On September 13, 2022 One Biosciences, a biotech company co-founded by Dr. Céline Vallot, Institut Curie and Home Biosciences, combining the power of AI and single-cell technologies to discover new therapeutic targets and develop novel precision medicines, reported that it initiated the LARYCARE prospective clinical study for single-cell profiling of larynx and hypopharynx carcinoma (Press release, One Biosciences, SEP 13, 2022, View Source [SID1234619510]).

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This new study aims at better understanding, with unprecedented granularity of information, the mechanisms involved in neoadjuvant chemotherapy response and resistance. The objective is to identify new predictive biomarkers of the response to neoadjuvant treatment in advanced larynx and hypopharynx carcinoma as well as discover potential new targeted therapies. One Biosciences will evaluate samples from patients enrolled at the Hartmann Clinic and Paris Saint-Joseph Hospital, in partnership with the Research Center of Institut Rafaël (Institut Rafaël Centre de Recherche).

This clinical study follows a first program launched in May 2021 in collaboration with Institut Curie in high grade serous ovarian cancer patients, aiming to identify new precision medicines, evaluating samples from the Institute’s SCANDARE trial.

One Biosciences has completed a seven million euros financing initiated at its inception in July 2020 with Home Biosciences, an asset centric biotech company, itself backed by US-based Redmile Group and France-based Sofinnova Partners, two leading VCs in the field of biotech. One Biosciences has also benefited from BPI France’s support through non-dilutive grants (BFTE, PIA and Aide au Développement DeepTech).

Dr Céline Vallot, co-founder and chair of One Biosciences’ Scientific Advisory Board, said: "Single-cell analysis of tumor tissues during treatment now allows researchers to access an unprecedented level of understanding of cellular mechanisms at work in cancer patients. Using unique molecular technologies and proprietary artificial intelligence algorithms, One Biosciences maps tumors with an unmatched resolution to shed light on new biological markers, making it possible to anticipate the response of each patient to chemotherapy. Our technological platform also paves the way for the development of ultra-targeted therapies against cancers and complex diseases that are difficult to treat."

Dr. Magali Richard, co-founder of Home Biosciences and CEO of One Biosciences, said "We have assembled a unique discovery engine in a record timeframe. We are now pursuing our aggressive growth trajectory with two programs already ongoing and two new projects to be soon initiated in high unmet medical needs. We are in line with our initial roadmap and reaffirm our ambition to make One Biosciences a leader in AI and single-cell powered therapeutics development."

One Biosciences is supported by a strong multidisciplinary Scientific Advisory Board, chaired by Dr. Céline Vallot, One Biosciences’ co-founder, who was awarded, on June 16, 2022, the prestigious CNRS Innovation medal. One Biosciences’ SAB is composed of Alexandre Gramfort, PhD Research Director in artificial intelligence at Inria, Sophie Postel-Vinay, MD/PhD, Senior Medical Oncologist – Clinician Scientist, Drug Development Department (DITEP), Team Leader ATIP U981 INSERM at Gustave Roussy Cancer Campus and Julien Zuber, MD/PhD, Transplant nephrologist at Necker Hospital and Professor of Clinical Immunology at Paris Descartes University.

On September 13, 2022 ProMIS Neurosciences, Inc. (Nasdaq: PMN) (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers, implicated in the development of neurodegenerative diseases, reported that it has appointed Gail M. Farfel, Ph.D., as Chief Executive Officer, effective September 19, 2022 (Press release, ProMIS Neurosciences, SEP 13, 2022, View Source [SID1234619509]).

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"The past 18 months have been transformative for ProMIS," stated Eugene Williams, ProMIS Chairman and Co-Founder. "During this period, we achieved strong capital formation led by a prominent group of Boston-based investors, and with tremendous shareholder, support accomplished our goal of listing ProMIS on Nasdaq. We also have expanded and strengthened our Board of Directors, with the addition of three industry veterans as Independent Directors: Josh Mandel-Brehm, Dr. Maggie Shafmaster, and Neil Warma. Our amyloid oligomer-selective lead therapeutic antibody candidate for Alzheimer’s disease (AD), PMN310, is poised for IND submission by year end and we have continued to expand our portfolio of antibody and therapeutic vaccine candidates targeting other neurodegenerative diseases. We have also continued to expand our strong management team, having added to the team earlier this year Dr. Larry Altstiel as Chief Medical Officer and, in late 2021, Gavin Malenfant as Chief Operating Officer. Perhaps the most important of these transformational accomplishments is bringing on Gail Farfel as CEO."

"Gail has a distinguished track record of accomplishments in both large pharma and biotech, and she has invaluable expertise in neurologic disease drug development. After an extensive search, we are confident that under Gail’s leadership ProMIS can achieve its tremendous potential. ProMIS’ Board and management welcome her to the CEO role as we work to complete the transition to a clinical stage, multi-product, Nasdaq listed company," added Gene Williams.

"I am honored and excited to take on the role of CEO at ProMIS," remarked Gail Farfel. "There is a rapidly growing number of emerging companies in the neurology space, an area of tremendous growth, but I feel ProMIS is uniquely well-positioned to make a meaningful contribution to the field. A very strong foundation has been built, anchored on a unique discovery platform, giving us the potential to advance what we believe to be differentiated products to address urgent unmet medical needs. I look forward to working with this impressive team and to providing my leadership as ProMIS seeks to become a clinical phase biotechnology company with multiple development opportunities."

Gail M. Farfel, Ph.D., is an accomplished pharma development and regulatory leader with over 25 years of experience in large and small pharma, including venture-backed and public companies. Gail has a strong record of accomplishments in neuropsychiatric clinical development and global regulatory submissions, including multiple successful investigational new drug (IND), new drug application (NDA) and marketing authorization application (MAA) registrations, U.S. Food and Drug Administration (FDA) Advisory Committee experience, and three successful global "first" indications. On the business side, Gail has played leadership roles in strategic planning and commercial positioning for partnership and launch, IPO, fundraising for publicly traded and private companies, and licensing and asset integration.

Prior to joining ProMIS, Gail served as Executive Vice-President and Chief Development Officer of Zogenix Inc, where she delivered successful Phase 3 programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS), leading to approvals from FDA (Dravet and LGS) and European Medicines Agency (EMA) approval for Fintepla in 2020 and 2021. Further, while an executive at Zogenix she supported capital raises in excess of US $700M; the acquisition of Modis Therapeutics; the alliance with Tevard Biosciences; and the acquisition of Zogenix by UCB Pharma in March 2022. In her earlier career, Gail held positions of increasing responsibility at Smithkline Beecham, Pfizer, Novartis, G. Meredith Consulting and Marinus Pharmaceuticals. Gail obtained her Ph.D. in neuropsychopharmacology from the University of Chicago.

On September 13, 2022 Imugene Limited (ASX:IMU), a clinical stage immunooncology company, reported a Placement of A$80 million at $0.20 per share (Press release, Imugene, SEP 13, 2022, https://mcusercontent.com/e38c43331936a9627acb6427c/files/f4997931-b58b-4f28-9ce2-e58e8df72379/IMUGENE_ANNOUNCES_A_80_MILLION_INSTITUTIONAL_PLACEMENT.pdf [SID1234619507]). The Placement is being subscribed by two leading institutional investors with significant healthcare and biotechnology expertise.

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The funds raised under the Placement, in addition to the Company’s existing cash position, will provide an extended runway for Imugene’s deep pipeline of clinical programmes. Partnering and licensing opportunities and R&D rebates have the potential to extend the runway further.

Imugene Founder and Executive Chairman Paul Hopper said: "This capital raising ensures a long runway for the existing programmes while also providing flexibility to add complementary assets should attractive opportunities present. The ability to introduce two high calibre institutional investors onto the share register following what has been a volatile period across biotechnology indices speaks to the quality of the Company’s unique clinical platforms. With minimal dilution to existing shareholders of only 6.8%, and with such a definitive statement of investment support for Imugene by two prominent funds, the Board believes we have a significant opportunity to maximise value for all Imugene shareholders."

Imugene Managing Director and CEO Leslie Chong said: "We are pleased to strengthen the company’s balance sheet and give ourselves an unimpeded runway to progress the numerous clinical trials that 1 Based on 30 June 2022 reported cash position, less offer costs IMUGENE LIMITED ACN 009 179 551 2 we have ongoing. By having these multiple shots on goal well-funded gives them the best chance of success, which we expect will translate into shareholder value and improved patient outcomes."

About the Placement
Under the terms of the Placement, the Company proposes to issue a total of 400 million New Shares to Placement Subscribers at a price of A$0.20 per share. The issue price represents a discount of 11.1% to the last close on 9 September 2022 (A$0.225), and a discount of 12.0% to the 5-day VWAP up to and including 9 September 2022 (A$0.227). New shares issued under the Placement represent approximately 6.8% of existing ordinary shares on issue.

For every two (2) New Shares subscribed for under the Placement, Imugene intends to issue one (1) free attaching New Option – a total of 200 million New Options offered to Placement Subscribers (Placement Options Offer). The New Options will have an exercise price of A$0.33 and will expire on 31 March 2026 and will be exercisable at any time up to and including the expiry date.

The Placement Options Offer will be set out in a prospectus (Prospectus). The options issued under the Placement will provide a further $66 million in funding, if fully exercised. The Placement is being conducted under Imugene’s existing placement capacity pursuant to ASX

The Company reserves the right to amend the above timetable, at its discretion, including for the purposes of any Australian Securities and Investments Commission (ASIC) and ASX requirements.

On September 13, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business and financial update for the first half of 2022 (Press release, ERYtech Pharma, SEP 13, 2022, View Source [SID1234619505]).

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"2022 has been so far, and will continue to be, a year of deep strategic refoundation for ERYTECH," said Gil Beyen, Chief Executive Officer of ERYTECH. "Earlier this year and as a first result of the strategic review initiated last Fall after the disappointment of our Phase 3 trial in pancreatic cancer, we made a first important step with the sale of our U.S. production facility in Princeton, which significantly improved ERYTECH’s financial prospects and gave us the latitude to continue the transformation of the Company. The recent decision to halt the submission process of our BLA dossier for eryaspase in hypersensitive ALL leads us now to focus on strategic alternatives for ERYTECH. We have prioritized our resources on our most promising preclinical programs, and we are making good progress on partnering discussions, for which we expect to report updates in the last quarter of this year."

Business Highlights

U.S. cell therapy manufacturing facility sold to Catalent for a total consideration of USD 44.5 million

In April 2022, ERYTECH sold its commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, to Catalent, for a total consideration of $44.5 million. ERYTECH’s staff at the site of 40 people has been fully transferred to Catalent.

ERYTECH maintained its GMP-approved manufacturing site in Lyon, France and its core expertise to continue innovating in cell therapy.

Good progress on strategic review and partnering alternatives

As announced on October 25th 2021, the Company has appointed a specialized advisor to evaluate its strategic and partnering options. After the transaction with Catalent, the Company has continued to evaluate further valuable strategic options to potentially leverage its assets and capabilities in a business combination with a strategic partner. Valuable options are under discussion and the Company expects to give further updates on these strategic initiatives in the 4th quarter of this year.

Plans to pursue a BLA submission for Graspa in hypersensitive ALL stopped following recent feedbacks and new additional requests from the FDA

Following positive results of a Phase 2 trial, sponsored by the Nordic Organization for Peadiatric Hematology and Oncology (NOPHO), ERYTECH had been in an extended dialogue with the U.S. Food and Drug Administration (FDA) to evaluate the possibility for an approval of Graspa in acute lymphoblastic leukemia (ALL) patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy.

A pre-BLA meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021 after which the Company confirmed its intention to submit a BLA, subject to successful completion of remaining activities, which included the submission of additional information to the FDA, responses to additional data requests, and the submission of the Initial Pediatric Study Plan (iPSP).

The Company submitted its iPSP in July 2022 and received feedback from the FDA in August 2022. After thorough evaluation of this feedback, which included a new request for additional data, and taking into account the changing competitive landscape, the Company decided to halt the BLA process of seeking approval.

Results of patients enrolled in TRYbeCA-2, Phase 2 clinical trial in triple-negative breast cancer (TNBC), reviewed

The TRYbeCA-2 trial evaluated eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone, in metastatic TNBC (first and second lines), with disease control rate as the primary end point of the trial.

Initial target enrollment was approximately 64 evaluable patients but following the disappointing results of eryaspase in the TRYbeCA-1 trial in second-line pancreatic cancer, the Company had decided, in consultation with the trial’s Steering Committee, to stop further enrollment in the trial. A total of 27 patients,11 and 14 evaluable patients in the eryaspase and control arms, respectively, have been finally enrolled.

The trial’s Steering Committee met in September 2022 to review the results of the 25 evaluable patients. No clinical benefit was demonstrated, which could be attributed to the immature closure of the trial and the small number of patients. The treatment was well tolerated.

Promising preclinical development with ERYCEVTM, novel red blood cell vesiculation technology

In April 2022, ERYTECH announced the presentation of its novel red blood cell vesiculation technology, ERYCEV, at the 24th Meeting of the European Red Cell Society (ERCS).

RBC-derived extracellular vesicles are formed naturally during senescence and storage of mature RBCs and are a potentially attractive drug delivery system. Vesiculation of RBCs that have already been loaded with active therapeutic compounds utilizing the ERYCAPS process, entails the potential of producing cargo-loaded RBC-derived extracellular vesicles for the development of novel therapeutic approaches.

ERYCEV results to date illustrate the versatility of ERYTECH’s encapsulation science in RBCs and its potential for leverage in further partnered developments.

1H 2022 Financial Results

Key financial figures for the first half of 2022 compared with the same period of the previous year are summarized below:

Net loss for the first half of 2022 was €1.0 million, a €27.0 million improvement over the same period of last year, related mostly to the €24.4 million net gain on the sale of the Princeton facility, while operating expenses of €25.2 million were also showing a €6.0 million decrease (-19%) year-over-year, with a €5.9 million decrease in R&D expenses and a €0.1 million decrease in G&A.
Total operating expenses of €25.2 million included an impairment provision of €2.5 million on the Lyon production facility, related to the end of eryaspase operations, and a €1.9 million provision for restructuring, related to the resizing of French operations and staff.
Income tax included in 2022 a provision of €3.7 million ($4.1 million), reflecting the best estimate to date of the tax impacts of the capital gain from the sale of the Princeton facility.
As of June 30, 2022, ERYTECH had cash and cash equivalents totaling €53.3 million (approximately $55.8 million), compared with €33.7 million as of December 31, 2021. The €19.6 million increase in cash position during the first half of 2022 was the result of the net cash of €37.6 million received from the sale of the Princeton facility, a €20.4 million net cash utilization in operating activities and investing activities (excluding the sale of the Princeton facility) and €2.0 million generated in financing activities, including €3.0 million in pre-funding of the expected 2021 R&D tax credit, while the variation of the U.S. dollar against the euro led to a €0.4 million positive currency exchange impact.
The Company has not drawn any tranche on the convertible loan facility (OCABSA) since 2021 and there are no outstanding and unconverted notes. The OCABSA financing line has expired in June 2022.
Earlier this year, the company initiated a deep restructuring and cost reduction program, now further intensified with the halt of the BLA process. Considering this ongoing reduction in operating expenses, the Company believes that its current cash position can fund its current programs and planned operating expenses to mid-2024.
Key News Flow and Milestones Expected Over the Next 6 Months

Results from the Phase 1 rESPECT Trial of eryaspase in combination with mFOLFIRINOX in first-line pancreatic cancer (2H 2022)
Update on partnering discussions (Q4 2022)
First Half 2022 Conference Call Details

ERYTECH management will hold a conference call and webcast on Tuesday, September 13, 2022, at 8:30am ET / 2:30 pm CEST on the business highlights and financial results for the first half 2022. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The audio call is accessible via the below registering link: https://register.vevent.com/register/BI8faf5b5c094c4e48b5ffac460994e65b

Once registered, participants will receive a unique access code and the call number details to join the teleconference.

The webcast can be followed live online via the link:
View Source

In addition, the replay of the webcast will be available for a period of one year on this same link.

Availability of the 2022 Half-Year financial report

The Half-Year financial report as of June 30, 2022 has been made available to the public and filed with the Autorité des Marchés Financiers (AMF).

On September 13, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales of $59.1 million for the month of August 2022 (Press release, Pacira Pharmaceuticals, SEP 13, 2022, View Source [SID1234619504]). The company’s net product sales include EXPAREL (bupivacaine liposome injectable suspension), ZILRETTA (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.

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"August sales were highlighted by year-over-year growth trends improving in the second half of the month and EXPAREL surpassing the 11 million patient mark," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "In addition to EXPAREL expansion across all target market segments, we continue to expect improving sales trends through the year for ZILRETTA and iovera° as we broaden education and awareness around these complementary and standalone non-opioid solutions for managing osteoarthritis pain."

August 2022 Preliminary Net Product Sales Highlights

•EXPAREL net product sales were $46.7 million, compared with $41.4 million for August 2021. The company also reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL average daily sales for the month of August 2022 were 108 percent of August 2021. The number of EXPAREL selling days were 23 in August 2022 and 22 in August 2021.
•ZILRETTA net product sales were $9.7 million for August 2022. ZILRETTA sales in August 2021 occurred prior to the completion of the company’s acquisition of Flexion in November 2021.
•iovera° net product sales were $1.5 million for August 2022, compared with $0.9 million for August 2021.
•Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.2 million in August 2022.

Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective

surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.

The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around labor shortages, COVID-19, and the pace of recovery for the elective surgery market. To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL, ZILRETTA, and iovera° until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2022.