On March 5, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the completion of the Dose Escalation Phase of the SECuRE trial (NCT04868604) (Press release, Clarity Pharmaceuticals, MAR 5, 2025, View Source [SID1234650876]). The SRC recommended the trial progress to the Cohort Expansion Phase (Phase II) at the 8 GBq of 67Cu-SAR-bisPSMA dose level based on the safety and efficacy data demonstrated in every cohort of the study.

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!

Across cohorts 1-4 of the SECuRE study, 68% of participants have shown reductions in PSA levels, despite the vast majority of the participants (77%) only receiving a single dose of 67Cu-SAR-bisPSMA. Most of these participants had a high level of bone metastases at study entry (77.3%), a high median PSA of 112.86 ng/mL (range 0.1-1503.1) and were heavily pre-treated with ≥3 lines of therapy (63.6%). Disease control based on radiographic assessment (complete response + partial response + stable disease) was achieved in 78% of the participants so far (including 2 partial responses and 1 complete response observed to date based on the RECIST assessment). The complete response was seen in a patient dosed twice at 12 GBq. This is the second complete response recorded following 67Cu-SAR-bisPSMA treatment, first being the patient previously reported to have a complete response following 2 doses at 8 GBq (first dose administered through the SECuRE trial, and a second dose administered under the the United States [US] Food and Drug Administration [FDA] Expanded Access Program [EAP]).

Safety profile of 67Cu-SAR-bisPSMA is favourable across cohorts 1-4 with the majority of AEs being Grade 1-2. Anaemia and thrombocytopenia were the most prevalent AEs among the haematological events. No overall trends in other haematological parameters or renal safety were observed in any of the cohorts. Only 1 DLT has been reported in the trial (transient Grade 4 thrombocytopenia, which improved to Grade 3 after 2 weeks) in a patient in the highest dose cohort (cohort 4). This participant had a baseline PSA of 1503.12 ng/mL, had been treated with multiple lines of therapy, including chemotherapy in the mCRPC setting and multiple doses of 177Lu-PSMA-617, and had bone metastases prior to entering the study. The participant’s baseline characteristics may have contributed to the lowering of the platelet levels. Despite the unfavourable prognosis of this participant, which included a very high PSA and being heavily pre-treated, 1 cycle of 67Cu-SAR-bisPSMA was still able to reduce his PSA by 10.7% (to 1341.80 ng/mL).

Pre-chemotherapy participants
Thirteen participants across cohorts 1-4 in the SECuRE trial were naïve to taxanes in the mCRPC setting (pre-chemotherapy), including 2 in cohort 1 and 3 in cohort 2. The majority of pre-chemotherapy participants had bone metastases (69.2%) with a median PSA of 42.41 ng/mL (range 0.1-182.4) at study entry. Almost half of these participants received ≥3 lines of therapy prior to trial enrolment (46.2%).

Despite the heavy disease burden and the majority of participants only receiving single doses of 67Cu-SAR-bisPSMA, there was an outstanding result observed in the pre-chemotherapy setting. Out of the total of 13 pre-chemotherapy participants across all cohorts, 12 had PSA drops greater than 35%. PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants. Disease control based on the RECIST assessment was also observed in 11 out of 12 pre-chemotherapy participants (92%) who had measurable disease at baseline. One participant reached a complete response with 2 doses of 12 GBq in cohort 4, 2 participants had partial responses (cohort 2 and cohort 4), and 8 participants achieved stable disease at this time.

Three participants in the pre-chemotherapy setting of the SECuRE trial had previously been treated with actinium-225 based radioligand therapies (RLT) and, in 1 case, in combination with lutetium-177 based therapy. All 3 participants showed reductions in PSA levels following treatment with 67Cu-SAR-bisPSMA in the trial. Notably, 1 of these 3 participants showed a PSA reduction of 83.4% following the administration of 2 doses of 12 GBq of 67Cu-SAR-bisPSMA in cohort 4, despite being heavily pre-treated. The lines of therapy administered to the patient prior to the SECuRE trial enrollment included androgen deprivation therapy (ADT), 2 androgen receptor pathway inhibitors (ARPIs), autologous cellular immunotherapy, and investigational agents (immunotherapy and 177Lu-PSMA-I&T plus 225Ac-J591).

Safety assessment in pre-chemotherapy participants was comparable to the overall patient population with most AEs being Grade 1 and Grade 2.

Cohort Expansion Phase
Based on the data from cohorts 1-4, the SRC recommends the SECuRE trial progress to Cohort Expansion (Phase II) at an 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6. This recommendation is based on the favourable safety profile of 67Cu-SAR-bisPSMA observed to date.

Cohort 2 (single dose of 8 GBq of 67Cu-SAR-bisPSMA) with 3 participants had the highest rate of PSA response in the trial, and all participants in the cohort had disease control based on the RECIST assessment (including one partial response). The PSA reductions were 81.4%, 95.2% and 99.4%. Only 1 participant in this cohort developed 67Cu-SAR-bisPSMA-related AEs (Grade 1 dry mouth and altered taste, both improved, and Grade 2 fatigue, resolved). No haematological toxicity was reported in the cohort.

The first patient to receive 2 doses of 67Cu-SAR-bisPSMA at 8 GBq (first dose through the SECuRE trial and second dose under the US EAP) achieved a complete anatomical, molecular and biochemical response (assessed by the RECIST criteria, positron emission tomography [PET] and PSA, respectively). He had been heavily pre-treated (chemotherapy in the neoadjuvant setting, ADT, 2 ARPIs and an investigational agent) prior to entering the SECuRE study. The patient’s recent follow up showed that he remains with undetectable PSA for almost 16 months, having received his first dose of 67Cu-SAR-bisPSMA over 20 months ago (June 2023). A recent PSMA PET showed no signs of recurrent or metastatic disease. Most AEs related to 67Cu-SAR-bisPSMA were mild or moderate, with the majority having either improved or resolved over time.

Based on these safety and efficacy data, where exceptional efficacy signals were observed at lower radiation doses, 8 GBq was chosen as an optimal dose for the Cohort Expansion Phase.

The SECuRE trial protocol has been amended to include evaluation of mCRPC participants who have not received chemotherapy in the metastatic (pre-chemotherapy) setting. This amendment is aligned with Clarity’s strategy of bringing 67Cu-SAR-bisPSMA to participants with earlier stages of the disease and is based on the promising safety and efficacy data, especially in pre-chemotherapy participants of the SECuRE trial.

The protocol amendment also incorporates an increase in the number of participants in the Cohort Expansion Phase of the trial from 14 to 24, in which a subset of participants will receive the combination of 67Cu-SAR-bisPSMA with enzalutamide, an ARPI. These changes are aimed at optimising the development of all of Clarity’s products in prostate cancer, following ongoing discussions with and advice from many important global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The SECuRE trial continues to generate extraordinary results, and we thank our team, Principal Investigators, members of the SRC, and especially the participants who have contributed to the study. Seeing the safety profile and already observing impressive signs of efficacy (despite the majority of participants only receiving a single cycle of 67Cu-SAR-bisPSMA and the primary focus of the Dose Escalation Phase being safety assessments), we are thrilled to progress to Phase II, the Cohort Expansion Phase, of our theranostic SECuRE trial.

"Dose escalation trial design has not been routinely used in other RLT studies. By pioneering this approach with the SECuRE trial, Clarity was looking to systematically evaluate the safety of 67Cu-SAR-bisPSMA in the context of its therapeutic effect. By gradually increasing the dose from one cohort to the next, we have minimised the risk of AEs and established a favourable safety profile for patients, while also demonstrating that 67Cu-SAR-bisPSMA is effective.

"We are looking forward to executing our strategy of bringing 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy with the recent protocol amendment, given the exciting data in pre-chemotherapy participants. We are also increasing the number of participants in the Cohort Expansion Phase. This decision is partly motivated by the increased demand from oncologists to include their participants into the trial, but it is also led by our decision to explore potential benefits of using a combination of 67Cu-SAR-bisPSMA with enzalutamide, following consultation with world-leading prostate cancer oncologists and nuclear medicine physicians.

"With our focus on treating earlier stage disease (pre-chemotherapy in the mCRPC setting), it is an incredible outcome to have 12 out of 13 pre-chemotherapy participants in the trial experiencing greater than 35% reductions in PSA and almost half of the 13 experiencing drops of 80% or greater. PSA reductions were seen across all cohorts, including the lowest 4 GBq cohort where all pre-chemotherapy participants exhibited greater than 50% drops in PSA from a single dose. Remarkably, one of those participants has had 4 additional doses under EAP and achieved disease control for over 2 years since first treatment. The results from 3 pre-chemotherapy participants who received 8 GBq of 67Cu-SAR-bisPSMA have been outstanding with a favourable safety profile and excellent efficacy, where PSA reductions were greater than 80% for all participants and above 95% for 2 out of the 3 participants, with all of them achieving radiographic disease control and 1 showing a complete response to date.

"The very compelling safety and efficacy data for SAR-bisPSMA that we continue generating stems from Clarity’s strong adherence to the highest level of scientific and clinical research. At the heart of this rigorous approach is the dimer "bis" molecule developed at the benchtop of Australian science and translated into the clinic. When optimising the PSMA molecule, the goal was to create an ideal candidate for both therapy and diagnosis of prostate cancer. We wanted to overcome the shortfalls of the current generation of PSMA-targeting products, increasing not only the amount of product in the lesions, but also how long the product is retained in the lesions over time. We are now seeing these results in the clinic with 67Cu-SAR-bisPSMA in the SECuRE trial and with 64Cu-SAR-bisPSMA in our diagnostic trials.

"The recent receipt of 3 Fast Track Designations from the US FDA for our optimised SAR-bisPSMA molecule, one of which was based off the data presented here, is testament to the high quality of this data, but also reflects a critical need for novel solutions in prostate cancer management. With an estimated combined market value of approximately US$10-15 billion by 2030 for PSMA-targeted products, we are hoping to address the evident high unmet need in this segment, from first diagnosis to the treatment of metastatic disease, and improve treatment outcomes for men with prostate cancer around the world.

"We look forward to swiftly recruiting into the next phase of the SECuRE trial, moving towards a Phase III pivotal trial. We are very excited about what the future holds for this promising product and are working tirelessly to bring it to people who need it most in a timely manner, whilst adhering to the highest standards of clinical research."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US and Australia. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide2. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease.

On March 05, 2025 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, reported that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the 2025 Virtual Investor Summit on Tuesday, March 11, 2025, at 10:30 a.m. ET (Press release, TONIX Pharmaceuticals, MAR 5, 2025, View Source [SID1234650910]).

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!

Investors interested in arranging a meeting with the Company’s management virtually during the conference should contact the Investor Summit conference coordinator. A live webcast of the presentation can be found here or under the IR Events tab of the Tonix website at www.tonixpharma.com.

On March 5, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported that the Company will participate in two upcoming investor conferences (Press release, Autolus, MAR 5, 2025, View Source [SID1234650911]).

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!

Jefferies Biotech on the Beach Summit
Management to host investor meetings
Date: March 11, 2025
Location: Miami, FL

Leerink Global Biopharma Conference
Fireside Chat Presentation
Date and time: March 12, 2025; 8:40am EDT / 12:40pm GMT
Location: Miami, FL
Presenter: Chief Executive Officer Dr. Christian Itin

A webcast of the fireside chat will be available on the "Events" page in the "Investor Relations & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On March 5, 2025 Ataraxis AI, the leading AI precision medicine company, reported its $20.4 million Series A financing led by AIX Ventures with participation from Floating Point, Thiel Bio, Founders Fund, Bertelsmann Investments, and existing investors, Giant Ventures and Obvious Ventures (Press release, Ataraxis AI, MAR 5, 2025, View Source [SID1234650912]). The round also received backing from angel investors and healthcare pioneers, including Mario Schlosser, co-founder and former CEO of Oscar Health (NYSE: OSCR), Ryan Fukushima, COO of Tempus, and others. Leading researchers from OpenAI and DeepMind also participated.

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!

Founded by Jan Witowski, MD, PhD, and Krzysztof Geras, PhD, Ataraxis AI is reshaping cancer diagnostics with a frontier AI foundation model called Kestrel. The capital infusion comes as the company’s first offering, Ataraxis Breast—the world’s first AI-native prognostic/predictive platform for breast cancer—was clinically validated in a landmark study to be 30 percent more accurate than the current standard of care for breast cancer. Ataraxis AI is on track to launch Ataraxis Breast for clinical use later this year for oncologists across the United States. This new financing will also support the continuing development of offerings by expanding treatment selection capabilities within and beyond breast cancer as well as the development of next-generation AI foundation models.

"This investment is a testament to the groundbreaking work our team is accomplishing and the immense potential of AI in precision medicine. It also reflects our progress, securing funding just a few months after receiving clinical validation," said Jan Witowski, MD, PhD, co-founder and CEO, Ataraxis AI. "With this capital, we are on track to further accelerate our mission to change how cancer is treated and ultimately impact at least 50 percent of new cancer cases by 2030."

Through novel optimization strategies and methodological sophistication, Kestrel beats existing state-of-the-art models with less required data and computational power. The model outperforms existing approaches by uncovering complex, previously undetectable patterns linked to patient outcomes across all disease types. Kestrel is the first of Ataraxis’ foundation models, which will power the development of treatment selection tools for all cancer types.

Ataraxis AI also announced its Clinical Advisory Board, which boasts an impressive roster of medical oncology key opinion leaders from top health systems, including: Dr. Francisco Esteva (Chief of Hematology and Medical Oncology at Northwell Lenox Hill), Dr. Lajos Pusztai (Co-Leader Genetics, Genomics and Epigenetics Program at Yale Cancer Center), Dr. Adam Brufsky (Co-Director of the Cancer Therapeutics Program at the UPMC Hillman Cancer Center), and Dr. Freya Schnabel (Director of Breast Surgery, NYU). These additions join Yann LeCun, PhD, Chief AI Scientist at Meta and Turing Award Laureate, who serves as the company’s AI advisor.

"In the next five years, the world’s leading oncology centers won’t just have top physicians—they’ll have AI copilots revolutionizing diagnosis and treatment. Ataraxis AI is at the forefront of this transformation, and its breakthrough platform, Kestrel, is setting a new standard for precision oncology," said Krish Ramadurai, Partner at AIX Ventures. "Jan and his team aren’t just building another AI tool—they’re redefining how cancer is detected and treated, with the potential to improve millions of lives. We couldn’t be more excited to back them on this journey."

On March 5, 2025, Dynavax Technologies Corporation (the "Company") entered into privately negotiated exchange and subscription agreements (the "Exchange and Subscription Agreements") with certain holders of its outstanding 2.50% Convertible Senior Notes due 2026 (the "2026 Notes") and certain new investors, pursuant to which the Company will issue $225.0 million aggregate principal amount of its 2.00% Convertible Senior Notes due 2030 (the "New Notes") (Filing, 8-K, Dynavax Technologies, MAR 5, 2025, View Source [SID1234650954]). The Company will issue approximately $185.3 million aggregate principal amount of the New Notes and pay cash in the amount of approximately $82.5 million, representing the premium and accrued and unpaid interest on the 2026 Notes, (the "Cash Payment") in exchange for approximately $185.3 million aggregate principal amount of the 2026 Notes (the "Exchange Transactions"). The Company will also issue approximately $39.7 million aggregate principal amount of the New Notes for cash (the "Subscription Transactions" and together with the Exchange Transactions, the "Transactions"). Following the closing of the Transactions, which is expected to occur on or about March 13, 2025 (the "Closing Date"), subject to customary closing conditions, approximately $40.2 million in aggregate principal amount of the 2026 Notes will remain outstanding with terms unchanged, in addition to $225.0 million aggregate principal amount of the New Notes.

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 Company will not receive any cash proceeds from the Exchange Transactions. The Company estimates that the gross proceeds from the Subscription Transactions will be approximately $39.7 million. The Company expects to use the gross proceeds from the Subscription Transactions, together with the net proceeds from the Unwind Transactions described below and cash on hand, to make the Cash Payment described above and the Share Repurchases (as defined below).

The New Notes will be issued pursuant to, and governed by, an indenture (the "New Notes Indenture"), to be dated as of the Closing Date, between the Company and U.S. Bank Trust Company, National Association, as trustee (the "Trustee"). When issued pursuant to the New Notes Indenture, the New Notes will bear interest from March 13, 2025 at a rate of 2.00% per annum, payable semiannually in arrears on March 15 and September 15 of each year, beginning on September 15, 2025. The New Notes will mature on March 15, 2030, unless earlier converted, redeemed or repurchased.

Holders may convert all or any portion of their New Notes at their option at any time prior to the close of business on the business day immediately preceding December 15, 2029 only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2025 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock (the "common stock") for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (2) during the five business day period after any ten consecutive trading day period (the "measurement period") in which the trading price (as defined in the New Notes Indenture) per $1,000 principal amount of the New Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the common stock and the conversion rate on each such trading day; (3) if the Company calls such New Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date but only with respect to the New Notes called (or deemed called) for redemption; or (4) upon the occurrence of specified corporate events. On or after December 15, 2029 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their New Notes at any time, regardless of the foregoing circumstances.

The conversion rate will initially be 54.9058 shares of the common stock per $1,000 principal amount of the New Notes (equivalent to an initial conversion price of $18.21 per share of the common stock, which reflects a conversion premium of 30% to the last reported sale price of the common stock on March 5, 2025). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or if the Company delivers a notice of redemption, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its New Notes in connection with such a corporate event or convert its New Notes called (or deemed called) for redemption during the related redemption period (as defined in the New Notes Indenture), as the case may be.

The Company may not redeem the New Notes prior to March 20, 2028. The Company may redeem for cash all or any portion of the New Notes (subject to the partial redemption limitation described in the New Notes Indenture), at its option, on or after March 20, 2028 and prior to the 26th scheduled trading day immediately preceding the maturity date, if the last reported sale price of the common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides a notice of redemption at a redemption price equal to 100% of the principal amount of the New Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the New Notes.

If the Company undergoes a fundamental change (as defined in the New Notes Indenture), subject to certain conditions and except as set forth in the New Notes Indenture, holders may require the Company to repurchase for cash all or any portion of their New Notes at a fundamental change repurchase price equal to 100% of the principal amount of the New Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The New Notes Indenture includes customary terms and covenants, including certain events of default. The following events are considered "events of default" with respect to the New Notes, which may result in the acceleration of the maturity of the New Notes: (1) the Company defaults in any payment of interest on any New Note when due and payable, and the default continues for a period of 30 days; (2) the Company defaults in the payment of principal of any New Note when due and payable at its stated maturity, upon optional redemption, upon any required repurchase, upon declaration of acceleration or otherwise; (3) failure by the Company to comply with the Company’s obligation to convert the New Notes in accordance with the New Notes Indenture upon exercise of a holder’s conversion right and such failure continues for three (3) business days; (4) failure by the Company to give a fundamental change notice, notice of a make-whole fundamental change (as defined in the New Notes Indenture) or notice of a specified corporate transaction, in each case when due and such failure continues for one (1) business day; (5) failure by the Company to comply with its obligations under the New Notes Indenture with respect to consolidation, merger and sale of the Company’s assets; (6) failure by the Company for 60 days after written notice from the Trustee or the holders of at least 25% in principal amount of the New Notes then outstanding has been received to comply with any of the Company’s other agreements contained in the New Notes or Indenture; (7) the Company or any of its significant subsidiaries (as defined in the New Notes Indenture) defaults with respect to any mortgage, agreement or other instrument under which there may be outstanding, or by which there may be secured or evidenced, any indebtedness for money borrowed with a principal amount in excess of $35.0 million (or its foreign currency equivalent) in the aggregate of the Company and/or any such significant subsidiary, whether such indebtedness now exists or shall hereafter be created (i) resulting in such indebtedness becoming or being declared due and payable prior to its stated maturity date or (ii) constituting a failure to pay the principal of any such debt when due and payable (after the expiration of all applicable grace periods) at its stated maturity, upon required repurchase, upon declaration of acceleration or otherwise, and, in the cases of clauses (i) and (ii), such acceleration shall not have been rescinded or annulled or such failure to pay or default shall not have been cured or waived or such indebtedness shall not have been paid or discharged, as the case may be, within 30 days after written notice to the Company by the Trustee or to the Company and the Trustee by holders of at least 25% in aggregate principal amount of New Notes then outstanding in accordance with the New Notes Indenture; (8) a final judgment or judgments for the payment of $35.0 million (or its foreign currency equivalent) or more (excluding any amounts covered by insurance) in the aggregate rendered against the Company or any of its significant subsidiaries, which judgment is not discharged, bonded, paid, waived or stayed within 60 days after (i) the date on which the right to appeal thereof has expired if no such appeal has commenced, or (ii) the date on which all rights to appeal have been extinguished; or (9) certain events of bankruptcy, insolvency, or reorganization of the Company or any of its significant subsidiaries.

If certain bankruptcy and insolvency-related events of default occur with respect to the Company or any of its significant subsidiaries, the principal of, and accrued and unpaid special interest, if any, on, all of the then outstanding New Notes shall automatically become due and payable. If an event of default other than certain bankruptcy and insolvency-related events of default with respect to the Company or any of its significant subsidiaries occurs and is continuing, the Trustee by notice to the Company, or the holders of at least 25% in principal amount of the outstanding New Notes by notice to the Company and the Trustee, may declare 100% of the principal of, and accrued and unpaid interest, if any, on, all of the then outstanding New Notes to be due and payable.

Notwithstanding the foregoing, the New Notes Indenture provides that, to the extent the Company elects, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the New Notes Indenture will, for the first 365 days after the occurrence of such an event of default, consist exclusively of the right of holders to receive additional interest on the New Notes.

The New Notes Indenture will provide that the Company shall not consolidate with, merge with or into, or sell, convey, transfer or lease all or substantially all of the consolidated properties and assets of the Company and its subsidiaries, taken as a whole, to, another person (other than any such sale, conveyance, transfer or lease to one or more of the Company’s direct or indirect wholly owned subsidiaries) unless: (1) the resulting, surviving or transferee person (if not the Company) shall be a "qualified successor entity" (as defined in the New Notes Indenture) (such qualified successor entity, the "successor company") organized and existing under the laws of the United States of America, any State thereof or the District of Columbia, and such successor company (if not the Company) shall expressly assume, by supplemental indenture all of the Company’s obligations under the New Notes and the New Notes Indenture; and (2) immediately after giving effect to such transaction, no default or event of default has occurred and is continuing under the New Notes Indenture.

The New Notes will be the Company’s general unsecured obligations and rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the New Notes, equal in right of payment with all of the Company’s existing and future liabilities that are not so subordinated, including the 2026 Notes, effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness, and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company’s existing or future subsidiaries.

The New Notes will be issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"). The Company is relying on this exemption from registration based in part on representations made by the investors in the New Notes in the Exchange and Subscription Agreements.

Separately, the Company entered or will enter into agreements with certain financial institutions party to the Company’s existing capped call transactions entered into in connection with the 2026 Notes (the "Existing Capped Call Counterparties" and the "Existing Capped Call Transactions", respectively) to terminate certain portions of the Existing Capped Call Transactions up to the notional amounts corresponding to the amount of 2026 Notes being exchanged in the Transactions (such terminations, the "Unwind Transactions").

In connection with the Transactions, the Company repurchased approximately $8 million of shares of common stock, using gross proceeds from the Subscription Transactions, net proceeds from the Unwind Transactions, or from cash on hand in privately negotiated transactions with certain purchases of the New Notes through a financial intermediary at a price per share of $14.01, which is the last reported sale price of the common stock on March 5, 2025 (the "Share Repurchases") in order to facilitate the Transactions.

A copy of the Form of Exchange and Subscription Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference herein. The foregoing description of the Form of Exchange and Subscription Agreement, including the exchange ratio of the 2030 Notes for 2026 Notes and the related cash payment in the Exchange Transactions, is qualified in its entirety by reference to such exhibit.

This Current Report on Form 8-K is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.