On May 13, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2022 (Press release, Soligenix, MAY 13, 2022, View Source [SID1234614521]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We remain focused on our significant upcoming milestones for 2022. We anticipate submitting a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing authorization of HyBryte (SGX301 or synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) in the second half of this year. We expect to initiate a Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) in the second half of this year as well. With approximately $22.9 million in cash, not including our non-dilutive government funding, we anticipate having the capital required to achieve our near-term milestones, including NDA filing and expansion into psoriasis with the initiation of the Phase 2a clinical study."

Dr. Schaber continued, "Supported by funding from the National Institute of Allergy and Infectious Diseases, our Public Health Solutions business segment continues to achieve key objectives with our heat stable vaccine platform technology, ThermoVax. Recently, we announced results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in non-human primates (NHPs) demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. As always, we continue to evaluate various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On April 19, 2022, the Company announced it had received approximately $1.4 million, net of transaction costs, in non-dilutive funding via multiple government tax programs. To view this press release, please click here.
On March 17, 2022, the Company announced the results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in NHPs demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. To view this press release, please click here.
Financial Results – Year Ended March 31, 2022

Soligenix’s revenues for the quarter ended March 31, 2022 were $0.2 million as compared to $0.1 million for the quarter ended March 31, 2021. Revenues primarily included payments on government contracts and grants received to support the development of: RiVax, our ricin toxin vaccine candidate; SGX943, for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization platform technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $4.3 million, or ($0.10) per share, for the quarter ended March 31, 2022, as compared to $2.4 million, or ($0.06) per share, for the quarter ended March 31, 2021. The increase in net loss was primarily attributed to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries as well as an increase in research and development expenses associated with preparation of the upcoming HyBryte NDA filing.

Research and development expenses were $1.7 million as compared to $1.3 million for the quarter ended March 31, 2022 and 2021, respectively. The increase in research and development spending for the quarter ended March 31, 2022 was primarily attributable to the increased expenses associated with preparation of the upcoming HyBryte NDA filing.

General and administrative expenses were $2.6 million and $1.0 million for the quarter ended March 31, 2022 and 2021, respectively. This increase in general and administrative expenses is primarily attributable to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries.

As of March 31, 2022, the Company’s cash position was approximately $22.9 million.

On May 13, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2022 (Press release, Leap Therapeutics, MAY 13, 2022, View Source [SID1234614520]).

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Leap Highlights:

Presented positive new data from the DisTinGuish Study of DKN-01 plus BeiGene’s anti-PD-1 antibody tislelizumab and chemotherapy in gastroesophageal junction/gastric (GEJ/G) cancer patients at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium

Completed enrollment in Part B of the DisTinGuish Study evaluating DKN-01 plus tislelizumab in second-line GEJ/G cancer patients whose tumors express high levels of DKK1 (DKK1-high)

Entered partnership on DKK1 companion diagnostic with Leica Biosystems

Presenting initial data from the investigator-sponsored Phase 1b/2a clinical trial of DKN-01 in prostate cancer at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting
"We are making consistent progress in advancing DKN-01 across multiple tumor types and look forward to Dr. David Wise of New York University presenting initial prostate cancer data at the upcoming ASCO (Free ASCO Whitepaper) conference," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "With compelling response and survival data for DKN-01 in combination with BeiGene’s tislelizumab in gastric cancer patients presented in January, and the recent completion of enrollment in our second-line cohort, we are preparing for updated data readouts from our DisTinGuish study in the second half of the year. We are also looking forward to hosting an R&D Day in late June to outline the next phase in the clinical development strategy for DKN-01."

DKN-01 Development Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the DKK1 protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

Positive New Data from the DisTinGuish Clinical Trial (NCT04363801) of DKN-01 Plus Tislelizumab and Chemotherapy Presented at the ASCO (Free ASCO Whitepaper) GI Cancer Symposium. In January 2022, the Company presented positive new progression-free survival (PFS) and overall response data from Part A, the first-line cohort of the Phase 2a study in patients with gastroesophageal junction or gastric (GEJ/G) cancer, and initial findings from Part B of the clinical trial, studying DKN-01 and tislelizumab in second-line advanced GEJ/G cancer patients with high tumoral DKK1 expression.

Part A First-Line Patients: Of the 25 first-line patients who received a full cycle of DKN-01 therapy, overall response rate (ORR) was 68.2%, with 90% ORR in DKK1-high patients (9 partial responses (PR)) and 56% in DKK1-low patients (1 complete response, 4 PR). Among those patients with low PD-L1 expression ORR was 79% (with 100% ORR in DKK1-high patients and 57% ORR in DKK1-low patients), and in patients with higher PD-L1 expression ORR was 67% (with 75% ORR in DKK1-high patients and 50% in DKK1-low patients). The preliminary median PFS was 10.7 months in the overall first-line population, and median overall survival had not been reached. The Company expects to present updated survival data from the study in the second half of 2022.

Part B Second-Line Patients: Of the 30 second line DKK1-high GEJ/G cancer patients who received a full cycle of DKN-01 therapy and were response evaluable, ORR was 25%, with an additional patient who experienced an irPR by iRECIST criteria.

Completed Enrollment in the DisTinGuish Clinical Trial (NCT04363801) of DKN-01 Plus Tislelizumab in DKK1-high Second Line GEJ/G Cancer Patients. In May 2022, the Company completed enrollment in Part B of the DisTinGuish clinical trial, studying DKN-01 and tislelizumab in second-line advanced GEJ/G cancer patients with high tumoral DKK1 expression.

Entered Partnership on Companion Diagnostic with Leica Biosystems to Advance Care for Cancer Patients. In January 2022, Leap and Leica Biosystems, a cancer diagnostics company, entered into an agreement to develop a companion diagnostic to detect DKK1 in patient tumor biopsies. The assay developed by Leica will utilize RNAscope technology on the BOND-III Automated Staining System, which allows for detection of DKK1 with high sensitivity and specificity to help identify patients for DKN-01 treatment.

Abstract Accepted for Poster Presentation at the Upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Highlighting Initial Clinical Data from the Phase 1b/2a Clinical Trial (NCT03837353) of DKN-01 Plus Docetaxel in Prostate Cancer. The Company will present initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL on June 3-7. Dr. David Wise of NYU Langone Medical Center is the lead investigator on the study.
Selected First Quarter 2022 Financial Results

Net Loss was $10.4 million for the first quarter 2022, compared to $9.1 million for the same period in 2021. The increase was primarily due to an increase in clinical trial costs due to the timing of patient enrollment and the duration of patients on study in the DisTinGuish trial and an increase in the number of research and development employees to support the development of DKN-01.

License revenues were $0.4 million for the first quarter 2021 and relate to the agreement with BeiGene for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. There were no license revenues recognized in the first quarter 2022, as the upfront payment was fully recognized as of December 31, 2021.

Research and development expenses were $7.8 million for the first quarter 2022, compared to $6.8 million for the same period in 2021. The increase in research and development expenses was due to an increase of $0.6 million in clinical trial costs due to timing of patient enrollment in the DisTinGuish study, an increase of $0.6 million in payroll and other related expenses, and an increase of $0.2 million in stock based compensation expense during the three months ended March 31, 2022. These increases were partially offset by a $0.4 million decrease in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns.

General and administrative expenses were $2.8 million for the first quarter 2022, compared to $2.7 million for the same period in 2021. The increase in general and administrative expenses was due an increase of a $0.2 million in stock based compensation expense and an increase of $0.1 million in payroll and other related expenses during the three months ended March 31, 2022. These increases were partially offset by a $0.2 million decrease in professional fees.

Cash and cash equivalents totaled $103.2 million at March 31, 2022. Research and development incentive receivables totaled $1.3 million at March 31, 2022.

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.