On May 11, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported financial results for the first quarter of 2022 (Press release, Pulse Biosciences, MAY 11, 2022, View Source [SID1234614219]).

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!

Company Updates

Increased the overall CellFX System commercial session utilization four week moving average1 during Q1 with decreasing trend in early Q2 due to transition in commercial strategy.
Appointed new commercial leadership and began initiation of the CellFX System utilization program in May with nine commercial clinics to establish commercial integration best practices. Established program goal for each clinic of 40 commercial sessions per month. Average monthly utilization of the nine participating clinics during Q1 was 14 sessions per month.
Generated first quarter 2022 revenue of $444 thousand.
Completed one commercial sale of a CellFX System in the first quarter of 2022.
Transitioned 10 Controlled Launch Program participants to commercial use in the first quarter totaling 39 commercial conversions at the end of the first quarter. There are 20 clinics remaining in the Controlled Launch program after a total of 11 clinics have opted out as of the end of Q1.
Met with FDA regarding the Additional Information (AI) letter response to the sebaceous hyperplasia 510(k). Provided additional analysis of the clinical data following the meeting, at FDA’s request, and anticipate further communication prior to any formal response to the AI letter.
1 Utilization is measured as commercial sessions defined as individual patient treatments, regardless of the number of lesions treated, performed using CellFX Systems that have been purchased or converted to commercial use from the controlled launch program.

"In the first quarter of 2022 we took steps to refocus our CellFX dermatology efforts by bringing in new commercial leadership. We have prioritized increasing CellFX System utilization at a subset of our commercial clinics, with the goal of developing commercial integration best practices that will drive utilization across all clinics. While these best practices are being established there will be a reduced focus on capital sales," said Darrin Uecker, President and CEO of Pulse Biosciences. "We also continue to prioritize indication expansion for the CellFX System and are actively working with FDA on this process."

First Quarter 2022 Results

Revenue for the three months ended March 31, 2022 was $444 thousand. System revenue for the three months ended March 31, 2022 was $367 thousand. Cycle units revenue for the three months ended March 31, 2022 was $77 thousand resulting from the purchase of cycle units to be used with commercial systems. Total revenues of $331 thousand were recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems during the quarter.

Total GAAP cost and expenses representing cost of revenues, research and development, sales and marketing and general and administrative expenses for the three months ended March 31, 2022 were $17.7 million, compared to $18.5 million for the prior year period. Non-GAAP cost and expenses for the three months ended March 31, 2022 were $14.7 million, compared to $11.3 million for the same period in the prior year. The year-over-year increase in non-GAAP cost and expenses was primarily driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities. The first quarter of 2022 also included a discrete restructuring charge of $733 thousand, of which $706 thousand remains in accrued expenses as of March 31, 2022.

GAAP net loss for the three months ended March 31, 2022 was ($17.3) million compared to ($18.6) million for the three months ended March 31, 2021. Non-GAAP net loss for the three months ended March 31, 2022 was ($14.2) million compared to ($11.4) million for the three months ended March 31, 2021.

Cash, cash equivalents and investments totaled $12.7 million as of March 31, 2022 compared to $59.9 million as of March 31, 2021 and $28.6 million as of December 31, 2021. Cash used in the first quarter of 2022 totaled $15.9 million compared to $10.7 million used in the same period in the prior year and $13.4 million used in the fourth quarter of 2021.

Reconciliations of GAAP to non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, May 11, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source

On May 11, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its senior management team are scheduled to participate in the following upcoming investor conferences (Press release, Innate Pharma, MAY 11, 2022, View Source [SID1234614237]):

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!

H.C. Wainwright Annual Global Life Sciences Conference
Event Date: May 23-25, 2022
Citi’s European Healthcare Conference
Event Date: June 16, 2022

On May 11, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with companies to develop and commercialize innovative products in the U.S., reported financial results for the first quarter ended March 31, 2022 (Press release, Tracon Pharmaceuticals, MAY 11, 2022, View Source [SID1234614259]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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!

"We are pleased with the pace of enrollment under the amended ENVASARC protocol and remain on track to deliver interim efficacy data in the second half of this year," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Additionally, with the arbitration hearing now completed we look forward to the outcome of the binding arbitration for the TJ4309 and Bispecific Antibody agreements during the second half of this year. We also continue preparations to initiate dosing of the Phase 1/2 clinical trial of envafolimab with our potential best-in-class CTLA-4 antibody, YH001, as well as doxorubicin chemotherapy in the second half of 2022."

Recent Corporate Highlights

In March, we announced the amended ENVASARC protocol using a higher dose of envafolimab was approved by the FDA.

In April, we announced the amended ENVASARC protocol was approved by internal review boards or ethic committees at each of the 30 clinical sites in the U.S. and U.K. and that all sites were open for enrolment, with more than 10 patients enrolled.
Expected Key Upcoming Milestones

Two interim safety reviews and the interim efficacy data review by the ENVASARC Independent Data Monitoring Committee (IDMC) in the second half of 2022.

Initiate dosing of a Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001 as well as with doxorubicin chemotherapy in the second half of 2022.

Report the International Chamber of Commerce (ICC) Arbitration Panel’s binding decisions on the legal disputes involving the TJ4309 and bispecific antibody agreements with I-Mab this year.

Complete the TJ4309 Phase 1 trial permitting I-Mab the opportunity to terminate the license for $9M this year.

Initiate dosing of a randomized Phase 2 trial of TRC102 in locally advanced non-small cell lung cancer sponsored and funded by the National Cancer Institute this year.
First Quarter 2022 Financial Results

Cash, cash equivalents and short-term investments were $16.6 million at March 31, 2022, compared to $24.1 million at December 31, 2021. The Company expects that its current cash and cash equivalents will fund operations into 2023.

Research and development expenses for the first quarter of 2022 were $3.0 million, compared to $2.3 million for the first quarter of 2021.

General and administrative expenses for the first quarter of 2022 were $6.5 million, compared to $2.7 million for the first quarter of 2021. The increase was primarily attributable to legal expenses incurred due to the arbitration hearing held in February 2022 with I-Mab related to the TJ4309 and bispecific antibody agreements, and the Company expects general and administrative expenses to decrease significantly for the remainder of the year.

Net loss for the first quarter of 2022 was $9.5 million, compared to $5.1 million for the first quarter of 2021.
Conference Call Details

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On May 11, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the financial results and corporate updates for the first quarter 2022 (Press release, Evotec, MAY 11, 2022, View Source [SID1234614176]).

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!

HIGHLIGHTS
STRONG REVENUE GROWTH IN ALL BUSINESS AREAS FUELLED BY ONGOING EXPANSION AND STRENGTHENS POSITIVE DEVELOPMENT
Group revenues increased by 24% to € 164.7 m (Q1 2021: € 133.1 m); like-for-like base revenue growth (excluding fx effects) up 19%
Revenues from milestones, upfronts and licenses of € 4.5 m above last year (Q1 2021: € 4.4 m)
Strong progress in both segments: Total EVT Execute revenues up 27% to € 174.5 m (Q1 2021: € 136.9 m); EVT Innovate revenues also up 27% to € 35.9 m (Q1 2021: € 28.2 m)
Adjusted Group EBITDA of € 18.9 m (Q1 2021: € 21.1 m) primarily driven by capacity expansions at all sites, in particular the continued ramp-up of our J.POD Redmond (US) facility, an increase in unpartnered R&D (up 12%), partially offset by positive currency effects
Other non-operating result of € (69.2) m (Q1 2021: € 47.7 m) affected from a non-cash fair value adjustments of the equity participation in public listed Exscientia plc.

SETTING THE PACE WITH PRECISION MEDICINE PLATFORMS
New data-driven drug discovery collaboration with Eli Lilly and Company ("Lilly") in metabolic diseases
Drug discovery partnership with Boehringer Ingelheim in ophthalmology based on induced pluripotent stem cells ("iPSCs")
Launch of Evotec’s translational molecular patient database E.MPD, one of the largest and highest quality molecular databases globally
Further strong progress in neuroscience and oncology collaboration with Bristol Myers Squibb ("BMS")
Strong growth momentum in all areas e.g., new INDiGO agreements, CMC, screening and sample management alliances as well as several new integrated drug discovery & development alliances
Grant from BMBF to support clinical development of EVT075 in viral indications
Bayer initiated Phase II of bradykinin receptor B1 BAY 2395840 in diabetic neuropathic pain but also terminated further development of P2X3 antagonist eliapixant
Expansion of licensing agreement with JingXin for EVT201, submission of regulatory approval in China through JingXin (after period-end)
Successful expansion of the EVOequity portfolio with new equity stakes in several highly promising companies (e.g., Tubulis; after period-end)

CORPORATE
Dr Matthias Evers joins Evotec as Chief Business Officer (after period-end)

BUSINESS OUTLOOK FOR FULL-YEAR 2022 AND MID-TERM TARGETS 2025 CONFIRMED
Group revenues expected to be in a range of € 700 – 720 m (€ 690 – 710 m at constant exchange rates) (2021: € 618 m)
Adjusted Group EBITDA expected to be in the range of € 105 – 120 m (€ 95 – 110 m at constant exchange rates) (2021: € 107 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58 m)
Mid-term goals target revenue growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m by 2025
The forecast takes in account – as far as possible – the current global uncertainties related to the COVID-19 pandemic and the Russian invasion of Ukraine.

Webcast/Conference Call

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details
To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.
The on-demand version of the webcast will be available on our website: View Source

On May 11, 2022 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its third quarter, fiscal year 2022 operating results on Tuesday, May 17, 2022, before the open of the U.S. financial markets (Press release, Palatin Technologies, MAY 11, 2022, View Source [SID1234614220]).

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!

Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on May 17, 2022, at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source