On November 3, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, reported business highlights and financial results for the third quarter ended Sept. 30, 2021 (Press release, Agios Pharmaceuticals, NOV 3, 2021, View Source [SID1234594256]).

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"In the third quarter, we have continued our strong clinical and operational execution. Following our NDA and MAA filings for mitapivat for adults with PK deficiency, the team is laser-focused on launch preparations in this indication, as well as on initiating three pivotal trials across thalassemia and sickle cell disease by year-end," said Jackie Fouse, Ph.D., chief executive officer at Agios. "As we look ahead to the end of the year and to 2022, Agios is extremely well-positioned to enter our next phase of growth, with our first genetically defined disease commercial launch on the horizon, the expected initiation of three pivotal adult trials and two pediatric PK deficiency trials and a robust pipeline filled with optionality and possibility. We look forward to sharing more insights on our clinical and preclinical pipeline and our commercial launch efforts at our investor day in November."

THIRD QUARTER 2021 & RECENT HIGHLIGHTS

Received Priority Review designation for the new drug application of mitapivat in PK deficiency by the U.S. Food and Drug Administration (FDA), accelerating review time from 10 months to six months from the day of filing acceptance; Prescription Drug User Fee Act (PDUFA) action date set for Feb. 17, 2022.
Initiated first global trial sites for Phase 3 ENERGIZE and ENERGIZE-T studies of mitapivat in not regularly transfused and regularly transfused adults with α- or β-thalassemia.
Continued start-up activities for the Phase 2/3 study of mitapivat in sickle cell disease. In collaboration with a global team of sickle cell disease patients and caregivers, developed study name – RISE UP – and unveiled it at the Sickle Cell Disease Association of America 49th Annual National Convention last month.
In Q3, repurchased approximately 5.3 million shares of Agios common stock at an average price of $47.94 per share. To date, the company has completed more than $800 million of the up to $1.2 billion of share repurchases authorized by the Board of Directors following the company’s sale of its oncology business to Servier, representing a reduction of just over 23% of our starting share count.
KEY UPCOMING MILESTONES

Host investor day on Nov. 17 to share updates on the company’s research and development pipeline, as well as provide additional insights into the commercial launch strategy and expectations for mitapivat in PK deficiency.
Initiate Phase 2/3 RISE UP study of mitapivat in sickle cell disease by year-end.
Data Presentations

Submitted the following select data for presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, hosted Dec. 11-14:
Long-term efficacy data of mitapivat in adults with PK deficiency who participated in the Phase 3 ACTIVATE and ACTIVATE-T trials
Long-term efficacy and safety data of mitapivat in adults with thalassemia who do not receive regular transfusions
Efficacy, safety and translational data of mitapivat in sickle cell disease from ongoing collaborator-led studies
Phase 1 healthy volunteer study data of AG-946, the company’s novel PK activator
THIRD QUARTER 2021 FINANCIAL RESULTS

The financial results discussion compares Agios’ continuing operations. All periods have been adjusted to exclude discontinued operations related to the divested oncology business.

Research and Development (R&D) Expenses: R&D expenses for continuing operations were $64.0 million for the third quarter of 2021 compared to $51.9 million for the third quarter of 2020. The year-over-year increase in R&D was driven primarily by start-up costs associated with the Phase 3 studies of mitapivat in thalassemia and sickle cell disease, as well as disease education and engagement efforts for mitapivat in PK deficiency, thalassemia and sickle cell disease.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for continuing operations were $27.2 million for the third quarter of 2021 compared to $28.3 million for the third quarter of 2020.

Non-Operating Income: Non-operating income included approximately $2.0 million from TIBSOVO (ivosidenib) royalties for the third quarter of 2021.

Net Loss: Net loss was $88.8 million for the third quarter of 2021 compared to a net loss of $99.0 million for the third quarter of 2020.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of Sept. 30, 2021, were $1.4 billion compared to $722.4 million as of Sept. 30, 2020. The company expects that its cash, cash equivalents and marketable securities will enable the company to execute its operating plan through major catalysts and to cash-flow positivity without the need to raise additional equity.

CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss third quarter 2021 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 5748074. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

November 17 Investor Event Webcast Information
Agios will host an investor webcast on November 17, 2021 at 2:00 p.m. ET to discuss the company’s research and development pipeline, as well as provide additional insights into the commercial launch strategy and expectations for mitapivat in PK deficiency. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors section of Agios’ website at www.agios.com. The archived webcast will be available on Agios’ website beginning approximately two hours after the event.

On November 3, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported third quarter 2021 financial results and highlighted recent achievements and developments (Press release, Oncorus, NOV 3, 2021, View Source [SID1234594255]).

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"We continue to make important progress advancing our broad portfolio of next-generation viral immunotherapies and creating a state-of-the-art process development and manufacturing infrastructure to support our planned future development activities and growth," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer at Oncorus. "Our Phase 1 clinical trial of ONCR-177 continues to enroll patients, and we are excited to begin sharing data from this trial at SITC (Free SITC Whitepaper) next week during a poster presentation beginning on November 12th. Across our oHSV and Synthetic vRNA Immunotherapy platforms we have multiple preclinical efforts underway as we advance our next programs toward the clinic. In addition, we are thrilled to report that the first phase of our manufacturing facility has been completed, with Oncorus team members now working onsite, overseeing process development activities."

Dr. Ashburn continued, "The breadth of activities we have underway is a testament to the tremendous competence and capabilities of our team. We continue to execute on our goal of building the leading viral immunotherapies company, based on world-class science, pipeline breadth, and an unwavering commitment to cancer patients."

Third Quarter 2021 and Recent Highlights

Initial data to be presented for ongoing Phase 1 clinical trial of ONCR-177 at SITC (Free SITC Whitepaper) 2021, taking place November 12 – 14 in Washington, DC and virtually. Oncorus continues to enroll patients across 11 sites in the United States and Canada in a Phase 1 clinical trial of ONCR-177, an intratumorally (iTu) administered oHSV viral immunotherapy, being developed for multiple solid tumor indications. The Phase 1 open-label, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177 alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. This presentation at SITC (Free SITC Whitepaper) will mark Oncorus’ first reporting of human data from its oHSV platform.
Continued to progress first Synthetic vRNA immunotherapy clinical candidates, ONCR-021 and ONCR-788. As disclosed earlier this year, ONCR-021 and ONCR-788 employ Oncorus’ pioneering IV-administered approach of encapsulating the genomes of RNA viruses known to kill cancer cells (i.e., oncolytic viruses, or OVs) in lipid nanoparticles (LNPs), creating, to the company’s knowledge, the first-ever Synthetic vRNA immunotherapy. ONCR-021 encodes an optimized strain of CVA21 (Coxsackievirus A21); ONCR-788 encodes a modified version of SVV (Seneca Valley Virus, or SVV). CVA21 and SVV both have extensive clinical experience and favorable safety profiles when administered intravenously. Oncorus’ novel Synthetic vRNA approach holds the potential for IV administration while avoiding the challenge of neutralizing antibodies seen in previous approaches with IV-administered OVs. (Learn more about Oncorus’ novel Synthetic vRNA Immunotherapy approach.)

Oncorus is currently initiating GLP safety and tolerability studies for ONCR-021 and anticipates submitting an IND for this program in the first half of 2023. The company is also conducting preliminary non-GLP safety and tolerability studies for ONCR-788 and is not yet providing guidance on timing of an IND submission for this program. Oncorus plans to investigate its novel Synthetic vRNA immunotherapies in multiple histologies, including cancers of the lung, both as monotherapy and in combination with immune checkpoint inhibitors and possibly other cancer treatments.
Upcoming preclinical presentation on ONCR-GBM at the International Oncolytic Virus Conference (IOVC) 2021. Leveraging its oHSV platform, Oncorus is pursuing ONCR-GBM to specifically target brain cancer, including glioblastoma multiforme (GBM). The company is utilizing its knowledge of microRNA expression to engineer a microRNA attenuation strategy to protect healthy brain tissue and to select a rational combination of payloads intended to address both the cancer itself and the specific drivers of immune suppression in the brain. Oncorus plans to submit an IND for ONCR-GBM in the second half of 2023.

Oncorus will present a poster titled, "ONCR-GBM: A Novel, Armed Oncolytic HSV-1 Vector Engineered for Efficacy and Safety in Glioblastoma" (Poster #10226), at IOVC 2021, which will take place November 5 – 7 in Sedona, Arizona and virtually. Part of the conference’s Virtual Poster Session, Oncorus’ e-poster will describe the design and evaluation of multiple features that will be incorporated into the ONCR-GBM program, including robust anti-tumor activity observed with IL-12 and a proprietary PD-1 antagonist nanobody. Link to the meeting website here.
Completed first phase of Process Development and Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility buildout. Oncorus has completed the first phase of its state-of-the-art, 88,000 square foot process development and GMP viral immunotherapy clinical manufacturing facility in Andover, Mass. Oncorus is building out the expansive facility to provide a comprehensive solution for its Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality control and supply of clinical-grade viral immunotherapies for IND-enabling and clinical studies. Process development and GMP readiness activities are now underway at the site. Oncorus anticipates the buildout to be completed and the site to be fully operational, including GMP multi-product manufacturing capabilities, in the first half of 2023.
Third Quarter Financial Results

Cash and cash equivalents were $145.6 million as of September 30, 2021 compared to $130.3 million as of December 31, 2020.
Research and development expenses for the quarter ended September 30, 2021 were $11.3 million compared to $6.9 million for the corresponding quarter in 2020. The increase in research and development expenses was mainly attributable to increased employee compensation costs, which was driven by increased headcount and increased stock-based compensation, increased rent expense related to the company’s new manufacturing facility and increased development costs related to the company’s nominated candidates.
General and administrative expenses for the quarter ended September 30, 2021 were $5.4 million compared to $2.0 million for the corresponding quarter in 2020. The increase in general and administrative expenses was primarily attributable to increases in employee compensation costs, including higher stock-based compensation, increased headcount and increased salary and related expenses. General and administrative expenses also increased due to higher insurance expense and professional and consultant expenses related to operating as a public company.
Other income (expense), net, for the quarter ended September 30, 2021 was income of $0.01 million compared to an expense of $10.6 million for the quarter ended September 30, 2020. The expense for the quarter ended September 30, 2020 included a non-cash charge of $10.6 million related to an increase in the fair market value of the company’s Series B preferred stock tranche rights liability that was settled in September 2020.
Net loss attributable to common stockholders for the quarter ended September 30, 2021 was $16.7 million, or $0.65 per share, as compared to a net loss attributable to common stockholders of $22.4 million, or $21.73 per share for the same quarter in 2020. The share and net loss per share amounts in the third quarter of 2021 include the impact of Oncorus’ IPO, which closed in October 2020, including the conversion of outstanding preferred stock into approximately 15.0 million shares of common stock.
Financial Guidance

Based upon its current operating plans and cash and cash equivalents, Oncorus expects to have sufficient capital to fund its operating expenses and capital expenditure requirements into late 2023.

On November 3, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the third quarter ended September 30, 2021, and provided a corporate update (Press release, BioCryst Pharmaceuticals, NOV 3, 2021, View Source [SID1234594254]).

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"With the significant revenue of $115 million to $120 million we expect to generate with ORLADEYO in its first year of launch, and an even larger fast-following pipeline that includes four separate indications currently in pivotal or proof of concept trials in the complement space with BCX9930, BioCryst plans to repeat our clinical and commercial success with ORLADEYO again and again as we bring these much-needed oral medicines to the patients who are waiting for them," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

U.S. Launch

"Almost a year into the launch of ORLADEYO, we continue to see strong, consistent demand from new patients switching to ORLADEYO from their existing injectable prophylactic and acute therapies, and it is exciting to see the positive impact ORLADEYO is having on their lives. With the excellent start to the launch, and the excitement we hear from physicians and patients, ORLADEYO is now on a trajectory to become the market leader in HAE prophylaxis," said Charlie Gayer, chief commercial officer of BioCryst.

ORLADEYO net revenue in the third quarter of 2021 was $37.0 million.

New patient demand for ORLADEYO remains strong and consistent with as many new patients added in Q3 as in Q2.

Patient switches continue to drive the launch with more than half of patients who were new to ORLADEYO in the third quarter switching from other prophylactic medicine to ORLADEYO and the remainder from acute-only treatment.

The number of new physicians prescribing ORLADEYO grew by another 25 percent in the third quarter and the ORLADEYO prescriber base has now increased to include nearly half of the top 500 hereditary angioedema (HAE)-treating physicians in the United States.

ORLADEYO has been very well received by payors and is now covered by nearly all national and regional pharmacy benefit managers.

Most patients continue to have an excellent experience on ORLADEYO and remain on therapy. Through the launch thus far, patient retention on therapy remains consistent with the one-year patient retention rate observed in the APeX-2 clinical trial.
ORLADEYO: Global Updates

ORLADEYO has received reimbursement approval in Norway and is expected to launch in Norway in early December.

On September 15, 2021, the company announced that the United Kingdom’s National Institute for Health and Care Excellence had recommended ORLADEYO for preventing recurrent attacks of HAE in eligible patients 12 years and older if they have at least two attacks per month.

On September 9, 2021, the company announced that the Ministry of Health and Prevention in the United Arab Emirates (UAE) had granted marketing authorization for ORLADEYO for the prevention of recurrent attacks in patients with HAE 12 years and older. To support commercialization efforts in the UAE, BioCryst has entered into a supply and distribution agreement with NewBridge Pharmaceuticals, which also covers the Gulf Cooperation Council and Iraq.

On August 25, 2021, the company announced that the new drug submission for ORLADEYO had been accepted for review by Health Canada for the prevention of recurrent attacks in patients with HAE 12 years and older. The company also announced that Swissmedic has accepted BioCryst’s marketing authorization application for ORLADEYO for review.
Complement Oral Factor D Inhibitor Program – BCX9930

Trial site start-up activities are underway at sites around the world for REDEEM-1 and REDEEM-2, two pivotal trials with the company’s oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 is a randomized, open-label, active, comparator-controlled comparison of the efficacy and safety of BCX9930 (500 mg bid) monotherapy in approximately 81 PNH patients with an inadequate response to a C5 inhibitor. REDEEM-2 is a randomized, placebo-controlled trial to evaluate the efficacy and safety of BCX9930 (500 mg bid) as monotherapy versus placebo in approximately 57 PNH patients not currently receiving complement inhibitor therapy. The primary endpoint for both trials is the change from baseline in hemoglobin, assessed at weeks 12 to 24 in REDEEM-1 and at week 12 in REDEEM-2. Patient enrollment is expected to begin in the fourth quarter of 2021.

In the fourth quarter of 2021, the company also is preparing to initiate a proof of concept trial of oral BCX9930 (500 mg bid) in renal complement-mediated diseases. The trial will be a basket study to evaluate BCX9930 for the potential to treat patients with C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy.

The company has completed a proof of concept trial in patients with PNH, including both treatment-naïve and those patients with an inadequate response to C5 inhibitors. Patients on BCX9930 have been allowed to roll over with continued follow-up into a long-term safety trial. The safety and efficacy data collected from these patients in the long-term safety trial provides the company with a high degree of confidence for the success of the pivotal trials.
Additional Updates

On September 20, 2021, the company announced the appointment of Amy McKee, M.D. to the BioCryst board of directors.

On September 1, 2021, the company announced that the U.S. Department of Health and Human Services had exercised its option to purchase an additional 10,000 doses of BioCryst’s antiviral influenza therapy, RAPIVAB (peramivir injection), for approximately $7 million.

On August 26, 2021, the company announced the appointment of Steven Galson, M.D., MPH to the BioCryst board of directors.

On July 28, 2021, the company announced the appointment of Vincent Milano to the BioCryst board of directors.
Third Quarter 2021 Financial Results

For the three months ended September 30, 2021, total revenues were $41.0 million, compared to $6.1 million in the third quarter of 2020. The increase was primarily due to $37.0 million in ORLADEYO net revenue in the third quarter of 2021.

Research and development expenses for the third quarter of 2021 increased to $50.0 million from $30.2 million in the third quarter of 2020, primarily due to increased investment in the development of BCX9930 and other research, preclinical and development costs, offset by a reduction in spend on the ORLADEYO program following our commercial launch in December 2020.

Selling, general and administrative expenses for the third quarter of 2021 increased to $35.0 million, compared to $17.2 million in the third quarter of 2020. The increase was primarily due to increased investment to support the U.S. commercial launch of ORLADEYO and expanded international operations.

Interest expense was $14.1 million in the third quarter of 2021, compared to $2.9 million in the third quarter of 2020. The increase was due to service on the royalty and debt financings, which were completed in December 2020. The interest payment-in-kind (PIK) option on the Athyrium term loan has been exercised and $5.4 million has been added in the third quarter of 2021 and $12.9 million since issuance, to the $125 million principal.

Net loss for the third quarter of 2021 was $58.8 million, or $0.33 per share, compared to a net loss of $46.1 million, or $0.26 per share, for the third quarter of 2020.

Cash, cash equivalents, restricted cash and investments totaled $203.9 million at September 30, 2021, compared to $148.5 million at September 30, 2020. Operating cash use for the third quarter of 2021 was $18.8 million.

Financial Outlook for 2021

Based on the strength of the ORLADEYO launch, and continued growth from new patient demand expected in the fourth quarter, the company now expects full year 2021 net ORLADEYO revenue to be between $115 million and $120 million. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2592545. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2592545.

On November 3, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company using its ARCUS genome editing platform to develop allogeneic CAR T and in vivo gene editing therapies, reported that it will publish financial results for the third quarter 2021 and provide a business update on November 10, 2021 (Press release, Precision Biosciences, NOV 3, 2021, View Source [SID1234594253]).

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Precision BioSciences also announced that Michael Amoroso, Chief Executive Officer will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference taking place November 15-17, 2021.

Details for the fireside chat are below:

Stifel 2021 Virtual Healthcare Conference
Date: Tuesday, November 16, 2021
Time: 1:20 PM ET

A live webcast of the fireside chat will be accessible on the Company’s website in the Investors section under Events & Presentations: View Source An archived replay of the webcast will be available for approximately 30 days.

On November 3, 2021 Alkermes plc (Nasdaq: ALKS) reported plans to present a poster related to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place Nov. 10-14, 2021 (Press release, Alkermes, NOV 3, 2021, View Source [SID1234594252]). The poster will include data from the ION-01 study, a phase 2 trial evaluating intravenous nemvaleukin in combination with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma that had previously progressed on an anti-PD-(L)1 therapy.

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Details of the presentation are as follows:

Abstract: 432
Title: Nemvaleukin alfa, a novel engineered IL-2 cytokine, in combination with the anti-PD-1 antibody pembrolizumab in patients with recurrent/metastatic head and neck squamous cell carcinoma (ION-01 study)
Presenter: Brian Gastman, M.D., Surgical Director, Melanoma & High-Risk Skin Cancer Program at the Cleveland Clinic, Cleveland, Ohio
Presentation Date: The poster and presentation will be available on the SITC (Free SITC Whitepaper) virtual meeting platform beginning Nov. 12, 2021. The poster is scheduled to be presented onsite at the meeting on Nov. 13, 2021.

About Nemvaleukin Alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the Nemvaleukin Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

ION-01 is a phase 2 trial being conducted in collaboration with Fred Hutchinson Cancer Research Center and is designed to estimate the response rate to intravenous nemvaleukin in combination with the anti-PD-1 therapy pembrolizumab in patients with advanced or recurrent head and neck squamous cell carcinoma who did not achieve complete remission with an anti-PD-(L)1 antibody treatment.