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.

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"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

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.

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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 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]).

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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 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, reported the promotion of current CMO, Marcel Rozencweig, M.D., to President and the appointment of Scott Z. Fields, M.D., as the new chief medical officer, effective tomorrow, Feb. 1, 2022 (Press release, NeoTX, JAN 31, 2022, View Source [SID1234607532]). Dr. Fields brings more than 30 years of experience in clinical drug development and has been previously the Senior Vice President and Pharmaceutical Development Head, Oncology at Bayer Pharmaceuticals.

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"We are thrilled that Marcel will be the President to lead NeoTX in its next chapter of growth and success. He has been a key part of NeoTX growth since its inception and, in his new role as President, will help to accelerate growth and expand strategic industry partnerships," said Asher Nathan, Ph.D., chief executive officer of NeoTX.

"I am very pleased and looking forward to leading, as President, in NeoTX’s advancement," said Dr. Rozencweig. "Additionally, as a founding member of NeoTX, it gives me great pleasure to welcome Dr. Fields to our leadership team."

"We, at NeoTX, are delighted that Scott is bringing his strong industry and operational leadership, which will prove valuable for our clinical development and registration strategies. His broad experience in oncology drug development, with over a dozen drug approvals, is an excellent fit with our vision," said Asher Nathan, Ph.D., chief executive officer of NeoTX.

"I’m thrilled to join NeoTX at this time of important growth and evolution of the company," said Dr. Fields. "Together with our experienced leadership team, I look forward to helping the company accelerate the development of our pipeline and bring innovative new medicines to patients."

As Global Head of Development for Oncology at Bayer Pharmaceuticals, Dr. Fields was responsible for early and late-stage development including several novel oncology medicines across the platforms for targeted therapies/precision medicine, antibody drug/alpha radiation conjugates and novel Immuno-Oncology agents. His group was responsible for the development and global registration of Darolutamide – a next generation androgen receptor inhibitor for prostate cancer and with partner Loxo, for Larotrectinb – a tissue agnostic NTRK inhibitor. He was also responsible for the Oncology Operations, Project Management, Regulatory, Biomarkers, Biostatistics and Medical Writing groups. Prior to his position at Bayer, Dr. Fields held senior positions at Vertex Pharmaceuticals, SmithKline Beecham, Amgen, Eisai, and Arno Therapeutics and helped bring over a dozen drugs to market. He also practiced oncology/hematology and transplant medicine in academic settings. Dr. Fields received his medical degree from SUNY Downstate Medical Center in New York, followed by training in internal medicine, hematology and oncology at Columbia University Medical Center.

On January 31, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious disease, reported that it will issue financial results for its third quarter fiscal year 2022, ended December 31, 2021, at 4:15 p.m. EST on Monday, February 14, 2022 (Press release, Aethlon Medical, JAN 31, 2022, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-third-quarter-financial-results-and-host-conference-call-on-february-14-2022-301471097.html [SID1234607531]).

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Management will host a conference call on Monday, February 14, 2022 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 14, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 2728183.