On February 13, 2024 CSL reported its Results Presentation for the Half-year ended 31 December 2023 (Presentation, CSL, FEB 13, 2024, View Source [SID1234642335]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On February 13, 2024 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that it has entered into an investment agreement for the sale of approximately $280 million of its common shares (the "Shares") to a select group of institutional investors in a registered direct offering, at a price per share of $71.50, representing a premium of greater than 10% to CRISPR Therapeutics’ 30-day volume-weighted average price (Press release, CRISPR Therapeutics, FEB 13, 2024, View Source [SID1234640026]). The financing is expected to close on or about February 27, 2024, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The financing is being led by EcoR1 Capital and SR One with participation from existing investors and a leading healthcare specialist investor.

"We are pleased with the quality of the new and existing long-term investors as we accelerate our programs and expand our pipeline with the goal of delivering paradigm-shifting gene editing therapies to patients," said Samarth Kulkarni, Ph.D., Chief Executive Officer and Chairman of CRISPR Therapeutics. "We are well positioned to execute on our on-going clinical trials in oncology, cardiovascular and diabetes, and further accelerate our auto-immune and in vivo gene writing programs, setting up a catalyst-rich 12-18 months for the company. This financing bolsters our already strong balance sheet, provides the opportunity for additional value creation, and gives us the flexibility to reach sustainability without requiring additional capital."

The Shares were offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on July 29, 2021 (File No. 333-258274). A final prospectus supplement containing additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

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

On February 13, 2024 Curasight A/S "Curasight" or the "Company" – (TICKER: CURAS) reported that it has resolved on a new issue of shares with preferential rights for the Company’s existing shareholders of up to DKK 51.2 million before transaction costs (the "Rights Issue") (Press release, Curasight, FEB 13, 2024, View Source [SID1234640054]). The proceeds are intended to be used to strengthen the Company’s capital structure and secure funding for the acceleration of clinical activities, including the preparation, planning and enrolment of the first patients in a therapy phase I/IIa basket trial in various cancer types, as well as to strengthen Curasight’s pipeline through preclinical development of new peptide-based radioligands.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are committed to advancing the theranostic approach in cancer care, aiming to provide clinicians and patients with innovative solutions that support a combined diagnostic and treatment approach for certain cancers. The Rights Issue enables us to expedite our therapeutic development activities including the launch of our therapeutic basket trial, so that we can develop both uTRACE and uTREAT in parallel. Additionally, it will allow us to secure a robust balance sheet that both supports our accelerated clinical strategy and ensures we are in a strong position when negotiating potential partnerships." said CEO Ulrich Krasilnikoff.

Summary of the Rights Issue

Each existing share in the Company, as of the record date on 22 February 2024, entitles the holder to one (1) subscription right. Seven (7) subscription rights entitle the holder to subscribe for one (1) new share at a subscription price of DKK 18 per share.
The subscription period runs from 23 February 2024, up to and including 7 March 2024.
The last day of trading in the shares with the right to receive subscription rights in the Rights Issue is 20 February 2024.
The Company’s management team, consisting of Ulrich Krasilnikoff (CEO and CFO), Andreas Kjær (CSO/CMO and co-founder) and Hanne Damgaard Jensen (CDO/COO), have committed to subscribe for shares in the rights issue for a total of approx. DKK 1.3 million, corresponding to 2.5 percent of the rights issue.
The Company intends to publish an information memorandum regarding the Rights Issue around 22 February 2024 (the "Information Memorandum").
The proceeds are intended to be used to strengthen the Company’s capital structure and secure funding for the acceleration of clinical activities, including the preparation, planning and enrolment of the first patients in a therapy phase I/IIa basket trial in various cancer types (brain, neuroendocrine, head and neck, non-small cell lung and pancreatic cancer), as well as to strengthen Curasight’s preclinical pipeline through development of new peptide-based radioligands.
Reasons for the Rights Issue

Curasight focuses on addressing the need for improved diagnosis and treatment of several cancer indications and has developed a highly specific PET imaging ligand, uTRACE (radioactive tracer) and uTREAT – both targeting the uPAR receptor. uPAR is expressed in many types of human cancers and the expression levels of uPAR have been shown to be strongly associated with metastatic disease, i.e. cancer aggressiveness, and subsequent poor prognosis. Curasight’s clinical PET ligand uTRACE has been succesfully validated in more than 400 patients in several clinical PET imaging trials with uTRACE in brain, prostate, head & neck, neuroendocrine, oral, breast and urinary bladder cancer with promising results.

Based on these results with uTRACE, combined with the strong preclinical results with uTREAT, both targeting the strong biomarker (uPAR) in human cancer, Curasight’s Board and management projects that uTREAT, together with its companion diagnostics, the uPAR-PET imaging ligand uTRACE, could become a successful radioligand therapy. It is foreseen that such a targeted radioligand therapy could become a game-changer in the treatment and management of cancer patients across several cancer indications.

Curasight will therefore pursue uPAR targeted radioligand therapy using the uTRACE ligand but "armed" with radiation therapy. By combining anti-cancer radiotherapy uTREAT (therapy) with uTRACE (diagnostics), the technology jointly known as theranostics, is foreseen to treat cancer in a much more gentle and efficient way than today’s method of external radiation therapy.

To further advance and commercialize the uPAR Theranostics platform with uTREAT and uTRACE for improved diagnosis and treatment across several cancer diseases, Curasight is now conducting a Right Issue of shares of up to DKK 51.2 million.

The proceeds from the Rights Issue will primarily finance the preparation, planning and enrolment of the first patients in a therapeutic phase I/IIa basket trial that will in parallel assess the therapeutic safety and efficacy of uTREAT in brain cancer (glioblastoma multiforme), neuroendocrine tumors, head and neck cancer, non-small scell lung cancer, and pancreatic cancer. Furthermore, the proceeds from the issue will be used to broaden the pipeline through development of new next generation peptide-based radioligand therapies.

Subscription Commitments

The Company’s management team, consisting of Ulrich Krasilnikoff (CEO and CFO), Andreas Kjær (CSO/CMO and co-founder) and Hanne Damgaard Jensen (CDO/COO), have committed to subscribe for shares in the rights issue for a total of approx. DKK 1.3 million, corresponding to 2.5 percent of the rights issue.

Information Memorandum

Full terms and conditions for the Rights Issue as well as other information about the Company and further information about subscription commitments, will be included in the Information Memorandum that the Company is expected to publish around 22 February 2024.

Preliminary Timetable for the Rights Issue

20 February 2024

Last day of trading in the share including the right to receive subscription rights

21 February 2024

First day of trading in the share excluding the right to receive subscription rights

21 February – 5 March 2024

Trading in subscription rights

22 February 2024

Record date for the Rights Issue

22 February 2024

Estimated date for the publication of the Information Memorandum

23 February – 7 March 2024

Subscription period

23 February until the Rights Issue is registered with the Danish Business Authority

Trading in temporary shares

Around 12 March 2024

Estimated publication of the outcome in the Rights Issue

Shares and Dilution

Assuming full subscription in the Rights Issue, the share capital will increase by DKK 142,099.20, from DKK 994,694.55 to DKK 1,136,793.75 through the issuance of 2,841,984 shares, resulting in the total number of shares increasing from 19,893,891 to 22,735,875, representing a dilution effect of approximately 12.5 percent of the share capital and number of shares. Shareholders who do not participate in the Rights Issue have the opportunity to financially compensate themselves for this dilution by selling their subscription rights.

Advisors

Redeye AB is acting as a financial advisor to Curasight. DLA Piper Denmark Advokatpartnerselskab is acting as the legal adviser of Curasight. VP Euronext Securities A/S is the Company’s issuing agent and Nordic Issuing is acting as the settlement agent.

On February 13, 2024, CRISPR Therapeutics AG (the "Company") reported to have entered into an investment agreement (the "Investment Agreement") with certain institutional investors relating to the issuance of 3,916,082 shares of the Company’s common shares, par value of CHF 0.03 per share (the "Common Shares"), to such investors (the "Offering") (Filing, CRISPR Therapeutics, FEB 13, 2024, View Source [SID1234641108]). The Common Shares will be issued to the investors at an issue price of $71.50 per share. The Investment Agreement contains customary representations and warranties, conditions to closing, termination provisions and indemnification obligations, including for liabilities under the Securities Act of 1933, as amended.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The gross proceeds from the Offering will be approximately $280 million, before paying estimated offering expenses. The Offering is being made pursuant to the automatically effective shelf registration statement on Form S-3 (File No. 333-258274) previously filed by the Company with the Securities and Exchange Commission on July 29, 2021.

The form of Investment Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K. The foregoing description of the respective terms of the Investment Agreement is not intended to be complete and is qualified in its entirety by reference to such exhibit. A copy of the opinion of Walder Wyss AG relating to the legality of the issuance and sale of the shares in the Offering is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On February 13, 2024 Ensysce Biosciences, Inc. (NASDAQ:ENSC) (the "Company"), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, reported the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 3,601,752 shares of common stock of the Company originally issued in May 2023, having an exercise price of $3.637 per share, at a reduced exercise price of $1.31 per share (Press release, Ensysce Biosciences, FEB 13, 2024, View Source [SID1234640027]). The shares of common stock issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-1 (No. 333-271480). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $4.7 million, prior to deducting placement agent fees and estimated offering expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 7,203,504 shares of common stock, at an exercise price of $1.06 per share and will be immediately exercisable upon issuance. 3,601,752 of the new warrants will expire on May 12, 2028, and 3,601,752 of the new warrants will have a term of eighteen months from the issuance date.

The offering is expected to close on or about February 14, 2024, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for activities related to preparation for Phase 3 clinical studies for its lead agent PF614, to repay the remaining amounts on the debt incurred in October and November 2023, and for general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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 the registration or qualification under the securities laws of any such state or jurisdiction.