Entry into a Material Definitive Agreement

On September 13, 2022, Sarepta Therapeutics, Inc. (the "Company") reported that entered into a Purchase Agreement (the "Purchase Agreement") with the several initial purchasers named in Schedule 1 thereto (the "Initial Purchasers"), for whom Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC acted as representatives (the "Representatives") relating to the sale of $980.0 million aggregate principal amount of 1.250% Convertible Senior Notes due 2027 (the "Offered Notes") to the Initial Purchasers (Filing, 8-K, Sarepta Therapeutics, SEP 13, 2022, View Source [SID1234619660]). The Company also granted the Initial Purchasers an option to purchase up to an additional $150.0 million aggregate principal amount of the Offered Notes, which option was exercised in full on September 14, 2022. The Purchase Agreement includes customary representations, warranties and covenants. Under the terms of the Purchase Agreement, the Company has agreed to indemnify the Initial Purchasers against certain liabilities.

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The foregoing description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Purchase Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Affiliated Investor Purchase Agreement

On September 13, 2022, the Company entered into a purchase agreement (the "Affiliated Investor Purchase Agreement") with Michael A. Chambers Living Trust (the "Affiliated Investor"), an entity affiliated with Michael Chambers, a member of the Company’s board of directors, to issue and sell $20.0 million in aggregate principal amount of 1.250% Convertible Senior Notes due 2027 (the "Affiliated Investor Notes" and together with the Offered Notes, the "Notes") in a private placement pursuant to an exemption from the registration requirements of the Securities Act of 1933, amended (the "Securities Act") afforded by Section 4(a)(2) of the Securities Act. The Affiliated Investor Purchase Agreement includes customary representations, warranties and covenants by the Company and customary closing conditions.

The foregoing description of the Affiliated Investor Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Affiliated Investor Purchase Agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.

Indenture and the Notes

The Notes were issued by the Company on September 16, 2022 pursuant to an Indenture, dated as of such date (the "Indenture"), between the Company and U.S. Bank Trust Company, National Association, as trustee (the "Trustee"). The Notes bear cash interest at the annual rate of 1.250%, payable on March 15 and September 15 of each year, beginning on March 15, 2023, and will mature on September 15, 2027 unless earlier redeemed, converted or repurchased. The Company will settle conversions of the Notes through payment or delivery, as the case may be, of cash, shares of common stock of the Company or a combination of cash and shares of common stock, at the Company’s option (subject to, and in accordance with, the settlement provisions of the Indenture). The initial conversion rate for the Notes is 7.0439 shares of common stock (subject to adjustment as provided for in the Indenture) per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $141.97 per share of the Company’s common stock, representing an approximately 35.0% conversion premium on the closing price of the Company’s common stock of $105.16 per share on September 13, 2022. 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, the Company may redeem for cash all or part of the Notes (subject to certain conditions), at its option, if the last reported sale price of the Company’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 the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption. If the Company elects to redeem fewer than all of the outstanding Notes, at least $150.0 million aggregate principal amount of Notes must be outstanding and not subject to redemption as of, and after giving effect to, delivery of the relevant notice of redemption.

Holders of the Notes may convert their Notes at their option at any time prior to the close of business on the business day immediately preceding March 15, 2027 in multiples of $1,000 principal amount, only under the following circumstances:


during any calendar quarter commencing after the calendar quarter ending on December 31, 2022 (and only during such calendar quarter), if the last reported sale price of the Company’s 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 for the Notes on each applicable trading day;


during the five business day period after any five consecutive trading day period (the "measurement period") in which the "trading price" (as defined in the Indenture) per $1,000 principal amount of Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate for the Notes on each such trading day;


if we call any or all of the notes for redemption, at any time prior to the close of business on the scheduled trading day immediately prior to the redemption date, but only with respect to the notes called (or deemed called) for redemption; or


upon the occurrence of specified corporate events described in the Indenture.

On or after March 15, 2027, until the close of business on the second scheduled trading day immediately preceding September 15, 2027, holders may convert their Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances.

If the Company experiences a fundamental change or gives a notice of redemption with respect to any or all of the Notes, as described in the Indenture, prior to the maturity date of the Notes, holders of the Notes will, subject to specified conditions, have the right, at their option, to require the Company to repurchase for cash all or a portion of their Notes at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but not including, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date of the Notes, the Company will increase the conversion rate for a holder who elects to convert its Notes in connection with such corporate event.

The Indenture provides for customary events of default. In the case of an event of default with respect to the Notes arising from specified events of bankruptcy or insolvency, all outstanding Notes will become due and payable immediately without further action or notice. If any other event of default with respect to the Notes under the Indenture occurs or is continuing, the Trustee or holders of at least 25% in aggregate principal amount of the then outstanding Notes may declare the principal amount of the Notes to be immediately due and payable.

In certain circumstances if, at any time during the six-month period beginning on, and including, the date that is six months after the last date of original issuance of the Offered Notes, the Company fails to timely file certain documents or reports required under the Securities Exchange Act of 1934, as amended, or the Offered Notes are not otherwise freely tradable by holders of the Offered Notes other than the Company’s affiliates, additional interest will accrue on the Offered Notes during the period in which its failure to file has occurred and is continuing or such Offered Notes are not otherwise freely tradable by holders other than the Company’s affiliates.

In addition, if, and for so long as, the restrictive legend on the Offered Notes has not been removed, the Offered Notes are assigned a restricted CUSIP number or the Offered Notes are not otherwise freely tradable by holders other than the Company’s affiliates (without restrictions pursuant to U.S. securities laws or the terms of the Indenture or the Notes) as of the 380th day after the last date of original issuance of the Notes, the Company will pay additional interest on the Offered Notes during the period in which the Offered Notes remain so restricted.

The foregoing description of the Indenture and the Notes does not purport to be complete and is qualified in its entirety by reference to each of the Indenture and form of Note, which are filed as Exhibits 4.1 and 4.2 to this Current Report on Form 8-K and are incorporated herein by reference.

Capped Call Transactions

In connection with the issuance of the Notes, on September 13, 2022, the Company entered into privately negotiated capped call transactions with Barclays Bank PLC, Goldman Sachs & Co. LLC, Mizuho Markets Americas LLC, Morgan Stanley & Co. LLC, and RBC Capital Markets, LLC (each, a "Counterparty," and together the "Counterparties," and such transactions, the "Base Capped Call Transactions"). In connection with the Initial Purchasers’ exercise in full of their option to purchase additional Notes, on September 14, 2022, the Company entered into additional capped call transactions with the Counterparties (together with the Base Capped Call Transactions, the "Capped Call Transactions").

The Capped Call Transactions have an initial strike price of approximately $141.97 per share, which corresponds to the initial conversion price of the Notes and is subject to anti-dilution adjustments generally similar to those applicable to the Notes, and have a cap price of approximately $210.32 per share, which represents a premium of 100.0% over the last reported sale price of Sarepta’s common stock of $105.16 per share on September 13, 2022, and is subject to certain adjustments under the terms of the Capped Call Transactions. The Capped Call Transactions cover, subject to anti-dilution adjustments, 8,100,485 shares of the Company’s common stock, which is the same number of shares of the Company’s common stock initially underlying the Notes.

The Capped Call Transactions are expected generally to reduce the potential dilution to the Company’s common stock upon conversion of the Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the Capped Call Transactions, is greater than the strike price of the Capped Call Transactions as adjusted pursuant to the anti-dilution adjustments. If, however, the market price per share of the Company’s common stock, as measured under the terms of the Capped Call Transactions, exceeds the cap price of the Capped Call Transactions, there would nevertheless be dilution upon conversion of the Notes to the extent that such market price exceeds the cap price of the Capped Call Transactions.

The Company has been advised that, in connection with establishing their initial hedges of the Capped Call Transactions, the Counterparties or their respective affiliates may purchase shares of the Company’s common stock and/or entered into various derivative transactions with respect to the Company’s common stock, in each case, concurrently with, or shortly after, the pricing of the Notes. This activity may impact the market price of the Company’s common stock or the Notes.

In addition, the Company has been advised that the Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivative transactions with respect to the Company’s common stock and/or by purchasing or selling the Company’s common stock or other securities of the Company 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 the Notes). This activity could also cause or avoid an increase or a decrease in the market price of the Company’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 the Company’s common stock and value of the consideration that holders will receive upon conversion of the Notes.

The Company intends to exercise options it holds under the Capped Call Transactions whenever Notes are converted on or after March 15, 2027, and expects that upon any conversions of Notes prior to March 15, 2027, or any repurchase of Notes by the Company, a corresponding portion of the Capped Call Transactions will be terminated. Upon such termination, the Company expects to receive from the Counterparties shares of its common stock, cash, or a combination thereof, in each case, with an aggregate market value equal to the then current value of the Capped Call Transactions or portion thereof, as the case may be, being early terminated, subject to the terms of the Capped Call Transactions. As a result, the Company may not receive the full expected benefit of the Capped Call Transactions. The Company has been advised that the Counterparties or their respective affiliates, in order to unwind their hedge positions with respect to those exercised or terminated options, are likely to buy or sell shares of the Company’s common stock or other securities or instruments of the Company, including the Notes, in secondary market transactions or unwind various derivative transactions with respect to such common stock. These unwind activities could have the effect of increasing or decreasing the trading price of the Company’s common stock and the Notes and could have the effect of increasing or decreasing the value of the consideration that holders of the Notes will receive upon conversion of the Notes.

The Capped Call Transactions are separate transactions entered into by and between the Company and the Counterparties and are not part of the terms of the Notes. Holders of the Notes will not have any rights with respect to the Capped Call Transactions.

The description of the Capped Call Transactions in this report is a summary and is qualified in its entirety by the terms of each of the confirmations for the Capped Call Transactions filed as Exhibits 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 10.10, 10.11 and 10.12 to this Current Report on Form 8-K, which are incorporated herein by reference.

POINT Biopharma Prices Public Offering of Common Stock

On September 13, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals, reported the pricing of its public offering of 13,900,000 shares of Common Stock at a public offering price of $9.00 per share (Press release, Point Biopharma, SEP 13, 2022, View Source [SID1234619558]). The gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $125 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 2,085,000 shares of its Common Stock. All of the shares to be sold in the offering are to be sold by POINT. The offering is expected to close on or about September 16, 2022, subject to customary closing conditions.

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Piper Sandler and Guggenheim Securities, LLC are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering.

POINT intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and investments, to fund clinical and preclinical research and development programs, pre-commercialization activities, and for working capital and other general corporate purposes.

The securities are being offered by POINT pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering has been filed with the SEC and is available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained for free from:

Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at [email protected].

Oppenheimer & Co., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055, or by email at [email protected].

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

Sermonix Pharmaceuticals Announces Results of Phase 2 Study of Lasofoxifene vs. Fulvestrant in Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation

On September 13, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported results of its signal-seeking Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1) Phase 2 study (Press release, Sermonix Pharmaceuticals, SEP 13, 2022, View Source [SID1234619554]). The results were initially shared Sept. 10 during a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris.

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The open-label ELAINE 1 (NCT03781063) study began U.S. enrollment in September 2019, assessing the efficacy and safety of oral lasofoxifene versus intramuscular fulvestrant, a selective estrogen receptor degrader (SERD), in 103 patients. All participants were post-CDK4/6 inhibitor/aromatase inhibitor therapy and had an ESR1 mutation. Progression-free survival was the primary endpoint.

Top-line data included:

Median progression-free survival (PFS) was 6.04 mos. (95% CI, 2.82–8.04) for lasofoxifene vs. 4.04 mos. (95% CI, 2.93–6.04) for fulvestrant, P=0.138 (HR, 0.699 [95% CI, 0.445–1.125])
Clinical benefit rate (CBR) was 36.5% for lasofoxifene vs. 21.6% for fulvestrant, P=0.12. CBR is defined as the percentage of all subjects with a complete or partial response; or stable disease for >/= 24 weeks
Objective response rate was 13.2% for lasofoxifene vs. 2.9% for fulvestrant, P=0.12, with 1 confirmed complete response (CR) (72-week duration) and 4 confirmed partial responses (PR) in the lasofoxifene arm vs. 1 PR in the fulvestrant arm
PFS was numerically and consistently greater with lasofoxifene vs. fulvestrant when visceral metastasis and/or Y537S ESR1 mutation subgroups were analyzed
While not reaching statistical significance in this 103-patient study, all endpoints numerically favored lasofoxifene
Exploratory endpoints included:

PFS at 6 mos. for lasofoxifene was 53.4% vs. 37.9% for fulvestrant; PFS at 12 mos. was 30.7% for lasofoxifene vs. 14.1% for fulvestrant
Clearance of ctDNA also favored lasofoxifene over fulvestrant
Most common adverse events were fatigue, nausea, arthralgias and hot flashes; most were Grade 1/2. No thrombotic events occurred
ELAINE 1 is the first clinical trial comparing lasofoxifene with fulvestrant in ESR1-mutated metastatic breast cancer patients with progression on an aromatase inhibitor (Al) in combination with a CDK4/6 inhibitor, and the first to demonstrate anti-tumor activity and target engagement of a novel selective estrogen receptor modulator (SERM) in this setting. ELAINE 2, a Phase 2 single-arm trial of lasofoxifene in combination with the CDK4/6 inhibitor abemaciclib, showed efficacy in heavily pretreated patients with ESR1-mutated mBC post-CDK4/6i (ASCO 2022).

"Sermonix is pleased with the outcomes reported in our ELAINE 1 trial comparing lasofoxifene with fulvestrant, suggesting lasofoxifene’s anti-tumor activity and potential to play a critical role in the targeted precision medicine treatment of ESR1-mutated advanced ER+ breast cancer," said Dr. David Portman, Sermonix founder and chief executive officer. "Lasofoxifene following endocrine/CDK4/6 inhibitor therapies continues to be studied and we anticipate efficacy will be confirmed in a larger clinical study. Sermonix is planning a Phase 3 registrational combination study based on these results as well as encouraging efficacy and safety demonstrated in the ELAINE 2 study of lasofoxifene and abemaciclib reported at this year’s ASCO (Free ASCO Whitepaper) annual meeting."

"ELAINE 1 suggested lasofoxifene’s activity in patients with metastatic breast cancer post-CDK4/6i and an ESR1 mutation," said Dr. Paul Plourde, Sermonix vice president for clinical oncology development. "While not reaching statistical significance in our modestly powered study, all efficacy parameters numerically favored lasofoxifene over fulvestrant. Moreover, the safety profile indicates lasofoxifene was well tolerated with few Grades 3 and 4 adverse events and a differentiated profile from injectable and oral SERDs. Lasofoxifene trials may offer new hope for patients with mutated ESR1 metastatic breast cancer."

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

Eurostars grant funding

On September 13, 2022 The Swedish scale-up company Genagon Therapeutics, together with Mosaique Diagnostics, reported that it receive 7 MSEK in funding from Eurostars for the continued development of biological treatment for triple negative breast cancer (Press release, Genagon Therapeutics, SEP 13, 2022, View Source;utm_medium=rss&utm_campaign=genagon-receive-eurostars-grant-funding [SID1234619530]).

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The consortium partners aim to jointly undertake major steps towards the transition from the preclinical to clinical development of GEN209 – a drug candidate for triple-negative breast cancer (TNBC). This will be a first-in-class monoclonal antibody-drug conjugate (ADC) targeting Clptm1, a novel molecular target expressed in solid tumors.

"This is very positive, and we are happy for this. This will help us secure in vivo efficacy data, identify biomarkers for patient selection and treatment outcome follow-up. We will also design regulatory and toxicology programs allowing for a successful transition to clinical trials", says Moa Fransson, CEO at Genagon Therapeutics.

FDA Grants GENFIT’s GNS561 Orphan Drug Designation for the Treatment of Cholangiocarcinoma

On September 13, 2022 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to GNS5611 (ezurpimtrostat), a novel clinical-stage autophagy/PPT1 inhibitor, for the treatment of cholangiocarcinoma (Press release, Genfit, SEP 13, 2022, https://ir.genfit.com/news-releases/news-release-details/fda-grants-genfits-gns561-orphan-drug-designation-treatment [SID1234619526]).

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Cholangiocarcinoma is a rare liver malignancy with high mortality and limited treatment options. It occurs mostly in people over the age of 50.

GNS561 (ezurpimtrostat) is a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor that blocks autophagy. Autophagy is activated in tumor cells in response to certain conditions, due to a tumor cell growth in advanced cancers. GNS561 has completed pre-clinical studies and a Phase 1b trial confirming the rationale for targeting cholangiocarcinoma. A Phase 2 trial is expected to start in the fourth quarter 2022, with a first patient visit expected in the first quarter 2023.

Dr Mark Yarchoan, Associate Professor of Oncology at John Hopkins Medicine (Baltimore, MD) commented: "Cholangiocarcinoma is a rare cancer with a high mortality rate. Patients have limited treatment options, particularly following first line therapy. This is why new therapies are urgently needed and is one of the reasons that GNS561 was granted Orphan Drug Designation by the FDA. There is a real path forward for new options for second line treatment in cholangiocarcinoma, and GNS561 represents a strong second-line therapy candidate and hope to patients."

ABOUT GNS561

GNS561 is a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor that blocks autophagy. Autophagy is activated in tumor cells in response to certain conditions, due to a tumor cell growth in advanced cancers. One of the key cellular organs implicated in the autophagy process is the lysosome. By entering the lysosomes and binding to its target, GNS561 has an important inhibiting activity on late-stage autophagy, which leads to tumor cell death.

ABOUT CHOLANGIOCARCINOMA

Cholangiocarcinoma is a type of cancer that forms in the slender tubes (bile ducts) that carry the digestive fluid bile. Cholangiocarcinoma occurs mostly in people over the age of 50. Cholangiocarcinoma is divided into intrahepatic and extrahepatic types based on where the disease occurs in the bile ducts. Cholangiocarcinoma is often diagnosed when it is advanced, making successful treatment difficult to achieve. Several risk factors of chronic inflammatory damage and increased cellular turnover have been established, such as primary sclerosing cholangitis (a cholestatic liver disease), liver flukes, biliary tract cysts, hepatolithiasis and toxins. Treatment options for cholangiocarcinoma are limited and associated with high rates of tumor recurrence, and short survival times.