On May 13, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported that it will host a virtual KOL investor event on Thursday, May 19, 2022, at 4:00 pm ET/ 1:00 pm PT (Press release, Aileron Therapeutics, MAY 13, 2022, View Source [SID1234614519]).

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The virtual event will feature presentations from the company’s President and Chief Executive Officer, Manuel Aivado, M.D., Ph.D., as well as key opinion leaders, Ralf Paus, M.D., DSc, FRSB, Professor of Dermatology, Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine and Eric Anderson, M.D., Ph.D., Medical Oncologist, Assistant Professor of Medicine, School of Medicine Oregon Health & Science University.

The presentations will highlight several topics related to ALRN-6924’s revolutionary potential as the first precision medicine-based supportive care drug, and the current supportive care landscape and unmet need associated with chemotherapy-induced toxicities, including:

New non-clinical data that will be presented in a late-breaking oral presentation at the Society for Clinical Dermatology 2022 Annual Meeting on May 19, 2022, demonstrating ALRN-6924 protected human hair follicles and their stem cells from chemotherapy-induced acute and permanent damage;
An overview of Aileron’s ongoing Phase 1b randomized, double-blind, placebo-controlled clinical trial of patients with p53-mutated advanced non-small cell lung cancer, including the trial design and its composite endpoint;
An introduction to Aileron’s upcoming Phase 1b randomized clinical trial of patients with p53-mutated ER+/HER2- neoadjuvant breast cancer, which is on track to initiate in 2Q 2022, and an update on the ongoing Phase 1 pharmacology study in healthy human volunteers; and
A review of the company’s planned data readouts in 2022
A live webcast of the event will be available on the "Events & Presentations" in the Investors & Media section of the company’s website at investors.aileronrx.com. A replay of the webcast will be available for 30 days following the presentation.

On May 13, 2022 Medtronic plc (NYSE: MDT), a global leader in healthcare technology, reported that it has completed the acquisition of Intersect ENT, expanding the company’s comprehensive ear, nose, and throat (ENT) portfolio with innovative products used in sinus procedures to improve post-operative outcomes and to treat nasal polyps (Press release, Medtronic, MAY 13, 2022, View Source [SID1234614513]).

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As a result of the close of the transaction announced on Aug. 6, 2021, Medtronic has acquired Intersect ENT’s PROPEL and SINUVA (mometasone furoate) sinus implant product lines and technology, intellectual property, and Menlo Park, Calif., facility. Intersect ENT employees also join Medtronic through this acquisition. A former Intersect ENT brand, Fiagon, was divested simultaneously at close, and those products ― Cube navigation system and VenSure balloon sinus dilation system ― were not included in the acquisition.

Intersect ENT’s product lines and customer base will further the efforts of Medtronic to have a positive impact for patients who suffer from chronic rhinosinusitis (CRS). CRS is one of the most common health care problems in the U.S., with approximately 30 million adults diagnosed annually. It has been associated with lost days of work, decreased productivity, and even depression and anxiety, with most patients reporting 5-15+ years of suffering and medical treatment.

Through this acquisition, Medtronic gains PROPEL and SINUVA, which are unique bioabsorbable, steroid-eluting implants for sinus patients. PROPEL implants are inserted following endoscopic sinus surgery to maintain sinus patency and provide localized steroid delivery. SINUVA implants are designed for use in the physician’s office setting for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery.

"By combining Intersect ENT’s groundbreaking localized drug delivery products with the leading navigation and powered instruments of Medtronic, we can now equip physicians with the right tools for many unique patient needs," said Vince Racano, president of the ENT business, which is part of the Neuroscience Portfolio at Medtronic. "This acquisition expands our portfolio, and we can now provide a more comprehensive continuum of care for CRS patients while supporting the bold ambition of Medtronic to be the global healthcare technology leader."

"We believe the market leadership and global footprint of Medtronic, coupled with enterprise resources to fuel pipeline innovation and commercialization, will advance our reach to customers and patients more quickly and serve our shared vision of improving patient access, outcomes, and satisfaction for millions of people around the world who suffer from ENT diseases," said Thomas West, president and CEO of Intersect ENT. "We are thrilled to combine these two companies as we now officially work together to bring more ENT options to patients. I am especially proud of our dedicated Intersect ENT employees, whose entrepreneurial spirit and passion for innovation have driven our ability to achieve this milestone."

PROPEL, PROPEL Mini, and PROPEL Contour implants are FDA approved in the U.S. and CE marked in the EU. SINUVA Sinus Implants are currently sold only in the U.S.

This acquisition is consistent with the strong commitment of Medtronic to strategic portfolio management and capital deployment — disciplined processes to accelerate the company’s weighted average market growth rate by strategically allocating resources to fuel innovation in fast-growing markets.

The Medtronic financial advisor for the transaction is Perella Weinberg Partners LP, with Ropes & Gray LLP acting as legal advisor. Intersect ENT’s financial advisor is Goldman Sachs & Co. LLC, with Cooley LLP acting as legal advisor.

On May 13, 2022 EXACT Therapeutics AS ("EXACT-Tx" or "the Company") Euronext Growth: EXTX), a clinical stage biopharmaceutical company with a mission to enhance the therapeutic efficacy of medicines through ultrasound-mediated drug delivery, reported that its new Chief Executive Officer ("CEO") Per Walday will start 6 June 2022 (Press release, Exact Therapeutics, MAY 13, 2022, View Source [SID1234614487]).

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As announced by the Company on 28th March 2022, Per, who worked alongside the Founders and some of the Board Members of EXACT-Tx during his time as Global Head of Project Management at GE Healthcare, is joining EXACT-Tx as CEO. During his time at GE Healthcare, he was responsible for all development programs of new pharmaceutical products which included R&D efforts within the field of ultrasound and microbubbles which paved the way for what would become years later EXACT-Tx’ Acoustic Cluster Therapy (ACT). Per was most recently CEO of PCI Biotech (OSE: PCIB) with a technology involving a drug-device combination developed for use in the field oncology. The experience and wealth of knowledge that he has acquired in those fields will be of enormous help to the success of ACT.

Dr Masha Strømme, Executive Board Chair, commented: "The Board and I look forward to working with Per. His intimate knowledge of ultrasound along with therapeutic expertise and strong leadership will lead the Company through the next phase of its development."

Dr Per Walday, Chief Executive Officer-designate of EXACT-Tx, said: "Remarkable innovation and progress have been made with the ACT platform since I led the development of related ultrasound technology initially aimed for diagnostic use in GE Healthcare. I am very excited to be joining EXACT- Tx in June and aim to further maximise the value of the innovative ACT platform for ultrasound mediated drug enhancement and accelerate our journey towards becoming a leading precision health company."

As a result of Per’s appointment, some of the activities of EXACT-Tx will be relocated to Oslo. Dominic Moreland will be stepping down as Chief Financial Officer ("CFO"). Dominic has a three month notice period and he will work in the transition period with Ole Fegth who will then assume the role of interim CFO. The Board of EXACT-Tx thanks Dominic for his contribution.

On May 13, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, reported financial results for the first quarter of 2022 (Press release, Abeona Therapeutics, MAY 13, 2022, View Source [SID1234614486]). The Company will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update.

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"During the quarter, we took significant steps to preserve our capital with the goal to fund operations over the next 12 months with existing cash resources," said Vish Seshadri, Chief Executive Officer of Abeona. "First, we began off-loading our MPS assets to reduce cash burn. Second, having completed accrual for the EB-101 pivotal Phase 3 VIITAL study, we are now focusing R&D resources on generating topline results in the third quarter of 2022, while aggressively exploring partnerships for commercialization of EB-101. Furthermore, we have initiated steps toward regaining compliance with Nasdaq listing requirements."

First Quarter and Recent Highlights

Completed patient enrollment in pivotal Phase 3 VIITAL study evaluating EB-101 for recessive dystrophic epidermolysis bullosa (RDEB), and anticipate topline data readout in the third quarter of 2022.
Additional long-term follow up data up to eight years and quality of life data from a completed Phase 1/2 study evaluating EB-101 for RDEB will be presented at the Society of Investigative Dermatology (SID) Annual Meeting, which will be held on May 18-21, 2022 in Portland, OR. The data will be featured in an oral presentation entitled "Long-term efficacy and safety of investigational autologous gene-corrected skin sheets (EB-101) for recessive dystrophic epidermolysis bullosa (RDEB)."
Reported non-human primate data for AAV204, a novel adeno-associated virus (AAV) capsid from Abeona’s AIM capsid library, highlighting its ability to produce more robust transduction in the macula area of the eye following para-retinal administration, which unlike subretinal administration does not create a retinal detachment. The data was featured at the Association for Research and Vision in Ophthalmology (ARVO) 2022 Annual Meeting.
Appointed Joseph Vazzano as Chief Financial Officer, who brings valuable experience while serving as the Chief Financial Officer at Avenue Therapeutics, Inc. where he secured multiple equity financings.
Nasdaq Compliance Plan

Requested a 180-calendar day extension to regain compliance with the Nasdaq Capital Market’s minimum closing bid price requirement of $1.00 per share.
As part of the Company’s strategy to regain compliance, Abeona intends to seek approval of a reverse stock split of the outstanding shares of common stock at a Special Meeting of stockholders at 10:00 am ET on June 14, 2022. Stockholders as of May 3, 2022, the record date, are entitled to attend the online Special Meeting, view the proxy statement and vote at: www.virtualshareholdermeeting.com/ABEO2022SM.
On May 2, 2022, Abeona completed a $25 million private placement offering of convertible redeemable preferred stock. Holders of the preferred stock will vote together with the Company’s common stockholders on a proposal to effect a reverse stock split of the Company’s common stock at the Special Meeting.
First Quarter Financial Results

The unaudited interim condensed consolidated financial statements for the quarter ended March 31, 2022, which were filed on Form 10-Q on May 13, 2022, have been prepared on the going concern basis, which assumes the Company will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the date the financial report is issued.

Cash, cash equivalents, restricted cash and short-term investments totaled $37.2 million as of March 31, 2022. Net cash used in operating activities was $13.7 million for the three months ended March 31, 2022.

License and other revenues in the first quarter of 2022 were $0.3 million, compared to nil in the first quarter of 2021. The revenue in the first quarter of 2022 consisted mainly of the recognition of deferred revenue related to grants for the ABO-102 and ABO-101 development programs.

Research and development (R&D) expenses for the three months ended March 31, 2022 were $10.5 million, compared to $8.3 million for the same period of 2021. General and administrative (G&A) expenses were $4.2 million for the three months ended March 31, 2022, compared to $6.3 million for the same period of 2021.

Net loss was $20.8 million for the first quarter of 2022, or $0.14 loss per common share as compared to a net loss of $16.0 million, or $0.17 loss per common share, in the first quarter of 2021. The net loss in the first quarter of 2022 includes $6.2 million in non-cash impairment charges resulting from the disposition of the ABO-102 and ABO-101 development programs as the Company focuses resources on its EB-101 pivotal program and preclinical eye gene therapy programs. The impairment charges have no impact on the Company’s cash position or cash flow from operating activities and do not have an impact on future operations.

Conference Call Details

Abeona Therapeutics will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 221025 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.

On May 13, 2022 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immuntoday providedotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the first quarter ended March 31, 2022 (Press release, Marker Therapeutics, MAY 13, 2022, View Source [SID1234614485]).

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"2022 has already been an exciting year for Marker as we reported encouraging initial results from the six-patient safety lead-in portion of our Phase 2 AML trial—including elimination of MRD in one MRD positive patient—and announced plans for Company-sponsored trials of our second cell therapy product candidate, MT-601, in pancreatic cancer and lymphoma," said Peter L. Hoang, Marker’s President and Chief Executive Officer. "We also implemented a new MultiTAA-specific T cell therapy manufacturing process, details of which were presented at the 2022 International Society for Cell & Gene Therapy (ISCT) annual meeting. After completing enrollment of the first 20 patients in the Phase 2 AML trial last year, we anticipate reporting topline data from the active disease group in the main phase of the trial next quarter."

PROGRAM UPDATES AND EXPECTED MILESTONES

Acute Myeloid Leukemia (MT-401)

In February 2022, Marker announced the initial results of the safety lead-in stage of its Company-sponsored Phase 2 AML trial evaluating MT-401, Marker’s lead MultiTAA-specific T cell product candidate. Results from the safety lead-in demonstrate that MT-401 was well-tolerated, eliminated measurable residual disease (MRD) based on peripheral blood analysis at Week 32 in one MRD positive patient and induced epitope spreading across multiple AML-associated antigens in that patient.
Enrollment of the first 20 patients of the main Phase 2 stage of the AML trial was completed in Q4 2021. Topline readout of Group 2 active disease is anticipated in Q2 2022.
Marker announced in February 2022 that it is developing MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. Marker’s open Investigational New Drug application (IND) for MT-401 for the treatment of AML includes an off-the-shelf program. The Company is in the process of developing a patient cell bank inventory and expects to dose the first patient with MT-401-OTS 2023.
Additional Clinical Programs (MT-601)

In January 2022, Marker announced that the U.S. Food and Drug Administration granted Orphan Drug designation to MT-601 for the treatment of pancreatic cancer.
Marker announced in February 2022 that the Company intends to file INDs for MT-601, Marker’s second MultiTAA-specific T cell product candidate, in lymphoma and pancreatic cancer in 2022. The Company expects to initiate these trials in 2023.
BUSINESS UPDATES

In April 2022, the Company announced that it entered into a services agreement with Wilson Wolf Manufacturing Corporation. The agreement includes an $8.0 million upfront cash payment by Wilson Wolf to Marker in exchange for services relating to Marker’s expertise in the manufacture of cell therapies. Wilson Wolf has agreed to pay Marker an additional $1.0 million if the certain work, as defined in the services agreement, is completed within one year from the onset of the services agreement.
FIRST QUARTER 2022 FINANCIAL RESULTS

Cash Position and Guidance: At March 31, 2022, Marker had cash, cash equivalents and restricted cash of $28.8 million.

R&D Expenses: Research and development expenses were $7.0 million for the quarter ended March 31, 2022, compared to $5.6 million for the quarter ended March 31, 2021.

G&A Expenses: General and administrative expenses were $3.7 million for the quarter ended March 31, 2022, compared to $3.1 million for the quarter ended March 31, 2021.

Net Loss: Marker reported a net loss of $9.9 million for the quarter ended March 31, 2022, compared to a net loss of $8.8 million for the quarter ended March 31, 2021.