On June 1, 2022 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases such as non-alcoholic steatohepatitis (NASH), obesity and cancer, reported the appointment of Kerry Russell, M.D., Ph.D., as chief medical officer (Press release, Terns Pharmaceuticals, JUN 1, 2022, View Source [SID1234615342]). Dr. Russell will report to Erin Quirk, M.D., who remains president and head of research and development.

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"We are thrilled to welcome Kerry to the Terns team; her deep experience broadens our expertise and brings important insights as we progress our pipeline across multiple therapeutic areas," said Dr. Quirk. "There are exciting times ahead at Terns, with key clinical trial data readouts expected for three of our programs, TERN-501, TERN-601 and TERN-701, across three indications over the next few years. I look forward to working closely with Kerry in advancing these multiple programs."

Prior to joining Terns, Dr. Russell was vice president of late clinical development at Dicerna Pharmaceuticals, Inc. (acquired by Novo Nordisk A/S in December 2021), where she led the development of siRNA therapeutics for rare diseases from June 2020 until May 2022. Before that, she served as vice president of clinical development at resTORbio, Inc. She previously served as senior director of translational cardiovascular and metabolic medicine at Novartis Institute of Biomedical Research and was an NIH-funded associate professor at Yale University School of Medicine for more than 13 years. Dr. Russell received her Ph.D. in molecular oncology from The University of Texas MD Anderson Cancer Center and her M.D. from the University of Texas Health Science Center at Houston. She completed her internship and residency in internal medicine at Yale New Haven Hospital and both her fellowship in cardiovascular medicine and postdoctoral fellowship in vascular biology at Yale University School of Medicine. She received her B.S. in biochemistry and biology from Rice University.

"Terns is at an important stage of growth," said Dr. Russell. "With the company’s renewed focus on dedicating resources to advance its most promising pipeline candidates and its multi-faceted, clinically validated approach to address NASH and other serious diseases like obesity and chronic myeloid leukemia, I believe Terns is making significant progress in its efforts to bring much needed, transformative medicines to patients. I look forward to working with the rest of the Terns team to reach this goal."

On June 1, 2022 Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is focused on developing ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported the appointment of Jedidiah Monson, M.D. to the position of Chief Medical Officer, effective June 1, 2022 (Press release, Beyond Cancer, JUN 1, 2022, View Source [SID1234615361]).

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"We are excited to appoint Dr. Monson as our Chief Medical Officer at this important point in the short history of Beyond Cancer. In this role, he will oversee our first-in-human trial in Israel, which is expected to begin by mid-2022, as well as spearhead our efforts to begin clinical trials in the U.S.," commented Selena Chaisson, CEO of Beyond Cancer. "Dr. Monson’s contributions to the field of oncology and to patients at a prestigious clinical care and research focused institution will be an invaluable resource for Beyond Cancer as we continue our mission of bringing ultra-high concentration nitric oxide (UNO) therapy to solid tumor patients."

"The concept of nitric oxide utilized at ultra-high concentrations to impart an immune response with potentially minimal side effects is an exciting prospect. The preclinical data presented by Beyond Cancer to date have shown UNO therapy has the potential to be a very important treatment option for cancer patients and their caregivers," commented Dr. Monson on his appointment as Chief Medical Officer. "I am excited to join Beyond Cancer as we look to begin enrolling patients in a first-in-human clinical trial."

Dr. Monson, a founding partner of cCARE in 2008, oversaw its growth into the largest private practice oncology group in the state of California with a focus on research and excellence in clinical care. In April 2022, cCARE merged with Integrated Oncology Network (ION) resulting in a nationwide oncology and healthcare management group, with a presence in 57 oncology centers across 14 states. He has previously held staff positions at the City of Hope National Medical Center, Valley Radiotherapy Associates, and 21st Century Oncology. In addition, Dr. Monson is a member of the American College of Radiology and the American Society of Therapeutic Radiology & Oncology.

Dr. Monson earned his M.D. from Stanford University School of Medicine and completed his radiation oncology residency at the Joint Center for Radiation Therapy at Harvard Medical School. During his residency, he received an M.P.H from Harvard School of Public Health.

About Nitric Oxide (NO)

Nitric Oxide (NO) is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries, and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate and adaptive immune system response and in vitro studies suggest that NO possesses broad-spectrum antimicrobial activity and anticancer properties.

On June 1, 2022 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) for a planned Phase 1a/1b dose escalation and expansion trial to evaluate AB248, Asher Bio’s novel investigational CD8-targeted interleukin 2 (IL-2), as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with locally advanced or metastatic solid tumors, including melanoma, renal cell carcinoma (RCC), non-small cell lung carcinoma (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) (Press release, Asher Biotherapeutics, JUN 1, 2022, View Source [SID1234615378]). Under the terms of the agreement, Asher Bio is responsible for conducting the Phase 1a/1b trial, which it expects to initiate in the second half of 2022.

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Mechanistically, IL-2 signaling is complementary to PD-1 checkpoint blockade: checkpoint inhibitors release the brakes on T cells, allowing them to kill cancer cells, while IL-2 pushes on the gas pedal driving an increase in the number and activity of T cells. In the clinic, there have been studies conducted on high dose IL-2 as a monotherapy to treat PD-1 failures and on high dose IL-2 in combination with PD-1 checkpoint inhibitors in earlier lines of therapy that both demonstrated encouraging activity. However, despite high dose IL-2 efficacy in these settings, severe toxicities significantly hamper use of IL-2 in practice.

Asher Bio previously reported preclinical data from studies of a murine surrogate of AB248, which achieved significant anti-tumor activity as monotherapy and in combination with anti-PD1, without toxicity associated body weight loss. In comparison, treatment with a "not α" IL-2 achieved lower anti-tumor activity and was accompanied by body weight loss.

"We are looking forward to initiating this trial in collaboration with Merck to evaluate AB248 in combination with KEYTRUDA in a range of cancers," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Treatment with PD-1 checkpoint blockade monotherapy or in combination with chemotherapy or another immunotherapy has become a recommended first line treatment in multiple indications. Yet for patients who failed to achieve a response or who relapse, treatment options are limited. In addition, there is a subset of first line patients where there is an opportunity to enhance the current standard of care. We believe that by precisely focusing the effect of IL-2 to the primary immune cell subset that drives anti-tumor efficacy, AB248 may have the potential to deliver a highly differentiated product profile that could become a backbone of immuno-oncology across a range of solid tumors."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.

About AB248
AB248 is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to a humanized IgG1 anti-CD8β antibody. It was specifically engineered to selectively and potently expand CD8+ T-cells, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. In some preclinical studies, AB248 exhibits an approximately 1,000-fold preference for the activation of CD8+ T cells over NK cells and Tregs. In other nonclinical studies, AB248 has demonstrated potent anti-tumor activity both alone and in combination with PD-1 checkpoint blockade in a wide variety of murine tumor models.

On June 1, 2022 Servier, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that data will be presented from multiple studies across its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, June 9-12 (Press release, Servier, JUN 1, 2022, View Source [SID1234615395]). Data highlighted at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include multiple company-sponsored and investigator-initiated trials, which underscore the breadth of Servier’s oncology portfolio and commitment to improving outcomes for patients with difficult-to-treat cancers, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), cholangiocarcinoma (CCA), colorectal cancer, pancreatic cancer and lung cancer.

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At both congresses, new data will be presented from Servier’s phase 3 AGILE study, a global, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO (ivosidenib tablets) in combination with azacitidine compared with placebo in combination with azacitidine, in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy (≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy). These data build on the efficacy and safety results presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. Patients with IDH1-mutated AML have a poor prognosis and have fewer treatment options, especially for newly diagnosed patients who are not eligible for intensive chemotherapy. This new AGILE data presentation comes on the heels of the U.S. Food and Drug Administration approval of TIBSOVO in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated AML.

Ivosidenib monotherapy has breakthrough therapy designation in IDH1 mutated R/R MDS and Servier will be presenting updated efficacy and safety results at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).

"Several of the studies being presented at this year’s ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) highlight the potential role of IDH inhibition and the company’s overall innovative research portfolio in generating new therapies based on precision approaches," said David K. Lee, CEO, Servier Pharmaceuticals. "Servier Pharmaceuticals has made immense progress since we’ve launched our oncology program in 2018, and we will continue to move the needle for patients with difficult-to-treat cancers."

In the short time the company has been in the U.S., Servier Pharmaceuticals has established a presence in oncology. The company has tripled its oncology portfolio since 2021 with 21 oncology assets at varying stages of clinical development, and 20 research projects.

"Our significant presence at these key congresses demonstrates our long-term commitment to developing innovative therapeutic solutions to meet the needs of patients with difficult-to-treat cancers," said Claude P. Bertrand, Executive Vice President of Research and Development, Servier Group. "We look forward to presenting to the scientific community data across our diverse portfolio, including research on the potential of IDH inhibition in the treatment of cancers with high unmet needs."

Key highlights of data from Servier and its partners at ASCO (Free ASCO Whitepaper) are listed below and are available online on the ASCO (Free ASCO Whitepaper) website: View Source

Abstract #7042/Poster #273: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia.

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: H. Dohner
Abstract #7019/Poster #250: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine

Date & Time: Saturday, June 4 at 1:15 p.m. CDT; poster will be on display in the poster hall from 8 – 11 a.m.
Poster Discussion: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: S. de Botton
Abstract/Publication Only: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine.

Author: A. Schuh
Abstract #7053/Poster #284: Ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS): Updated enrollment and results of a phase 1 dose escalation and expansion substudy

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: D. Andrew Sallman
Abstract #7005/Oral Presentation: Overall survival by IDH2 mutant allele (R140 or R172) in patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib or conventional care regimens in the phase 3 IDHENTIFY triali

Date & Time: Tuesday, June 7 at 11:33 a.m. CDT
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: S. de Botton
Abstract #7032/Poster #263: Health-related quality of life (HRQoL) with enasidenib vs conventional care regimens in older patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML)i

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C. Dinardo
Abstract #3568/Poster #362: Trifluridine/tipiracil plus bevacizumab (FTD/TPI + BEV) and trifluridine/tipiracil (FTD/TPI) monotherapy in metastatic colorectal cancer (mCRC): results of a meta-analysisii

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Presenting Author: T. Yoshino
Abstract/Publication Only: Characterizing Platinum Sensitivity among Medicare FFS Patients with Limited vs Extensive Stage Small Cell Lung Cancer Receiving NCCN Category 1 Regimensiii

Presenting Author: G. Dieguez
Abstract/Publication Only: Patient Characteristics and Outcomes Associated with Small Cell Lung Cancer by Treatment Status in a U.S. Medicare Populationiii

Presenting Author: P. Cockrum
Abstract/Publication Only: Treatment Patterns and Outcomes Associated with Small Cell Lung Cancer by Platinum Sensitivity Status in a U.S. Medicare Populationiii

Presenting Author: P. Cockrum
Abstract #8584/Poster #210: Trends in Treatment Patterns Associated with Small Cell Lung Cancer in a U.S. Medicare Populationiii

Date & Time: Monday, June 6 at 8 a.m. CDT
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Presenting Author: R. Ramirez
Abstract #7018/Poster #249: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated hematologic malignancies

Date & Time: Saturday, June 4 at 8 a.m. CDT
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C. Lachowiez
Abstract #3612/Poster #406: Phase II, multicenter, open-label, non-randomized study of neoadjuvant chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by chemoradiotherapy in patients with rectal cancer in a watch-and-wait program

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Presenting Author: C. Gregorio Muñoz
Abstract #TPS4185/Poster #157b: A randomized phase II study of gemcitabine and nab-paclitaxel compared with 5-fluorouracil, leucovorin, and liposomal irinotecan in older patients with treatment-naïve metastatic pancreatic cancer (GIANT): ECOG-ACRIN EA2186—Trials in progress

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: E. Dotan
Abstract #4005/Oral Presentation: NET-02: A multi-centre, randomised, phase II trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients (pts) with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC)

Date & Time: Sunday, June 5 at 9 a.m. CDT
Oral Abstract Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: M. McNamara
Servier will be hosting a continuing medical educational program at ASCO (Free ASCO Whitepaper) focused on hematology:

"Advantage with Innovation in AML: Guidance on Developing and Delivering Effective and Highly Personalized Care," administered by PeerView, June 3, 2022
In addition, encore presentations from ASCO (Free ASCO Whitepaper) will be presented at EHA (Free EHA Whitepaper):

Poster #2209: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: H. Dohner
Poster #2374: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: A. Schuh
Poster #2356: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: S. de Botton
Poster #P765: Updated enrollment and results from the phase 1 substudy of ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS)

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: C. DiNardo

On June 1, 2022 Regeneron Pharmaceuticals, Inc., a New York corporation ("Regeneron" or the "Company"), and Sanofi Biotechnology SAS, a société par actions simplifée organized under the laws of France ("Sanofi Biotechnology"), reported that entered into the Amended and Restated Immuno-Oncology License and Collaboration Agreement (the "A&R IO LCA"), which amends the Immuno-Oncology License and Collaboration Agreement, dated as of July 1, 2015 and executed as of July 27, 2015 (as amended), by and between the Company and Sanofi Biotechnology (the "Original IO LCA") (Filing, 8-K, Regeneron, JUN 1, 2022, View Source [SID1234615411]). The A&R IO LCA is subject to and will become effective on the first day of the first month following receipt of all necessary authorizations and expiration of all necessary waiting periods applicable to the consummation of the A&R IO LCA (such date, the "A&R Effective Date").

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The Original IO LCA provides for Regeneron and Sanofi Biotechnology to collaborate on the development and commercialization of certain immuno-oncology products, including Libtayo (cemiplimab). From and after the A&R Effective Date, Regeneron will have the sole right to develop and commercialize Libtayo worldwide and no other products will be subject to the A&R IO LCA; and Regeneron will also obtain a license under certain intellectual property rights of Sanofi Biotechnology to develop and commercialize Libtayo worldwide and Sanofi Biotechnology will transfer to Regeneron certain regulatory, promotional, and other rights relating to the commercialization of Libtayo outside the United States. The parties have also entered into a transition services agreement, a transitional distribution agreement, and a manufacturing services agreement, pursuant to which, during certain transitional periods, Sanofi Biotechnology will perform for Regeneron certain transition, distribution, and manufacturing services, respectively.

Under the A&R IO LCA, the quarterly period ended March 31, 2022 is the last quarter for which Sanofi Biotechnology and Regeneron share net profits and losses for Libtayo under the Original IO LCA. From and after April 1, 2022 (after giving effect to certain true-up payments as set forth in the A&R IO LCA), Regeneron will be entitled to all profits from Libtayo and will pay Sanofi Biotechnology an 11% royalty on net product sales of Libtayo through March 31, 2034. In addition, the A&R IO LCA provides for the following payments by Regeneron to Sanofi Biotechnology: (i) a $900 million upfront payment, payable within 10 business days after the A&R Effective Date; (ii) a $100 million development milestone payment upon the first marketing approval from the U.S. Food and Drug Administration or the European Commission of Libtayo in non-small cell lung cancer in combination with chemotherapy; and (iii) sales milestone payments of up to $100 million in the aggregate upon achieving certain amounts of worldwide net product sales of Libtayo in 2022 or 2023.

Under the A&R IO LCA, the amount of development costs incurred under the Original IO LCA for which Regeneron is obligated to reimburse Sanofi Biotechnology is $35 million. Regeneron will reimburse Sanofi Biotechnology for such development costs by paying Sanofi a 0.5% royalty on Regeneron’s net product sales of Libtayo until Regeneron has reimbursed Sanofi Biotechnology for all such development costs.

Fifth Amendment to Antibody LCA. On June 1, 2022, Regeneron, Sanofi Biotechnology, and Sanofi, a société anonyme organized under the laws of France ("Sanofi Parent"), entered into the Fifth Amendment to Amended and Restated License and Collaboration Agreement (the "Fifth Amendment"), which amends the Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended), by and between the Company, Sanofi Biotechnology (as successor in interest to Aventis Pharmaceuticals Inc.) and Sanofi Parent (the "Antibody LCA") and will become effective on the A&R Effective Date. Pursuant to the Fifth Amendment, the parties amended the Antibody LCA, among other matters, to, from and after April 1, 2022, increase from 10% to 20% the percentage of Regeneron’s share of profits used to reimburse Sanofi Biotechnology for the remaining development costs incurred under the Antibody LCA subject to reimbursement by Regeneron.

The foregoing description of the A&R IO LCA and the Fifth Amendment is qualified in its entirety by reference to the full text of the A&R IO LCA and the Fifth Amendment, a copy of each of which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Quarterly Report on Form 10-Q to be filed by the Company for the quarterly period ending June 30, 2022.