On July 12, 2022 Locust Walk reported that deal team members compile key statistics and trends on strategic transactions and financings (Press release, Locust Walk Partners, JUL 12, 2022, View Source;utm_medium=rss&utm_campaign=2022-q2-report-global-trends-in-biopharma-transactions [SID1234616610]). Our 2022 Second Quarter Report applies the latest data to analyze current activities in the life sciences deal landscape.

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The steady deterioration of the life science public market has had far reaching ripple effects to other parts of the ecosystem, from a deep decline in public and private financings to the rise in high value partnering and M&A transactions. In this quarter’s market conditions report, Locust Walk reviews the factors driving current negative sentiment and provides our advice for navigating the road ahead.

We believe the industry has further to go before conditions reset and a steady recovery can begin. With the public market quiet and the private markets more selective, companies of all sizes are showing increased interest in strategic partnerships as a source of non-dilutive financing. Big Pharma has remained on the M&A sidelines, until recently with the announcement of a flurry of large transactions. Ultimately, this deal activity, combined with reset valuations and positive news flow, may be our path to recovery.

Despite the near-term challenges, Locust Walk remains optimistic about our industry’s long-term fundamentals. While the sector is now experiencing overhang from its status as a previously hot area, Biopharma’s fundamental societal role and advancements in our understanding of disease and how to address them have not changed. We invite you to read our report and would welcome the opportunity to discuss its contents with you.

On July 12, 2022 Fresenius reported that Romidepsin Injection, a drug used to treat cutaneous T-cell lymphoma (CTCL) in adults, is now available from Fresenius Kabi in the United States (Press release, Fresenius, JUL 12, 2022, View Source [SID1234616609]). This is the newest addition to the company’s portfolio of generic IV oncology products – the largest such portfolio in the U.S.

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On July 12, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it has reached a key milestone on the path to commercialization of Rhenium-186 NanoLiposome (186RNL) as the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions (PPS) (Press release, Cytori Therapeutics, JUL 12, 2022, View Source [SID1234616607]). Additionally, the intermediate drug product is in stability testing and compliant with U.S. Food and Drug Administration (FDA) guidance for manufacture of liposomal products for use in late-stage clinical trials and commercialization.

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In early 2021, Plus Therapeutics entered into a master services agreement with PPS for the development, manufacture and supply of the Company’s 186RNL drug intermediate product and has now completed the associated technology transfer of analytical test methods and development activities with PPS.

"The Company has met another significant CMC milestone by having fully compliant 186RNL intermediate, and is on time and on budget to have GMP drug availability in the second half of 2022 for ongoing and planned clinical trials in adults with recurrent glioblastoma, leptomeningeal metastases and future disease targets," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Furthermore, in the third quarter of 2022, we plan to issue specific guidance on feedback obtained from two FDA meetings, one based on potential acceptability of Plus Therapeutics’ CMC package and one for feedback on our future plans for clinical development of 186RNL for recurrent glioblastoma."

On July 12, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, reported that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor to issue 1,774,309 shares of common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to an aggregate of 1,774,309 shares of common stock and Series B warrants to purchase up to an aggregate of 1,774,309 shares of common stock, at a purchase price of $2.818 per share of common stock (or pre-funded warrant) and associated warrants, in a private placement priced at-the-market under Nasdaq rules, for expected gross proceeds to Histogen of approximately $5 million, before deducting placement agent fees and other offering expenses payable by the Company (Press release, Conatus Pharmaceuticals, JUL 12, 2022, View Source [SID1234616606]).

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement.

Each share of common stock (or pre-funded warrant) was sold in the private placement together with a Series A warrant to purchase one share of common stock and a Series B warrant to purchase one share of common stock. The Series A warrants have an exercise price of $2.568 per share of common stock, will be exercisable commencing immediately upon issuance for a period of five and one-half years from the date of issuance. The Series B warrants have an exercise price of $2.568 per share of common stock, will be exercisable commencing immediately upon issuance for a period of eighteen months from the date of issuance.

The closing of the private placement is expected to occur on or about July 15, 2022, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The Company also has agreed that certain warrants to purchase an aggregate of 447,800 shares of common stock of the Company that were issued to such investor in November 2020 through December 2021 with exercise prices ranging from $8.50 to $34.00 per share and expiration dates ranging from May 18, 2026 to June 21, 2027, will be amended, among others, to have a reduced exercise price of $2.568 per share, will expire five and one-half years following the closing of the private placement, at an additional offering price of $0.0316 per amended warrant.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock to be issued to the investors (including the shares of common stock issuable upon the exercise of the warrants) no later than 15 days and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 75 days in the event of a "full review" by the SEC.

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 sale of these securities in any state or other 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 other jurisdiction.

On July 12, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical data from BT7480, a Bicycle tumor-targeted immune cell agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137 (4-1BB), was published in the Journal of Medicinal Chemistry (Press release, Bicycle Therapeutics, JUL 12, 2022, View Source [SID1234616605]). The article, titled "Discovery and Optimization of a Synthetic Class of Nectin-4-Targeted CD137 Agonists for Immuno-oncology" is available at the publications section of the Bicycle website at this link.

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"CD137 is a co-stimulatory receptor on immune cells that can drive anti-tumor immunity and Nectin-4 is a cell adhesion molecule that is overexpressed in a wide range of solid tumors. We discovered BT7480 by using a series of novel Bicycles targeting CD137, which were conjugated to novel Bicycles targeting Nectin-4," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "The work that was published today demonstrated our goal to discover a Nectin-4-targeted CD137 agonist clinical candidate with unique properties – small size, dependency on binding to Nectin-4 bearing tumor cells for activity and very potent CD137 agonism. Furthermore, we engineered the molecule so that it could be dosed once a week in the clinic. We deployed a multipronged approach to optimize the molecule’s affinity to both targets, linker length, binder stoichiometry, solubility, and pharmacokinetic properties. By exploring the valency of the Bicycles in rodent studies, it was demonstrated that the 1:2 format Nectin-4/CD137 may lead to promising immune response in solid tumors. BT7480 is currently in Phase I development with dose escalation ongoing."