On February 13, 2024 Immunome, Inc. ("Immunome") (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, reported the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a price to the public of $20.00 per share (Press release, Immunome, FEB 13, 2024, View Source [SID1234640055]). All of the shares are to be sold by Immunome.

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The gross proceeds to Immunome from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $200.0 million. In addition, Immunome has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on February 16, 2024, subject to the satisfaction of customary closing conditions.

J.P. Morgan, TD Cowen, Leerink Partners and Guggenheim Securities are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 13, 2024 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering were filed with the SEC and are available for free on the SEC’s website located at View Source A final prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected].

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 registration or qualification under the securities laws of any such state or 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.

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"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 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that management will present at the 2024 BIO CEO & Investor Conference being held on February 26-27, 2024, in New York, NY (Press release, Sapience Therapeutics, FEB 13, 2024, View Source;investor-conference-302060120.html [SID1234640053]).

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Sapience CEO and President, Dr. Barry Kappel, will present a company overview on Monday, February 26, 2024, at 4:00 pm ET. Company management will also participate in one-on-one meetings with investors during the conference.

More information can be found on the BIO CEO & Investor Conference website.

On February 13, 2024 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ("SHPH" or the "Company"), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), along with its wholly-owned subsidiary, Shuttle Diagnostics, Inc., a Maryland corporation ("Diagnostics"), reported its intent to commence a Rights Offering where it plans to raise up to $4.5 million through the distribution of subscription rights and the exercise thereof, which full rights will entitle existing SHPH stockholders to purchase from the Company units (the "Units"), with each Unit consisting of (i) one share of SHPH common stock, (ii) a warrant to purchase one share of SHPH common stock exercisable at a per share purchase price of $2.35 per share, and (iii) a percentage of equity interest in Diagnostics (Press release, Shuttle Pharmaceuticals, FEB 13, 2024, View Source [SID1234640052]). The Units will be sold at a per Unit price equal to 90% of the VWAP of SHPH common stock for the five trading days immediately preceding closing.

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SHPH has separately entered into a securities purchase agreement with SRO LLC, a Nevada limited liability company, pursuant to which SRO LLC agreed to commit to purchasing from the Company $2.25 million of Units from the Company. In addition, in the event the Company fails to raise a full $4.5 million in the Rights Offering, SRO LLC agreed to a backstop commitment pursuant to which it would have the right to purchase any remaining Units not purchased by existing SHPH stockholders in the Rights Offering, up to an additional $2.25 million.

In conjunction with its entry into the Purchase Agreement, on February 7, 2024, the Company entered into a placement agent and advisory services agreement with Boustead Securities, LLC ("BSL"), pursuant to which BSL and BSL’s affiliates will provide the Company with regular and customary financial consulting advice and will act as placement agent, on a best efforts basis, for the Rights Offering.

SHPH intends to file with the Securities and Exchange Commission (the "Commission") a registration statement under the Securities Act of 1933, as amended, in order to effect the Rights Offering, which Rights Offering will be made to holders of SHPH common stock, and other security holders having the right to participate, as of a yet-to-be-determined record date. SHPH currently plans to fix a record date following its filing of a registration statement on Form S-1 registering the Rights Offering and after it completes the requisite review process by the Commission’s staff. At such time, SHPH stockholders as of the record date will be notified of their right to participate in the Rights Offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy nor will there be any sale of any securities referred to in this press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. The Rights Offering, when commenced, will be made only by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

On February 13, 2024 Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, reported that it has entered into agreements with VBI Vaccines, Inc. ("VBI", NASDAQ: VBIV), ensuring expansion and control of future clinical and commercial supplies of BRII-179, a late-stage clinical asset in Brii Bio’s HBV functional cure portfolio (Press release, VBI Vaccines, FEB 13, 2024, View Source [SID1234640051]).

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Under these agreements, Brii Bio will issue a $2.5 million promissory note to VBI initially. This will eliminate royalty and milestone payments for PreHevbri. Upon meeting specific conditions, the note will increase to $10 million, securing all of VBI’s intellectual properties (IP) for BRII-179, with associated payments also eliminated. In addition, subject to certain approvals, Brii Bio and VBI will work together to transfer the manufacturing technologies of BRII-179 to a site designated by Brii Bio. Upon completion of essential activities relating to such technology transfer, subject to certain potential adjustments, Brii Bio will issue up to an additional $8 million promissory note to VBI. After satisfaction of certain conditions, Brii Bio will also take control of VBI’s Rehovot-based manufacturing facilities for BRII-179 and PreHevbrio/PreHevbri for $10 million cash on or after June 30, 2024, when Brii Bio and VBI plan to enter into supply agreement under which Brii Bio will become VBI’s commercial supplier for PreHevbrio and PreHevbri.

Separately, subject to achievement of certain conditions by VBI, Brii Bio will secure an exclusive license to develop and commercialize VBI-1901, VBI’s glioblastoma (GBM) immunotherapeutic candidate, in the Asia Pacific (APAC) region excluding Japan and issue a $5 million promissory note to VBI. VBI-1901 has received fast-track and orphan drug designations from the U.S. Food and Drug Administration (FDA) and a Phase 2b study is ongoing.

"We are grateful to our VBI colleagues at the Rehovot site who despite significant challenges continued to provide uninterrupted supplies of BRII-179," said Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "As Brii transitions to late-stage development of HBV programs, a global manufacturing strategy becomes critically important. We look forward to working together with the biologics manufacturing experts at the Rehovot site and timely integration of our R&D and manufacturing capabilities."

About BRII-179

BRII-179 (VBI-2601) is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. BRII-179 is currently being investigated in two Phase 2 clinical trials in combination with BRII-835 or PEG-IFNα as part of a potential functional cure regimen for the treatment of chronic HBV infection.

Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018, providing Brii Bio with commercial rights to BRII-179 in the licensed territories of China, Hong Kong, Macau, and Taiwan. The exclusive license for BRII-179 has been extended to worldwide markets since July 2023. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation.

About PreHevbri

PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio (US/Canada), PreHevbri (EU/EEA/UK), and Sci-B-Vac (Israel).

About VBI-1901

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.