Xeris Pharmaceuticals | Top Diabetes Care Company 2019

MedTech Outlook Magazine

Xeris Pharmaceuticals
Combating Hypoglycemia with Simplicity

John Shannon, Chief Operating Officer, Xeris PharmaceuticalsJohn Shannon, Chief Operating Officer
As per the National Diabetes Statistics Report 2017, 1 in 10 Americans and approximately 1 in 3 American adults suffer from diabetes and prediabetes, respectively. The consequences of severe diabetes can be lethal, often culminating in kidney failures, heart attacks, amputations, nerve damage, and more. However, one must take into account that drastic measures to keep diabetes in check or aggressively treating it can be equally damaging, resulting in life-threatening bouts of hypoglycemia. Situations as such demand immediate attention before patients are incapacitated by seizures or even slip into coma. Chicago-based Xeris Pharmaceuticals is developing an apt solution to rise to the predicament of diabetic patients—a silver bullet in the hour of need. The specialty pharmaceutical company, Xeris, is developing a proprietary formulation technology— XeriSol™—for the delivery of highly concentrated, non-aqueous, ready-to-use, room temperature stable formulation of the peptide, glucagon.

The chief operating officer of Xeris, John Shannon, attributes the success of the company to the relentless efforts of one of its co-founders, Steve Prestrelski, the chief scientific officer at Xeris, and his team. A formulation technology scientist, Prestrelski and his team have dedicated a decade of their careers in architecting non-aqueous delivery systems for drugs that are unstable in water. Shannon goes on to say, “The persistent endeavor of the Xeris team is what helped us craft the XeriSol technology, specifically, creating the first and only room temperature liquid stable glucagon.”

Glucagon is a peptide unstable in water that has so far been difficult to formulate in a ready-to-use format. With XeriSol technology, glucagon is put in a liquid form available for immediate use. “We have also added a 2-step auto-injector devise that can be used for people with diabetes in an emergent case of acute hypoglycemia,” adds Shannon. In contrast, in adverse situations like this, a caregiver generally has to follow nine different steps with glucagon emergency kits that are currently available on the market—a difficult task in an emergency situation.

The persistent endeavor of the Xeris team is what helped us craft the XeriSol technology, specifically, creating the first and only room temperature liquid stable glucagon


The XeriSol technology along with the auto-injector makes administering glucagon easier and more efficient, assuring millions of diabetic patients, especially on insulin, another option in the case of a severe hypoglycemic event. “If approved by FDA, our revolutionary technology may help patients and their families, healthcare professionals, and payers tackle such situations with a rescue solution at hand without having to rely on the existing emergency kits, which people fail to administer correctly the majority of the time,” continues Shannon.

Speaking about the company’s culture, Shannon proudly mentions that the Xeris team is highly motivated owing to the benefits that the ready-to-use glucagon can bring to the healthcare space. “In addition to hypoglycemia, the ready-to-use glucagon is being studied in other critical hypoglycemic conditions like Post-Bariatric Hypoglycemia, Hypoglycemia-Associated Autonomic Failure (HAAF), Congenital Hyperinsulinism, and more,” explains Shannon. These significant strides toward a better quality of care for people who experience severe hypoglycemic conditions function as the impetus for the Xeris team. “When it comes to a ready-to-use liquid stable form of glucagon, there are bigger organizations that failed to come up with an intuitive, elegant solution like ours. Xeris persisted.”

The company is also conducting a program with Diazepam to create a ready-to-use liquid form in an easy-to-use autoinjector approach for epileptic seizures.

While a product—mainly small molecules and peptides—is formulated into a stable, ready-to-use liquid in XeriSol, larger molecules are suspended in an injectable XeriJect paste that can pass through a needle, just like a liquid, then is reconstituted using the body’s water.

Currently, Xeris plans to commercialize glucagon rescue pen in the US; look for potential commercialization partners outside the US; and aims to collaborate with European and Asian countries.

Top 10 Diabetes Care Companies - 2019

Company
Xeris Pharmaceuticals

Management
John Shannon, Chief Operating Officer

Description
Xeris Pharmaceuticals is a pharmaceutical firm specialized in developing and marketing ready-to-use and stable liquid injectables using novel formulation technology platforms. The unique technology allows physicians and caregivers to use medications more quickly. In order to reduce much-related therapy burden and enhance the life of the patient, Xeris develops creative ready-to-use alternatives for different therapeutical classifications. Xeris allows medicines with trust and tranquility to effectively cure severe hypoglycemia. Xeris works to provide PBH assistance to clients. Xeris works to enable infants and kids with CHI to use glucagon

Xeris Pharmaceuticals News

Xeris Biopharma Raises Full-Year Financial Guidance and Reaffirms Cash Flow Breakeven in Q4 2023

Raises year-end cash, cash equivalents, and short-term investment guidance from $55M-$65M to $65M-$70M
2023 Cash Utilization expected to be $52M-$57M
Tightens 2023 Total Revenue guidance from $145M-$165M to $155M-$165M
Received $6M milestone payment for successfully formulating sub-cutaneous TEPEZZA®
Q3 2023 financial results conference call and webcast November 9, 2023 at 8:30 a.m. ET
CHICAGO, : Xeris Biopharma Holdings, Inc.l (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that, it is raising its full-year 2023 financial guidance and that it has received a $6 million milestone payment from Amgen, which acquired Horizon Therapeutics, for developing an ultra-concentrated, ready-to-use, subcutaneous injection of TEPEZZA® that met the target product profile set forth in the research collaboration and option agreement signed in November 2022.
Steven Pieper, Chief Financial Officer of Xeris stated, "We remain on track to achieve cash flow breakeven in the fourth quarter which would be an important milestone for the company. We are also raising our year-end 2023 cash guidance from $55-65 million to $65-$70 million. This would suggest a net cash outflow in the 2nd half of 2023 of approximately $11-16 million, which is a significant improvement over the first half net cash outflow of approximately $41 million. Our total cash utilization for full-year 2023 is expected to be $52-57 million. As the business continues to perform, our rate of cash utilization continues to improve. Given the strength of all three brands and achievement of the Horizon milestone, we are also tightening our total revenue guidance from $145-$165 million to $155-$165 million."
"We are also proud to announce that we have successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA, and as such, received the associated $6 million success payment," said Paul R. Edick, Chairman and CEO of Xeris. "They also have an option to license the XeriJect technology to further the development of the XeriJect subcutaneous TEPEZZA. We want to thank the legacy Horizon team for being an incredible partner throughout this part of the process and look forward to continuing great work together, should Amgen pick up the option to move forward with continued development of XeriJect subcutaneous TEPEZZA. If the option is executed, Xeris may be entitled to receive development milestones, regulatory milestones, sales-based milestones, and royalties based on future sales."
Third Quarter Conference Call Details
Xeris will host a conference call and webcast on Thursday, November 9, 2023 at 8:30 a.m. Eastern Time. To pre-register for the conference call, please use the following link: https://www.netroadshow.com/events/login?show=59946218&confId=55658. After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Thursday, November 23, 2023 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 328140.

Xeris Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

CHICAGO - Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that on April 1, 2024, the Compensation Committee of Xeris’ Board of Directors granted restricted stock units for an aggregate of 103,000 shares of its common stock to 18 new employee(s) under Xeris’ Inducement Equity Plan.
Xeris’ Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously employed by Xeris or one of its subsidiaries as an inducement material to such individual's entering into employment with Xeris or one of its subsidiaries, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The restricted stock units will vest over a period of three years in equal annual installments, and are subject to the employees’ continued employment with Xeris or one of its subsidiaries. All equity awards are subject to the terms and conditions of Xeris’ Inducement Equity Plan and forms of award agreements covering the grants.

Xeris Biopharma Announces Positive Topline Phase 2 Clinical Data of Its Investigational XeriSol™-Formulated Once-Weekly Subcutaneous (SC) Levothyroxine (XP-8121)

XeriSol™ formulation enabled predictable bioavailability and sustained levels of levothyroxine in a once-weekly subcutaneous presentation
Once-weekly SC levothyroxine (XP-8121) participants normalized TSH/T4 levels using 45% less drug than would be needed for their daily oral dose on a weekly basis
Data established an average once-weekly SC dose of XP-8121 and confirmed previous Phase 1 study of a 4X target dose conversion factor when switching from once-daily oral administration of levothyroxine
Participants who completed the study rated higher treatment satisfaction with XP-8121 compared to oral and a majority (72%) indicated a strong preference for the SC route of administration
Study exposed the challenges of achieving and maintaining normal TSH with daily oral levothyroxine therapy
FDA End-of-Phase 2 interaction to facilitate a Phase 3 pivotal study program is expected by year-end
CHICAGO -Xeris Biopharma Holdings, Inc. announced topline results from its recently completed Phase 2 multi-center, open label, study of XP-8121 for the treatment of adults with hypothyroidism. XP-8121 employs the Company’s XeriSol™ formulation technology to enable a novel once-weekly SC injection of levothyroxine. This novel formulation significantly increases the bioavailability of levothyroxine reducing overall drug exposure and enabling a dosing regimen with the potential to mitigate the many challenges associated with achieving and maintaining a normal level of thyroid stimulating hormone (TSH) with daily oral formulations of levothyroxine.
The Phase 2 study (NCT05823012) was a non-randomized, open-label, single arm, self-controlled study of XP-8121 (levothyroxine sodium) to determine a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 (levothyroxine sodium) in 46 patients with hypothyroidism and to assess the safety and tolerability of XP-8121 (levothyroxine sodium) after once-weekly SC injections. The Phase 2 study leveraged the bioavailability observations of a previous Phase 1 study in which PK analysis showed that participants could achieve comparable systemic exposure with XP-8121 at only 57% of a weekly oral dose. The Phase 2 study included the following periods: Screening, Titration Period (2 to 8 weeks), and Maintenance Period (4 weeks). Participants entered the study on a stable oral dose (≥ 3 months) with normal TSH and free T4 laboratory values.
Participants were receiving a daily oral levothyroxine dose of 83.7 ± 31.14 mcg (mean ± SD) at study entry. To ensure the safety of study participants, once-weekly SC injection of XP-8121 was initiated at 2X their daily dose and titrated every 2 weeks to a target of 4X their daily dose. Participants completing the Maintenance Period were receiving a weekly XP-8121 dose of 324.4 ± 125.59 mcg. The geometric mean ratio of the once-weekly dose of XP-8121 to the daily dose levothyroxine (aka dose conversion factor) was 4.02 [90% CI 3.79, 4.27]. A total of 30 participants (65.2%) experienced at least 1 TEAE (Treatment Emergent Adverse Event) with most rated mild (87%) and moderate (13%) in severity. The most frequent (> 2 participants) TEAE included fatigue (21.7%), injection site pain (10.9%), headache (8.7%) and urinary tract infection (6.5%). No deaths or other serious adverse events (SAEs) were reported. Injection site tolerability was assessed with every SC administration of XP-8121 (> 450 injections). There were very few reports of discomfort (18%; mostly mild intensity), erythema (7%; Draize scale) or edema (1%; Draize scale). No participant discontinued from the study due to an injection site reaction. The Treatment Satisfaction Questionnaire for Medication (TSQM-9) was administered to assess patient satisfaction. XP-8121 scored consistently higher in all three domains (effectiveness, convenience, and global satisfaction) compared to oral levothyroxine. At the conclusion of the study, participants were asked to rate preference for once-weekly XP-8121. A majority (72%) indicated a strong preference for the SC route of administration based on categorical attributes of convenience (60.6%), ease of administration (45.5%), frequency of administration (54.5%), level of compliance (27.3%) and confidence in therapy (36.4%).
“A 2022 study published in the Journal of the Endocrine Society estimated the prevalence of hypothyroidism in the U.S. grew to 11.7% or approximately 30 million adults in 2019*. Innumerable reports have been published documenting the various compliance and absorption challenges that can interfere with the bioavailability of oral levothyroxine. Interestingly, in our own Phase 2 study, 40% of patients considered stable at the time of screening were found to have their TSH or T4 outside of normal range. We believe our once-weekly SC injection can enable control in patients who struggle with oral preparations for a variety of reasons,” said Paul R. Edick, Xeris’ Chairman and CEO.
“We are excited by the initial top line results of our Phase 2 dose-finding study of XP-8121. These results are further evidence of our target dose conversion and consistent with the estimates generated from the prior Phase 1 study in healthy volunteers,” said Kenneth E. Johnson, PharmD, Xeris’ Senior Vice President, Global Development and Medical Affairs. “Given the known challenges of oral bioavailability of levothyroxine and further by the high rate of screen failures observed in our phase 2 study, we believe that XP-8121 could fill a substantial unmet medical need. We look forward to meeting with the FDA later this year and expect to present complete study results at upcoming medical meetings as well as submission to peer-reviewed medical journals.”

Xeris to Participate in the Jefferies Global Healthcare Conference

CHICAGO - Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced that members of its senior management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 6 at 2:00pm Eastern Time.
A live webcast of the event will be available on the 'Events & Presentations' section of Xeris’ Investor Relations website at https://xerispharma.com/investor-relations or https://wsw.com/webcast/jeff302/xers/1871136. A replay of the webcast will be available for 60 days.