On January 31, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal, reported preliminary unaudited year-end financial results for the twelve months ended December 31, 2021 (Press release, IceCure Medical, JAN 31, 2022, View Source [SID1234607533]).

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!

Revenues increased to $4.1 million in 2021 compared to $3.9 million in 2020, primarily driven by sales through distribution agreements in Europe and sales of the Company’s ProSense system and probes in the United States.

As of December 31, 2021, the Company’s cash and cash equivalents totaled $25.6 million compared to $3.5 million for the period ending December 31, 2020, as a result of the two equity raises in 2021 totaling $32 million.

"2021 was pivotal for IceCure, beginning with a private placement of $15 million early in the year, listing of our shares on the Nasdaq, followed by an additional $17 million offering at a greater enterprise value. We have expanded the global distribution network for ProSense and increased our sales in the United States and Europe. Furthermore, our U.S. ICE3 trial demonstrated supportive data for our cryoablation technology in combating early-stage breast cancer which we reported at various academic meetings," stated Mr. Eyal Shamir, the Chief Executive Officer of IceCure.

"Notably, we remain focused on expansion on all fronts from both a commercial and product development standpoint, and we have also made important progress on the development of our next-generation cryoablation, single-probe, and multi-probe systems with a European patent-pending for our cryogenic pump which will potentially expand clinical applications with cryoablation for bigger tumors or multiple tumors simultaneously."

"In 2022, we intend to further advance our regulatory and commercial strategies in the United States, China, and Japan. We also plan to engage with new strategic commercial partners. One of our major focuses will be additional regulatory approvals in major countries for our business, namely, the United States and China. In the United States, we’ve already filed a pre-submission package with the Food and Drug Administration (the "FDA") for early-stage breast cancer and high risk to surgery and suggested a De Novo classification based on our ongoing ICE3 clinical trial. We hope that our Breakthrough Device Designation with the FDA will secure priority review," Mr. Shamir concluded.

IceCure plans to report full 2021 audited financial results upon filing its annual report on Form 20-F with the U.S. Securities and Exchange Commission.

The above information reflects preliminary estimates with respect to certain results of IceCure Medical for the full year ended December 31, 2021, based on currently available information. Because the audit for 2021 is not yet complete, IceCure’s final results may vary from the preliminary estimates.

On January 31, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that key program and business updates (Press release, FierceBiotech, JAN 31, 2022, View Source [SID1234607518]).

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!

Initiating rolling BLA submission for omidubicel. Following the recent receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA), Gamida Cell will initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of a stem cell transplant, in the first quarter of 2022 and plans to complete the full BLA submission in the first half of 2022.
Evaluating strategic alternatives for omidubicel. In parallel with the planned BLA submission, the company will be assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
Reducing operating expenses. With the objective of extending its cash runway into mid-2023, consistent with the timeline for potential U.S. approval of omidubicel, the company is reducing operating expenses primarily by implementing a workforce reduction of approximately 10% and delaying other hiring and planned spending in 2022.
Readying to advance GDA-201. The company is addressing comments received from FDA in connection with the clinical hold placed on the IND submission for GDA-201, its lead NAM-enabled innate NK cell immunotherapy. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
Advancing genetically modified NK cell immunotherapy programs. The company continues to advance itsNAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated strategies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company plans to execute preclinical proof of concept studies for these genetically modified NK therapeutic targets and to select pipeline candidates for IND enabling studies by the end of 2022.
"We are pleased that productive interactions with the FDA enable us to initiate a rolling submission of the BLA for omidubicel this quarter and to complete the full BLA submission during the first half of this year," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "As we advance omidubicel towards potential approval, we will be assessing strategic alternatives for the best way to bring this important therapy to patients, including potential U.S. or global commercialization partnerships. With the strategic steps we are taking, we believe Gamida Cell will be in a stronger position to support omidubicel through the regulatory approval process while we also continue to advance our NK cell pipeline programs, all as intended to serve our goal of providing access to life-saving cell therapies to patients in need."

2022 Financial Guidance

Gamida Cell ended 2021 with approximately $96.1 million in cash and cash equivalents (unaudited). The company expects cash used for ongoing operating activities in 2022 to range from $60 million to $70 million in cash and cash equivalents based on its current operating plans. The company anticipates that its current cash will support the company’s ongoing operating activities into mid-2023, excluding any additional financing or business development activities that may be undertaken. Gamida Cell plans to report its fourth quarter and full-year 2021 financial results on March 16, 2022, at which time the company will provide an update on its 2022 milestones and more detailed financial guidance.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a bone marrow transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and shorter days of hospitalization. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On January 31, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that initiation of IND-enabling studies for IDE161, a potential first-in-class PARG inhibitor development candidate (Press release, Ideaya Biosciences, JAN 31, 2022, View Source [SID1234607534]). The company also exercised its option for an exclusive worldwide license from Cancer Research Technology Ltd., dba Cancer Research UK (CRUK), and University of Manchester.

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!

IDE161 is a potential first-in-class small molecule inhibitor of poly (ADP-ribose) glycohydrolase, or PARG, a novel target in the same clinically validated pathway as poly (ADP-ribose) polymerase, or PARP. IDEAYA plans to evaluate IDE161 in patients having tumors with homologous recombination deficiencies (HRD), including BRCA1 and BRCA2, and potentially other genetic alterations identified through IDEAYA’s biomarker discovery platform.

"We are very excited about potential development opportunities for IDE161. We have shown dose-dependent in vivo efficacy of PARG inhibitors as monotherapy with tumor regression or stasis in multiple CDX models and PDX models, including in ovarian cancer, gastric cancer and breast cancer models. Significantly, we have observed in vivo efficacy of PARG inhibitors in BRCA1 and BRCA2 models which are refractory to or have acquired resistance to PARP inhibitors, suggesting an opportunity for clinical differentiation," said Dr. Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA.

"We identified IDE161 through our internal drug-discovery platform, and in parallel, we have invested significantly in translational biology and biomarker discovery. We believe PARG inhibitors could be substantially impactful for BRCA1 and BRCA2 patients non-responsive to PARP inhibitors. We are excited to advance IDE161 as a first-in-class development candidate toward the clinic," said Yujiro Hata, President and Chief Executive Officer of IDEAYA.

IDEAYA is targeting an IND submission for IDE161 in the fourth quarter of 2022, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.

Following the option exercise with Cancer Research UK and University of Manchester, IDEAYA holds exclusive worldwide license rights covering a broad class of PARG inhibitors. IDEAYA owns or controls all commercial rights in IDE161, subject to certain economic obligations pursuant to its exclusive, worldwide license with Cancer Research UK and University of Manchester.

On January 31, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that it has initiated IMX-110 Good Manufacturing Practice ("GMP") scale-up manufacturing, potentially accelerating the timeline to clinical data from two ImmixBio clinical trials planned for 2022: first, planned monotherapy IMX-110 clinical trial in soft tissue sarcoma ("STS"); second, planned combination IMX-110 + BeiGene anti-PD-1 tislelizumab clinical trial in advanced solid tumors (Press release, Immix Biopharma, JAN 31, 2022, View Source [SID1234607519]).

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!

"Initiating GMP manufacturing 36 days after the closing of our IPO puts us on a path of potentially accelerating our clinical trials," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We believe this step paves the way to execute our planned milestones at an accelerated pace."

About IMX-110

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110

On January 31, 2022 The Stockholm-based Digital Therapeutics (DTx) company Alex Therapeutics and world leading pharmaceutical company Pfizer reported that they have joined forces to provide evidence based, clinically validated and personalized digital therapies to patients (Press release, Pfizer, JAN 31, 2022, View Source [SID1234607535]). Together, the companies cover a broad range of expertise in the fields of medicine, marketing, clinical validation, AI, software development and psychology. The partnership will initially focus on Germany, one of the world’s largest unified healthcare markets.

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 our efforts to give patients access to new, innovative forms of therapy, it is our aim to fully benefit from the possibilities of digitization. Alex Therapeutics is a very promising company due to its approach of combining the latest psychological findings on dealing with harmful behavior with the possibilities of artificial intelligence" says Aylin Tüzel, Country Manager Pfizer Germany, explaining the choice of cooperation partner.

"Alex DTx Platform" uses Artificial Intelligence to treat medical conditions
The partnership will utilize Alex Therapeutics’ AI-powered digital therapeutics platform "Alex DTx Platform". The platform combines evidence-based psychology, primarily Cognitive Behavioural Therapy (CBT) and Acceptance and Commitment Therapy (ACT) with AI, and provides personalised standalone treatments to address unmet needs among patients worldwide.

John Drakenberg Renander, CEO of Alex Therapeutics, is excited by the opportunity to scale their novel treatments: "The collaboration with Pfizer enables us to combine our technology and expertise with one of the world’s leading pharmaceutical companies and gives us unique access to an attractive healthcare market. Pfizer’s unique experience of the needs of patients and doctors provides us with the opportunity to put our technology into the hands of those that need it the most."

The initial focus of the partnership is a digital therapy treating nicotine addiction via smartphone. The medical device was developed by Alex Therapeutics and adapted to the requirements of the German healthcare system together with Pfizer Germany. Pfizer is currently conducting an extensive clinical trial in Germany to further validate the medical benefits of the solution.

Germany has emerged as one of the leading countries in Digital Therapeutics
Josh Raysman, the leader of Pfizer’s Digital Innovation Lab, sees in the partnership a proof-point for collaborations in digital health. "We are working around the globe to leverage innovative digital approaches to enhance patient experiences and improve health outcomes. With the recent Digital Supply Act, the expertise of Pfizer’s colleagues in Germany, and the capabilities of Alex Therapeutics we have an opportunity to demonstrate the potential of patient-centric partnerships focused on transforming healthcare with digital treatments"

German-Swedish Collaboration
In January 2017, Germany and Sweden decided on a comprehensive partnership for innovation. The partnership tackles societal challenges within key areas, such as ehealth and AI, where Germany and Sweden have strong positions, and holds potential to develop the role of the EU.

"This is a great example of how innovative companies such as Alex Therapeutics in Sweden and Pfizer in Germany can come together in the fields of ehealth and AI. Together, they will provide new solutions to the benefit of patients."
Per Thöresson, Swedish Ambassador in Germany