On September 12, 2022 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that Fierce Biotech has named it as one of 2022’s Fierce 15 biotechnology companies, designating it as one of the most promising early-stage biotechnology companies in the industry (Press release, ReCode Therapeutics, SEP 12, 2022, View Source;utm_medium=rss&utm_campaign=fierce-biotech-names-recode-therapeutics-as-one-of-its-fierce-15-biotech-companies-of-2022%25ef%25bf%25bc [SID1234619536]).

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"In recent years, we’ve seen major advances in mRNA and gene correction therapeutics. However, their utility has been limited by current delivery systems. Thanks to the pioneering science behind ReCode’s novel selective organ targeting (SORT) lipid nanoparticle (LNP) technology, we are poised to transform the paradigm for genetic medicines with the ability to precisely target and deliver any form or combination of genetic cargo to specific organs and cells, beyond the liver," said Shehnaaz Suliman, M.D., MBA, M.Phil., chief executive officer and board member, ReCode Therapeutics. "It is an honor to be recognized among this distinguished group of Fierce 15 industry innovators."

ReCode is differentiated by its first-in-class modular genetic medicines delivery platform. The company’s selective organ targeting (SORT) lipid nanoparticle technology (LNP) platform is the foundation for its pipeline. Pioneered by co-founder Professor Daniel J. Siegwart, Ph.D., of the University of Texas, and described by Nature as one of the "Seven Technologies to Watch in 2022," ReCode’s SORT LNP platform is an innovation beyond the lipid delivery system used by the mRNA COVID vaccines and novel RNA and gene correction therapeutics.

LNPs are used to package and deliver genetic cargo such as mRNA. When delivered into the blood, first-generation LNPs are primarily taken up by the liver, which limits their utility for broad therapeutic applications. ReCode’s SORT LNPs are engineered with a biochemically distinct fifth lipid to help the body "sort" and direct the LNPs to other targeted organs such as the lung and spleen, with the ability to bypass the liver, if desired.

Beyond its highly selective targeting capability, ReCode’s SORT LNP platform is further distinguished by its versatility in both mode of administration (including IV, inhaled, subcutaneous, intramuscular and intrathecal), and the diversity of genetic cargo that can be delivered (including mRNA, siRNA, DNA, gene correction components and mixed cargoes). Together, these qualities offer vast opportunities to address a wide range of unmet medical needs through a precision medicine approach that delivers the right medicine to the right organs and cells using the optimal mode of administration.

In June, ReCode announced the close of a Series B extension financing round which infused a total investment of $200M to fund the diversification of ReCode’s pipeline into central nervous system, liver, and oncology indications, while continuing to advance ReCode’s lead mRNA programs for primary ciliary dyskinesia and cystic fibrosis into the clinic.

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 20th annual Fierce 15 selection. An internationally recognized daily report reaching a network of over 450,000 biotech and pharma industry professionals, Fierce Biotech provides subscribers with an authoritative analysis of the day’s top stories. Every year Fierce Biotech evaluates hundreds of early-stage companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

On September 12, 2022 Hypertrust Patient Data Care reported that Numerous industry experts will meet there to share insights on the latest technologies in CAR and TCR therapies (Press release, Hypertrust Patient Data Care, SEP 12, 2022, http://www.hypertrust-patient.com/7th-car-tcr-summit-on-the-development-of-safe-effective-and-commercially-viable-car-and-tcr-therapies [SID1234619531]). Developments in the industry are moving incredibly fast, which is exactly why it’s important to stay up-to-date. At Hypertrust Patient Data Care, we are pleased to be a leading company in providing the end-to-end supply chain management solution that is essential for the support of these therapies. We are aware of our responsibility and ready to look optimistically into the future with our existing solution Hypertrust X-Chain. Our heart beats for making Advanced & Personalized Therapies safer and better.

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The event will provide an opportunity to gain comprehensive insight from both established thought leaders and innovators who are bringing breakthrough technologies from the lab to the bedside and from the vein to the vein. We look forward to meeting you there!

About 7th CAR-TCR Summit

Over three main conference days and eight tracks, more than 200 CAR and TCR experts will discuss with you and your colleagues novel allogeneic approaches with improved safety aspects, the latest in vivo genetic techniques, and advances in CMC strategies and analytical development to ensure the development of high-quality cell products.

On September 12, 2022 Codiak BioSciences, Inc. (Nasdaq: CDAK) ("Codiak"), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock and accompanying warrants to purchase shares of common stock in an underwritten public offering (Press release, Codiak Biosciences, SEP 12, 2022, View Source [SID1234619525]). Codiak intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock and warrants to purchase shares of common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions. All the securities to be sold in the proposed offering will be sold by Codiak. The offering is subject to market and other conditions, and there can be no assurances as to whether or when the offering may be completed, or as to the actual size and terms of the offering.

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Jefferies is acting as the sole book-running manager for the offering.

The securities are being offered by Codiak pursuant to a shelf registration statement on Form S-3 (File No. 333-260781) that was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on November 15, 2021. A preliminary prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained from the SEC’s website at View Source or by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected].

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

On September 12, 2022 Alnylam Pharmaceuticals, Inc. ("Alnylam") (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it has commenced a private offering of $900 million aggregate principal amount of convertible senior notes due 2027 (the "notes") to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Alnylam, SEP 12, 2022, View Source [SID1234619523]). In connection with this offering, Alnylam expects to grant the initial purchasers of the notes an option to purchase, for settlement within a 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $135 million aggregate principal amount of the notes. The offering of the notes is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The notes will be senior, unsecured obligations of Alnylam, will accrue interest payable semi-annually in arrears and will mature on September 15, 2027, unless earlier converted, redeemed or repurchased. Noteholders will have the right to convert their notes in certain circumstances and during specified periods. Alnylam will settle conversions by paying or delivering, as applicable, cash, shares of its common stock, par value $0.01 per share ("common stock"), or a combination of cash and shares of its common stock, at Alnylam’s election. The notes will be redeemable, in whole or in part (subject to certain limitations), for cash at Alnylam’s option at any time, and from time to time, on or after September 20, 2025 and on or before the 21st scheduled trading day immediately preceding the maturity date, if the last reported sale price per share of Alnylam’s common stock exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

In connection with the pricing of the notes, Alnylam 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 potential dilution to Alnylam’s common stock upon conversion of any notes and/or offset any potential cash payments Alnylam is required to make in excess of the principal amount of converted notes, as the case may be, with such reduction and/or offset subject to a cap.

Alnylam 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 Alnylam’s common stock and/or enter into various derivative transactions with respect to Alnylam’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 Alnylam’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 Alnylam’s common stock and/or purchasing or selling Alnylam’s common stock or other securities of Alnylam 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 cause or avoid an increase or a decrease in the market price of Alnylam’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 notes, it could affect the amount and value of the consideration that holders will receive upon conversion of the notes.

Alnylam intends to use a portion of the net proceeds from the offering to pay the cost of the capped call transactions. If the initial purchasers exercise their option to purchase additional notes, Alnylam expects to use a portion of the net proceeds from the sale of the additional notes to enter into additional capped call transactions. In addition, Alnylam intends to use approximately $762.0 million of the net proceeds from the offering to repay borrowings and accrued and unpaid interest, and to pay the prepayment premium, under and terminate its current credit agreement, and the remainder of the net proceeds for general corporate purposes.

The notes will be offered only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold absent registration or except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or any shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

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.