On June 28, 2022 Calliditas Therapeutics AB (publ) (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas" or "the Company") reported that it has filed with the U.S. Securities and Exchange Commission (the "SEC") a registration statement including a prospectus ("Prospectus") relating to a U.S. At-the-Market framework of up to an aggregate amount of $75,000,000, pursuant to which the Company may, at its option, sell American Depositary Shares ("ADSs") in the United States at market price, from time to time, in "at the market" transactions on The Nasdaq Global Select Market (the "ATM Program") (Press release, Calliditas Therapeutics, JUN 28, 2022, View Source [SID1234616345]). If the Company chooses to use the ATM Program, the ADSs will be sold pursuant to an Open Market Sale Agreement (the "Sale Agreement") with Jefferies LLC ("Jefferies"). The timing of any potential sales under the ATM Program will depend on a variety of factors and Calliditas is not under any obligation to utilize the ATM Program in a specified amount or at all.

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The ADSs intended to be sold under the Sale Agreement, if any, will be issued and sold by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, pursuant to a shelf registration statement on Form F-3 (the "Registration Statement"), once declared effective by the SEC. The number of ADSs sold pursuant to the Sale Agreement will be limited to the number of underlying common shares approved for transfer pursuant to the shareholder authorization obtained at the annual general meeting held on May 19, 2022 in respect of maximum 5,908,019 shares being valid up until the annual general meeting 2023. Such transfers, if any, may be made effective at a price in cash which corresponds to the market price at the time of the transfer of the Calliditas shares transferred as the Board of Directors finds appropriate. No assurance can be made that sales under the ATM Program will take place. No transactions under the ATM Program will take place on Nasdaq Stockholm. As of today, Calliditas does not hold any of its own shares, but has issued 5,908,018 class C shares to Aktieinvest which the Company intends to repurchase. All C shares are pending conversion into ordinary shares before they are transferred under the ATM Program.

To the extent that ADSs are sold pursuant to the ATM Program, the Company expects to use the net proceeds primarily to fund the development of candidates from the Company’s NOX inhibitor platform, including setanaxib, in indications for which they may have therapeutic potential, including PBC and squamous carcinoma of the head and neck, or for any indications which are in early development, to fund commercial activities for TARPEYO, to fund the development of Budenofalk in AIH, and to fund the acquisition, development and commercialization of product candidates that the Company may acquire or in-license and for working capital and other general corporate purposes.

The information was sent for publication, through the agency of the contact persons set out above, on June 28, 2022 at 11:15 p.m. CEST.

The Registration Statement was filed with the SEC on June 28, 2022 and has not yet been declared effective. Any sales under the ATM Program will be made pursuant to the Prospectus relating to the ATM Program once the Registration Statement has been declared effective. Before purchasing ADSs in the offerings, prospective investors should read the Prospectus, together with the documents incorporated by reference therein. A copy of the Prospectus may be obtained on the SEC’s website at www.sec.gov. Alternatively, a copy of such Prospectus may be obtained from Jefferies LLC, Attention: Prospectus Department, 520 Madison Avenue, New York NY 10022, or by telephone at 1-877-821-7388, or by email at [email protected].

This company announcement does not and shall not constitute an offer to sell or a solicitation to buy the securities mentioned and no sale of such securities will be made in the United States, any state or province in which such offer, solicitation or sale would be unlawful until the securities are registered or their distribution is permitted under the securities laws of that state or province. In particular, no public offering of the ADSs will be made in Europe.

On June 28, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported that Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx, will participate in the virtual H.C. Wainwright Preclinical Cancer Drug Discover: Emerging Targets and Modalities Conference on Wednesday, June 29, 2022 (Press release, Ambrx, JUN 28, 2022, View Source [SID1234616344]).

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Dr. Tian will participate in a virtual presentation that will be available on demand starting on Wednesday, June 29, 2022 at 7:00 AM Pacific Time / 10:00 AM Eastern Time.

Dr. Tian will participate in a live panel discussion moderated by Robert Burns on the treatment landscape of HER2 on Wednesday, June 29, 2022 at 9:00 AM Pacific Time / 12:00 PM Eastern Time.

Interested parties can access the live and pre-recorded webcasts for these conferences from the Investor Relations section of the company’s website at www.Ambrx.com. The webcast replays will be available after the conclusion of the respective presentations for approximately 90 days.

On June 28, 2022 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule cancer therapeutics, reported that data from the ongoing Phase 1b clinical trial studying RGX-202-01 in combination with FOLFIRI and bevacizumab (FOLFIRI/BEV) in second-line advanced colorectal cancer (CRC) at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer being held June 29 through July 2, 2022 in Barcelona, Spain (Press release, Inspirna, JUN 28, 2022, View Source [SID1234616343]).

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"These clinical data continue to demonstrate the clear potential of RGX-202-01 to improve on the standard of care for patients with advanced or metastatic colorectal cancer, especially for those whose tumors harbor KRAS mutations," said Andrew Hendifar, M.D., Assistant Professor at Cedars-Sinai Medical Center and Principal Investigator on the study. "RGX-202-01 employs a novel mechanism by inhibiting the creatine transporter SLC6a8, which enables cells to generate ATP as well as other nucleotides by importing phospho-creatine (p-creatine). These results also show that KRAS mutant tumors are highly sensitive to the effects of SLC6a8 inhibition by RGX-202-01. The drug is also very well-tolerated, enabling a safe and effective combination therapy with FOLFIRI/BEV to provide further optionality for patients."

RGX-202-01 is an oral, potential first-in-class small molecule inhibitor of SLC6a8, a creatine transporter that drives colorectal cancer and certain other cancers’ progression. It is currently being evaluated in a Phase 1b dose escalation and expansion study in combination with FOLFIRI/BEV in second-line, advanced or metastatic CRC. The primary endpoint of the study is to determine maximum tolerated dose (MTD), overall response rate (ORR), and treatment-emergent adverse events (TEAEs). In the dose escalation stage of the study, two dose levels of RGX-202-01 with FOLFIRI/BEV have been evaluated in patients with advanced or metastatic CRC who have progressed on available oxaliplatin based first line therapy. In the ongoing expansion stage, additional patients with CRC are being treated at the dose of 3000mg PO BID to provide further characterization of the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the treatment.

Key findings to be presented at ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer:

Previously reported data from the study (at ASCO (Free ASCO Whitepaper) 2022) as of a data cutoff of April 28, 2022 included 19 patients who were enrolled in the study, including eight total patients in the dose escalation stage treated with either 2400mg twice daily (BID) of RGX-202-01 plus FOLFIRI/BEV (n = 4) or 3000mg BID RGX-202-01 plus FOLFIRI/BEV (n = 4), and 11 patients treated in the expansion stage with 3000mg BID RGX-202-01 plus FOLFIRI/BEV.
17 patients were evaluable for response per RECIST v1.1 at data cutoff, of which 10 patients had KRAS mutant tumors and seven patients had KRAS wild-type tumors.
In the KRAS mutant population, five patients (50%) had confirmed partial responses (PR) and five patients (50%) had stable disease (SD).
In the KRAS wild-type population, one patient (14%) had an unconfirmed PR, five patients (71%) had SD, and one patient (14%) had progressive disease (PD).
Preliminary median progression-free survival (mPFS) was 11.8 months in the enrolled patients with KRAS mutant tumors.
Tumor regression was observed to deepen over time in patients with KRAS mutant tumors, with first radiographic achievement of PR appearing as late as 40 weeks post-treatment induction.
Updates since April 28, 2022 (data cutoff date) through June 10, 2022:
Two patients with KRAS mutant tumors had follow up imaging: patient 102-3112 remains in PR status and patient 102-2407 now has SD.
Two patients with KRAS WT tumors had follow up imaging: patient 102-3121 remains in SD status and patient 103-3127 maintained SD radiographically but was declared clinical PD as per the Investigator.
The ORR remains unchanged (50% in KRAS mutant group, 14% in the KRAS WT group).
Two grade 3 TEAEs (neutropenia, pulmonary embolus) deemed unrelated to RGX-202-01.
No grade 4 or 5 TEAEs reported.
The poster is available at the Annals of Oncology website and View Source

Poster Presentation Details

Title: Phase 1b study of RGX-202-01, a first-in-class oral inhibitor of the SLC6a8/CKB pathway, in combination with FOLFIRI and bevacizumab (BEV) in second-line advanced colorectal cancer (CRC)

On June 28, 2022 Bayer reported that unveiled Calantic Digital Solutions, a new cloud-hosted platform delivering access to digital applications, including AI-enabled programs, for medical imaging (Press release, Bayer, JUN 28, 2022, View Source [SID1234616342]). The offering contains tools to help triage critical patient findings for expedited review, improve lesion detection and automate tasks. With this launch, Bayer expands its radiology portfolio beyond contrast media, devices, software and services, with the ultimate goal of supporting healthcare professionals to aid in the detection of disease patterns throughout the patient’s journey.

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The launch comes at a time when chronic diseases are on the rise, increasing the demand for medical imaging. With radiology’s increasing complexity, including a five-fold jump in the number of magnetic resonance imaging (MRI) images produced per scan, to meet workload demands, an average radiologist in some cases would need to interpret one image every 3-4 seconds in an 8-hour workday.1 Exacerbating this situation is a shortage of radiologists.2 Time pressure and workload contribute to the prevalence of burn-out among radiologists.3 In addition, data show the rate of diagnostic errors rises with long hours of overtime.4 Digital technologies can help manage the mounting workload of radiologists and their teams, ultimately striving to improve patient care.

"AI has the potential to transform healthcare, and, particularly in medical imaging, it can turn the growing amounts of data into value-adding insights to support radiologists and their teams in their decision-making," says Dr. Ryan Lee, Chair, Department of Radiology, Einstein Healthcare Network, Philadelphia. "It is crucial to drive innovation in this area and broaden access to digital tools that can help address the rising demand for solutions which improve the speed and accuracy of diagnoses."

The apps will be centered around three key areas to help manage efficiencies across the radiology workflow: triage apps to flag suspected pathologies and findings that warrant urgent review and treatment; detection apps to improve lesion detection; and quantification apps for automation of routine tasks.

"Built on our leading industry knowledge and deep medical understanding across a multitude of diagnostic and therapeutic areas, Calantic Digital Solutions underlines our commitment to continue accelerating innovation for the benefit of patients and their physicians," says Gerd Krüger, Head of Radiology, Bayer Pharmaceuticals. "With Calantic Digital Solutions, we are entering the fastest growing segment in the radiology market and taking the next step from a product provider to a solution provider, following our mission to provide an ecosystem of third-party and Bayer products to deliver innovative disease-oriented solutions for radiologists and their teams."

About Calantic Digital Solutions
Calantic Digital Solutions is a suite of digital radiology AI-enabled applications which assist radiologists and their teams at critical steps within a patient’s treatment journey. The vendor-neutral, cloud-based platform includes a growing number of applications designed to aid in prioritization, lesion detection, and quantification, as well as apps that automate routine tasks and measurements, improve the radiology suites’ workflow, and potentially free up time for radiologists and their teams. The offering is orchestrated by body region and diagnostic procedure, initially focusing on thoracic and neurological diseases, such as pulmonary nodule detection and triage of suspected intracerebral hemorrhage and large vessel occlusions. More disease-specific application packages will be added moving forward. Bayer provides services around installation, configuration, and training of the platform and its applications. First launch markets to include the US and several European countries, with more regions to follow, upon local regulatory approvals as applicable.

About AI in Medical Imaging
The radiology AI market is growing dynamically, with an estimated compound annual growth rate (CAGR) of more than 25 percent through 2025.1 Innovation powered by AI is more needed than ever: aging populations and changing lifestyles are leading to an increase in chronic conditions such as cardiovascular disease and cancer.5,6 Consequently, the demand for medical imaging to detect diseases, guide treatment decisions and support therapy planning is growing.

About Radiology at Bayer
Everyone deserves clear answers about their health, starting with an early and accurate diagnosis. As a true life-science company with a heritage of over 100 years in radiology, Bayer is committed to providing excellence, from innovative products to high-quality services. Bayer’s portfolio of contrast media for computed tomography (CT), X-Ray and magnetic resonance imaging (MRI), devices for their precise administration, informatics solutions to support efficient and optimized patient care, as well as acknowledged educational programs, generated €1.8bn sales in 2021. Following the company’s ambition to outperform the radiology market’s average annual growth of five percent until 2030, Bayer is strongly committed to research and development, including leveraging AI and driving innovation in medical imaging. Each of these offerings provide effective tools to support radiologists in their mission to deliver treatment critical answers and clear direction – from diagnosis to care.

On June 28, 2022 SonALAsense, a pioneer in the development of SONALA-001 and sonodynamic therapy (SDT), a new drug-device combination developed to manage deadly cancers so patients can become survivors, reported clinical, organizational and growth updates (Press release, SonALAsense, JUN 28, 2022, View Source [SID1234616341]). It is the only company with SDT in clinical trials .

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"At SonALAsense, we have been on a journey to develop a non-invasive treatment option for patients with rare brain cancers who often have little hope," said Mark de Souza, PhD, Founder and Chief Executive Officer. "Today we are excited to announce the culmination of our hard work as we confidently advance SDT into clinical trials as the only non-invasive drug-device combination therapy for the treatment of recurrent glioblastoma multiforme (rGBM) and diffuse intrinsic pontine glioma (DIPG)."

Clinical Update
SonALAsense is working on two trials to evaluate the therapeutic potential of SONALA-001 SDT for DIPG and rGBM. The DIPG trial is actively recruiting and the rGBM clinical trial will begin recruiting shortly.

The primary objective of the Phase 1/2 DIPG study is to evaluate the safety and tolerability of ALA SDT and determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 in patients with DIPG. This rare, and deadly, childhood brain tumor is aggressive and affects the pons or brainstem, which controls many of the body’s functions.

The Phase 2 trial in rGBM builds on positive proof of concept results from the first-in-human Phase 0/1 clinical trial of SONALA-001 SDT in recurrent high grade gliomas (rHGG) being conducted by Dr. Nader Sanai at the Ivy Brain Tumor Center. The initial results indicated that SDT rapidly led to targeted oxidative stress and cell death in human HGG tissue without off-target effects and was well tolerated in patients. The Phase 0/1 trial is continuing to enroll rHGG patients.

Growth Update
SonALAsense was founded and is led by scientific, medical and administrative professionals with decades of experience in developing and commercializing drug-device systems in photodynamic therapy and new drug therapies for rare diseases. They have assembled a diverse and exceptional team of thought leaders who are committed to improving treatment options for patients.

"We continue to expand the depth and breadth of our leadership and scientific expertise," said Stuart Marcus, MD, PhD, Founder, Chief Medical Officer, and Chief Scientific Officer at SonALAsense. "Many of my colleagues have worked alongside me for two decades, applying our accumulated knowledge as a close-knit team to efficiently bring this breakthrough technology from bench to bedside and positively impact the lives of those battling these deadly brain tumors."

Three new established individuals have joined the SonALAsense team of industry veterans. April Freeman has joined as Director of Patient Engagement and Advocacy, along with respected doctors Margaret Dugan and Graeme Woodworth who have recently joined the Scientific Advisory Board.

Ms. Freeman has more than 15 years of experience in the biotech industry, working as a patient advocate at bluebird bio and at BridgeBio where she worked closely with Dr. de Souza.

Dr. Dugan has led several drug development programs in oncology through FDA approval, including temozolomide, the standard of care in GBM. She is the former Senior VP & Global Program Head at Novartis Oncology and held clinical development positions at Schering-Plough and American Cyanamid.

Dr. Woodworth is Professor of Neurosurgery at the University of Maryland School of Medicine and Director of its Brain Tumor Treatment & Research Center. He is a leading neurosurgeon and researcher in the therapeutic potential of focused ultrasound to treat brain tumors.

Funding Update
The Company’s growth strategy continues to advance after raising $25 million funding from successful Series A and B financing rounds and a ~$2 million NCI SBIR grant to help fund the DIPG clinical trial. Proceeds from the financing have allowed the Company to build a team of R&D experts focused on advancing SDT through clinical trials for patients with rGBM and DIPG.