On February 15, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that data published in the International Journal of Radiation Oncology, Biology, Physics (aka, "The Red Journal") demonstrate that the company’s Decipher Prostate Genomic Classifier can improve risk stratification among men with clinically high-risk prostate cancer (Press release, Veracyte, FEB 15, 2023, View Source [SID1234627270]). The data, from a pre-specified analysis of three phase 3 trials, represent the first validation of any gene-expression biomarker on pre-treatment biopsy samples from prospective randomized trials, and suggest the Decipher test provides clinically useful prognostic information to help personalize shared treatment decision-making.

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Approximately 30% of men with newly diagnosed localized prostate cancer present with high-risk disease, meaning they have an increased risk of disease recurrence, metastasis and death compared to men with lower-risk disease. However, previous studies have shown that more than 70% of men with high-risk prostate cancer who receive standard-of-care definitive radiotherapy and long-term androgen deprivation therapy (ADT) will never develop metastatic disease.

"High-risk prostate cancer is heterogenous and standard prognostic tools do a poor job of discriminating which men are likely to develop distant metastases and may benefit from more aggressive therapy, and who will do well when treated with standard radiotherapy and ADT," said Paul L. Nguyen, M.D., vice-chair for Clinical Research in the Department of Radiation Oncology at The Dana Farber/Brigham Cancer Center and professor at Harvard Medical School, and lead author of the published manuscript. "Because of this, clinicians are forced to use a one-size-fits-all approach that inherently leads to under- and over-treatment of many men. The data published today validate the role of the Decipher Prostate test in more accurately prognosticating patient outcomes, even within a high-risk group, to better personalize care. This utility is being further examined prospectively in ‘PREDICT-RT’, two parallel, randomized phase 3 clinical trials conducted by NRG Oncology and sponsored by the National Cancer Institute."

The Decipher Prostate Genomic Classifier is a 22-gene prognostic biomarker that provides a low, intermediate or high score indicating the aggressiveness of an individual patient’s cancer, to help healthcare professionals more accurately categorize risk and select appropriate treatment.

For the current analysis, Dr. Nguyen and colleagues obtained Decipher test scores on 265 biopsy samples from men with prostate cancer that was designated "high-risk" by National Comprehensive Cancer Network (NCCN) classification and who participated in one of three NRG Oncology randomized Phase 3, definitive radiotherapy trials (RTOG 9202, RTOG 9413 and RTOG 9902). With a median follow-up of 11 years, the researchers evaluated the association between Decipher scores and participants’ time to distant metastases (DM), prostate cancer-specific mortality (PCSM) and overall survival (OS).

Results demonstrate the Decipher Prostate test was independently prognostic for DM, PCSM and OS, with Decipher high-risk patients experiencing worse outcomes than Decipher low-risk patients on all three endpoints. After adjusting for age, PSA, Gleason score, cT-stage, trial, and randomized treatment arm, the analysis found that the Decipher test scores were independently associated with DM (HR 1.22, 95%CI 1.09-1.36), PCSM (sHR 1.23, 95%CI 1.09-1.39), and OS (HR 1.12, 95%CI 1.05-1.20). Notably, the Decipher test had similar prognostic ability in patients receiving short-term (4 months) or long-term (>24 months) ADT, though the absolute improvement in outcomes varied by Decipher risk. For example, at 10 years, the DM estimates were 31% for short-term vs 20% for long-term ADT in those with higher Decipher Prostate risk scores (an absolute benefit of 11%) but were 7% vs 4% in those with lower Decipher Prostate risk scores (an absolute benefit of 3%).

"This comprehensive analysis of three high-quality, randomized Phase 3 studies demonstrates that the Decipher Prostate Genomic Classifier provides information that can meaningfully impact clinical care for men with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Rigorous analyses and data like these are why we believe the Decipher Prostate test was given ‘Level 1’ evidence status in the NCCN’s most recent prostate cancer guidelines – the only gene-expression test to receive such designation. We believe the new data generated by Dr. Nguyen and colleagues could help physicians considering various treatment options for men with high-risk disease and who desire to tailor the duration and intensity of hormonal therapy for their patients on an individual basis."

On February 15, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported preliminary results of a study to assess the feasibility of home instillation of UGN-102 (mitomycin) for intravesical solution, an investigational therapy in development for primary chemoablation of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) (Press release, UroGen Pharma, FEB 15, 2023, View Source [SID1234627269]). In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment.

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"Many bladder cancer patients are elderly and suffer from comorbidities that make frequent office visits for treatment a real burden," said study investigator David Morris, M.D., F.A.C.S., Urologist at Urology Associates PC, Nashville, TN. "Moving healthcare out of the clinical setting and into a patient’s home would represent a new treatment paradigm for bladder cancer, which may reduce clinic and hospital costs while increasing patient comfort and convenience."

Eight patients were enrolled and treated with UGN-102 by 4 investigators. Median age was 75 years (range 55-84). Six patients completed treatment (6 doses), and 2 patients discontinued the study (5 doses and 4 doses, respectively) due to adverse events (AEs) unrelated to treatment. All 8 patients were evaluable for treatment response, and 6 of 8 (75%) achieved a complete response 3 months after starting treatment. The 2 patients who discontinued were assessed as non-responders. Treatment-related AEs were mild to moderate in severity (most common: dysuria and fatigue in 2 patients), and 3 patients with significant comorbidities had a serious AE, all of which were unrelated to treatment with UGN-102.

Patients, nurses and investigators completed home instillation feasibility questionnaires. These standardized feasibility questionnaires highlighted that all 8 patients preferred at-home to in-office treatment, and 5 of 6 patients recommended UGN-102 home instillation instead of transurethral resection of bladder tumors (TURBT). Home instillation was reported as feasible for visiting nurses, and 3 of 4 investigators considered at-home treatment "not different" than in-office treatment.

"As a urologic oncologist, I feel confident that the home instillation study results, appearing on the heels of our Phase 2 program and following the complete enrollment of our pivotal Phase 3 ENVISION study for UGN-102, provide us with even more reasons to believe that our novel approach to treating LG-IR-NMIBC has the potential to address genuine unmet needs of patients with bladder cancer," said Arie Belldegrun, M.D., Board Chair of UroGen.

The study enrolled patients with recurrent LG-IR-NMIBC who agreed to receive UGN‑102 at home. Six weekly doses of UGN-102 were administered. The first dose was administered on-site by a physician and the five remaining doses were administered at home by a visiting nurse. Patients were followed for AEs and treatment response was evaluated by visual observation, for cause biopsy, and urine cytology 3 months after treatment initiation. Complete response was defined as the absence of disease by white light cystoscopy, cytology, and histopathology.

"This study is another example of how UroGen continues to advance its mission to pioneer the way urothelial cancers are treated," says Liz Barrett, President and Chief Executive Officer, UroGen. "2023 will be a pivotal year for UroGen as we report on the ATLAS study of UGN-102 and start combinatorial treatments in the Phase 1 study of UGN-301. UroGen is in a strong position to achieve leadership in uro-oncology."

About LG-IR-NMIBC

Approximately 800,000 people are living with bladder cancer in the U.S., of that 80,000 suffer from LG-IR-NMIBC. Patients with LG-IR-NMIBC face a future of recurrence and additional surgeries. Currently, the only primary treatment available is a surgical procedure known as TURBT, which requires anesthesia. Every time TURBT is performed it may impose more burden and serious risks on patients, including pain, bleeding, infection and injury (including perforation).

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.

On February 15, 2023 TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported that the first accelerator-based BNCT (AB-BNCT) clinical research center at Xiamen Humanity Hospital (XHH) has now treated 12 patients in its Investigator Initiated Trial (IIT) aimed at evaluating the safety and efficacy of BNCT in the treatment of advanced refractory malignant tumors (Press release, TAE Life Sciences, FEB 15, 2023, View Source [SID1234627268]). Treated with the NeuPex System from Neuboron with TLS’s electrostatic Neutron Beam System (NBS), these are the first human patients treated with AB-BNCT technology outside of Japan.

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With traditional cancer therapies exhausted, these twelve patients diagnosed with recurrent head and neck, glioma and melanoma cancers underwent BNCT through permission from Xiamen Hospital’s Institutional Review Board (IRB) validated by a large-scale animal preclinical study. Patients met the BNCT requirements and were evaluated using F18-BPA PET/CT imaging, which measures the accumulation of boron in the tumor. The treatments lasted less than one hour, and interim results are encouraging with evidence of tumor control. Patient treatments under IIT are expected to continue throughout the year.

"The treatment of patients with BNCT at Xiamen Humanity Hospital is a tremendous step forward in the journey to treat invasive, recurrent and difficult-to-treat cancer," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "We completed installation of our Neutron Beam System in early 2022 during a global pandemic and this milestone underscores the momentum of our collaboration with Neuboron and XHH as we work to establish BNCT as an effective cancer treatment."

TLS’ Neutron Beam System in the NeuPex System enables a new treatment option for patients diagnosed with the most aggressive and recurrent cancers such as gliomas, head and neck tumors and melanomas. With the ability to deliver more precise, targeted radiation to cancer cells while sparing damage to surrounding healthy tissue, this technique holds a therapeutic potential where previous treatment options have been exhausted or are unavailable.

The clinical protocol utilized the boron-containing drug BPA and PET imaging drug F-BPA supplied by Neuboron. There was no evidence that remarkable adverse events or side effects were found in these first patients after four months, instead, early demonstration is seen of superior tumor control and signs of tumor shrinkage. The clinical study preliminarily verifies the safety of the combined treatment of neutron radiation and BPA drug and demonstrated good clinical treatment value.

The XHH BNCT Center, completed in 2020, is the first BNCT clinical research center operating in China. It is fully designed to safely operate two horizontal beams and one vertical beam using the Neuboron NeuPex AB-BNCT system. The center has 3 simulation rooms in addition to the 3 treatment rooms, allowing for the facilitation of patient positioning work and increasing patient turnover rate.

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On February 15, 2023 Seagen Inc. (Nasdaq:SGEN) reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, Seagen, FEB 15, 2023, View Source [SID1234627267]). The Company also highlighted PADCEV (enfortumab vedotin-ejfv), TUKYSA (tucatinib), ADCETRIS (brentuximab vedotin) and TIVDAK (tisotumab vedotin-tftv) commercial and development accomplishments, as well as progress across its potentially transformative oncology pipeline.

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"We delivered total revenue of nearly $2 billion in 2022, reflecting 25 percent growth compared to 2021 driven by strong demand for our portfolio of approved products," said David Epstein, Chief Executive Officer of Seagen. "We made excellent progress in growing our four marketed brands. Importantly, the FDA is currently reviewing our supplemental regulatory submission under the accelerated approval program for PADCEV as first-line treatment for cisplatin-ineligible patients with advanced urothelial cancer, which has the potential to be a meaningful growth driver for the brand. We anticipate multiple key data and regulatory catalysts in 2023, which will provide a path for us to build a more global oncology leader with the potential to address the needs of still larger populations of cancer patients."

PRODUCTS HIGHLIGHTS

PADCEV

Announced FDA Acceptance of Supplemental Biologics License Application (sBLA) for PADCEV with KEYTRUDA (pembrolizumab) for First-Line Advanced or Metastatic Urothelial Cancer; PDUFA Date April 21, 2023: In December 2022, Seagen, Astellas and Merck announced the FDA granted Priority Review of the sBLA and set a target action date of April 21, 2023. The application is seeking accelerated approval based on the results of the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869) Dose Escalation/Cohort A and Cohort K. The trial evaluated PADCEV with KEYTRUDA as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy.
Completed Enrollment in Global Phase 3 Clinical Trial, called EV-302, in First-Line Advanced Urothelial Cancer: In November 2022, Seagen and its partner Astellas completed patient enrollment in the EV-302 trial evaluating the combination of PADCEV and KEYTRUDA versus chemotherapy alone in patients with previously untreated locally advanced or metastatic urothelial cancer. EV-302 includes metastatic urothelial cancer patients who are either eligible or ineligible for cisplatin-based chemotherapy. The trial is intended to support global registrations and potentially serve as a confirmatory trial if accelerated approval is granted based on EV-103.
Presenting New Data from the EV-103 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers (ASCO GU) Symposium: Seagen will highlight new data for PADCEV including a podium presentation featuring noteworthy patient-reported outcomes from the EV-103 Cohort K study. The ASCO (Free ASCO Whitepaper) GU meetingis taking place February 16-18, 2023.
TUKYSA

Received FDA Accelerated Approval of TUKYSA in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer: In January 2023, the FDAgranted accelerated approval to TUKYSA in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This is the first FDA-approved treatment specifically for HER2-positive metastatic colorectal cancer. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
ADCETRIS

Received FDA Approval of New ADCETRIS Indication for Children with Previously Untreated High Risk Hodgkin Lymphoma: In November 2022, ADCETRIS received approval for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma. The approval resulted in a grant of pediatric exclusivity, which extends the period of U.S. market exclusivity for ADCETRIS by an additional six months.
TIVDAK

Elevated to Preferred Regimen by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Cervical Cancer: In December 2022, the NCCN guidelines were updated elevating TIVDAK to a Category 2A Preferred Regimen for second-line or subsequent recurrent or metastatic cervical cancer.
PIPELINE PROGRAMS

Presented Data Highlighting SGN-B6A, a Novel Antibody-Drug Conjugate, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting: In November 2022, Seagen reported initial phase 1 clinical data for SGN-B6A in patients with relapsed or refractory metastatic solid tumors at the SITC (Free SITC Whitepaper) Annual Meeting. SGN-B6A demonstrated a manageable and tolerable safety profile at the explored dose levels and schedules. The initial anti-tumor activity observed in heavily pre-treated patients is encouraging and has triggered expansion cohorts in non-small cell lung cancer, head and neck cancer and esophageal cancer.
Initiated Clinical Trial of SGN-BB228, a Novel Bispecific Antibody-Anticalin Candidate: In January 2023, the first patient was dosed in a phase 1 trial of SGN-BB228, a CD228x4-1BB bispecific molecule, in advanced melanoma and other solid tumors.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.

CORPORATE HIGHLIGHTS

Appointed David Epstein as CEO and member of the Board of Directors: Mr. Epstein has more than 30 years of experience in the biopharmaceutical industry, including more than 25 years at Novartis where he built its oncology business unit from initiation to second largest in the world and then served as CEO of Novartis Pharmaceuticals, a division of Novartis AG. More recently, he was executive partner at Flagship Pioneering.
Announced Roger Dansey, M.D., appointed as President, Research and Development: Dr. Dansey has served as Seagen’s Chief Medical Officer since 2018 and served as Interim CEO from May 2022 until Mr. Epstein’s appointment.
Appointed Sandra Swain, M.D., to the Board of Directors: Dr. Swain has more than 30 years of breast cancer clinical research experience. She currently serves as Associate Dean for Research Development and Professor of Medicine at Georgetown University Medical Center and is the Vice President of Genetic Medicine for MedStar Health. She is also on the Conquer Cancer Foundation Board of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and chairs the Women Who Conquer Cancer committee.
FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

Revenues: Total revenues in the fourth quarter and year ended December 31, 2022 were $528 million and $2.0 billion, respectively, compared to $430 million and $1.6 billion for the same periods in 2021. Revenues in the 2022 periods reflected higher net product sales across the Company’s commercial portfolio.

Revenues were comprised of the following components:

Three months ended December 31,

Full years ended December 31,

(dollars in millions)

2022

2021

% Change

2022

2021

% Change

Total Net Product Sales

$

464

369

26%

$

1,707

$

1,386

23%

ADCETRIS

238

176

35%

839

706

19%

PADCEV

122

93

32%

451

340

33%

TUKYSA

86

94

(9)%

353

334

6%

TIVDAK

18

6

191%

63

6

923%

Royalty Revenues

53

46

16%

165

151

9%

Collaboration and License Agreement Revenues
11
15

(24)%
91
38

139%

Note: Sum of product sales may not equal total net product sales due to rounding. Percent change reflects actual (unrounded) values.

Net Product Sales: The increases in net product sales for the periods in 2022 compared to the same periods in 2021 were driven by continued commercial execution across the portfolio. ADCETRIS growth was related to diagnosis rates which we believe have returned to pre-pandemic levels for the frontline indications, favorable pricing dynamics and greater use in frontline advanced Hodgkin lymphoma. PADCEV growth was a result of additional eligible patients in the second-line, post-checkpoint maintenance setting for metastatic urothelial cancer and to a lesser extent, sales of drug product for use in clinical trials being conducted by another company. TUKYSA performance reflected expected competitive dynamics in its current indication. TIVDAK commercialization began in the U.S. following FDA approval in September 2021 and reflects meaningful adoption in its labeled indication.
Royalty Revenues: Royalty revenues were primarily driven by sales of Takeda’s ADCETRIS outside the U.S. and Canada as well as royalties from Roche’s sales of Polivy (polatuzumab vedotin), which is an ADC that uses Seagen technology.
Collaboration and License Agreement Revenues: The increase in collaboration and license agreement revenues for the full year in 2022 compared to the same period in 2021 reflects clinical milestones and payments from ADC collaborators, royalty contribution from Astellas’ sales of PADCEV in its territory and a $30 million upfront license fee from Zai Lab related to a regional collaboration for TIVDAK.
Cost of Sales: Cost of sales in the fourth quarter were $108 million, compared to $87 million in the fourth quarter of 2021. Cost of sales were $410 million for the full year in 2022, compared to $312 million for the same period in 2021. The increases in 2022 were primarily driven by higher sales of our medicines and the related gross profit share amounts owed to collaboration partners, which were $64 million and $253 million in the fourth quarter and full year in total, respectively, compared to $46 million and $162 million for the same periods in 2021. Cost of sales also reflects amortization of TUKYSA acquired in-process technology costs, third-party royalties owed for PADCEV and TUKYSA net product sales, and cost of products sold.

Research and Development (R&D) Expenses: R&D expenses in the fourth quarter were $358 million, compared to $304 million in the fourth quarter of 2021. R&D expenses were $1.3 billion for the full year in 2022, compared to $1.2 billion in 2021. The increase in full year in 2022 primarily reflected continued investment in clinical development of the Company’s approved drugs and pipeline programs.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses in the fourth quarter were $216 million, compared to $211 million in the fourth quarter of 2021. SG&A expenses were $821 million for the full year in 2022, compared to $716 million for the same period in 2021. The increases in 2022 were driven by ongoing commercialization efforts, legal costs, and other corporate activities.

Non-cash share-based compensation expense for the full year in 2022 was $221 million, compared to $173 million for the same period in 2021.

Net Income / Loss: Net loss for the fourth quarter of 2022 was $148 million, or $0.80 per diluted share, compared to net loss of $175 million, or $0.95 per diluted share, for the fourth quarter of 2021. For the full year in 2022, net loss was $610 million, or $3.30 per diluted share, compared to net loss of $674 million, or $3.70 per diluted share, for the year in 2021. Net loss in full year 2021 included a $200 million upfront payment to RemeGen.

Cash and Investments: As of December 31, 2022, Seagen had $1.7 billion in cash and investments.

2023 FINANCIAL OUTLOOK

Seagen anticipates 2023 revenues, operating expenses and other costs to be in the ranges shown in the table below.

REVENUES

Net Product Sales1

$1,925 million to $2,000 million

Royalty revenues

$170 million to $185 million

Collaboration and license agreement revenues

$45 million to $55 million

Total revenues1

$2,140 million to $2,240 million

OPERATING EXPENSES AND OTHER COSTS

Cost of Sales

$420 million to $470 million

R&D expenses

$1,425 million to $1,525 million

SG&A expenses

$880 million to $930 million

Non-cash expenses2 (primarily attributable to share-based compensation)

$330 million to $375 million

1. Net Products Sales include sales of ADCETRIS, PADCEV, TUKYSA and TIVDAK.

2. Non-cash expenses include share-based compensation, depreciation and amortization of intangible assets.

Conference Call Details

Seagen management will host a conference call and webcast with supporting slides to discuss its fourth quarter and full year 2022 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be simultaneously webcast and available for replay from the Seagen website at investor.seagen.com. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or 412-717-9224 (international) and asking for the Seagen conference call. Supporting slides are available on the Seagen website at investor.seagen.com under the Investors section. A webcast replay will be archived on the Company’s website, investor.seagen.com, under the Investors section.

On February 15, 2023 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines, reported the closing of the Private Placement of 10,344,822 Units initially at an issue price of US$0.58 per Unit (further details of which were set out in the announcement of 9 February 2023) (Press release, Midatech Pharma, FEB 15, 2023, View Source [SID1234627265]).

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Each such Unit comprises either (i) one American Depository Share ("ADS"), one A Warrant and one and one-half B Warrants, or (ii) one Pre-Funded Warrant, one A Warrant and one and one-half B Warrants. The Company will therefore issue, in aggregate, 2,600,160 new ADSs (representing 65,004,000 new ordinary shares of 0.1p each ("Ordinary Shares") (the "Placing Shares") and 7,744,662 Pre-Funded Warrants (subject to adjustment as set out in the Company’s announcement of 9 February 2023) under the Private Placement.

The 65,004,000 Placing Shares issued in respect of the Private Placement were admitted to trading on AIM at 8.00 a.m. today. The Placing Shares rank pari passu with the pre-existing Ordinary Shares.

The net proceeds to the Company raised via the Private Placement are expected to be approximately US$5.2 million (approximately £4.3 million), after deducting the placement agent’s fees and other estimated expenses. Midatech intends to use such net proceeds primarily to continue funding of the clinical development program of MTX110, its product for recurrent glioblastoma and DIPG, and for working capital and general corporate purposes.

Ladenburg Thalmann & Co. Inc. acted as the exclusive placement agent for the Private Placement.

In addition, subject to shareholder approval being obtained at the planned forthcoming general meeting, the Company intends to grant, in aggregate, 10,344,822 A Warrants and 15,517,236 B Warrants to the investors in the Private Placement. The A Warrants and B Warrants, if issued, will afford the holder the right to subscribe for one ADS for nil consideration, will be immediately exercisable and expire in five years and three years, respectively.

A circular convening the general meeting is expected to be sent to shareholders shortly.

Change of Broker

Midatech announces the appointment of Strand Hanson Limited ("Strand Hanson") as the Company’s sole broker with immediate effect. Strand Hanson remains the Company’s Nominated Adviser.