On May 17, 2022 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported unaudited financial results for the first quarter 2022 (Press release, EDAP TMS, MAY 17, 2022, View Source [SID1234614814]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "As we announced in our business update press release just a few weeks ago, the first quarter was one in which the positive impact of our new U.S. organization, led by CEO Ryan Rhodes, was featured prominently. We ended 2021 on a strong note and continued that momentum into Q1 by adding three more highly regarded U.S. academic medical centers to our client roster, including New York-Presbyterian/Weill Cornell Medical Center, Beth Israel Deaconess Lahey Health, an affiliate of Harvard Medical School, and University of California Davis Medical Center in Sacramento. We also sold a Focal One outside of the U.S.

"Combined with another strong quarter from our distribution business, we grew revenue 26% year-over-year in the first quarter. We have a very rich pipeline of US prospects – both academic medical centers and community hospitals – and I am confident that we will continue to convert these to Focal One reference sites this year as acceptance of focal therapy as a treatment option within the urology suite continues to gain acceptance."

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, "2022 represents the first year in which we entered the year with a right-sized U.S. organization capable of capturing the significant untapped opportunity at a time when more and more urologists are recognizing the value of HIFU along the prostate cancer care continuum. The interest in our technology that we saw at last week’s American Urology Association meeting confirms that we are in the right place at the right time, with a cutting-edge platform that can truly make a positive difference in the lives of prostate cancer patients. I believe we are set up for a successful year even while we continue to make measured investments in our U.S. infrastructure."

First Quarter 2022 Results

Total revenue for the first quarter 2022 was EUR 13.0 million (USD 14.5 million), an increase of 26% as compared to total revenue of EUR 10.3 million (USD 12.4 million) for the same period in 2021.

Total revenue in the HIFU business for the first quarter 2022 was EUR 3.8 million (USD 4.3 million), as compared to EUR 1.8 million (USD 2.2 million) for the first quarter of 2021. The increase was driven by four Focal One units sold in the first quarter 2022 versus zero units sold in the first quarter 2021.

Total revenue in the LITHO business for the first quarter 2022 was EUR 2.2 million (USD 2.5 million), as compared to EUR 2.9 million (USD 3.5 million) for the first quarter of 2021. The decline was driven by one lithotripsy unit sold in the first quarter of 2022 as compared to six units sold in the first quarter of 2021.

Total revenue in the Distribution business for the first quarter 2022 was EUR 7.0 million (USD 7.8 million), as compared to EUR 5.6 million (USD 6.7 million) for the first quarter of 2021. The increase was driven primarily by nine ExactVu units sold during the first quarter of 2022 as compared to five units sold during the first quarter of 2021.

Gross profit for the first quarter 2022 was EUR 5.8 million (USD 6.4 million), compared to EUR 4.4 million (USD 5.2 million) for the year-ago period. Gross profit margin on net sales was 44.3 % in the first quarter of 2022, compared to 42.4% in the year-ago period.

Operating expenses were EUR 5.9 million (USD 6.6 million) for the first quarter of 2022, compared to EUR 4.1 million (USD 5.0 million) for the same period in 2021.

Operating loss for the first quarter of 2022 was EUR 0.1 million (USD 0.1 million), compared to an operating profit of EUR 0.2 million (USD 0.3 million) in the first quarter of 2021.

Net income for the first quarter of 2022 was EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share, as compared to net income of EUR 0.8 million (USD 0.9 million), or EUR 0.03 per diluted share in the year-ago period.

As of March 31, 2022, the company held cash and cash equivalents of EUR 46.5 million (USD 51.6 million) as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, May 18, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On May 17, 2022 Diffusion Pharmaceuticals Inc.(NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that Robert Cobuzzi, Jr., Ph.D., the Company’s President and Chief Executive Officer, will be presenting at the H.C. Wainwright Global Investment Conference being held at the Fontainebleau Miami Beach Hotel from May 23-26, 2022 (Press release, Diffusion Pharmaceuticals, MAY 17, 2022, https://www.diffusionpharma.com/press-release/diffusion-pharmaceuticals-to-present-at-h-c-wainwright-global-investment-conference/ [SID1234615256]).

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The presentation will be virtual and will provide an overview of recent business and corporate achievements at Diffusion, including an update on TSC clinical trials.

Details of the presentation are as follows:

Date & Time: On demand, beginning 7.00 a.m. ET, Tuesday, May 24, 2022

A replay of the presentation will be available under the presentations section of the Company website at www.diffusionpharma.com. In addition, Dr. Cobuzzi will be available for one-on-one meetings during the conference. Registered investors will be able to request a meeting with management via the conference portal.

On May 16, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the first quarter of 2022 (Press release, Hookipa Biotech, MAY 16, 2022, View Source [SID1234614590]).

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"We observed strong external validation of our novel arenaviral platform in the first quarter with our collaboration agreement with Gilead and our capital raise, which drew funding from new and existing top-tier investors," said Joern Aldag, Chief Executive Officer at HOOKIPA. "On the heels of our AACR (Free AACR Whitepaper) data presentations, which showcased T cell and tumor response with our technology alone and in novel combinations, we remain focused on advancing our portfolio across cancer types. We look forward to sharing Phase 1 data from our HB-200 program mid-year and early Phase 2 data on HB-200 in combination with pembrolizumab in late 2022, as well as progressing with IND preparations for our HB-300 program in prostate cancer."

Quarter Highlights

In January 2022, the first patient was dosed in the Phase 2 trial to assess HB-200 in combination with pembrolizumab as 1st-line and 2nd-line treatment for advanced head and neck squamous cell carcinoma (HNSCC). Results from the ongoing Phase 1 study have highlighted the potential additive benefits of this combination to improve anti-tumor response. Preliminary data is anticipated in the second half of 2022.

In February 2022, HOOKIPA and Gilead agreed to advance its partnered HIV program, triggering a $54 million commitment from Gilead. HOOKIPA assumed development responsibility for the HB-500 program through the completion of a Phase 1b clinical trial; Gilead has the exclusive right for further development thereafter. Financial terms included a $4 million preclinical milestone, a $15 million non-refundable initiation fee and $35 million equity commitment at a premium to market price. The $35 million equity commitment includes a first tranche of $5 million (purchased at a $3 share price on February 15) and the remaining $30 million can be drawn at a 30 percent premium in a second tranche or at market price in a third tranche. If Gilead pursues further development, HOOKIPA is entitled to potential development and sales milestone payments exceeding $237 million, as well as royalties on net product sales.

Klaus Orlinger, Ph.D. was named Chief Scientific Officer. He was promoted from his previous role as Executive Vice President, Research. Klaus has played a leading role in the development of novel arenaviral immunotherapies and advancing them to the clinic since he joined the company in 2012.

In March 2022, HOOKIPA announced the acceptance of four poster presentations on preclinical, translational and clinical biomarker data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April. The data provided further evidence of the potential of the arenaviral platform in various cancers, either alone or with other modalities. Specifically, the data showed:

the combination of co-stimulatory 4-1BB agonists with arenaviral immunotherapy in a preclinical setting increased tumor control and resulted in a higher cure rate than arenaviral immunotherapy alone;
replicating immunotherapy sequentially combined with adoptively transferred TCR transgenic T cells resulted in tumor cures in a preclinical setting;
arenaviral immunotherapy was able to overcome immune tolerance, induce potent T cell responses against two different tumor self-antigens and reduce tumor growth in these cancers in a preclinical setting;
HB-200 induced robust antigen-specific T cells that were high quality, expanding on previously reported data in patients with Human Papillomavirus 16-positive (HPV16+) head and neck cancer. Additional Phase 1 data, including the recommended Phase 2 dose for HB-202/HB-201 was recently accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June.

In April, HOOKIPA reported the addition of Tim Reilly, Ph.D. to its Board of Directors. Tim brings extensive product development experience to the Board.
Upcoming Milestones

Phase 1 HB-200 data in HPV16+ head and neck cancer: Mid-2022
Phase 2 HB-200 data in combination with pembrolizumab in HPV16+ head and neck cancer:
1st-line initial data: 2H 2022
2nd-line initial data: 2H 2022
Randomized Phase 2 HB-200 study in combination with pembrolizumab in 1st line for HPV16+ HNSCC: 1H 2023 (Fast Track designation)
Prostate cancer IND: 3Q 2022
Hepatitis B therapeutic IND: 2022 (Gilead-led)
First Quarter 2022 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of March 31, 2022 was $141.8 million compared to $66.9 million as of December 31, 2021. The increase was primarily attributable to funds resulting from the amended and restated Gilead collaboration agreement, and the follow-on financing in March 2022, partly offset by cash used in operating activities.

Revenue was $1.4 million for the three months ended March 31, 2022, and $5.3 million for the three months ended March 31, 2021. The decrease was primarily due to lower cost reimbursements received under the Collaboration Agreement with Gilead and the fact that the $4.0 million milestone payment and the $15.0 million initiation fee received in the three months ended March 31, 2022 were mostly recorded as deferred revenue to be recognized in future accounting periods.

Research and Development Expenses: HOOKIPA’s research and development expenses were $16.6 million for the three months ended March 31, 2022, compared to $20.2 million for the three months ended March 31, 2021.

The decrease for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 was attributable to a decrease in direct research and development expenses, partially offset by an increase in indirect research and development expenses.

The decrease in direct research and development expenses was primarily driven by lower manufacturing expenses for our HB-200 and Gilead partnered programs and lower clinical study expenses due to the completion of patient enrollment of the Phase 2 study for our HB-101 program. Indirect research and development expenses increased slightly because of an increase in professional and consulting fees, partially offset by a decrease in personnel related costs.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2022 were $5.0 million, compared to $4.3 million for the three months ended March 31, 2021. The increase was primarily due to an increase in professional and consulting fees, and an increase in personnel-related expenses, partially offset by a decrease in other expenses. The increase in personnel-related expenses resulted from increased stock compensation expenses, a growth in headcount along with increased salaries in our general and administrative functions. The increase in professional and consulting fees was primarily attributable to intellectual property costs incurred in connection with filing and prosecuting patent applications as well as third-party license fees.

Net Loss: HOOKIPA’s net loss was $18.0 million for the three months ended March 31, 2022 compared to a net loss of $17.2 million for the three months ended March 31, 2021. This increase was due to a decrease in revenues from collaboration and licensing, a decrease in grant income, an increase in general and administrative expenses, partially offset by a decrease in research and development expenses.

On May 16, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity" or the "Company"), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, Celularity, MAY 16, 2022, View Source [SID1234614639]).

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"We have continued to achieve multiple transformational milestones and make significant progress this year with three ongoing Phase 1 clinical trials of two investigational drugs, CYNK-001 and CYNK-101, both of which have been granted Fast Track and Orphan Drug Designations for certain indications," said Robert J. Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity. We expect to have data readouts for all three ongoing Phase 1 programs later this year. As such, we believe we are well-positioned to continue executing our business strategy and developing cellular therapies for cancer, infectious and degenerative diseases that leverage our proprietary placental-based technology platform."

First Quarter Clinical and Regulatory Updates

CYNK-001 for the Treatment of AML and GBM:

CYNK-001 is Celularity’s unmodified cryopreserved human placental hematopoietic stem cell-derived NK cell therapy candidate that is enriched with CD56+/CD3- NK cells and expanded from human placental CD34+ cells. CYNK-001 is currently being investigated in two Phase 1 clinical trials, in AML and in GBM, with data readouts expected in the second half of 2022.
Celularity continues to enroll new cohorts in both arms of the Phase 1 AML study with clinical trial protocol adjustments communicated in December 2021, which include an addition of interleukin-2 (IL-2) to the treatment regimen; a fourth dose on day 21; and an increase in the dose of NK cells.
CYNK-101 for the Treatment of Gastric Cancer:

CYNK-101 is a novel allogeneic off-the-shelf human placental CD34+-derived NK cell product candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. CYNK-101 is currently being investigated in the Phase 1 portion of a Phase 1/2a clinical trial in advanced HER2+ gastric cancer.
In January 2022, the FDA granted Fast Track designation to CYNK-101, which is being developed in combination with standard chemotherapy, trastuzumab and pembrolizumab in first-line locally advanced unresectable or metastatic HER2/neu positive gastric/gastroesophageal (G/GEJ) adenocarcinoma.
In February 2022, the FDA granted Orphan Drug Designation to CYNK-101 for the treatment of G/GEJ cancer.
CYCART-19 for the Treatment of B-Cell Malignancies:

CYCART-19 is an allogeneic Chimeric Antigen Receptor (CAR) engineered human placental-derived T cell that is a potential drug candidate in B-cell malignancies.
Preclinical data demonstrating the feasibility and functionality of expressing a CAR directed to CD19 on placental CD34+derived, cryopreserved, off-the-shelf, allogeneic CYNK cells were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021.
Celularity submitted an Investigational New Drug (IND) application to FDA to investigate CYCART-19 for the treatment of B-cell malignancies in the first quarter of 2022 and in April 2022, received email notification from FDA that it will be requesting additional information before Celularity can proceed with the planned Phase 1/2 clinical trial. Celularity anticipates a formal written communication by late May 2022 and plans to work with the FDA in an effort to resolve its questions as promptly as possible and, if the IND is cleared, commence a Phase 1/2 clinical trial of CYCART-19 in B-cell malignancies in the second half of 2022.
First Quarter 2022 Financial Results

Cash and Cash Equivalents: Cash, cash equivalents and marketable securities were $48.0 million as of March 31, 2022, compared to $37.2 million as of December 31, 2021. In March 2022, we amended and restated certain warrants to reduce the exercise price per share to $3.50 per share, among other items, following which the holders exercised such warrants in full for cash for approximately $46.5 million and we issued the holders an aggregate 13,281,386 shares of our Class A common stock.
Total Revenues: Total revenues were $5.9 million for the first quarter of 2022, compared to $2.7 million for the first quarter of 2021. This increase in revenues was primarily driven by sales activity from supply and distribution agreements for Celularity’s degenerative disease products.
Research & Development (R&D) Expenses: R&D expenses were $21.7 million for the first quarter of 2022, compared to $17.0 million for the first quarter of 2021. The increase was primarily driven by higher clinical development expenses.
Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $16.5 million for the first quarter of 2022, compared to $7.6 million for the first quarter of 2021. The increase in SG&A expenses was primarily caused by higher expenses related to being a public company, such as stock-based compensation, insurance and consulting fees.
Net loss: Net loss for the first quarter of 2022 was $62.9 million, or $(0.48) per share for both basic and diluted shares. Net loss for the first quarter of 2021 was $81.5 million, or $(3.40) per share for both basic and diluted shares.

On May 16, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the first quarter ended March 31, 2022 and provided recent corporate updates (Press release, Galera Therapeutics, MAY 16, 2022, View Source [SID1234614655]).

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"We are excited to announce our plan to submit an NDA for avasopasem by year end following discussions with the FDA," said Mel Sorensen, M.D., Galera’s President and CEO. "Based on the positive data readout from our Phase 3 ROMAN trial, Galera continues to execute on its development strategy to advance its lead program, avasopasem, toward potential commercialization. To that end, we are delighted to attend the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting where our ROMAN data will be highlighted in an oral presentation. In addition, we recently announced positive topline data from our Phase 2a AESOP study of avasopasem for chemoradiotherapy-induced esophagitis in patients with lung cancer. We are encouraged by these results, which further demonstrate avasopasem’s ability to reduce radiation toxicity in high-risk patient populations."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

The Company announced plans to submit a New Drug Application (NDA) for avasopasem, its lead product candidate, for the treatment of radiotherapy-induced SOM to the U.S. Food and Drug Administration (FDA) by the end of 2022.
An abstract on the Phase 3 ROMAN data of avasopasem for SOM was accepted for an oral presentation on June 3rd at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Esophagitis

The Company reported positive topline data from the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy. Overall, avasopasem was well tolerated and the incidence of Grade 3 esophagitis was substantially reduced in comparison to literature. No patients experienced Grade 4 or 5 esophagitis at any point during the trial.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

Enrollment is ongoing in the Phase 2b, 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of rucosopasem, Galera’s second dismutase mimetic product candidate, in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival.
A Trials in Progress abstract on GRECO-2 was accepted for presentation at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
First Quarter 2022 Financial Highlights

Research and development expenses were $8.1 million in the first quarter of 2022, compared to $12.4 million for the same period in 2021. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.
General and administrative expenses were $5.0 million in the first quarter of 2022, consistent with the first quarter of 2021.
Galera reported a net loss of $(15.4) million, or $(0.58) per share, for the first quarter of 2022, compared to a net loss of $(18.7) million, or $(0.75) per share, for the same period in 2021.
As of March 31, 2022, Galera had cash, cash equivalents and short-term investments of $60.9 million. Galera expects that its existing cash, cash equivalents and short-term investments will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2023.