Entry into a Material Definitive Agreement

On November 30, 2022, Agenus Inc. (the "Company") entered into an Amendment to Notes, Termination of Warrants and Sale of New Warrants (the "Amendment") with existing noteholders, pursuant to which the Company (Filing, 8-K, Agenus, DEC 2, 2022, View Source [SID1234624738]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


extended the maturity date of the $13.0 million senior subordinated promissory notes previously issued by the Company to such noteholders in 2015 (the "2015 Notes") by two years from February 20, 2023 to February 20, 2025;

terminated the warrants held by such noteholders to purchase 1,300,000 shares of the Company’s common stock previously issued in 2015;

terminated the warrants held by such noteholders to purchase 650,000 shares of the Company’s common stock previously issued in 2020; and

issued to such noteholders new warrants to purchase 1,300,000 shares of the Company’s common stock that will expire February 20, 2026 and issued new warrants to purchase 650,000 shares of the Company’s common stock that will expire February 20, 2028, all such warrants having an exercise price of $2.84 per share, which represented a 15% premium over the 30-day average trailing closing price of the Company’s common stock for the period ending November 9, 2022, and (the "New Warrants").

The foregoing description of the Amendment and the New Warrants do not purport to be complete and are qualified in their entirety by reference to the text of the Amendment and the forms of New Warrants. The Amendment will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the forms of New Warrants are attached as exhibit 4.1 and 4.2 hereto.

A brief description of the other terms and conditions of the 2015 Notes can be found in Item 2.03 of the Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission on February 26, 2015 and such brief description is incorporated by reference herein.

The securities issued in connection with the Amendment were issued in reliance on the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended (the "Securities Act"). Neither the New Warrants nor the underlying shares of common stock have been registered under the Securities Act. Neither the New Warrants nor such underlying shares of common stock may be offered or sold in the United States absent registration or an applicable exemption from registration requirements. No commission or other remuneration was paid or given directly or indirectly for soliciting such issuance.

EVT801 pre-clinical data published in peer-reviewed cancer research journal

On December 1, 2022 Evotec partner Kazia Therapeutics Limited ("Kazia", NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported the publication of positive pre-clinical data for EVT801, a clinical-stage drug candidate currently in a clinical trial for multiple forms of cancer (Press release, Evotec, NOV 30, 2022, View Source [SID1234624732]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The publication, by Michael Paillasse and colleagues, summarises a large body of pre-clinical research conducted principally by scientists at Evotec SE and at the University Cancer Institute of Toulouse – Oncopole over a period of several years. It is now published in Cancer Research Communications, a recently-launched journal published by the American Association of Cancer Research ("AACR"). The data formed the basis of Kazia’s in-licensing of EVT801 from Evotec in 2021 and has since supported transition of the compound into an ongoing Phase I clinical trial in patients with advanced solid tumours.

The publication may be accessed via the journal website at
View Source

For further information, please follow this link to the full version of the press release from Kazia Therapeutics.

Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On November 30, 2022 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on November 30, 2022 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 42 individuals hired by Sarepta in November 2022 (Press release, Sarepta Therapeutics, NOV 30, 2022, View Source [SID1234624637]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The employees received, in the aggregate, options to purchase 55,000 shares of Sarepta’s common stock, and in the aggregate 28,500 restricted stock units ("RSUs"). The options have an exercise price of $122.81 per share, which is equal to the closing price of Sarepta’s common stock on November 30, 2022 (the "Grant Date"). One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of the Grant Date and thereafter 1/48th of the shares underlying each employee’s option will vest monthly, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting dates.

One-fourth of the RSUs will vest yearly on each anniversary of the Grant Date, such that the RSUs granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting date.

Kiniksa Pharmaceuticals to Present at Bank of America Securities 2022 Biotech SMID Cap Conference

On November 30, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that management will participate in a fireside chat at the Bank of America Securities 2022 Biotech SMID Cap Conference on Wednesday, December 7, 2022 at 10:15 a.m. Eastern Time (Press release, Kiniksa Pharmaceuticals, NOV 30, 2022, View Source [SID1234624636]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

Aeglea BioTherapeutics Appoints Jeffrey M. Goldberg as Chief Executive Officer

On November 30, 2022 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, reported the appointment of Jeffrey M. Goldberg as president, chief executive officer and member of the board of directors effective November 29, 2022 (Press release, Aeglea BioTherapeutics, NOV 30, 2022, View Source [SID1234624635]). Mr. Goldberg is an accomplished biotech executive with over 25 years of experience leading teams from preclinical discovery through commercialization and previously served as president and chief executive officer of Immunitas Therapeutics.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Jeff has successfully built and managed teams across a wide variety of functions, providing strong leadership and strategic direction. His breadth of experience spans from the founding of companies to overseeing successful global launches of rare disease therapies," said Russell J. Cox, chair of the board of directors of Aeglea. "His proven ability to match business capabilities to unmet patient needs and then drive the strategy and execution needed to achieve those goals will be an important asset to Aeglea. I look forward to working closely with Jeff and welcome him to the Aeglea team."

"To me, the most important and fulfilling part of my job has been being able to bring therapies forward that have had significant impact on patients’ lives. Aeglea shares that mission and has built world-class programs in Homocystinuria and Arginase 1 Deficiency with the potential to benefit all the key stakeholders, including employees, shareholders, physicians, and most importantly patients and their families," said Mr. Goldberg. "I’m incredibly excited to be joining the team and helping to facilitate the mission of developing novel medicines for patients battling devastating diseases."

Mr. Goldberg served as president and chief executive officer at Immunitas from 2019-2021. Under his leadership, Immunitas grew significantly, raised additional capital, and is now in the clinic with its first asset. Prior to joining Immunitas, Mr. Goldberg served as the founding chief operating officer at Akcea where he was responsible for building functions and leading teams across all aspects of the business and eventually grew the team from two employees to over 250 in multiple geographies. Mr. Goldberg played a significant role in the company’s initial public offering and fundraising activities, business development and the global launch of two rare disease drugs. Prior to Akcea, he was the vice president of business operations at Proteostasis Therapeutics, a rare disease company. He also held roles of increasing responsibility at Genzyme, where he led teams through product development and global launches across multiple therapeutic areas. Mr. Goldberg has an MBA and a MS in Chemical Engineering from the Massachusetts Institute of Technology, and a B.S. in Chemical Engineering from Cornell University.

Jim Kastenmayer, JD, PhD, will step down as interim chief executive officer and retain his position as Aeglea’s general counsel. "On behalf of the entire board of directors, I want to thank Jim for his service and commitment to Aeglea and its mission. Jim has provided exceptional leadership during a period of critical execution and has kept the team focused on advancing the Homocystinuria program," said Mr. Cox.

Following the leadership transition and as part of the related evaluation of near-term corporate and clinical development strategy, Aeglea no longer plans to announce interim clinical data from the ongoing Phase 1/2 clinical trial of pegtarviliase in Classical Homocystinuria in the fourth quarter of 2022. Enrollment in the third cohort of the Phase 1/2 trial is ongoing with two patients having completed dosing in the cohort. Additionally, the company has decided not to participate in the Piper Sandler 34th Annual Healthcare Conference and 5th Annual Evercore ISI HealthCONx Conference, both being held November 29-December 1, 2022. Aeglea looks forward to delivering a clinical update on the pegtarviliase program when more comprehensive data from the third cohort becomes available.