Sarepta Therapeutics Announces Proposed Offering of $1.0 Billion of Convertible Senior Notes Due 2027

On September 12, 2022 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported that it intends to offer, subject to market and other conditions, $1.0 billion aggregate principal amount of convertible senior unsecured notes that will mature on September 15, 2027, unless earlier redeemed, repurchased or converted (Press release, Sarepta Therapeutics, SEP 12, 2022, View Source [SID1234619506]). The notes will be offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Rule 144A offering"). Sarepta also expects to grant the initial purchasers of the notes an option to purchase up to an additional $150 million aggregate principal amount of notes.

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Sarepta intends to use a portion of the net proceeds from the offerings to pay the cost of certain capped call transactions (described below) and to repurchase a portion of its 1.50% Convertible Senior Notes due 2024 (the "2024 Notes"), inclusive of any applicable premium and accrued interest (described below). In addition, Sarepta intends to use a portion of the net proceeds from the offerings to repay borrowings and accrued and unpaid interest, to pay the prepayment premium under, and terminate, its credit agreement and the remaining net proceeds to fund general corporate purposes. Sarepta believes that, along with current cash and projected revenue, this offering is sufficient to fund operations to profitability.

The notes will be senior, unsecured obligations of Sarepta and bear cash interest, payable on March 15 and September 15 of each year, beginning on March 15, 2023. The notes will be convertible, only during certain periods and subject to certain circumstances, into cash, shares of Sarepta common stock, or a combination of cash and shares of Sarepta common stock, at Sarepta’s election. Prior to September 20, 2025, the notes will not be redeemable. On or after September 20, 2025 and on or before the 41st scheduled trading day immediately preceding the maturity date, Sarepta may redeem for cash all or part of the notes (subject to certain conditions), at its option, if the last reported sale price of Sarepta’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which Sarepta provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which Sarepta provides notice of redemption. Final terms of the notes, including interest rate, conversion rate, conversion price, and certain other terms of the offerings, will be determined at the time of pricing.

In connection with the pricing of the notes, Sarepta expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers or their respective affiliates or other financial institutions (the "option counterparties"). The capped call transactions are expected generally to reduce the potential dilution to Sarepta’s common stock upon conversion of any notes and/or offset any potential cash payments Sarepta is required to make in excess of the principal amount of converted notes, as the case may be, subject to a cap. If the initial purchasers of the notes exercise their option to purchase additional notes, Sarepta expects to enter into additional capped call transactions with the option counterparties.

Sarepta has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to purchase shares of Sarepta’s common stock and/or enter into various derivative transactions with respect to Sarepta’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Sarepta’s common stock or the notes at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Sarepta’s common stock and/or by purchasing or selling Sarepta’s common stock or other securities of Sarepta’s in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes). This activity could also cause or avoid an increase or a decrease in the market price of Sarepta’s common stock or the notes, which could affect the ability of holders to convert the notes and, to the extent the activity occurs following conversion or during any observation period related to a conversion of the notes, it could affect the number of shares of Sarepta’s common stock and value of the consideration that holders will receive upon conversion of the notes.

Contemporaneously with the pricing of the notes in this offering, Sarepta expects to enter into separate, privately negotiated transactions with certain holders of its 2024 Notes to repurchase for cash a portion of the 2024 Notes on terms to be negotiated with such holders (the "concurrent note repurchases"). The terms of the concurrent note repurchases are anticipated to be individually negotiated and will depend on several factors, including the market price of Sarepta’s common stock and the trading price of the 2024 Notes at the time of each such concurrent note repurchase. No assurance can be given as to how much, if any, of the 2024 Notes will be repurchased or the terms on which they will be repurchased.

Sarepta expects that holders of any 2024 Notes that Sarepta agrees to repurchase that have hedged their equity price risk with respect to such notes (the "hedged holders") will, concurrently with the pricing of the notes, unwind their hedge positions by buying Sarepta’s common stock and/or entering into or unwinding various derivative transactions with respect to Sarepta’s common stock.

In connection with the issuance of the 2024 Notes, Sarepta entered into capped call transactions (the "existing capped call transactions") with certain financial institutions (the "existing option counterparties"). In connection with the concurrent note repurchases, Sarepta expects to enter into agreements with the existing option counterparties to terminate a portion of the existing capped call transactions in a notional amount corresponding to the principal amount of the 2024 Notes repurchased in the concurrent note repurchases. In connection with any such termination of a corresponding portion of the existing capped call transactions, Sarepta expects that such existing option counterparties and/or their respective affiliates will sell shares of Sarepta’s common stock in secondary market transactions, and/or unwind various derivative transactions with respect to Sarepta’s common stock. In connection with such terminations, Sarepta anticipate that it will receive proceeds from the existing counterparties, which it intends to use for general corporate purposes.

Any repurchase of the 2024 Notes and the termination of a corresponding portion of the existing capped call transactions described above, and the potential related market activities by holders of the 2024 Notes participating in the concurrent note repurchases and the existing counterparties, as applicable, could increase (or reduce the size of any decrease in) or decrease (or reduce the size of any increase in) the market price of Sarepta’s common stock, which may affect the trading price of the notes at that time and the initial conversion price of the notes. Sarepta cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or Sarepta’s common stock.

The offer and sale of the notes are not being registered under the Securities Act, or any state securities laws. The notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws.

This news release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the laws of such jurisdiction.

Novo Nordisk A/S – Share repurchase programme

On September 12, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, SEP 12, 2022, View Source [SID1234619489]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 August 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 August 2022 to 31 October 2022.

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 20,012,478 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 9 September 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 18,301,699 B shares at an average share price of DKK 769.09 per B share equal to a transaction value of DKK 14,075,566,796

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 50,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn and YouTube.

New Tubulis Paper in Blood highlights potential of next-generation ADC for effective & safe treatment of acute myeloid leukemia

On September 12, 2022 Tubulis reported that Together with our collaborators at LMU Klinikum Munich, the German Cancer Consortium DKTK and the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) we have published a new paper in Blood, highlighting the great potential of a next-generation ADC for the effective & safe treatment of acute myeloid leukemia (AML) in preclinical in vivo models (Press release, Tubulis, SEP 12, 2022, View Source [SID1234619486]).

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With a 5-year overall survival rate of 29.5% in America, AML treatment remains a challenge and the demand for new therapeutic options is high. Therefore, we utilized our novel P5 conjugation platform to create 20D9-ADC targeting a commonly occurring FTL3 mutation in AML. We could not only show a significant and durable tumor reduction but also reduced liver toxicity in preclinical cancer models. Moreover, a combined treatment with the marketed therapeutic midostaurin, a tyrosine kinase inhibitor, showed a synergistic effect broadening possible application scenarios for 20D9-ADC.

Advaxis Reports Third Quarter Ended July 31, 2022 Financial Results and Provides a Business Update

On September 12, 2022 Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported its financial results for the third quarter ended July 31, 2022 and provides a business update (Press release, Advaxis, SEP 12, 2022, View Source [SID1234619481]).

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Third Quarter Ended July 31, 2022 Financial Results and Recent Key Accomplishments:

Announced completion of first dose level in investigator-sponsored study in biochemically recurrent prostate cancer.
The preliminary clinical assessment showed that at the first dose level ADXS-504 monotherapy is safe and well tolerated.
The company plans to present clinical data and PSA values, for patients in both cohorts at a future medical conference.
Announced enrollment initiation for second dose level cohort of investigator-sponsored clinical trial of ADXS-504 (HOT Prostate) in biochemically recurrent prostate cancer at Columbia University.
Management Commentary

Kenneth A. Berlin, President and Chief Executive Officer of Advaxis said, "We continue to make progress in our development of ADXS-504. We announced that we have completed the first dose level in our investigator-sponsored trial of ADXS-504 in biochemically recurrent prostate cancer and the data suggest that this novel therapeutic is safe and well-tolerated. In addition, we have initiated enrollment for the second dose cohort and look forward to reporting safety and initial clinical data in the first half of 2023." Mr. Berlin added, "Given the measures we have undertaken to control expenses, we continue to expect that our cash runway will reach into the third fiscal quarter of 2024."

Third Quarter Ended July 31, 2022 Financial Results

Research and development expenses for the third quarter of fiscal year 2022 were $2.2 million compared with $1.7 million for the third quarter of fiscal year 2021. The increase of $0.5 million was primarily attributable to patient recruitment and manufacturing costs associated with our ADXS-503 clinical trial program. General and administrative expenses for the three months ended July 31, 2022 were approximately $2.1 million, compared to $2.7 million in the same three-month period in 2021. The decrease of $0.6 million primarily relates to legal and consulting fees with a previously proposed merger transaction and proxy solicitation fees in the prior period, partially offset by settlements from stockholder demand letters in the current period.

As of July 31, 2022, the Company had approximately $28.2 million in cash and cash equivalents.

ESMO 2022: REVEAL GENOMICS®️ PRESENTS NEW VALIDATION DATA OF HER2DX®️ IN THE PerELISA TRIAL

On September 12, 2022 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported another validation of HER2DX️, the world’s first specialized genomic test for HER2+ breast cancer (Press release, REVEAL GENOMICS, SEP 12, 2022, View Source [SID1234619479]).

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Her2dx
Her2dx
Prof. Valentina Guarneri from the University of Padova presented the data at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 held in Paris, France. The data obtained from the analysis of tumor samples from the PerELISA phase II clinical trial showed that the HER2DX️ pCR-score and the HER2DX️ ERBB2-score predicted the probability of a patient responding to the triple-drug combination of trastuzumab, pertuzumab and letrozole, when given before surgery (i.e., the neoadjuvant setting). These findings in patients with newly diagnosed HER2+/hormone receptor positive (HER2+/HR+) breast cancer can help identify better who might benefit from dual HER2 blockade with trastuzumab and pertuzumab.

"This is the first study to show the ability of HER2DX️ to predict response to trastuzumab and pertuzumab in the absence of chemotherapy. The performance of the test in PerELISA is remarkable and supports the predictive value of the test in the neoadjuvant setting", said Prof. Guarneri.

Dr. Aleix Prat, CSO of REVEAL GENOMICS️, added: "The ability of HER2DX️ to predict response to trastuzumab-based neoadjuvant therapies has now been demonstrated in more than 590 patients across 5 studies. Our commitment is to keep providing patients and physicians with the highest level of test evidence to help them make the right treatment decision".

HER2DX️ in the PerELISA trial

The PerELISA trial led by Prof. Valentina Guarneri and Prof. Pierfranco Conte, investigators from the University of Padova, evaluated the efficacy of a chemotherapy-free neoadjuvant regimen of trastuzumab and pertuzumab in 64 patients with HER2+/HR+ breast cancer. The results of the trial were published in 2019 in Annals of Oncology.

Patients recruited in PerELISA were first treated with 2-weeks of letrozole monotherapy and a tumor biopsy was performed. A relative decrease of Ki67 of more than 20% was observed in 44 (69%) patients; these patients continued in the trial and received trastuzumab, pertuzumab and letrozole for 5 cycles, after which surgery was performed. The overall response to this non-chemotherapy-based regimen, measured as the rate of pathological complete response (pCR), was observed in approximately 1 out of 5 patients.

HER2DX️ was evaluated in pre-treatment baseline tumor samples from 55 patients. HER2DX️ pCR score fairly accurately predicted the probability of responding to 2-weeks of letrozole monotherapy (AUC=0.780). In addition, in 40 patients who responded to letrozole and received 5 cycles of trastuzumab, pertuzumab and letrozole, HER2DX️ pCR score and HER2DX️ ERBB2-score predicted the probability of response with a good level of accuracy (AUC=0.80 and 0.90, respectively). The rates of pCR in HER2DX️ pCR-high, -medium and -low groups were 100%, 46% and 8%, respectively. The rates of pCR in HER2DX️ ERBB2-high, -medium and -low groups were 53%, 8% and 0%, respectively.

Results obtained in this new study endorse the value of HER2DX️ in predicting response to anti-HER2-based treatments before surgery and supports the prospective incorporation of HER2DX️ in dedicated trials focused on HER2+ breast cancer.

About HER2DX️

HER2DX️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS️ since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX️ is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️ predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.
About HER2+ breast cancer

HER2+ breast cancer accounts for 20% of all diagnosed breast tumors. This represents more than 390,000 new cases diagnosed worldwide every year, meaning that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically and biologically heterogeneous, and standard clinical-pathological assessment has proven insufficient in capturing this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.

About this research collaboration

This study was led by investigators of the Translational Genomics and Targeted Therapeutics (TGTT) group at the Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS, Barcelona, Spain) and the University of Padova (Italy). The HER2DX️ Research Use Only (RUO) test was performed at the TGTT laboratory.