On March 31, 2022 Insud Pharma reported that it has entered into an agreement with Fresenius Kabi (Press release, mAbxience, MAR 31, 2022, View Source [SID1234611328]). Under the terms of the agreement Fresenius Kabi will acquire 55% of mAbxience, the global fully-fledged biotech company of the Spanish group.

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Founded in 2010, mAbxience has over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. The company operates three state-of-the-art and R&D manufacturing facilities, located in Spain and Argentina, and has been developing a range of biopharmaceutical products focused on multiple therapeutic areas. mAbxience also offers contract development and manufacturing (CDMO) services to customers.

The company has successfully established alliances with key partners which have enabled multiple biosimilars to be launched across international markets allowing patients access to high quality biopharmaceutical products on a global basis.

As a result of this agreement, mAbxience will continue its ambitious growth plans and will keep its well-defined corporate identity, and team of around 600 professionals, ensuring continuity of its current business strategy. The boards of directors of both companies have unanimously approved the transaction, which is expected to close by midyear 2022, subject to regulatory and other conditions customary for a transaction of this type.

With this alliance, Insud Pharma plans to accelerate its biotech unit, bringing new and exciting opportunities to mAbxience customers and increasing its research activities – at the beginning of May, it is expected to open a new R&D facility in Spain-.

Furthermore, this transaction will be meaningful for the Spanish group Insud Pharma, which will continue to grow and invest worldwide, whilst entering into new activities.

"We’re delighted to announce our combination with Fresenius Kabi for the future development of mAbxience. This collaboration recognizes mAbxience’ s capabilities in biopharmaceuticals and our strong team of dedicated employees. This transaction is a tremendous opportunity to add further value to the industry, to make mAbxience bigger and stronger and to collaborate and work together with a company such as Fresenius Kabi", stated Lucas Sigman, CEO at Insud Pharma.

"mAbxience is the perfect example of how innovation, cutting-edge R&D and manufacturing platform technology is used to deliver high quality medicines to patients, provide cost-effective alternatives to healthcare systems and guarantee its sustainability. Today’s announcement is testament to the hard work of our people that have grown mAbxience from its inception to the leading business it is today", stated Sigman.

He continued "Furthermore, this is also great news for Insud Pharma. This transaction will give our company the chance to continue investing more and to open the door to faster expansion into new areas and opportunities. As joint partners with Fresenius Kabi, we fully expect to further accelerate our mission to deliver affordable medicines to patients worldwide", stated Sigman.

Emmanuelle Lepine, mAbxience CEO, said "We believe this new strategic partnership with Fresenius Kabi represents the best possible next step in line with mAbxience´s strategic growth plan. This partnership will allow the further progression of our development pipeline and will enable the acceleration of our capacity expansion, both of which will benefit patients, customers, and health systems. This new stage in the evolution of our company will bolster opportunities to grow our biopharmaceutical platform in key areas of high technological development and manufacturing, as well as accelerate access in strategic markets, adding a key collaboration to our already strong global partnership base".

She continued "Driven by a shared value in people and purpose, this partnership with Fresenius Kabi will enable mAbxience to advance towards its vision of bringing biopharma solutions that are Affordable, Accessible and Across the globe. We are convinced that this partnership will enhance our commitment to the long-term sustainable growth potential for the business and will be highly beneficial to the growth and development of the whole team".

Goldman Sachs acted as exclusive financial advisor to Insud Pharma, while Baker McKenzie acted as legal advisor.

On March 31, 2022 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to defeating cancer using RNA therapeutics, reported financial results for 2021 and recent business progress (Press release, TransCode Therapeutics, MAR 31, 2022, View Source [SID1234611344]).

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"2021 was a foundational year for TransCode, highlighted by our successful IPO on Nasdaq in July," said Michael Dudley, co-founder, president and CEO of TransCode. "With resources from the IPO, as well an important Small Business Innovation Research (SBIR) grant, we drove significant progress across the organization, including key additions to our team that bring valuable expertise, and continued advancement of our lead candidate and our preclinical development programs. We are now building on this foundation as we move toward clinical development which we expect will demonstrate the power and versatility of our TTX platform in solving the challenges of RNA delivery in oncology."

TransCode Therapeutics co-founder and Chief Technology Officer, Dr. Zdravka Medarova, added, "We are on track to submit an exploratory Investigational New Drug Application (eIND) this year to test our lead therapeutic candidate, TTX-MC138, in a Phase 0 study in metastatic solid tumors. We believe this study has the potential to establish proof-of-mechanism for our platform, upon which we hope to build a broad and diverse pipeline of therapeutics and diagnostics with the potential to reach previously undruggable genetic targets."

Key 2021 Highlights

·Completed an over-subscribed initial public offering on Nasdaq in July, raising gross proceeds of $28.8 million; the Company’s outstanding convertible promissory notes were converted into common stock upon completion of the IPO.

·Expanded the leadership team with the appointment of TransCode’s scientific co-founder, Zdravka Medarova, Ph.D., as Chief Technology Officer effective October 1. Dr. Medarova is a leader in the field of non-coding RNA delivery to cancer and has authored multiple high-impact publications on the topic of RNA delivery, nanotechnology, and the biology of cancer metastasis. Leadership team further strengthened in 2021 with additional key appointments, including:

Susan Duggan as VP of Clinical Operations, Dustan Bonnin as VP of Corporate Strategy and Subrata Ghosh, Ph.D, as Principal Scientist; and
Dejan Juric, M.D., appointed to the Scientific Advisory Board. Dr. Juric, a renowned expert in personalized cancer medicine and a breast cancer specialist, serves as director of the Henri and Belinda Termeer Center for Targeted Therapies and Investigational Cancer Therapeutics Program at Massachusetts General Hospital.

·Awarded a Fast-Track Small Business Innovation Research (SBIR) grant from National Institutes of Health (NIH), totaling $2.3 million. The award is a fast track award based on milestones achievement, to support the clinical evaluation of TTX-MC138, including translational experiments to identify and optimize a method for measuring miR-10b expression in breast cancer clinical samples, as well as IND-enabling activities and measurement of delivery of TTX-MC138.

Expected Upcoming Milestones

TransCode’s goals to continue to advance its portfolio include:

·TTX-MC138

Submission to FDA of an eIND application for First-in-Human (FIH) clinical trial.
Initiation of a FIH Phase 0 clinical study evaluating delivery of TTX-MC138 to metastatic lesions in 10 Stage IV patients with solid tumors
Concurrent completion of IND-enabling studies to support filing of an IND application for a Phase I clinical trial of TTX-MC138.

·Publication of preclinical results supporting the lead therapeutic candidate TTX-MC138 in pancreatic cancer and glioblastoma multiforme.

·Continuation of preclinical studies for therapeutic candidates TTX-RIGA, TTX-siPDL1, and TTX-siLin28b.

2021 Financial Highlights (in millions)

•Cash: $ 20.8
•R&D Expenses: $ 2.8
•G&A Expenses: $ 3.4
•Operating Loss: $ 6.8

Financial Guidance

TransCode expects that its cash of $20.8 million as of December 31, 2021, together with additional funding expected from an April 2021 SBIR award, are sufficient to fund planned operations into the first quarter 2023 but not for a full 12 months from the date of our financial statements.

Conference Call

The Company will host an investor conference call at 4:30 p.m. ET on April 7, 2022. A question-and-answer session will follow management’s presentation.

If you are unable to participate during the live call, the call will be recorded and later made available on the Company’s website.

On March 31, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, will participate in a panel to discuss new approaches of treating acute myeloid leukemias (AML) at Canaccord Genuity’s 2022 Horizons in Oncology Virtual Conference (Press release, Aptose Biosciences, MAR 31, 2022, View Source [SID1234611237]):

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Canaccord Genuity’s 2021 Horizons in Oncology Virtual Conference

•Panel: Attacking AML: New Approaches

Date: Thursday, April 14, 2022
Time: 1:30 – 2:30 PM ET
Format: Panel Moderated by John Newman, Ph.D., Managing Director, Biotechnology Analyst
Webcast: Link
The audio webcast also will be accessible through the Aptose website at www.aptose.com and will be archived shortly after the live events.

The Aptose management team will be hosting 1×1 investor meetings during the event.

On March 31, 2022 Nirogy Therapeutics, a biopharmaceutical company focused on oncology and Immune diseases, reported that presented at the Cancer Immunotherapy: Decoding the cancer immunity interactome, Keystone Conference that took place from March 21-25, 2022 (Press release, Nirogy Therapeutics, MAR 31, 2022, View Source [SID1234611276]).

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A poster highlighting pre-clinical data of a small molecule dual inhibitor of lactate transporters demonstrates the potential of immune activation in the TME by differential metabolic reprogramming of various immune cells in the TME on treatment with the compound.

nirogy therapeutics to- present at keystone symposia on cancer immunotherapy decoding the cancer immunity interactome british columbia canada
The conference poster presentation "A dual MCT1 and MCT4 inhibitor blocking lactate transport impacts human immune cell response under conditions mimicking the tumor microenvironment" is available on our website at View Source

On March 31, 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 fourth quarter and full year of 2021 (Press release, Pulse Biosciences, MAR 31, 2022, View Source [SID1234611292]).

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Company Updates

Implemented changes to commercial leadership, salesforce and strategy, to focus on increasing commercial clinic utilization and over near-term reducing emphasis on new system sales.

Appointed two medical technology industry veterans to commercial leadership positions; Kevin Danahy to the newly created role of Chief Commercial Officer and Joe Talarico as Vice-President of North American Sales.

Initiated operating expense reduction programs, including workforce reductions, expected to lower costs by approximately 20% from the current run rate, resulting in expected 2022 operating expenses in line with 2021.

Achieved fourth quarter 2021 revenue of $844 thousand and full year 2021 revenue of $1.4 million.

Completed the first three commercial sales of CellFX Systems, two in the fourth quarter of 2021 and one in the first quarter of 2022.

Transitioned 17 Controlled Launch Program participants to commercial use in the fourth quarter and expect an additional 10 participants to transition in the first quarter, resulting in 39 total commercial conversions at the end of the first quarter.

20 clinics remain in the Controlled Launch program after a total of 11 clinics have opted out at the end of Q1.

FDA meeting expected in Q2 2022 to discuss Additional Information letter regarding the sebaceous hyperplasia 510(k).

"2021 included a number of milestones for Pulse Biosciences, including regulatory approvals in the U.S., Europe, Canada and Australia, onboarding 70 Controlled Launch Program participants, the transition of 29 clinics to commercial use, and sales of our first two commercial CellFX Systems," said Darrin Uecker, President and CEO of Pulse Biosciences. "In 2022, our focus is on increasing utilization at commercial clinics to develop CellFX reference centers for the benign lesion market under new commercial leadership. At the same time, we will remain focused on expanding the CellFX System’s indications for use in dermatology and beyond."

Fourth Quarter 2021 Results

Revenue for the three months ended December 31, 2021 was $844 thousand. System revenue for the three months ended December 31, 2021 was $699 thousand, with approximately $600 thousand recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems. Cycle units revenue for the three months ended December 31, 2021 was $145 thousand resulting from the purchase of cycle units to be used with commercial systems.

Total GAAP gross loss* for the three months ended December 31, 2021 was ($0.4) million. Excluding non-cash expenses for stock-based compensation and depreciation and amortization, non-GAAP gross loss for the three months ended December 31, 2021 was ($0.3) million. Following the transition to commercial operations in the third quarter of 2021, all uncapitalized manufacturing operations costs are now recorded in cost of revenue. Prior to commercialization, these costs were recorded in research and development expenses.

Total GAAP operating expenses representing research and development, sales and marketing and general and administrative expenses for the three months ended December 31, 2021 were $15.0 million, compared to $13.8 million for the prior year period. Non-GAAP operating expenses for the three months ended December 31, 2021 were $11.2 million, compared to $11.1 million for the same period in the prior year. The year-over-year increase in operating expenses was primarily driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities offset by uncapitalized manufacturing operations costs now recorded in cost of revenue.

GAAP net loss for the three months ended December 31, 2021 was ($15.4) million compared to ($13.8) million for the three months ended December 31, 2020. Non-GAAP net loss for the three months ended December 31, 2021, was ($11.5) million compared to ($11.1) million for the three months ended December 31, 2020.

Full Year 2021 Results

Revenue for the full year of 2021 was $1.4 million. System revenue for the full year of 2021 was $1.2 million including $1.1 million recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems. Cycle units revenue for the full year of 2021 was $229 thousand resulting from the purchase of cycle units to be used with commercial systems.

Total GAAP gross loss* for the full year of 2021 was ($0.6) million. Excluding non-cash expenses for stock-based compensation and depreciation and amortization, non-GAAP gross loss for the full year of 2021 was ($0.4) million. Following the transition to commercial operations in the third quarter of 2021, all uncapitalized manufacturing operations costs are now recorded in cost of revenue. Prior to commercialization, these costs were recorded in research and development expenses.

Total GAAP operating expenses representing research and development, sales and marketing and general and administrative expenses for the full year of 2021 were $62.5 million, compared to $50.0 million for 2020. Non-GAAP operating expenses for the full year of 2021 were $46.9 million, compared to $38.8 million for the same period in 2020. The year-over-year increase in operating expenses was driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities and investments to expand use of the CellFX System outside dermatology.

GAAP net loss for the full year of 2021 was ($63.7) million compared to ($49.9) million for 2020. Non-GAAP net loss for the full year of 2021, was ($47.9) million compared to ($38.7) million for 2020.

Cash, cash equivalents and investments totaled $28.6 million as of December 31, 2021 compared to $20.5 million as of December 31, 2020 and $42.0 million as of September 30, 2021. Cash used in the fourth quarter of 2021 totaled $13.4 million compared to $9.2 million used in the same period in the prior year and $13.8 million used in the third quarter of 2021. Excluding net proceeds from equity offerings, cash used in the full year of 2021 totaled $52.9 compared to $34.9 million used in 2020.

* Gross loss is calculated as total revenues less cost of revenues.

Reconciliations of GAAP to non-GAAP operating 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, March 31, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source