On March 24, 2022 Calliditas Therapeutics AB (publ) (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that CEO Renée Aguiar-Lucander has subscribed for 175,000 shares through Calliditas’ warrant program 2018/2022 (Press release, Calliditas Therapeutics, MAR 24, 2022, View Source [SID1234610866]). Following the new subscription for shares, Renée Aguiar-Lucander’s shareholding in the company will amount to 593,000 common shares.

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!

All members of the management team who are warrant holders in the program have today exercised their opportunity to subscribe for shares in the 2018/2022 warrant program, which comprises 856,586 warrants and can be exercised until 31 March 2022. To partially finance the share subscriptions, warrant holders in the program, including the CEO and some members of the management, have sold warrants. The sale of the block, which consisted of the equivalent of 488,000 shares, was made outside the market to a tier one long-term investor.

"I am very excited about the company’s development and success to date, especially as Calliditas now has an approved product on the market in the US, partnerships and upcoming potential market approvals in several other geographies and an exciting late stage pipeline, which holds the promise of continued significant value creation." says Renée Aguiar Lucander, CEO of Calliditas Therapeutics. "I also note that all warrant holders in the management team subscribed for shares according to their ability in the warrant program, which reflects everyone’s commitment to the future growth of Calliditas."

If all shares within the framework of the warrant program 2018/2022 are subscribed for, Calliditas will receive SEK 63.6 million in cash.

On March 24, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the fourth quarter and full year 2021 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAR 24, 2022, View Source [SID1234610865]).

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!

"Bellicum made great progress in the past year in the clinical development of our GoCAR-T cell therapies and in broadening the impact of our technology via licensing," said Rick Fair, President and Chief Executive Officer. "In 2021, we opened the BPX-601 trial in prostate cancer and reported a confirmed response in the first cohort treated, initiated the BPX-603 trial in HER2+ solid tumors, signed licensing agreements for our CaspaCIDe safety switch for use in six new CAR-T and CAR-NK programs, and raised additional capital expected to fund the company beyond our next data milestones for our GoCAR-T programs. The Omicron COVID-19 variant had a significant impact on our clinical trial sites and trial enrollment over the last two quarters, but we have recently seen an uptick in site activation and screening activity as cases decline. We believe we are well positioned to further demonstrate the value of GoCAR-T in the coming year."

Program Highlights and Current Updates

BPX-601 GoCAR-T

Enrollment in the Phase 1/2 dose escalation clinical trial in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC) is ongoing. On December 6, 2021, Bellicum provided an interim data update and reported that one of the first three mCRPC patients treated in the study achieved a confirmed partial response by RECIST v1.1 criteria. Additionally, no dose-limiting toxicities were observed. The company expects to present a data update on BPX-601 in the first quarter of 2023.
BPX-603 GoCAR-T

Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is the company’s first dual-switch GoCAR-T product candidate that incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. On December 6, 2021, the company reported initial Phase 1 data from this trial demonstrating a favorable safety profile in the first dose cohort of the study. The company expects to present a data update on BPX-603 in the first half of 2023.
Private Placement Completed

As previously reported, Bellicum entered into an agreement for a $35 million private placement of equity securities in December 2021 with two biotechnology specialist investment funds. Proceeds from the financing are expected to extend cash runway into the second quarter of 2023 and will be used to support ongoing clinical development of BPX-601 and BPX-603.
Regained Compliance with Nasdaq

On December 10, 2021, Nasdaq notified Bellicum that it had regained compliance with Listing Rule 5550(b)(1), which requires stockholders’ equity of at least $2.5 million for continued listing of the company’s common stock. Accordingly, the Company is now in compliance with the continued listing requirements of The Nasdaq Capital Market.
Charity Scripture Named Chief Development Officer

Dr. Scripture rejoined Bellicum in a full-time capacity effective December 1, 2021 after spending the previous year as VP, Business and Development Operations at ACELYRIN, a private biopharmaceutical company. Previously, Dr. Scripture was Vice President, Clinical & Medical Affairs at Bellicum. Prior to joining Bellicum, Dr. Scripture held clinical development leadership positions at AbbVie/Stemcentrx and Pharmacyclics, and spent almost a decade with Amgen in oncology clinical development and medical affairs.
Financial Results for the Fourth Quarter and Year Ended December 31, 2021

Revenues: Bellicum reported revenue of $0.5 million and $6.2 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $0.5 million during each of the comparable periods in 2020. The increase in revenues was due to agreements executed with external parties during the year. In the first quarter of 2021, Bellicum entered into a multi-year supply agreement with Takeda Development Center Americas, Inc. for the supply of rimiducid for potential use in clinical trials of TAK-007. Initial clinical trial supply was fulfilled in the second quarter of 2021 generating revenue of $0.7 million. Revenues from up-front and annual maintenance payments related to CaspaCIDe licensing agreements were $0.5 million and $5.5 million for the fourth quarter and full year 2021, compared to $0.5 million in 2020.

R&D Expenses: Research and development expenses were $4.0 million and $23.6 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $8.7 million and $39.1 million for the fourth quarter and year ended December 31, 2020, respectively. The decrease in R&D expenses for the fourth quarter and year ended December 31, 2021, compared to the prior year, was primarily due to reduced expenses related to rivo-cel related activities, the sale of the manufacturing facility, and the reduction in force that was implemented in the fourth quarter of 2020, partially offset by an increase in expenses related to Bellicum’s GoCAR-T programs. This resulted in $12.3 million reduction in employee-related expenses and a $3.2 million reduction in other R&D expenses.

G&A Expenses: General and administrative expenses were $1.6 million and $7.0 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $3.4 million and $15.5 million for the comparable periods in 2020. The decrease in G&A expenses for the fourth quarter and year ended December 31, 2021, compared to the year ended December 31, 2020, was primarily due to the reduction in force that reduced employee-related expenses by $6.8 million as well as the reduction in rivo-cel related commercialization activities that reduced expenses by $1.7 million.

Loss from Operations: Bellicum reported a loss from operations of $5.1 million and $24.9 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $13.0 and $51.7 million for the comparable periods in 2020. The results for the year ended December 31, 2021 include loss on dispositions of $0.5 million whereas for the year ended December 31, 2020, a gain on dispositions of $3.7 million was recognized.

Net Income/Loss: Bellicum reported net income of $2.5 million and a net loss of $9.7 million for the fourth quarter and year ended December 31, 2021, respectively, compared to net income of $18.8 million and a net loss $7.7 million for the fourth quarter and year ended December 31, 2020, respectively. The results included gain from change in fair value of warrant derivative liabilities of $7.6 million and $15.1 million for the fourth quarter and year ended December 31, 2021, respectively.

Shares Outstanding: As of March 21, 2022, Bellicum had 8,552,207 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock is convertible into 10 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $47.7 million as of December 31, 2021, compared to $37.0 million as of December 31, 2020. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2023.

On March 24, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported that research led by Roswell Park Comprehensive Cancer Center medical oncologist Shipra Gandhi, MD, has been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, being held April 8-13, 2022, in New Orleans, Louisiana (Press release, AIM ImmunoTech, MAR 24, 2022, View Source [SID1234610864]).

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!

Details of the poster presentation are as follows:

Title: Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod
Presenting Author: Shipra Gandhi, MD
Poster Number: 3127
Session: PO.TB06.05 – Secreted Soluble Factors and Exosomes in the Microenvironment
Presentation Type: E-Poster presentation
Session Date and Time: Tuesday, April 12, 2022, from 1:30 to 5:00 p.m. CDT

"Paclitaxel is known to have both immunostimulatory and immunosuppressive effects, but its impact on the chemokine system within the tumor microenvironment remains unclear," commented Dr. Gandhi, who is undertaking these studies in collaboration with senior author Pawel Kalinski, MD, PhD, Chair of Immunology at Roswell Park. "High levels of the cytotoxic T cell attractants CXCL9, CXCL10 and their common receptor CXCR3 in the breast tumor microenvironment predict higher probability of pathological complete response and improved long-term outcomes in patients treated with neoadjuvant taxanes, but are seen only in a limited portion of patients. Our current data highlight the potential for the chemokine modulatory regimen to enhance the effectiveness of taxane-based chemotherapy of breast cancer and potentially other diseases."

The accepted abstract detailed data gathered from evaluating paclitaxel’s impact on chemokine production in the human breast tumor microenvironment (TME) and the ability of a chemokine modulatory regimen (CKM) of Ampligen and Interferon-α to mitigate potentially undesirable aspects of taxane chemotherapy.

For the study, fresh breast cancer tissues obtained during routine surgeries, breast cancer cell lines BT-549 and MDA-MD-231 and peripheral blood monocyte-derived macrophages were analyzed immediately or cultured ex vivo for 24 hours in the absence or presence of paclitaxel and/or CKM components. The expression of chemokine genes and secretion of chemokines by freshly harvested and ex vivo-treated tumor explants, cancer cell lines and macrophages were analyzed by quantitative PCR (Taqman) and ELISA. Paired Student t-test was used for statistical analyses.

Breast cancer explants spontaneously expressed high levels of MDSC/Treg-attractants CXCL12 and CCL22, but only marginal levels of cytotoxic T cell (CTL) and natural killer (NK) cell attractants CXCL9, CXCL10, CXCL11 and CCL5. Unexpectedly, paclitaxel treatment resulted in further elevation of granulocyte/MDSC-attractant CXCL8 and CCL22, which was reversed by the combination of paclitaxel with the CKM including Ampligen. At the same time, while paclitaxel alone did not induce any of the CTL attractants tested, its combination with a CKM regimen of Ampligen and Interferon-α was highly effective in inducing CXCL9, CXCL10, CXCL11 and CCL5.

"Building off of a previously developed chemokine modulatory regimen combining interferon-α with TLR3 agonist Ampligen, Roswell Park set out to further evaluate paclitaxel’s impact on chemokine production. Based on the results, we believe that the combination chemokine modulatory regimen including Ampligen has the potential to mitigate undesirable aspects of taxane chemotherapy. We look forward to further evaluation," added Thomas Equels, Chief Executive Officer of AIM.

The results of the study identify an undesirable aspect of paclitaxel’s impact on breast cancer. The ability of CKM to enhance the expression of CTL/NK cell attractants and suppress the production of Treg/MDSC attractants produced by paclitaxel provides a strong rationale for further study of the combined use of CKM in taxane-based chemo-immunotherapy of breast cancer and potentially other diseases.

On March 24, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported that it will announce fourth quarter and full year 2021 financial results and provide a business update on Tuesday, March 29, 2022 (Press release, Scynexis, MAR 24, 2022, View Source [SID1234610847]). The company will host a conference call and webcast at 8:30 a.m. Eastern Daylight Time on the same day.

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!

A recording of the webcast will be posted on the Company’s website, www.scynexis.com, following the event.

On March 24, 2022 Monopar Therapeutics Inc. (Monopar or the Company) (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 fourth quarter and full-year 2021 financial results and summarized recent program developments (Press release, Monopar Therapeutics, MAR 24, 2022, View Source [SID1234610846]).

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!

Recent Program Developments and Highlights

Validive – International Phase 2b/3 VOICE Clinical Trial, Actively Recruiting

·Validive is a novel mucobuccal tablet formulation for clonidine that has been designed to provide for prolonged and enhanced local delivery of clonidine to the regions of oral mucosal radiation damage in patients being treated for oropharyngeal cancer.

·Monopar received clearance in the U.S. and multiple European countries to conduct its Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) (NCT04648020 / EudraCT No. 2021-000999-11) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer.

·The VOICE trial now has 44 active clinical trial sites in the U.S. and Europe, continues to open additional sites globally, and is on track to reach the interim analysis in mid-2022. Based on findings extracted from public reporting of recently completed SOM trials, Monopar is presently evaluating potential enhancements to and exact timing of the interim analysis.

·There is no FDA-approved prevention or treatment for CRT-induced SOM.

Camsirubicin – Phase 1b Dose-Escalation Trial, Actively Recruiting

·Camsirubicin, a propriety doxorubicin analog, has been engineered specifically to retain the anticancer activity of doxorubicin while minimizing the toxic effects on the heart.

·In August 2021, Monopar received clearance from the U.S. Food and Drug Administration to proceed under an Investigational New Drug (IND) application with an open-label Phase 1b dose-escalation clinical trial evaluating camsirubicin plus growth factor support (pegfilgrastim/G-CSF) in patients with advanced soft tissue sarcoma (ASTS) (NCT 05043649).

·First patient was dosed in October 2021.

·Monopar is currently enrolling the third dose-level, which is a higher dose level of camsirubicin than tested in any previous clinical trial.

·Early signs of clinical benefit have been observed with camsirubicin in this Phase 1b trial.

MNPR-101 and Related Compounds

·MNPR-101 is a preclinical stage uPAR-targeted antibody being developed as a radioimmunotherapeutic and companion diagnostic for advanced cancers and severe COVID-19.

·In collaboration with NorthStar Medical Radioisotopes, Monopar filed a provisional patent describing antibody conjugates of the metal binding agent PCTA, based on the unexpected observation of nearly 100% binding of Ac-225 to the PCTA-antibody conjugates.

·A provisional patent was also filed covering a radiotherapeutic consisting of Monopar’s proprietary antibody MNPR-101 bound to Actinium-225 (Ac-225) via the metal binding agent PCTA (MNPR-101-PCTA-Ac-225).

·Currently evaluating pathways to initiating a first-in-human study.

MNPR-202

·MNPR-202 is a novel analog of camsirubicin, modified to potentially enable it to evade doxorubicin drug resistance mechanisms.

·Monopar entered into a collaboration and commenced work with Cancer Science Institute of Singapore to evaluate activity of MNPR-202 in preclinical models of multiple cancers.

·Composition of matter patent covering MNPR-202 has been allowed in the U.S.

Results for the Fourth Quarter and Year Ended December 31, 2021, Compared to the Fourth Quarter and Year Ended December 31, 2020

Cash and Net Loss

Cash and cash equivalents as of December 31, 2021, were $20.3 million. Monopar anticipates that its current cash and cash equivalents will fund: the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through at least March 2023. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development through and beyond the ongoing open-label, dose escalation Phase 1b clinical trial.

Net loss for the fourth quarter of 2021 was $2.7 million or $0.21 per share compared to net loss of $2.1 million or $0.19 per share for the fourth quarter of 2020. Net loss for the year ended December 31, 2021 was $9.1 million or $0.73 per share compared to net loss of $6.3 million or $0.58 per share for the year ended December 31, 2020.

Research and Development (R&D) Expenses

R&D expenses for the fourth quarter of 2021 were $2.0 million compared to $1.6 million for the fourth quarter of 2020. This increase of $0.4 million was primarily due to increases of $0.5 million for R&D personnel expenses and $0.4 million for VOICE clinical trial expenses offset by a decrease of $0.5 million for Phase 1b camsirubicin clinical material manufacturing and other clinical trial planning expenses.

R&D expenses for the year ended December 31, 2021 were $6.5 million compared to $4.1 million for the year ended December 31, 2020. This increase of $2.4 million was primarily due to increases in expenses of $1.4 million for VOICE clinical trial expenses and $1.2 million for R&D personnel expenses offset by a decrease of $0.2 million for Phase 1b camsirubicin clinical material manufacturing expenses.

General and Administrative (G&A) Expenses

G&A expenses for the fourth quarter of 2021 were $0.7 million, compared to $0.6 million for the fourth quarter of 2020. This increase of $0.1 million was primarily due to an increase in G&A personnel expenses.

G&A expenses for the year ended December 31, 2021 were $2.6 million, compared to $2.4 million for the year ended December 31, 2020. This increase of $0.2 million was primarily due to an increase in G&A personnel expenses.