On November 22, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported the pricing of its "reasonable best efforts" public offering with participation from the CEO and existing and new healthcare focused investors for the purchase and sale of up to 40,000,000 shares of common stock and warrants to purchase up to 20,000,000 shares of common stock at a combined offering price of $0.20 per share and accompanying warrant (the "Offering") (Press release, Aptose Biosciences, NOV 22, 2024, View Source [SID1234648572]). The Company expects to receive aggregate gross proceeds of approximately $8 million, before deducting placement agent fees and other offering expenses, and assuming no exercise of the warrants. The warrants will have an exercise price of $0.25 per share, will be exercisable immediately and will expire five years from the issuance date.

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 closing of the Offering is expected to occur on or about November 25, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this Offering for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent for the Offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-281201) previously filed with the Securities and Exchange Commission ("SEC") on August 2, 2024, as amended, which was declared effective on November 21, 2024. This Offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the Offering has been filed with the SEC. An electronic copy of the final prospectus relating to the Offering may be obtained, when available, on the SEC’s website located at View Source and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

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 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 November 22, 2024 Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") reported that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by the company with global intellectual property rights for the treatment of neuroendocrine cancer, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) (Press release, Nanjing Leads Biolabs, NOV 22, 2024, View Source [SID1234648556]). This marks another significant milestone following the Breakthrough Therapy Designation granted to LBL-024 by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) in China.

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!

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "LBL-024 obtained Breakthrough Therapy Designation from CDE in October this year for the treatment of advanced extrapulmonary neuroendocrine cancer. Our clinical data to date has been very encouraging, suggesting that LBL-024 could meaningfully improve outcomes of patients living with this devastating disease. The grant of ODD from FDA further underscores the exceptional potential of LBL-024 to address a critical gap in this therapeutic area. These policy supports for obtaining Orphan Drug qualification will greatly expedite the commercialization of LBL-024, potentially changing the treatment landscape for patients with advanced neuroendocrine cancer who currently have few therapeutic options."

Dr. Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said "The receipt of ODD for LBL-024 from FDA represents a pivotal milestone in our global strategy. This designation not only enables LBL-024 to receive additional policy support and resource allocation during its development, accelerating its path to market and positioning it as a potential first-in-class therapeutic antibody targeting 4-1BB worldwide, but also provides us with greater market opportunities and avenues for growth on a global scale."

About LBL-024

LBL-024 is a tetravalent bispecific antibody that simultaneously targets PD-L1 and 4-1BB, serving dual functions: blocking the immunosuppressive PD-1/PD-L1 pathway, and selectively co-stimulating 4-1BB in the tumor microenvironment to enhance immune responses. The dual functions of LBL-024—lifting PD-1/PD-L1 immune inhibition and intensifying 4-1BB modulated T cell activation—synergistically enhance the anti-tumor immune response.

LBL-024 received IND approvals from both FDA and NMPA on July 30, 2021 and September 9, 2021 respectively to conduct phase Ⅰ/Ⅱ clinical research, and has achieved outstanding results. Sponsored by Leads Biolabs, led by Professor Shen Lin from Beijing Cancer Hospital with participation of multiple clinical trial centers, the current clinical data demonstrate that LBL-024 monotherapy has more than doubled both the Objective Response Rate (ORR) and Overall Survival (OS) compared to existing treatments for this disease. Based on the current treatment status and the available safety and efficacy data, LBL-024 has entered into a single-arm pivotal trial for extrapulmonary neuroendocrine carcinomas in July 2024 and stands as the globally first 4-1BB-targetd drug candidates to have reached pivotal stage, according to Frost & Sullivan.

About Neuroendocrine Cancer

Neuroendocrine carcinoma (NEC) is a class of poorly differentiated, high-grade neuroendocrine neoplasms (NEN), which originate in the diffuse neuroendocrine cell system and may occur in many different sites. Its molecular characteristics are significantly different from those of neuroendocrine tumors (NET). NEC can be divided into pulmonary NEC and extrapulmonary NEC, among which pulmonary NEC includes small cell lung cancer (SCLC) and pulmonary large cell neuroendocrine carcinoma (p-LCNEC). According to previous data collected, the number of new cases of SCLC is about 98,193, p-LCNEC is about 19,639, and extrapulmonary NECs is about 9,820 in the United States every year. As a result, there are an estimated 127,652 new cases of NECs in the United States each year, meeting the FDA’s definition of a rare disease.

Symptoms of NEC can vary depending on the type of tumor, its location in the body and the hormone released. The survival rate of NEC varies according to the type of cancer and whether it spreads. Specifically, the 5-year survival rate of pulmonary NECs is 5.6%, digestive tract NECs is 13.1%, and other primary NECs are 26.0%. Due to the limited effective treatment options available for patients, the overall survival rate of NEC is low, and more effective new treatment options are urgently needed.

About Orphan Drug Designation

Orphan drugs are medications used for the prevention, treatment, and diagnosis of rare diseases. According to the Orphan Drug Act of the United States, Orphan Drug Designation is established to encourage the development of drugs for treating rare diseases. It provides a series of incentives for new drug development, including but not limited to: (1) tax credits for clinical trial expenses; (2) specific guidance from FDA on all stages of clinical research; (3) exemption of the application fee for new drug registration; and (4) 7 years of market exclusivity after listing.

On November 21, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that it has entered into a securities purchase agreement with certain investors to raise up to approximately $105 million in gross proceeds (Press release, Cidara Therapeutics, NOV 21, 2024, View Source [SID1234648543]). The private placement is being led by new investor, Venrock Healthcare Capital Partners, and includes significant participation by new and existing life sciences-focused investors, including RA Capital Management, TCGX, BVF Partners LP, Vivo Capital, Spruce Street Capital, Adage Capital Partners LP, and Checkpoint Capital.

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!

Pursuant to the terms of the securities purchase agreement, Cidara will issue an aggregate of 3,892,274 shares of its common stock at a purchase price of $14.912 per share. In lieu of shares of common stock, certain investors are purchasing pre-funded warrants to purchase an aggregate of 3,149,035 shares of common stock at a purchase price of $14.9119 per pre-funded warrant, which equals the purchase price per share of common stock, less the $0.0001 per share exercise price of each pre-funded warrant. The private placement is expected to close on or about November 25, 2024, subject to satisfaction of customary closing conditions.

Cidara intends to use the net proceeds from the private placement to fund research and development of product candidates, working capital and general corporate purposes.

RBC Capital Markets acted as the sole placement agent for the private placement. Guggenheim Securities acted as financial advisor to the Company.

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 reoffered or resold 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. Cidara has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock purchased in the private placement and shares of common stock underlying the pre-funded warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On November 21, 2024 Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or the "Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the issuance and sale of 1,237,113 shares of its common stock in a registered direct offering at a purchase price of $2.425 per share (Press release, Intensity Therapeutics, NOV 21, 2024, View Source [SID1234648578]).

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!

In a concurrent private placement (the "Private Placement" and together with the Registered Offering, the "Offerings"), the Company also agreed to issue to the same investor warrants to purchase up to 1,237,113 shares of its common stock (the "Common Warrants"). The Common Warrants have an exercise price of $2.95 per share, will be exercisable commencing six months from the date of issuance, and will expire five and one-half years following the date of issuance.

The gross proceeds from the Offerings, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $3 million. The Company expects to use the net proceeds from the Offerings for general working capital.

A.G.P./Alliance Global Partners is acting as lead placement agent for the Offerings and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as a co-placement agent for the Offerings.
The Offerings are expected to close on or about November 22, 2024, subject to the satisfaction of customary closing conditions.

The shares (or common stock equivalents in lieu thereof) offered to the institutional investor described above are being offered pursuant to a registration statement on Form S-3 (File No. 333-280681), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 11, 2024. The Offering is being made only by means of a prospectus which is a part of the effective registration statement. The Common Warrants will be issued in a concurrent private placement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected], or Brookline Capital Markets, a division of Arcadia Securities, LLC, 600 Lexington Avenue, 20th Floor, New York, NY 10022, or by telephone at (646) 256-5258, or by email at [email protected].
The private placement of the Common Warrants and the shares underlying the Common Warrants offered to the institutional investor will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Regulation D promulgated thereunder. Accordingly, the securities issued in the concurrent private placements 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.

On November 21, 2024 – Helix BioPharma Corp. (TSX: "HBP", OTC PINK: "HBPCD", FRANKFURT: "HBP0") ("Helix" or the "Company), a clinical-stage biopharmaceutical company developing novel and unique therapies in the field of immuno-oncology, based on its proprietary technological CEACAM6 platform, DOS47, reported the issuance of U.S. Patent No. 11931422 (Press release, Helix BioPharma, NOV 21, 2024, View Source [SID1234648544]).

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!

U.S. Patent No. 11931422, entitled ‘Antibody-Urease Conjugates for Therapeutic Purposes’, relates to Helix’ first-in-class antibody-drug conjugate (ADC) platform, L-DOS47, and the optimization of conjugation ratios for a proprietary antibody that precisely binds to tumor cells expressing high levels of CEACAM6, conjugated to urease, an enzyme capable of alkalizing the acidic tumor microenvironment (TME).

CEACAM6 is a tumor antigen highly expressed on hard-to-treat, prevalent cancers where currently available treatments are not achieving meaningful enough clinical benefits for patients (including non-small cell lung cancer, pancreatic and colorectal cancers). Binding to CEACAM6, Helix’ LDOS47 converts urea into ammonia and alkalizes the TME, promoting tumor regression, restoring function to local immune cells (such as T cells) and opening the possibility to significantly enhance the treatment outcomes of available, established therapies, including chemotherapy, checkpoint inhibitors (immunotherapies) and targeted small molecules.

Jacek Antas, CEO of Helix, stated: "We are very pleased to receive the issuance of this patent in the U.S., an important oncology market with a significant need for novel treatment modalities and better clinical outcomes. The timing is also advantageous, considering our ongoing discussions about expanding our pipeline with synergistic oncology products."