On October 12, 2021 Bicycle Therapeutics plc (the "Company") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC and SVB Leerink LLC (the "Representatives"), as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell 3,240,741 American Depositary Shares ("ADSs"), each representing one of the Company’s ordinary shares, nominal value £0.01 per share, at a public offering price of $54.00 per ADS (the "Offering") (Filing, 8-K, Bicycle Therapeutics, OCT 12, 2021, View Source [SID1234591239]). The net proceeds to the Company from the Offering are expected to be approximately $163.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company also granted the Underwriters an option to purchase 486,111 additional ADSs at the public offering price.

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The Offering is being made pursuant to the Company’s registration statement on Form S-3 (File No. 333-260179), which became effective upon filing with the Securities and Exchange Commission on October 12, 2021, a base prospectus dated October 12, 2021 and the related prospectus supplement dated October 12, 2021. The Offering is expected to close on October 15, 2021, subject to customary closing conditions.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The Company’s directors and executive officers have agreed, subject to certain exceptions, not to sell or transfer any ordinary shares (including ADSs representing ordinary shares) for 60 days, and the Company has agreed not to sell or transfer any ordinary shares (including ADSs representing ordinary shares) for 60 days, in each case, after October 12, 2021, without first obtaining the written consent of the Representatives.

On October 12, 2021 Inspyr Therapeutics, Inc. ("Inspyr") reported (i) a 1-for-75 reverse stock split of its common stock and (ii) a holding company restructuring whereby Rebus Holdings, Inc. ("Rebus"), a newly created entity will serve as the new holding company that will replace Inspyr as the public company trading on the OTC Markets trading under the symbol RBSH (Press release, Inspyr Therapeutics, OCT 12, 2021, View Source [SID1234591209]). The reverse stock split and holding company reorganization will occur concurrently.

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Inspyr has completed a restructuring consisting of reacquiring its rights to its now lead asset RT-AR001 and transforming into a holding company structure. Management believes that reacquiring the Adenosine assets and its new structure will lead to a more streamlined company that will increase stockholder value. A pre-IND meeting for RT-AR-001 was held with the FDA in Q1 of 2021. Following that meeting the company has moved forward with manufacturing and non-clinical studies to support the submission of an IND. The company expects to provide a further clinical update in the first half of 2022. The Company is also in the process of launching and rebranding its new corporate website at www.rebus-corp.com.

The company anticipates that subsequent to the reverse split it will be able to apply to list its Common Stock on the OTCQB tier of the OTC Markets Group, and eventually apply for a listing on a national exchange, in order to provide stockholders with more liquidity and allow the company more flexibility in accessing the capital markets.

Immediately after the 1-for-75 reverse stock split, existing shares of Inspyr common stock will be automatically converted, on a one-for-one basis, into shares of Rebus common stock having the same designation, rights, powers, and preferences and qualifications, limitations, and restrictions as a share of Inspyr common stock immediately prior to the reorganization. Outstanding Inspyr convertible debt securities and warrants will be similarly converted on the same terms into like securities of Rebus.

Accordingly, Inspyr stockholders will automatically become stockholders of Rebus with the same ownership percentage of shares as they held in Inspyr immediately prior to the reorganization. Inspyr will subsequently operate as a wholly-owned subsidiary of Rebus.

Effective at the open of the market on Tuesday, October 12, 2021, Inspyr will cease to trade under NSPX and Rebus will begin trading under the new ticker symbol RBSH with a CUSIP of 75619J 103.

The Board of Directors and the executive officers of Inspyr immediately prior to the reorganization will continue in their same roles at Rebus.

The holding company reorganization, which is intended to be a tax-free transaction for U.S. federal income tax purposes for the stockholders, will modernize the Company’s operating and legal structure, and will provide financial and administrative flexibility.

On October 12, 2021 Agilent Technologies Inc. (NYSE: A) reported its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio (abemaciclib) in combination with endocrine therapy is being considered (Press release, Agilent, OCT 12, 2021, View Source [SID1234591195]). This is the first IHC assay measuring Ki-67 expression to receive FDA approval in the context of treatment with Verzenio and was developed in collaboration with Eli Lilly and Company.

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"Agilent’s Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay for the Dako Omnis advanced staining platform has been designed and tested to aid in evaluating risk of recurrence in early breast cancer (EBC)"

Understanding the risk of recurrence in EBC is vital for informing disease management, as identifying patients at high risk can provide clarity for patients as well as facilitate treatment decisions to potentially improve outcomes. Conventional methods for evaluating the risk of recurrence in EBC are based on staging and are performed according to standard clinical and pathological features of the disease. However, these standard features may not capture the full risk of recurrence for individuals with EBC.

The American Joint Committee on Cancer has identified the Ki-67 biomarker as Level of Evidence III in diagnosing EBC due to its association with cellular proliferation. Ki-67 is thus an important component of comprehensive risk assessment, but it has been inconsistently applied in the past.1

"Agilent’s Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay for the Dako Omnis advanced staining platform has been designed and tested to aid in evaluating risk of recurrence in early breast cancer (EBC)," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "Its approval establishes a clinically relevant standard for recurrence risk assessment in EBC so that more high-risk patients who may experience clinical benefit from treatment with Verzenio are identified."

This approval builds on Agilent’s previous successes in expanding the clinical applicability of therapeutic biomarker analysis, further cementing the company’s position as a provider of diagnostic assays that deliver high quality and ease of implementation.

On October 12, 2021 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported preliminary financial results for its third quarter ended September 30, 2021 (Press release, Sarepta Therapeutics, OCT 12, 2021, View Source [SID1234591185]).

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Sarepta expects its net product revenues for the quarter to be approximately $166.9 million, compared to net product revenues of $121.4 million for the same period of 2020.
The Company had approximately $1.6 billion in cash, cash equivalents and investments as of September 30, 2021, compared to $1.9 billion as of December 31, 2020.
These preliminary financial results are the responsibility of management and have been prepared on a consistent basis with prior periods. The Company has not completed its financial closing procedures for the quarter ended September 30, 2021 and its actual results could be materially different from these preliminary financial results. In addition, the Company’s independent registered public accounting firm has not reviewed, compiled, or performed any procedures with respect to these preliminary financial results.

On October 12, 2021 Sarepta Therapeutics, Inc. (Nasdaq:SRPT), the leader in precision genetic medicine for rare diseases, reported that it is offering to sell, subject to market and other conditions, $500,000,000 in shares of its common stock in an underwritten public offering (Press release, Sarepta Therapeutics, OCT 12, 2021, View Source [SID1234591184]). Sarepta also intends to grant the underwriters a 30-day option to purchase up to an additional $75,000,000 in shares of its common stock.

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Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC and Credit Suisse Securities (USA) LLC are acting as the underwriters of the proposed offering.

Sarepta intends to use the net proceeds from the offering principally for the continuation of, and initiation of further, clinical trials, commercialization, manufacturing, business development activities, including the potential licensing or acquisition of complementary products, technologies and entities, and other general corporate purposes.

The shares are being offered by Sarepta pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). The offering is being made only by means of a written prospectus and prospectus supplement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained from the offices of Goldman Sachs & Co. LLC, at Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 866-471-2526, by facsimile at 212-902-9316 or by e-mail at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Raleigh, North Carolina 27560, Telephone: 1-800-221-1037, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of Sarepta, nor shall there be any sale of 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.