PreciseDx to Present on AI-enabled Breast Cancer Grade and Phenotyping Assay at United States and Canadian Academy of Pathology (USCAP) Annual Meeting

On March 8, 2023 PreciseDx, a leading innovator in AI-powered, patient-specific disease analysis, reported that it will present a poster showcasing the development and validation of its AI-enabled hematoxylin and eosin (H&E) image analysis grading and phenotyping Platform to predict risk of early-stage breast cancer recurrence (Press release, PreciseDx, MAR 9, 2023, View Source [SID1234628455]). Data from a retrospective development and validation study on the benefits of the Company’s novel breast cancer (BC) grading and phenotyping method will be presented at the United States and Canadian Academy of Pathology (USCAP) 112th Annual Meeting, taking place March 11 through March 16, 2023 in New Orleans, Louisiana.

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"We are proud to share the positive results with the pathology community, highlighting the need for decision support tools such as ours to improve reproducibility and prognostic accuracy for histologic grade (HG) in clinical practice," said Michael Donovan, MD, PhD, Co-Founder and Chief Medical Officer. "We envision that our unique Platform holds significant potential for enhancing patient-centric BC treatment decision-making. This research underscores the efficacy of applying image analysis tools to current workflows, and further demonstrates that we’re succeeding in our mission to improve outcomes and facilitate access to high-quality medical care for all patients."

With decades of experience in pathology and a unique perspective of the speciality’s current processes, PreciseDx’s founders have identified the unmet need for more quantifiable information to raise the standard of patient diagnosis and prognosis. Through the PreciseDx Platform, clinical care teams and pathologists have the ability to examine every cell – and their relationships to one another – beyond what’s detected with the human eye. This comprehensive view provides an unprecedented amount of information to ultimately improve patient management and outcomes.

The poster, titled, "Development and Validation of an Artificial-Intelligent (AI) H&E Image Analysis Grading and Phenotyping Platform to Predict Risk of Early-Stage Breast Cancer Recurrence," will be presented on Tuesday, March 14 at 9:30am CT.

For the event’s full agenda, visit: View Source

EDAP to Announce Fourth Quarter and Full-Year 2022 Financial Results on Thursday, March 30th

On March 9, 2023 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that it will release its financial results for the fourth quarter and full-year ended December 31, 2022, before the markets open on Thursday, March 30th, 2023 (Press release, EDAP TMS, MAR 9, 2023, View Source [SID1234628453]).

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An accompanying conference call and webcast will be hosted by Marc Oczachowski, Chairman of the Board and Chief Executive Officer, Ryan Rhodes, CEO of EDAP U.S., and François Dietsch, Chief Financial Officer. The call will be held at 8:30am ET on Thursday, March 30th, 2023. Please refer to the information below for the conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday, March 30th@ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
CallMe : Link
Webcast: View Source;tp_key=be6fe8ba22

UroGen Pharma to Report Fourth Quarter and Full-Year 2022 Financial Results on Thursday, March 16, 2023

On March 9, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will report fourth quarter and full-year 2022 financial results on Thursday, March 16, 2023, prior to the open of the stock market (Press release, UroGen Pharma, MAR 9, 2023, View Source [SID1234628445]). The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

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A live public webcast of the earnings conference call can be accessed on UroGen’s Investor Relations website. Following the live webcast, a replay will be available on the site for approximately 30 days.

Entry into a Material Definitive Agreement

On March 9, 2023 Teva Pharmaceutical Finance Netherlands II B.V. ("Teva Finance II"), a wholly owned subsidiary of Teva Pharmaceutical Industries Limited (the "Company"), issued €800,000,000 aggregate principal amount of 7.375% Sustainability-Linked Senior Notes due 2029 (the "2029 Euro Notes") and €500,000,000 aggregate principal amount of 7.875% Sustainability-Linked Senior Notes due 2031 (the "2031 Euro Notes" and, together with the 2029 Euro Notes, the "Euro Notes"); and (ii) Teva Pharmaceutical Finance Netherlands III B.V. ("Teva Finance III" and, together with Teva Finance II, the "Issuers"), a wholly owned subsidiary of the Company, issued $600,000,0000 aggregate principal amount of 7.875% Sustainability-Linked Senior Notes due 2029 (the "2029 USD Notes") and $500,000,000 aggregate principal amount of 8.125% Sustainability-Linked Senior Notes due 2031 (the "2031 USD Notes" and, together with 2029 USD Notes, the "USD Notes" and together with the Euro Notes, the "Notes") (Filing, 8-K, Teva, MAR 9, 2023, View Source [SID1234628444]).

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Teva intends to use the net proceeds from the Notes (i) to fund the announced tender offer for a maximum combined aggregate purchase price (exclusive of accrued and unpaid interest) of up to $2,500,000,000 (equivalent) (upsized from a previously announced cap of $2,250,000,000), (ii) to pay fees and expenses in connection therewith, and (iii) to the extent of any remaining proceeds, for the repayment of outstanding debt upon maturity, tender offer or earlier redemption. Net proceeds may be temporarily invested pending application for their stated purpose.

The Euro Notes were issued pursuant to a Senior Indenture, dated as of March 14, 2018 (the "Euro Notes Base Indenture"), by and among Teva Finance II, the Company, as guarantor, and The Bank of New York Mellon, as trustee, as supplemented by the Fourth Supplemental Indenture, dated as of March 9, 2023 (the "Euro Notes Supplemental Indenture" and, together with the Euro Notes Base Indenture, the "Euro Notes Indenture"), by and among Teva Finance II, the Company, as guarantor, The Bank of New York Mellon, as trustee, and The Bank of New York Mellon, London Branch, as paying agent. The USD Notes were issued pursuant to a Senior Indenture, dated as of March 14, 2018 (the "USD Notes Base Indenture"), as supplemented by the Fourth Supplemental Indenture, dated as of March 9, 2023 (the "USD Notes Supplemental Indenture" and, together with the USD Notes Base Indenture, the "USD Notes Indenture" and, together with the Euro Notes Indenture, the "Indentures"), in each case, by and among Teva Finance III, the Company, as guarantor, and The Bank of New York Mellon, as trustee.

Interest will be payable on the Notes semi-annually in arrears on March 15 and September 15 of each year, beginning on September 15, 2023, until their maturity dates of September 15, 2029 for the 2029 Euro Notes and the 2029 USD Notes and September 15, 2031 for the 2031 USD Notes and the 2031 Euro Notes. The Euro Notes and the USD Notes are senior unsecured obligations of Teva Finance II and Teva Finance III, respectively, and the Notes are guaranteed on a senior unsecured basis by the Company.

From and including September 15, 2026 (the "Step-up Date"), the interest rate payable on the Notes shall increase by:

(a) 0.100% per annum unless Teva has achieved the Regulatory Submissions Target as of the Testing Date (each as defined in the Euro Notes Supplemental Indenture and the USD Notes Supplemental Indenture);

(b) 0.100% per annum unless Teva has achieved the Product Volume Target as of the Testing Date (each as defined in the Euro Notes Supplemental Indenture and the USD Notes Supplemental Indenture); and

(c) 0.100% per annum unless Teva has achieved the Emission Reduction Target as of the Testing Date (each as defined in the Euro Notes Supplemental Indenture and the USD Notes Supplemental Indenture);

Teva Finance II may redeem the Euro Notes of any series, in whole or in part, at any time or from time to time, upon at least 10 days’, but not more than 60 days’, prior notice delivered to the registered address of each holder of the Euro Notes to be redeemed with a copy of such notice delivered to the trustee and the paying agent. The Euro Notes will be redeemable at a redemption price equal to the greater of (1) 100% of the principal amount of the Euro Notes of such series to be redeemed or (2) the sum of the present values of the Remaining Scheduled Payments (as defined in the Euro Notes Indenture) of the Euro Notes of such series being redeemed discounted, on a semi-annual basis (assuming a 360-day year consisting of twelve 30-day months), at the applicable Reinvestment

Rate (as defined in the Euro Notes Indenture), plus accrued and unpaid interest thereon, if any to, but not including, the redemption date; provided that if Teva Finance II elects to redeem the 2029 Euro Notes at any time on or after June 15, 2029 (three months prior to the maturity date of the 2029 Euro Notes) or to redeem the 2031 Euro Notes at any time on or after June 15, 2031 (three months prior to the maturity date of the 2031 Euro Notes), Teva Finance II may redeem the such Euro Notes, in whole or in part, at a redemption price equal to 100% of the principal amount of such series of Euro Notes then outstanding to be redeemed, plus accrued and unpaid interest thereon, if any, to, but not including, the redemption date.

Teva Finance III may redeem the USD Notes, of any series, in whole or in part, at any time or from time to time, upon at least 10 days’, but not more than 60 days’, prior notice. The USD Notes will be redeemable at a redemption price equal to the greater of (1) 100% of the principal amount of the USD Notes to be redeemed or (2) the sum of the present values of the Remaining Scheduled Payments (as defined in the USD Notes Indenture) of the USD Notes of such series being redeemed discounted, on a semi-annual basis (assuming a 360-day year consisting of twelve 30-day months), using a discount rate equal to the sum of the Treasury Rate (as defined in the USD Notes Indenture) plus 50 basis points, plus in each case accrued and unpaid interest thereon, if any, to, but not including, the redemption date; provided that if Teva Finance III elects to redeem the 2029 USD Notes at any time on or after June 15, 2029 (three months prior to the maturity date of the 2029 USD Notes) or to redeem the 2031 USD Notes at any time on or after June 15, 2031 (three months prior to the maturity date of the 2031 USD Notes), Teva Finance III may redeem the USD Notes, in whole or in part, at a redemption price equal to 100% of the principal amount of such series of USD Notes then outstanding to be redeemed, plus accrued and unpaid interest thereon, if any, to, but not including, the redemption date.

The terms of the Indentures, among other things and subject to specified exceptions, limit the ability of (a) the Company and its subsidiaries to (i) create liens upon certain of their property and (ii) enter into sale-leaseback transactions; and (b) the applicable Issuer and the Company to merge, consolidate or sell, lease or convey all or substantially all of their assets. The Indentures provide for customary events of default, which include (subject in certain cases to customary grace and cure periods), among others, nonpayment of principal or interest; breach of other covenants or agreements in the Indentures; acceleration of certain other indebtedness; failure of the Company’s guarantee to be enforceable; and certain events of bankruptcy or insolvency. The offering of the Notes was registered under the Securities Act of 1933, as amended (the "Securities Act"), and is being made pursuant to the Company’s Registration Statement on Form S-3ASR (File No. 333-260519) and the prospectus included therein (the "Registration Statement"), filed by the Company with the Commission on October 27, 2021, the preliminary prospectus supplement relating thereto, dated February 27, 2023, and filed with the Commission on February 27, 2023 pursuant to Rule 424(b)(3) promulgated under the Securities Act and the free writing prospectus related thereto, dated March 1, 2023, and filed with the Commission on March 1, 2023 pursuant to Rule 433 under the Securities Act.

The foregoing summary descriptions of the Euro Notes Base Indenture, Euro Notes Supplemental Indenture, USD Notes Base Indenture, USD Notes Supplemental Indenture and each series of Notes are not complete and are qualified in their entirety by reference to the Euro Notes Base Indenture, the Euro Notes Supplemental Indenture, the form of 2029 Euro Notes, the form of 2031 Euro Notes, the USD Notes Base Indenture, the USD Notes Supplemental Indenture, the form of 2029 USD Notes and the form of 2031 USD Notes, which are filed as Exhibits 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7 and 4.8, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

Olema Oncology Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Strategic Update

On March 9, 2023 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the fourth quarter and full-year ended December 31, 2022, and provided a strategic update (Press release, Olema Oncology, MAR 9, 2023, View Source [SID1234628443]).

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"2022 was a successful year for Olema as we generated important clinical data advancing the opportunity for OP-1250, our complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD), as both a monotherapy and in combination with a CDK4/6 inhibitor. We continue to have confidence in OP-1250’s ability to become a best-in-class treatment option for ER+/HER2- metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are committed to realizing the full potential of OP-1250, which we believe has demonstrated a clear, differentiated advantage as a complete ER antagonist and the potential endocrine therapy of choice. Given the challenging equity market environment, we made some difficult decisions regarding our organization and earlier-stage programs. As we sharpen our focus on the late-stage clinical development of OP-1250, we remain steadfast in our goal of bringing this potentially transformative therapy to women living with breast cancer."

Olema’s restructuring announced today is the result of a strategic decision to focus resources on the late-stage clinical development of OP-1250, which includes the initiation of the company’s first pivotal Phase 3 trial in the second half of this year. As a result of the restructuring, Olema’s workforce will be reduced by approximately 25%, affecting employees across research, early development, and general and administrative functions. Chief Business Officer Kinney Horn will be departing the company, and Cyrus Harmon, Ph.D., co-founder of Olema, will step down from his role as the Chief Research Officer and remain a member of Olema’s Board of Directors.

"I am grateful to our employees for their strong commitment to our mission and dedication to patients. I would like to thank Kinney for his important contributions to Olema since joining in 2020, and we wish him well in his future endeavors," continued Dr. Bohen. "Cyrus, who is a co-founder of Olema, has been an inspirational leader and was instrumental in the discovery and early development of OP-1250. His continued guidance as a member of the Board will be vital as we progress OP-1250 though late-stage development."

2022 Corporate Highlights

● Presented clinical results from a Phase 1/2 clinical study of OP-1250 at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022), which demonstrated that, across 68 heavily pre-treated patients, OP-1250 was well tolerated with attractive pharmacokinetics and sustained drug exposure levels approximately 20 times that of fulvestrant at the 120 mg daily dose. In addition, OP-1250 demonstrated strong anti-tumor activity, with 41% of patients seeing reductions in target tumor lesions, and durable benefit with a 39% clinical benefit rate (CBR) at the 120 mg dose level on a maturing dataset. Six partial responses (four confirmed and two unconfirmed) were observed in 57 efficacy-evaluable patients.
● Presented clinical results from a Phase 1b combination study at the 2022 San Antonio Breast Cancer Symposium (SABCS), which demonstrated OP-1250’s combinability with palbociclib with a tolerability profile consistent with palbociclib in combination with an aromatase inhibitor or fulvestrant, no drug-drug interaction, and no induced metabolism of palbociclib.
● Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for OP-1250 for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor.
● Initiated a Phase 1b combination study with CDK4/6 inhibitor, ribociclib, and phosphoinositide 3-kinase alpha (PI3Ka) inhibitor, alpelisib.
● Announced an exclusive global license agreement with Aurigene Discovery Technologies Limited (Aurigene) to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target.
Anticipated Upcoming Milestones

● Initiate a pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer in the second half of 2023.
● Present Phase 2 combination with CDK4/6 inhibitor (palbociclib) clinical study results in the second quarter of 2023.
● Present Phase 2 monotherapy clinical study results in the second half of 2023.
● Present Phase 1b combination with CDK4/6 inhibitor (ribociclib) clinical study results in the second half of 2023.

Fourth Quarter and Full-Year 2022 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2022, were $204.4 million. Olema anticipates that this balance will be sufficient to fund operations into 2025.

Net loss was $26.2 million and $104.8 million for the quarter and year ended December 31, 2022, respectively, as compared to $21.6 million and $71.1 million for the quarter and year ended December 31, 2021, respectively. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development activities including an $8.0 million upfront payment to Aurigene in the second quarter, and an increase in general and administrative (G&A) costs.

GAAP research and development (R&D) expenses were $21.6 million and $82.3 million for the quarter and year ended December 31, 2022, respectively, as compared to $16.0 million and $51.1 million for the quarter and year ended December 31, 2021, respectively. The increase in R&D expenses was primarily related to increases in advancing ongoing clinical studies of OP-1250 and associated manufacturing costs, nonclinical research and discovery program activities, including an $8.0 million upfront payment to Aurigene in the second quarter, and personnel-related expenses due to higher headcount, including non-cash stock-based compensation expenses.

Non-GAAP R&D expenses were $18.2 million and $69.8 million for the quarter and year ended December 31, 2022, respectively, excluding $3.4 million and $12.5 million non-cash stock-based compensation expense, respectively. Non-GAAP R&D expenses were $13.1 million and $41.8 million for the quarter and year ended December 31, 2021, respectively, excluding $2.9 million and $9.3 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $5.6 million and $24.7 million for the quarter and year ended December 31, 2022, respectively, as compared to $5.8 million and $20.4 million for the quarter and year ended December 31, 2021, respectively. The increase in G&A expenses was primarily related to increases in personnel-related expenses due to higher headcount, including non-cash stock-based compensation expense, and public company-related expenses, including legal compliance and other corporate costs.

Non-GAAP G&A expenses were $4.1 million and $18.3 million for the quarter and year ended December 31, 2022, respectively, excluding $1.5 million and $6.4 million non-cash stock-based compensation expense respectively. Non-GAAP G&A expenses were $4.1 million and $13.8 million for the quarter and year ended December 31, 2021, excluding $1.7 million and $6.6 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.