believe FOTIVDA has the potential to serve as a standard of care for these later line patients," said Michael Bailey, president and chief executive officer of AVEO. "Opening enrollment for our pivotal Phase 3 TiNivo-2 trial of tivozanib and nivolumab marks an important milestone in our efforts to assess tivozanib’s potential as an earlier line of therapy and in the immunotherapy combination setting."

Mr. Bailey continued: "Following the recent receipt of Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for ficlatuzumab and cetuximab in relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC), we believe the clinical development of ficlatuzumab is well positioned to advance in this important potential new treatment option. We expect to commence manufacturing of ficlatuzumab clinical supply in the second quarter of 2022, with the initiation of a potential registrational clinical trial in the human papillomavirus negative (HPV-) HNSCC patient population anticipated in the first half of 2023."

Third Quarter 2021 and Recent Highlights

Strong Third Quarter Sales Growth for U.S. Commercial Launch of FOTIVDA for the Treatment of Adult Patients with R/R Advanced RCC Following Two or More Prior Systemic Therapies.
U.S. net product revenue for the third quarter of 2021 was $14.3 million, which reflects inventory shipped to distributors and a gross-to-net estimate of 16% during the quarter. As of September 30, 2021, year-to-date U.S. net product revenue since FOTIVDA’s commercial launch on March 22, 2021 was $22.1 million.
$14.3 million of U.S. net product revenue for the third quarter of 2021, representing a 113% increase from $6.7 million in the second quarter of 2021.
619 commercial prescriptions filled in the third quarter of 2021, representing a 119% increase from 283 commercial prescriptions filled in the second quarter of 2021.
Approximately 260 accounts have ordered as of September 30, 2021, representing a 90% increase compared to 137 accounts having ordered as of June 30, 2021.
Quarter-end inventory of approximately two weeks for the third quarter of 2021 suggests that the Company’s quarterly sales revenue are currently primarily driven by end user demand.
As planned, the Company’s early launch sampling program has decreased to 75 samples delivered in the third quarter of 2021 compared to 180 samples in the second quarter of 2021.
Enrollment Open for Pivotal Phase 3 TiNivo-2 Trial in IO Advanced Refractory RCC. Patient enrollment opened this quarter for the Phase 3 TiNivo-2 trial evaluating tivozanib in combination with nivolumab, Bristol Myers Squibb’s (NYSE: BMS) antibody directed against programmed death-1, in patients with advanced refractory RCC following one or two lines of therapy, one of which is immunotherapy. Per the previously announced March 2021 clinical trial collaboration and supply agreement, BMS will provide nivolumab clinical drug supply for the trial.
Ficlatuzumab Well-Positioned to Advance in Clinical Development for Treating R/R HNSCC Following FTD Being Granted by the FDA. In September 2021, AVEO announced that the FDA granted FTD for the investigation of ficlatuzumab and cetuximab for the treatment of patients with R/R HNSCC. Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.

The Company expects to commence manufacturing of ficlatuzumab clinical supply in the second quarter of 2022, subject to availability of key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing, with the initiation of a potential registrational clinical trial in HPV- HNSCC now anticipated in the first half of 2023. The Company expects to continue to discuss potential ficlatuzumab pivotal clinical trial designs with the FDA and to continue to seek a strategic partner.
Third Quarter 2021 Financial Highlights

AVEO ended Q3 2021 with $94.0 million in cash, cash equivalents and marketable securities, as compared with $102.9 million at the end of June 30, 2021 and $61.8 million at December 31, 2020.
Total revenue for Q3 2021 was approximately $15.2 million compared with $3.6 million of total revenue for Q3 2020.
FOTIVDA U.S. net product revenue for Q3 2021 was $14.3 million.
Research and development expense for Q3 2021 was $7.5 million compared with $5.9 million for Q3 2020.
Selling, general and administrative expense for Q3 2021 was $15.1 million compared with $5.8 million for Q3 2020.
The increase in selling, general and administrative expense for Q3 2021 is primarily due to costs associated with the commercial launch of FOTIVDA.
Net loss for Q3 2021 was $10.4 million, or net loss of $0.30 per basic and diluted share, compared with a net loss of $8.4 million for Q3 2020, or net loss of $0.33 per basic and diluted share.
Financial Guidance

AVEO believes that its $94.0 million in cash, cash equivalents and marketable securities as of September 30, 2021, along with expected net product revenues from the commercial launch of FOTIVDA in the United States, would enable AVEO to maintain its current operations for a period of at least 12 months following the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021.

In 2021, AVEO expects commercial spend will be approximately $40 million, research and development expense will be approximately $30 million and general and administrative expense will be approximately $20 million. Gross margins are expected to be in the mid-to-high 80th percentile.

Conference Call and Webcast

In connection with this announcement, AVEO will host a conference call and audio webcast today, November 8, 2021, at 4:30 PM Eastern Time. The call can be accessed by dialing (844) 882-7841 (U.S. and Canada) or (574) 990-9828 (international). The passcode for the conference call is 1647457. To access the live webcast, or the subsequent archived recording, please visit the Calendar of Events sub-section within the Investors section of the AVEO website at www.aveooncology.com.

About FOTIVDA (tivozanib)

FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.1 FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.2 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,3 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.

On November 8, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Pascal Touchon, President and Chief Executive Officer of Atara, will participate at three upcoming virtual conferences (Press release, Atara Biotherapeutics, NOV 8, 2021, View Source [SID1234594704]).

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Cowen 5th Annual IO Next Summit
Fireside chat on Monday, November 15, 2021 at 9:45 a.m. EST

Stifel 2021 Virtual Healthcare Conference
Fireside chat on Monday, November 15, 2021 at 4:40 p.m. EST

Evercore ISI 4th Annual HealthCONx Virtual Conference
Fireside chat on Tuesday, November 30, 2021 at 10:05 a.m. EST

Live video webcasts will be available by visiting the Investor Events and Presentations section of atarabio.com. Archived replays will be available on the Company’s website for 30 days following the live webcasts.

On November 8, 2021 Ascendis Pharma A/S (Nasdaq: ASND) reported that provided an update on the Company’s previously announced $25 million American Depositary Shares (ADS) Share Repurchase Program (Press release, Ascendis Pharma, NOV 8, 2021, View Source [SID1234594703]). Each ADS represents one ordinary share of Ascendis Pharma A/S. The program is executed under Rules 10b-18 and 10b5-1 of the U.S. securities regulations.

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In accordance with the program initiated on November 1, 2021, Ascendis Pharma A/S is authorized to repurchase up to $25 million of ADSs in the period starting November 1, 2021 and expected to end no later than December 31, 2021. A maximum of 300,000 ADS in total can be repurchased during the trading period. The maximum number of ADS that can be repurchased on a single trading day may not exceed 10% of the average daily trading volume of Ascendis Pharma A/S ADS, in the prior full four weeks of trading.

Since the initiation of the program, the following transactions have been executed.

Trade Date
Number of ADS Weighted Average
Purchase Price

Total Value*
November 1, 2021 24,540 $159.15 $3,906,181
November 2, 2021 24,631 $162.99 $4,015,444
November 3, 2021 24,631 $163.09 $4,017,730
November 4, 2021 24,631 $161.09 $3,968,488
November 5, 2021 23,989 $160.69 $3,855,409
Purchased under the program 122,422 $161.41 $19,763,252
*Total value includes fees and costs associated with the repurchase program.

Following these transactions, Ascendis Pharma A/S has repurchased a total of 122,422 ADSs under the Share Repurchase Program.