On August 16, 2023 NuCana plc (NASDAQ: NCNA) reported financial results for the second quarter ended June 30, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, AUG 16, 2023, View Source [SID1234634453]).

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!

As of June 30, 2023, NuCana had cash and cash equivalents of £24.6 million compared to £31.0 million at March 31, 2023 and £41.9 million at December 31, 2022. NuCana continues to advance its various clinical programs and reported a net loss of £5.4 million for the quarter ended June 30, 2023, as compared to a net loss of £3.9 million for the quarter ended June 30, 2022. Basic and diluted loss per share was £0.10 for the quarter ended June 30, 2023, as compared to £0.07 per share for the comparable quarter ended June 30, 2022.

"During the first half of 2023, we focused on advancing our ProTides through clinical development and look forward to providing data updates from these studies in the second half of this year," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We anticipate data updates from the three ongoing studies of NUC-3373, a ProTide that has the potential to replace 5-FU across multiple tumor types. These studies include: the Phase 2 part of the NuTide:302 study evaluating NUC-3373 combined with leucovorin and either irinotecan (NUFIRI) or oxaliplatin (NUFOX) plus bevacizumab in second-line patients with colorectal cancer; the randomized Phase 2 NuTide:323 study of NUFIRI plus bevacizumab compared to the standard of care FOLFIRI plus bevacizumab in patients with second-line colorectal cancer; and the Phase 1b/2 NuTide:303 modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer."

Mr. Griffith continued: "NUC-7738, our ProTide transformation of 3’-deoxyadenosine continues to progress well. We anticipate sharing data later this year from the Phase 2 part of the NuTide:701 study investigating NUC-7738 as monotherapy in patients with solid tumors and in combination with pembrolizumab in patients with melanoma."

Mr. Griffith concluded, "With a cash runway expected to extend into 2025 and through many key milestones for both NUC-3373 and NUC-7738, we look forward to a busy and exciting rest of the year as we progress towards our goal of significantly improving treatment outcomes for patients with cancer."

2023 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)

In 2023, NuCana expects to:

Announce data from the Phase 2 (NuTide:302) study of NUC-3373 combined with irinotecan and bevacizumab (NUFIRI-bevacizumab) and in combination with oxaliplatin and bevacizumab (NUFOX-bevacizumab) in second-line patients with colorectal cancer;
Announce preliminary data from the randomized Phase 2 (NuTide:323) study of NUFIRI-bevacizumab versus the standard of care FOLFIRI-bevacizumab for the second-line treatment of patients with colorectal cancer; and
Announce data from the Phase 1b (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer to identify additional indications for development.

NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2023, NuCana expects to:

Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 as monotherapy in patients with solid tumors and in combination with pembrolizumab in patients with melanoma.

As previously reported on a Current Report on Form 8-K, on March 10, 2021, INmune Bio Inc. (the "Company"), entered into an At-The-Market Sales Agreement (the "Sales Agreement") with BTIG, LLC ("BTIG"), pursuant to which the Company may offer and sell, from time to time, through BTIG, as sales agent, shares of its common stock, par value $0.001 per share (the "Common Stock"), having an aggregate offering price of up to $45,000,000, subject to certain limitations on the amount of Common Stock that may be offered and sold by the Company set forth in the Sales Agreement (Filing, 8-K, INmune Bio, AUG 16, 2023, View Source [SID1234634452]). The Company is not obligated to make any sales of Common Stock under the Sales Agreement and any determination by the Company to do so will be dependent, among other things, on market conditions and the Company’s capital raising needs.

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 August 16, 2023, the Company and BTIG entered into Amendment No. 1 to the Sales Agreement ("Amendment No. 1 to the Sales Agreement") in order to provide that the offers and sales of Common Stock by the Company under the Sales Agreement, as amended, if any, will be made through a prospectus supplement to the prospectus forming a part of the Company’s shelf registration statement on Form S-3 (File No. 333-254221) declared effective by the Securities and Exchange Commission (the "SEC") on May 5, 2021 (the "Registration Statement"). The Company filed with the SEC a prospectus supplement dated August 16, 2023, specifically relating to offers and sales of Common Stock under the Sales Agreement (the "ATM Prospectus Supplement"), together with the prospectus forming a part of the effective registration statement.

Shares may be sold through the ATM Prospectus Supplement by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made through The Nasdaq Capital Market or any other trading market for the common stock, sales made to or through a market maker other than on an exchange or through an electronic communications network, or in negotiated transactions pursuant to terms set forth in a placement notice delivered by the Company to BTIG under the Sales Agreement. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, BTIG will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of The Nasdaq Capital Market, to sell the Shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. BTIG is not obligated to purchase any shares of Common Stock on a principal basis pursuant to the Sales Agreement.

The foregoing description of Amendment No. 1 to the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment No. 1 to the Sales Agreement. A copy of the Amendment No. 1 to the Sales Agreement is filed with this Current Report on Form 8-K as Exhibit 1.1 and is incorporated herein by reference.

A copy of the opinion of Sichenzia Ross Ference LLP relating to the validity of the Shares that may be offered and sold under the ATM Prospectus Supplement, is filed with this Current Report on Form 8-K as Exhibit 5.1.

This Current Report on Form 8-K does not constitute an offer to sell or the solicitation of offers to buy any securities of the Company, and shall not constitute an offer, solicitation or sale of any security 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 August 16, 2023 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us"), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that additional NXC-201 clinical data for relapsed/refractory AL Amyloidosis has been selected for oral presentation at the 20th International Myeloma Society Annual Meeting to be held in Athens, Greece, September 27-30, 2023 (Press release, Immix Biopharma, AUG 16, 2023, View Source [SID1234634451]).

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 pleased to present additional clinical data in the NEXICART-1 clinical study evaluating NXC-201 in patients with relapsed/refractory light chain AL amyloidosis at the upcoming International Myeloma Society Annual Meeting in September," said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and NXC-201 principal study investigator. "We continue to make progress in this important indication, in the hope of providing patients with new treatment options."

Poster Presentation Details:

Event 20th International Myeloma Society Annual Meeting, Athens, Greece
Title "Feasibility of a novel academic anti-BCMA chimeric antigen receptor T-cell (CART) (HBI0101) for the treatment of relapsed and refractory AL amyloidosis"
Presentation
Date/Time (EEST)
September 27, 2023 9:00am – 14:30pm;
September 28, 2023 10:00 – 13:30pm;
September 29, 2023 9:30 – 14:15pm
About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.

About NEXICART-1
NEXICART-1 (NCT04720313) is Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.
The primary objective of the Phase 1b portion of the study is to characterize the safety and confirm the recommended Phase 2 dose (RP2D) of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma (R/R MM) patients, according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis (R/R ALA) according to consensus recommendations.
The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in R/R MM and R/R ALA in order to expand the ongoing clinical trial to the U.S.
The expected primary endpoint for the Phase 2 portion of the ongoing trial in R/R MM is overall response rate and duration of response. Nexcella plans to submit data to the FDA once 100 patients have been treated. The expected primary endpoint for NXC-201 in R/R ALA is overall response rate. Nexcella plans to submit data to the FDA once 30-40 patients have been treated.

About AL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by these cells cause a buildup of misfolded immunoglobulin proteins in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage and high mortality rates.
AL amyloidosis affects roughly 30,000 – 40,000 patients in the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases annually in the U.S. The estimated annual global incidence ~15,000 patients.
The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.

On August 16, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted two employees nonqualified stock options to purchase an aggregate of 32,500 shares of its common stock with an exercise price of $1.70, which is equal to the closing price of Gritstone’s common stock on August 7, 2023, the date of the grant (Press release, Gritstone Bio, AUG 16, 2023, View Source [SID1234634450]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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 stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

On August 16, 2023 Gilead Sciences presented its corporate presentation (Presentation, Gilead Sciences, AUG 16, 2023, View Source [SID1234634449]).

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!