On December 8, 2023 NightHawk Biosciences, Inc., a Delaware corporation (the "Company"), reported to have entered into a Sales Agreement (the "Sales Agreement") with A.G.P./Alliance Global Partners (the "Sales Agent" or "A.G.P.") providing for the sale by the Company of its shares of common stock, par value $0.0002 per share (the "Common Stock"), from time to time, through or to A.G.P., as sales agent or principal, with certain limitations on the amount of Common Stock that may be offered and sold by the Company as set forth in the Sales Agreement (the "Offering") (Filing, 8-K, NightHawk Biosciences, DEC 8, 2023, View Source [SID1234638328]). Prior to entering into the Sales Agreement with A.G.P., the Company terminated the 2020 ATM Sales Agreement (as defined below) that it previously entered into with B. Riley Securities, Inc. and Cantor Fitzgerald & Co.

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Offers and sales of shares of Common Stock by the Company, if any, under the Sales Agreement, will be made through a prospectus supplement, dated December 8, 2023 and an accompanying base prospectus, dated December 22, 2020, contained therein (the "ATM Prospectus Supplement"), which prospectus forms a part of the Company’s shelf registration statement on Form S-3, as amended (File 333-251255), initially filed by the Company with the U.S. Securities and Exchange Commission (the "SEC") on December 10, 2020 (the "Registration Statement") and declared effective by the SEC on December 22, 2020. The aggregate market value of the shares of Common Stock eligible for sale under the ATM Prospectus Supplement will be subject to the limitations of General Instruction I.B.6 of Form S-3, to the extent required under such instruction.

Pursuant to the Sales Agreement, the Company will set the parameters for the sale of shares of Common Stock, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, the Sales Agent may sell the shares by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on the NYSE American or on any other existing trading market for the Common Stock. In addition, with the Company’s prior written approval, the Sales Agent may also sell shares by any other method permitted by law, including in privately negotiated transactions.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Sales Agent will use its commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of the NYSE American, to sell shares of Common Stock from time to time based upon the Company’s instructions. The Company has no obligation to sell any shares of Common Stock under the Sales Agreement and may at any time suspend solicitation and offers under the Sales Agreement. The Sales Agent is not obligated to purchase any shares of Common Stock on a principal basis pursuant to the Sales Agreement.

The Sales Agreement provides that the Company will pay the Sales Agent commissions for its services in acting as agent in the sale of shares of Common Stock pursuant to the Sales Agreement. The Sales Agent will be entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the Sales Agreement. The Company has agreed to provide the Sales Agent and certain affiliates of the Sales Agent with customary indemnification and contribution rights, including for liabilities under the Securities Act. The Company also will reimburse the Sales Agent for certain specified expenses in connection with entering into the Sales Agreement up to $50,000, and certain specified expenses on an annual basis not to exceed $10,000. The Sales Agreement contains customary representations and warranties and conditions to the placements of shares of Common Stock pursuant thereto, obligations to sell shares under the Sales Agreement are subject to satisfaction of certain conditions, including the effectiveness of the Registration Statement and other customary closing conditions.

The Sales Agreement will terminate upon the earlier of (i) the sale of all shares of Common Stock subject to the Sales Agreement; (ii) termination of the Sales Agreement as permitted therein, including by the Company to the Sales Agent upon one (1) day’s prior written notice and by the Sales Agent to the Company upon five (5) days’ prior written notice, in each instance without liability of any party; and (iii) termination by the Sales Agents upon written notice to the Company at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any sale of such 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.

A copy of the legal opinion of Blank Rome LLP regarding the legality of the shares of Common Stock that may be issued pursuant to the ATM Prospectus Supplement is attached to this Current Report on Form 8-K as Exhibit 5.1.

On December 8, 2023 Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, and The Leukemia & Lymphoma Society (LLS), the largest private funder of blood cancer research, reported a clinical collaboration to evaluate Kura’s menin inhibitor, ziftomenib, in combination with chemotherapy in pediatric patients with relapsed/refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutant acute leukemia (Press release, Kura Oncology, DEC 8, 2023, View Source [SID1234638327]).

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"We are honored to be designated for the PedAL initiative, marking Kura’s continued development of ziftomenib for the treatment of acute leukemias," said Mollie Leoni, M.D., Executive Vice President, Clinical Development. "Kura remains committed to developing new treatment options across the continuum of care, including for pediatric patients with acute leukemias where poor outcomes and significant unmet medical need remain. We are proud to collaborate with an exceptional organization such as LLS, which recognizes the importance of expanding patient populations beyond adults to provide effective therapies to infants and children with blood cancers."

In partnership with the PedAL Initiative, LLS will serve as the coordinating sponsor in North America and the Princess Máxima Center for Pediatric Oncology in Utrecht, the Netherlands, will serve as the coordinating sponsor in Europe. PedAL is a pioneering global master clinical trial for Pediatric Acute Leukemia, founded and led by LLS, which aims to advance more effective, safer treatments with fewer long-term side effects, for children with blood cancer.

"We developed PedAL as part of LLS’s Dare to Dream Project to fundamentally change how children with acute leukemia are treated and to provide a clinical trial framework that would help innovative companies like Kura accelerate research into precision treatments for pediatric patients," said Gwen Nichols, M.D., Chief Medical Officer, The Leukemia & Lymphoma Society. "For too long, progress for children with cancer has lagged behind; this collaboration with Kura is a major step in the right direction."

Under the terms of the agreement, LLS and the Princess Máxima Center will sponsor the Phase 1 study of ziftomenib in pediatric patients with acute leukemias. Kura will supply LLS and the Princess Máxima Center with ziftomenib for the study.

About Ziftomenib

Ziftomenib is a novel, once-daily, oral investigational drug candidate targeting the menin-KMT2A/MLL protein-protein interaction for treatment of genetically defined AML patients with high unmet need. In the KOMET-001 Phase 1 study, ziftomenib demonstrated an encouraging safety profile and tolerability with reported events most often consistent with features and manifestations of underlying disease. Clinical activity of ziftomenib as a monotherapy was optimal at the 600 mg daily dose and a 35% complete remission rate was observed in 20 patients with NPM1-mutant AML treated at the recommended Phase 2 dose (600 mg). Ziftomenib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML. Additional information about clinical trials for ziftomenib can be found at kuraoncology.com/clinical-trials/#ziftomenib.

On December 8, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported that it will focus its resources in two strategic areas: (i) treating colorectal cancer using IgM death receptor 5 (DR5) agonist antibodies, and (ii) treating autoimmune diseases using IgM T cell engager antibodies (Press release, IGM Biosciences, DEC 8, 2023, View Source [SID1234638326]). As an expansion of its autoimmune efforts, the Company also announced today that it plans to file an Investigational New Drug (IND) application to begin the clinical development of IGM-2644, its CD38 x CD3 T cell engager antibody, for the treatment of autoimmune diseases. As part of its strategic refocus, the Company is halting all hematologic oncology clinical development as well as the clinical development of its targeted cytokine product candidate. The Company will continue to focus on the development of oncology and immunology and inflammation product candidates under its collaboration with Sanofi. In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent. As a result of these actions, IGM expects to extend its cash runway into the second quarter of 2026.

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"IGM continues to have a tremendous opportunity to transform a variety of disease areas using an entirely new class of antibody medicines," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Although we are very encouraged by the clinical and preclinical data that we have generated for the programs we are halting, given the difficult conditions in the capital markets for our industry, we have decided to focus our capital resources on those opportunities that we believe have the most potential to produce significant near-term value. We are very sorry that some of our dedicated and talented employees will be leaving IGM as part of this strategic refocusing, and we wish to extend our sincere thanks and assistance to them in this difficult transition."

Pipeline Update:

Aplitabart (DR5 agonist)

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Clinical development of aplitabart in colorectal cancer prioritized.
o
Enrollment continues in randomized colorectal cancer clinical trial. The Company continues to enroll patients in a randomized clinical trial of aplitabart, a death receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer, with a goal of enrolling approximately 110 patients by the end of the first quarter of 2024. In addition to clinical trial sites in the United States, this trial includes multiple clinical trial sites in Asia and Europe.
o
Treatment at 10 mg/kg ongoing in the single arm colorectal cancer clinical trial continues. The Company also continues to treat later line colorectal cancer patients in its single arm combination clinical trial of 10 mg/kg of aplitabart and FOLFIRI. The Company expects to complete enrollment of patients in this 10 mg/kg single arm combination study in the first half of 2024.

Imvotamab (CD20 x CD3)

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Clinical development of imvotamab in autoimmune diseases prioritized. The Company is prioritizing the clinical development of imvotamab, an IgM-based CD20 x CD3 bispecific T cell engaging antibody in autoimmune diseases. The Company currently has two Phase 1b clinical trials underway, one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA). These clinical trials are being expanded to include multiple U.S. and international clinical trial sites. The Company also recently received clearance from the FDA of its IND application for the use of imvotamab in treating idiopathic inflammatory myopathies (myositis), and preparations are underway to move this clinical trial forward.

IGM-2644 (CD38 x CD3)

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Clinical development of IGM-2644 in autoimmune diseases prioritized. The Company is prioritizing the clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases, and it plans to file an IND for these purposes in 2024.

As a part of this strategic refocusing, the Company will halt the following clinical development activities:

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Aplitabart in acute myeloid leukemia and in combination with birinapant
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IGM-2644 (CD38 x CD3) in multiple myeloma
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IGM-2537 (CD123 x CD3)
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IGM-7354 (IL-15 x PD-L1)

On December 8, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on December 05, 2023, the compensation committee of BridgeBio’s board of directors granted thirty new employees restricted stock units for an aggregate of 147,373 shares of the Company’s common stock (Press release, BridgeBio, DEC 8, 2023, View Source [SID1234638320]). One-fourth of the shares underlying each employee’s restricted stock units will vest on November 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019 and amended and restated on February 10, 2023.

On December 8, 2023 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported new clinical data from its Phase 1 expansion study of CART-ddBCMA, now known as anitocabtagene autoleucel (anito-cel). Anito-cel utilizes a novel D-Domain BCMA binder that is compact and stable, which results in a drug product with a high proportion of CAR+ cells and high-surface expression, potentially enhancing antigen binding and more efficient Multiple Myeloma cell killing (Press release, Arcellx, DEC 8, 2023, View Source [SID1234638319]).

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The data continue to demonstrate robust long-term responses with median duration of response, progression free survival (PFS), and overall survival rate not reached. The data are from an October 15, 2023 data cut, with median follow-up after anito-cel infusion of 26.5 months. These latest study findings will be presented as an oral presentation during the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on Monday, December 11, 2023 at 5 p.m. PT. The company also has a medical affairs booth (#748) in Hall E of the San Diego Convention Center.

As of October 15, 2023, 38 patients were evaluable for efficacy and safety analysis based on a median follow-up of 26.5 months following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level (100 (+/- 20) million CAR+ T cells, n=6) and the second dose level (300 (+/- 20) million CAR+ T cells, n=6), and a dose expansion cohort at 100 (+/- 20) million CAR+ T cells (n=26). The median dose administered to patients in the first dose level and dose expansion cohorts was 115 million CAR+ T cells. All patients evaluable for this analysis have poor prognostic factors with 38 of 38 (100%) patients triple-refractory, 26 of 38 (68%) penta-refractory, and 34 of 38 (89%) refractory to last line of treatment under International Myeloma Working Group (IMWG) criteria. Additionally, 9 of 38 (24%) patients had high tumor burden with >60% bone marrow plasma (BMPC) cells, 13 of 38 (34%) patients had extra-medullary disease (EMD), and 11 of 38 (29%) patients had high-risk cytogenetics (Del 17p, t(14;16), t(4;14)) at screening/baseline. Further, 24 of 38 (63%) had at least one high-risk clinical feature, defined as presence of EMD, BMPC >60%, or Beta 2 microglobulin (B2M) >5.5 mg/L at screening/baseline. All 38 patients had at least three prior lines of therapy.

The interim anito-cel Phase 1 clinical results (October 15, 2023 cutoff date) demonstrate deep and durable responses in patients with poor prognostic factors.

All Patients:

Of the 38 evaluable patients with a median follow-up of 26.5 months

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100% overall response rate (ORR) achieved in all patients per IMWG criteria

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29 of 38 evaluable patients achieved a complete response (CR) or a stringent complete response (sCR) (>CR rate, 76%)

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35 of 38 patients achieved a very good partial response or higher (>VGPR rate, 92%)

Of those evaluable for MRD testing to date (n=28), 25 (89%) were MRD-negative at a minimum of 10-5 sensitivity. Median duration of response, progression free survival (PFS), and overall survival were not reached at the time of the October 15, 2023 data cut. While median PFS is yet to be reached, the estimated Kaplan-Meier median progression free survival for the study population was 28 months at the time of the data cut with 26.5 months of median follow-up.

The Kaplan-Meier method estimated PFS rates for 6, 12, 18 and 24 months were 92%, 76%, 64% and 56%, respectively. Durable responses were also observed in patients with high-risk features (EMD, BMPC ≥60%, or B2M ≥5.5 mg/L at baseline) and high-risk cytogenetics.

Estimated PFS rates at 6, 12, 18, and 24- months by Kaplan-Meier method were:

PFS Rates (%)
6-month 12-month 18-month 24-month
All dosed (n=38)

92.1 75.9 63.7 56.0
Age ≥65 years (n=20)

95.0 85.0 74.3 61.3
High Risk Features* (n=24)

91.7 74.2 64.6 58.7
Extramedullary Disease (n=13)

92.3 67.1 67.1 57.5
High Risk Cytogenetics (n=11)

81.8 71.6 71.6 71.6

*
High risk features defined as presence of EMD, BMPC ≥60, or B2M ≥5.5 mg/L. Note: increased from prior presentation from 22 to 24 subjects as a result of database update based on ongoing data review.

Anito-cel dosed at RP2D (115 million (+/- 10) CAR+ T cells) continues to be well-tolerated at the time of the October 15, 2023 data cut:

•
Adverse events with anito-cel, including CRS and ICANS, were manageable

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No cases of grade 3 (or greater) CRS and only one case (3%) of grade 3 ICANS event with no additional cases from previously reported

•
No tissue-targeted toxicities were observed

•
No cases of delayed neurotoxicity events or parkinsonian symptoms were observed

Matthew J. Frigault, M.D., anito-cel study investigator, Clinical Director of the Cellular Therapy Service at Mass General Cancer Center, and Assistant Professor at Harvard Medical School said, "It is encouraging to see continued deep and durable responses with anito-cel. While access to CAR-T treatment options for patients with multiple myeloma is expanding, it is still limited, and additional therapeutics can help close the treatment gap. In light of this encouraging clinical profile of anito-cel, I look forward to continuing to enroll patients in the iMMagine-1 study."

Arcellx’s Chairman and Chief Executive Officer, Rami Elghandour continued, "This latest data set further underscores our confidence in the potential of anito-cel to become a best-in-class treatment option for patients with relapsed or refractory multiple myeloma. Building on this momentum, we look forward to completing enrollment in our iMMagine-1 study and planning for commercial launch with our partners at Kite."

ASH Presentation Details:

Title: Phase 1 Study of CART-ddBCMA for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Results from at Least 1-Year Follow-up in All Patients

Speaker: Matthew J. Frigault, M.D., Clinical Director of the Cellular Therapy Service at Mass General Cancer Center, and Assistant Professor at Harvard Medical School

Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR-T Cell Therapies for Multiple Myeloma and B Cell Lymphomas

Session Date: Monday, December 11, 2023

Session Time: 4:30—6:00 p.m. PT (Oral presentation for anito-cel will be at 5 p.m. PT)

Location: San Diego Convention Center, Room 6A, San Diego, California

Publication Number: 1023

A copy of the presentation can be accessed from Arcellx’s website at www.arcellx.com on the Scientific Publications page.

Webcast Event:

Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Monday, December 11, 2023 at 8 p.m. PT. The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

About Multiple Myeloma

Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About anito-cel

Anito-cel, formerly known as CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. Anito-cel is currently in a Phase 2 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.