Kiromic BioPharma Arranges Up to $10 Million Financing

On October 27, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported it entered into a Standby Equity Purchase Agreement (the "SEPA") with YA II PN, LTD, a partnership managed by Yorkville Advisors Global LP, a global investment manager, to sell up to $8 million of the Company’s stock at any time during the 24 months following the date of the SEPA, subject to the effectiveness of a registration statement with the Securities and Exchange Commission and other conditions (Press release, Kiromic, OCT 27, 2022, View Source [SID1234622509]).

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The SEPA gives Kiromic the right, but not the obligation, to sell up to $5 million of shares of common stock, which may be increased by an additional $3 million of shares of common stock, at the Company’s request, subject to terms and limitations set forth in the agreement. The number of shares issuable under the SEPA is limited to a number equivalent to 19.99 % of the outstanding common stock of the Company as of the date of the SEPA agreement unless certain pricing conditions are met, which could have the effect of limiting the total proceeds under the SEPA.

Kiromic separately also secured $2 million in gross proceeds from a new investor through the issuance of a secured convertible promissory note. The convertible note converts into the Company’s common stock at a conversion price equal to $0.35 per share.

Following the close of the two financings, Kiromic also announced the completed settlement of its prior litigation with Sabby Capital Management, another institutional shareholder and certain affiliates.

"This equity facility is an important piece of our financing strategy that not only provides flexibility and additional runway towards achieving our clinical milestones, but also enables us to settle a key prior legal issue," stated Pietro Bersani, Chief Executive Officer of Kiromic. "We believe Yorkville Advisors will be a strong financial partner for us. With the combination of both financings, we have the facilities in place whereby we have the potential to raise up to $10 million of financing, subject to certain conditions, of which $2 million has already been secured, and we look forward to ongoing discussions with additional potential investors," continued Mr. Bersani.

For further information on the SEPA or convertible note, including important terms and conditions, please see Company’s filings with the Securities and Exchange Commission, including the Company’s Current Reports on Form 8-K filed with the Securities and Exchange Commission.

Rigel Announces Conference Call and Webcast to Report Third Quarter 2022 Financial Results and Business Update

On October 27, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that it will report its third quarter 2022 financial results after market close on Thursday, November 3, 2022 (Press release, Rigel, OCT 27, 2022, View Source [SID1234622508]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.

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Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

Biomea Fusion Announces First Patient Dosed with Chronic Lymphocytic Leukemia (CLL) in COVALENT-101 Trial

On October 27, 2022 Biomea Fusion, Inc. ("Biomea")(Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported the dosing of the first patient in the CLL cohort of COVALENT-101, the company’s ongoing Phase I clinical trial evaluating BMF-219, Biomea’s investigational covalent menin inhibitor, in patients with R/R AML, ALL, DLBCL, MM, and now CLL (Press release, Biomea Fusion, OCT 27, 2022, View Source [SID1234622507]).

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"Despite the advances in the treatment of CLL, we know that the majority of patients relapse and are in need of a new, novel therapy," stated Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "Based on the remarkable preclinical data we presented at ASCO (Free ASCO Whitepaper) of BMF-219’s effect in CLL models, including comparisons to currently available treatments, we believe BMF-219 could represent a transformative treatment option for CLL patients. With many of the Biomea Fusion team members having a long history and involvement with the successful development of CLL agents, and ibrutinib in particular, it’s quite special to be able to now evaluate the clinical potential of BMF-219 for those CLL patients that are still in need of a therapy."

At ASCO (Free ASCO Whitepaper), Biomea presented data demonstrating BMF-219’s powerful cell-killing activity as a novel, first-in-class single agent against CLL patient samples, representing a broad spectrum of mutational profiles, including those with poor prognostic mutations, such as TP53 and NOTCH1, chromosomal aberrations such as del(13q), trisomy 12 and complex karyotype. BMF-219 demonstrated near 100% response even in samples resistant to multiple standard-of-care agents.

"I am very proud of our research and translational team’s ability to further elucidate the central role of the scaffold protein menin and identify a host of specific subsets across various cancers where BMF-219 is achieving robust preclinical results. We are very excited to continue to advance this new therapeutic approach for patients with multiple liquid and solid tumors, many of whom have very little remaining alternatives," concluded Thomas Butler.

Biomea’s preclinical presentations on CLL can be accessed at the following link: View Source

About COVALENT-101

COVALENT-101 is a Phase I, open-label, multi-center, dose escalation and dose expansion study originally designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of oral dosing of BMF-219 in patients with R/R acute leukemias —including subpopulations where menin inhibition is expected to provide maximal therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations), multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL). The study design has now been expanded to include a cohort for patients with R/R CLL. Additional information about the Phase I clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

About Chronic Lymphocytic Leukemia (CLL)

CLL is a chronic leukemia that progresses relatively slowly and typically impacts older adults. In the United States, approximately 20,000 patients are diagnosed with CLL each year. While the existing treatment options produce 5-year survival outcomes greater than 87%, there is an unmet need for patients that have high- or medium-risk cytogenetic profiles and those who have relapsed or were refractory to existing treatments.

Monopar Announces Timeline of Upcoming Data Events for Validive, Camsirubicin, and MNPR-202

On October 27, 2022 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported that it will be presenting clinical data on camsirubicin and preclinical data on MNPR-202 in November and December, and is planning to report out the interim go/no-go analysis for its Validive Phase 2b/3 VOICE trial in Q1 2023 (Press release, Monopar Therapeutics, OCT 27, 2022, View Source [SID1234622506]).

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November 2022:

Poster of Camsirubicin Phase 1b Clinical Trial Data to be Presented at CTOS 2022

Event: Connective Tissue Oncology Society (CTOS) Annual Meeting Conference
Date: November 16-19, 2022
Location: Vancouver Convention Centre, Vancouver, BC, Canada

December 2022:

Poster of MNPR-202 Preclinical Data to be Presented at ASH (Free ASH Whitepaper) 2022

Event: 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition
Date: December 10-13, 2022
Location: Ernest N. Morial Convention Center, New Orleans, Louisiana

Q1 2023:

Interim go/no-go Analysis for Validive Phase 2b/3 VOICE Clinical Trial

The Company plans to report out the interim go/no-go decision for its Validive Phase 2b/3 VOICE clinical trial in Q1 2023. All patients required for the interim analysis have been enrolled. Patient enrollment will continue, as will adding additional clinical sites (currently 71 sites across the U.S. and Europe), in preparation for a potentially positive interim analysis.

ImmunityBio to Participate in the Jefferies London Healthcare Conference

On October 27, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that the company will be presenting at the Jefferies London Healthcare Conference, which is taking place in London from November 15-17, 2022 (Press release, ImmunityBio, OCT 27, 2022, View Source [SID1234622505]).

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A replay of the presentation will be available by visiting the "Events" section of the ImmunityBio website and will be archived for 90 days.