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).

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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]).

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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.

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"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.

Liminatus Pharma LLC and Iris Acquisition Corp to combine to incorporate and accelerate much-needed cancer treatments

On November 30, 2022 Liminatus Pharma LLC ("Liminatus"), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies and Iris Acquisition Corp ("Iris") (Nasdaq: IRAA), a publicly traded special purpose acquisition company ("SPAC") formed for the purpose of acquiring or merging with one or more businesses, reported they have entered into a definitive business combination agreement (Press release, Liminatus Pharma, NOV 30, 2022, View Source [SID1234624633]). Upon closing of the transaction, the combined company will be renamed "Liminatus Pharma, Inc.". The combined company’s common stock is expected to be listed on the Nasdaq Capital Market. The transaction funding includes commitments for a $15 million common stock PIPE financing and a $25 million convertible note financing to further support Liminatus’ business growth strategy.

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As part of the agreement the new entity is expected to develop three much-needed cancer treatments which have originated from the Thomas Jefferson University (TJU) in the US and a South Korean biotech firm, Innobation Bio Ltd. ("Innobation"). The lead product candidate, the GCC Vaccine is currently in Phase II clinical trials and is designed to elicit immune responses against colorectal, pancreatic, gastric, and esophageal cancers that express Guanylyl Cyclase C ("GCC"). Further to the work in this area, Liminatus expects to use the increased capital from this agreement to progress its GCC CAR-T therapy to a first in human clinical trial, and complete IND enabling studies for its next generation CD47 immune checkpoint inhibitor.

About the Transaction

The business combination implies a pro forma enterprise value of the combined company of approximately $334 million. The combined company is expected to receive gross cash proceeds of up to $316 million, comprising the $276 million held in Iris’ trust account (assuming no redemptions by public shareholders of Iris) and a concurrent, committed $15 million equity PIPE financing of common stock issued at $10.00 per share and $25 million convertible note financing with an initial conversion rate of $11.50 per share of common stock, subject to future adjustments based upon the price of Iris’ publicly traded common stock. The combined company will bear deferred underwriting commissions and transaction expenses out of the gross proceeds.

The transaction, which has been approved by Liminatus’s and Iris’ boards of directors, is expected to close in the first half of 2023, subject to review by the Securities and Exchange Commission ("SEC") and effectiveness of the registration statement on Form S-4 to be filed with the SEC, approval by Iris’ shareholders, and satisfaction of the closing conditions set forth in the business combination agreement, including any applicable regulatory approvals.

"The agreement with Iris and the treatments we are now set to develop which have originated from leading global cancer scientists at the Thomas Jefferson University in the US and from Innobation in South Korea, will be a game changer for this area of the healthcare market. There is a significant unmet need for improved treatment for the cancer indications we are targeting, and with the increased capital, we are hopeful that the timelines for getting these potentially life-saving medicines to market have been accelerated", said Chris Kim, CEO Liminatus.

Sumit Metha, CEO of Iris, commented, "Immuno-therapies are much in-demand and we believe they are one of the most promising medical treatments for cancer. This deal presents a good opportunity for our company to tap into a rapidly growing global cancer immunotherapy market, expected to hit around $262 billion dollars by 2030. We are very confident that our investors will be excited for this deal because of the position of these treatments in their development cycle, the global demand and the excellent team of scientific advisors and executives at Liminatus.

Nimble Therapeutics names Pete Gough as Chief Scientific Officer

On November 30, 2022 Nimble Therapeutics, an industry-leading peptide therapeutics company, reported the appointment of Pete Gough, D. Phil. as Chief Scientific Officer (CSO) (Press release, Nimble Therapeutics, NOV 30, 2022, View Source [SID1234624632]). In this newly created role, Dr. Gough will spearhead the expansion of Nimble’s internal drug discovery capabilities that will enable further development of its own pipeline of proprietary therapeutics and drive Nimble towards becoming a fully integrated biotechnology company.

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Dr. Gough has more than 25 years of experience in discovery research, both in academic settings as well as in the life sciences industry, and a track record of success in drug discovery and development, driving research programs into clinical study by building and leading high-performance teams. Prior to joining Nimble, Pete served as the CSO for Inzen Therapeutics, a Flagship company pioneering the newly discovered science of Thanokine Biology. At Inzen, he helped advance the company from seed stage to a successful Series B through the development of their pipeline of potentially transformational Immuno-Oncology therapeutics. Previously, Pete spent 15 years at GSK in roles of increasing responsibility. He served as Head of the Hepatitis B Virus Discovery Performance Unit (DPU) where he led GSK’s efforts to develop a functional cure for HBV including proof of concept studies for bepirovirsen. He also served as Head of the Host Defense DPU, and prior to that was Head of Biology and DMPK in the Pattern Recognition Receptor DPU. Pete led, and oversaw, the discovery and development of a number of clinical assets across multiple therapeutic areas including RIP1 kinase inhibitor GSK2982772 and STING agonist GSK3745417.

"We’re excited to welcome Pete to our management team at Nimble," said Jigar Patel, PhD, Founder and CEO of Nimble Therapeutics. "Since our formation in 2019, Nimble has worked diligently to optimize and validate our peptide discovery platform. Pete brings invaluable experience in drug discovery and development across multiple therapeutic areas that will enable Nimble to deliver on the promise of peptide therapeutics through progressing and expanding our own internal pipeline."

"Nimble has built the industry leading platform for discovering peptide therapeutics that solves for the challenges that everyone else in the field is struggling with," said Dr. Gough. "I’m very excited to be part of the team and to help realize the truly transformative nature of the Nimble platform by advancing novel medicines into the clinic."

Earlier in his career, Pete was a Research Assistant Professor in the Department of Pathology at the University of Washington. He received his D. Phil. and M. A. from the University of Oxford. Pete has authored/co-authored over 100 scientific papers in peer-reviewed journals and has been an invited speaker at numerous academic institutions and scientific conferences.