On March 2, 2023 Sesen Bio, Inc. (Nasdaq: SESN) ("Sesen Bio" or the "Company"), reported that its stockholders have voted to approve all proposals, including the pending merger with Carisma Therapeutics Inc. ("Carisma"), at the Company’s Special Meeting of Stockholders (the "Special Meeting") held earlier today (Press release, Sesen Bio, MAR 2, 2023, View Sourcenews-releases/news-release-details/sesen-bio-stockholders-approve-merger-carisma-therapeutics" target="_blank" title="View Sourcenews-releases/news-release-details/sesen-bio-stockholders-approve-merger-carisma-therapeutics" rel="nofollow">View Source [SID1234628087]).

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Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio, said, "We are pleased with the outcome of today’s Special Meeting and thank our stockholders for their support of the merger with Carisma. The fact that over 88% of stockholders voted in favor of the merger provides further confidence that our thorough strategic process maximizes value for stockholders. Throughout the process, we have been actively conserving capital and we are closing the merger with approximately $150 million in cash and cash equivalents, of which roughly half will go directly to Sesen Bio stockholders in the form of a $75 million special dividend we announced today, with the remainder going toward funding the combined company."

"Looking ahead, our stockholders are positioned to benefit from the upside potential of ownership in the combined company, as well as the CVR, which provides additional potential cash upside from any sale of Sesen Bio’s legacy assets, including Vicineum, and from the potential $30 million milestone payment under the Roche Asset Purchase Agreement. We look forward to completing the merger and realizing our bright future with Carisma."

Based on a preliminary count of the voting results from today’s meeting of stockholders, more than 88% of the votes cast were voted in favor of Proposal No. 1 to approve the issuance of Sesen Bio common stock to Carisma stockholders in the merger and approximately 86% of votes were cast in favor of Proposal No. 2, representing more than 57% of outstanding shares of Sesen Bio common stock, to approve the amendment to Sesen Bio’s certificate of incorporation to effect a reverse stock split of outstanding shares of Sesen Bio common stock at a ratio of 1-for-20. The approval of Proposal Nos. 1 and 2 was needed to complete the merger. Sesen Bio currently anticipates that the reverse stock split will become effective after trading hours on March 7, 2023, such that trading of post-split Carisma ("CARM") common stock will commence on March 8, 2023.

The merger is expected to close on March 7, 2023, subject to customary closing conditions. The final voting results for the company’s special meeting will be disclosed in a Form 8-K filed with the Securities and Exchange Commission (the "SEC") and will also be available at View Source, after certification by the company’s inspector of elections.

In connection with the transaction, the Sesen Bio Board of Directors has declared a one-time, special cash dividend of $75 million. Based on the current number of shares outstanding, the special cash dividend is expected to result in $0.361 per share to all common stockholders of record as of the close of business on March 7, 2023, payable no later than March 10, 2023.

Sesen Bio stockholders of record will also be issued one Contingent Value Right (CVR) for each outstanding share of Sesen Bio common stock, representing the right to receive any potential proceeds from the sale of Vicineum and Sesen Bio’s preclinical assets prior to March 31, 2027 and any proceeds from the potential milestone payment under the Roche Asset Purchase Agreement. The issuance of the special cash dividend and CVR remain contingent on the closing of the approved transaction.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the SEC on January 19, 2023, which is available at the SEC’s website, www.sec.gov, and at the company’s website, www.sesenbio.com.

SVB Securities is acting as exclusive financial advisor to Sesen Bio for the transaction and Hogan Lovells US LLP is serving as its legal counsel.

On March 2, 2023 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported plans to release its financial results for the fourth quarter and full-year ended December 30, 2022 on Thursday, March 9 prior to the open of financial markets (Press release, Akebia, MAR 2, 2023, View Source [SID1234628086]).

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Akebia will host a conference call on Thursday, March 9 at 8:30 a.m. ET to discuss its financial results and recent business highlights. To access the call by phone, please click on this Registration Link and you will be provided with dial in details. To avoid delays, we encourage dialing into the conference call fifteen minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the Investors section of Akebia’s website at: View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source

On March 2, 2023 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase biology platform, reported that it will report fourth quarter and full year 2022 financial results and provide a corporate update after the market close on Thursday, March 9, 2023 (Press release, aTyr Pharma, MAR 2, 2023, https://investors.atyrpharma.com/news-releases/news-release-details/atyr-pharma-webcast-conference-call-reporting-fourth-quarter-1 [SID1234628085]). Management will host a conference call and webcast to review the results and provide an operational update.

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Conference Call and Webcast Details:
Date: Thursday, March 9, 2023
Time: 5:00 p.m. EST / 2:00 p.m. PST
Dial-In Registration: https://register.vevent.com/register/BI01f8362bebee42539116051051ef9145
Webcast Registration: View Source

Participants who wish to join the conference call by telephone must register at the above dial-in registration link in order to receive the dial-in number and a personalized PIN code that will be required to access the call. Participants may join the live webcast by accessing it at the above webcast registration link on the aTyr Events page. For more information or questions, please contact aTyr’s investor relations team at [email protected].

On March 2, 2023 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity, reported that management will participate in three upcoming investor conferences in March 2023 and provided program updates across the Company’s development programs as outlined below (Press release, Terns Pharmaceuticals, MAR 2, 2023, View Source [SID1234628084]).

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"We are delighted to have completed enrollment in the Phase 2a DUET trial of TERN-501 and express our gratitude to the people participating in this trial. We would also like to recognize the excellence of the study investigators and the Terns team in recruiting the trial. This milestone takes us one step closer to bringing TERN-501, our THR-β agonist with potentially class-leading efficacy, safety and tolerability profiles, to people living with NASH. With top-line data expected in the third quarter of this year, our team is expeditiously preparing for a potential initiation of a Phase 2b/3 clinical program in 2024," said Erin Quirk, M.D., president, head of research and development of Terns. "We are also eagerly looking forward to a Type C meeting in May 2023, which was granted by the U.S. FDA to discuss the opportunity to leverage non-invasive endpoints to support NASH product development and, potentially, for seeking approval for NASH. While we are at the beginning of the journey towards potential pathways to accelerated approval based on non-invasive technologies, we look forward to working with the agency to explore the utility of these exciting technologies with the potential to play an important role in real world settings," added Dr. Quirk.

"I am excited by the continued execution of our team as we strive to bring better medicines to people living with serious diseases," said Sen Sundaram, chief executive officer of Terns Pharmaceuticals. "We expect significant progress across all of our clinical programs in 2023. In addition to NASH, we continue to progress towards initiating both our Phase 1 trial for TERN-701 in CML in the U.S. and our Phase 1 trial for TERN-601 for obesity in the second half of 2023, positioning us for three significant clinical readouts across our three lead programs by the end of 2024."

Program Updates

TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)

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Terns expects to initiate a clinical trial for TERN-701 in the United States in the second half of 2023, with potential top-line readouts from initial dose-escalation cohorts in 2024
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The Phase 1 trial for TERN-701 is expected to include sites from Europe and other Terns territories, in addition to the United States
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Terns has initiated production of TERN-701 drug supply in support of the planned Phase 1 trial initiation in the second half of 2023
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A trial-in-progress (TiP) abstract has been submitted to an upcoming major oncology conference and summarizes the ongoing Phase 1 study of TERN-701 (HS-10382) in China conducted by Terns’ partner Hansoh. The TiP abstract includes an update on enrollment progress across dose-escalation cohorts of TERN-701 (HS-10382) administered once daily
o
The Hansoh trial is a dose-escalation and dose-expansion trial (NCT05367700) evaluating the tolerability, efficacy, and pharmacokinetics of TERN-701 (HS-10382) in approximately 100 people with CML in China
TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist for NASH

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The Phase 2a DUET trial (NCT05415722), evaluating TERN-501 as a monotherapy and in combination with TERN-101, completed enrollment in February 2023 with top-line data expected in the third quarter of 2023
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Final enrollment in DUET exceeds 160, increased from the planned enrollment of 140 based on high demand for study participation
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Primary endpoint is the relative change from baseline in liver fat content as measured by MRI protein density fat fraction (MRI-PDFF) at Week 12 for TERN-501 monotherapy compared with placebo
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Secondary endpoints include assessment of safety and tolerability, pharmacokinetics, changes in MRI-PDFF and MRI corrected T1 (cT1)
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DUET is the first clinical trial assessing a THR-β agonist as monotherapy and in combination with an FXR agonist in people with NASH
•
FDA Type C meeting has been scheduled for May 2023
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Terns plans to explore the opportunity to leverage non-invasive endpoints to facilitate NASH development
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The Type C meeting, together with data from the ongoing DUET trial, is expected to inform the next stages of clinical development for Terns’ NASH program

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Terns aims to present additional preclinical data to support the dosing of TERN-501 +/- TERN-101 at a scientific conference in the second quarter of 2023
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Drug supply manufacturing is underway, and chronic toxicity data are expected by the third quarter of 2023, to enable the initiation of Phase 2b/3 development following DUET data availability
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

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Terns’ lead GLP-1 receptor agonist program remains on track with the goal of initiating a Phase 1 first-in-human clinical trial in subjects with elevated BMI in the second half of 2023 and with top-line data expected in 2024
o
Terns anticipates completing TERN-601 drug product manufacturing in the first quarter of 2023
•
An abstract evaluating food-intake suppression in TERN-601 treated transgenic mice expressing human GLP-1 receptor has been submitted to a major diabetes-focused scientific conference
TERN-800: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulators for obesity

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Lead structural series of GIPR modulators have been identified, with lead optimization efforts underway in 2023
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Candidate nomination and initiation of IND-enabling activities expected in 2024
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GIPR modulators have the potential for combination with GLP-1 receptor agonists, such as TERN-601
Financial Update

Terns’ third quarter cash balance as of September 30, 2022, along with $112 million in December 2022 equity financing proceeds, result in an adjusted cash balance of $293 million1, which is expected to provide cash runway into 2026.

Investor Conferences

Members of Terns’ senior leadership team will participate at the following upcoming investor conferences in March:

43rd Annual TD Cowen Health Care Conference

Date: March 6-8, 2023

Location: Boston

Format: Leukemia Panel Discussion

Date/Time: Wednesday, March 8th from 12:50 p.m. – 1:50 p.m. ET

Oppenheimer 33rd Annual Healthcare Conference

Date: March 13-15, 2023

Location: Virtual

Format: Company presentation

Date/Time: Tuesday, March 14th from 2:40 p.m. – 3:10 p.m. ET

Evercore ISI NASH Renaissance

Date: March 30, 2023

Location: Virtual

Format: Fireside Discussion

Date/Time: 1:30 p.m. – 1:55 p.m. ET

A live webcast of these events will be available on the investor relations page of the Terns Pharmaceuticals website at View Source A replay of the webcast will be archived on Terns’ website for 30 days following the event. The Evercore ISI NASH event webcast link is available from Evercore ISI and will require registration.

About the DUET Trial

The Phase 2a DUET trial (NCT05415722) is a multicenter, randomized, double-blind, placebo-controlled clinical trial in noncirrhotic NASH using a factorial design including both monotherapy and combination arms of TERN-501 and TERN-101. The trial has enrolled over 160 adults with elevated body mass index (BMI ≥ 25 kg/m2) and NASH with fibrosis, but not cirrhosis, based on prior liver biopsy and/or imaging and clinical criteria. All participants must have liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) of ≥10%, MRI corrected T1 (cT1) relaxation time of ≥ 800 msec, and meet other inclusion and exclusion criteria. The trial includes a 12-week treatment period and a 4-week follow-up period. The primary endpoint is the relative change from baseline in MRI-PDFF at Week 12 for TERN-501 monotherapy compared with placebo. Secondary endpoints include assessment of changes in MRI-PDFF (combination vs. placebo) and cT1 (TERN-501 monotherapy vs. placebo as well as 501+101 combination vs. placebo). DUET is the first trial assessing a THR-β agonist as monotherapy and in combination with an FXR agonist in people with NASH.

On March 2, 2023 ORPHELIA Pharma, the French biopharmaceutical company that develops and markets pediatric medicines in the fields of oncology and neurology, reported the recruitment of the last patient of its TEMOkids clinical trial evaluating its ready-to-use temozolomide oral suspension, named KIMOZO or Ped-TMZ, in children with a solid tumor from the age 1 year (Press release, ORPHELIA Pharma, MAR 2, 2023, View Source;utm_medium=rss&utm_campaign=orphelia-pharma-announces-completion-of-patient-recruitmentfor-the-temokids-clinical-trial [SID1234628083]).

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The TEMOKids trial, during which KIMOZO was administered to children for the first time, is a major milestone in its clinical development. In addition to generating pharmacokinetic data, the trial also evaluates the safety and acceptability of the suspension in the study population and collects data on treatment response.
TEMOkids complements the study previously carried out in adults, which demonstrated the bioequivalence between KIMOZO oral suspension and the capsule form of temozolomide, which is not adapted to children and yet regularly used in the absence of a pediatric form. ORPHELIA Pharma will present the results of the TEMOkids study at an upcoming scientific congress and will submit the marketing authorization dossier to the European Medicines Agency in 2023.

"We have completed the enrollment of the TEMOkids clinical study thanks to the involvement and motivation of the investigating physicians, which underlines the medical need. With the support of a pediatric oncology network at the European level, we enrolled 43 children in 11 centers across 5 countries: France, Spain, the United Kingdom, the Netherlands and Germany", says Caroline Lemarchand, Director of Pharmaceutical Development and coordinator of the TEMOkids study.

"The inclusion of the last patient in TEMOkids is a key milestone of the clinical development of KIMOZO. This new drinkable formulation of temozolomide addresses major medical needs for the management of cancers affecting young children," concludes Jeremy Bastid, Director of Development at ORPHELIA Pharma. "Our goal is to make the product available to all patients as soon as possible. The ORPHELIA Pharma team is mobilized to enable the filing of the European registration dossier in 2023 and to fill the needs of young patients through special access programs, in close liaison with and with the approval of the national regulatory authorities in Europe," he adds.

About the TEMOkids study
The clinical trial "TEMOkids Study: A Phase I Pediatric Study for KIMOZO, Oral Suspension of temozolomide" (NCT04610736) is an international, open-label, non-randomized Phase I study in 40 pediatric patients aged one year or older. The primary objective of the study is to evaluate the pharmacokinetics of KIMOZO/Ped-TMZ in the study population. Secondary objectives are to assess tolerability and response to treatment, as well as acceptability in children. Eleven clinical centers are actively involved in the TEMOkids study: Gustave Roussy, Villejuif, France (coordinating center); Institut Curie, Paris, France; CHU Timone Enfants, Marseille, France; Institute of Hematology and Pediatric Oncology, Lyon, France; Centre Oscar Lambret, Lille, France; Princess Maxima Center for Pediatric Oncology, Utrecht, the Netherlands; Hospital Universitari Vall d’Hebron, Barcelona, Spain; Hospital La Fe, Valencia, Spain; University Pediatric Hospital Niño Jesús, Madrid, Spain; Southampton General Hospital, Southampton, United Kingdom; Great Ormond Street Hospital (GOSH) for Children NHS Trust, London, United Kingdom; Charité University Medicine Hospital, Berlin, Germany.
For more information, please visit www.temokids.eu.

About KIMOZO/Ped-TMZ oral suspension, 40 mg/ml
KIMOZO 40 mg/ml is a ready-to-use, taste-masked oral liquid formulation of temozolomide jointly developed by the ORPHELIA Pharma development team and the pharmacists and clinicians of Gustave Roussy for the treatment of relapsed or refractory neuroblastoma, a childhood cancer with a poor prognosis.
The product obtained an Early Access Authorization from the French authorities in March 2022.