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.

On September 13, 2022 Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First North Copenhagen1: ONXEO), hereafter "Onxeo" or the "Company", a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), reported its consolidated half-year financial results to June 30, 2022 and provides an update on its activities (Press release, Onxeo, SEP 13, 2022, View Source [SID1234619503]).

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Dr. Shefali Agarwal, President and CEO of Onxeo, said: "This first half of the year has been an opportunity for Onxeo to undergo profound transformations, both in its organization and governance, with the aim of refocusing our clinical research efforts and strengthening our presence globally. This new focus has been made possible due to the support of our long-term shareholders Invus and Financière de la Montagne, who participated in our latest capital increase, which secures our operations until the second quarter of 2023.

One of the important achievements of our thoughtful development plan was the very first approval by the Food and Drug Administration (FDA) of the initial Investigational New Drug (IND) application for AsiDNA, an encouraging progress since the formation of our U.S. team this April. We expect to initiate a clinical trial based on the safe to proceed letter from FDA in the second half of 2022 at multiple U.S. clinical sites.

We also continue our two Phase 1b/2 clinical trials, Revocan and the clinical trial targeting recurrent high-grade glioma in children, sponsored respectively by our partners Gustave Roussy and the Institut Curie.

Finally, we have continued our efforts to optimize our OX400 family of compounds and other preclinical assets, with the objective of entering clinical trials for a first drug candidate in 2023 and thereafter."

FINANCIAL RESULTS FOR THE FIRST HALF OF 2022

Consolidated income statement (IFRS)

In thousands of euros

30/06/2022

30/06/2021

Revenues, of which:

0

589

Recurring revenues

0

0

Non-recurring revenues

0

589

Operating expenses, including:

(9,631)

(5,367)

R&D expenditure

(4,107)

(1,389)

Other current operating income

282

33

Current operating income

(9,348)

(4,745)

Other non-recurring operating income and expenses

385

198

Income from companies accounted for by the equity method

Operating profit after share of profit of associates

(8,963)

(4,547)

Financial result

(2,448)

(238)

Income tax expense

(55)

15

Net income

(11,471)

(4,770)

The half-year accounts as of June 30, 2022, drawn up according to IFRS standards and approved by the Board of Directors on September 13,22, have not been audited.

The Group has not recorded any consolidated revenues for the period ended June 30, 2022.

Operating expenses amounted to €9.6 million. The increase compared to €5.4 million in 2021 is mainly due to the evolution of the Company’s headcount in France and the United States and to the growth in R&D expenses. The latter increased by €1.4 million in the first half of 2022 to reach €4.1 million, mainly due to industrial development and manufacturing of clinical batches for AsiDNA. This increase was partially offset by a decrease in general and administrative expenses.

Financial result was a loss of €2.4 million and consisted mainly of the interest expense on the bond loan with SWK Holdings.

The Group’s total net loss was thus €11.5 million in the first half of 2022, compared with a loss of €4.8 million for the same period in 2021.

CASH POSITION AT JUNE 30, 2022

At June 30, 2022, the Group’s cash position was €26.9 million, compared to €17.9 million euros at December 31, 2021. This increase comes mainly from the issue of new shares (€8 million) and the convertible bond issue (€4 million), carried out during the first half of the year. These resources provide the Company with sufficient visibility to carry out its projects, including the expansion of the clinical development of AsiDNA and the continuation of the preclinical development of the OX400 compounds, until Q2 2023.

HIGHLIGHTS OF THE FIRST HALF OF 2022 AND RECENT DEVELOPMENTS

AsiDNA

The Food and Drug Administration (FDA) approved the initial Investigational New Drug (IND) application for AsiDNA at the end of June, allowing Onxeo to initiate a multicenter Phase 1b/2 trial to evaluate the safety and efficacy of AsiDNA in combination with the PARP inhibitor Olaparib in patients with epithelial ovarian cancer, breast cancer and metastatic castration-resistant prostate cancer who have progressed despite initial treatment with PARP inhibitors. This is the first IND filed by Onxeo since the arrival of the U.S. team in April 2022. The Company plans to launch this clinical trial in the second half of 2022 at 3 to 5 potential clinical sites in the United States.
Two trials conducted in collaboration with two academic research centers of excellence in oncology continued during the semester:
The phase 1b/2 Revocan trial evaluating the addition of AsiDNA to combat resistance to PARP inhibitors in the 2nd line maintenance treatment of recurrent ovarian cancer for which Gustave Roussy is the study sponsor. Due to a slower than expected patient recruitment rate, first results are now expected in the second half of 2022.
The Phase 1b/2 trial evaluating AsiDNA in combination with radiotherapy in the treatment of recurrent high-grade glioma in children ("Children" study), an indication with a particularly poor prognosis. The Institut Curie is the sponsor of this study, which is being conducted by the European ITCC consortium2, and is funded by the European Fight Kids Cancer program. Treatment of a first patient has been announced for August 2022.
Onxeo presented innovative new data at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies 2022 Congress on March 7-8, 2022, confirming the relevance of combining AsiDNA with PARP inhibitors (PARPi) in the treatment of tumors with an active homologous recombination pathway to overcome intrinsic or acquired resistance in the clinical setting.
The Company also presented new data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held on April 8-13, 2022, demonstrating AsiDNA’s ability to overcome tumor resistance and protect against the toxicity of cancer treatments. Specifically, these data support AsiDNA’s ability to overcome resistance to tyrosine kinase inhibitors in lung cancer models and to protect healthy cells when combined with conventional anti-tumor treatments.
OX400

During the first half of 2022, Onxeo continued the optimization of OX401, the first compound of the OX400 family from its PlatON platform, to improve its action on the PARP protein, involved in tumor DNA repair pathways, and its activation of the anti-tumor immune response via the cGAS-STING pathway. The Group expects to select the optimized compound and enter preclinical development in 2022.
Governance

On January 3, 2022, Onxeo announced the appointment of Julien Miara as interim Chief Executive Officer, replacing Judith Greciet. Mrs Greciet left the Company during the first half of 2022.
On April 7, 2022, Dr. Shefali Agarwal succeeded Julien Miara and was appointed President and CEO of Onxeo.
The Combined General Meeting of June 15, 2022 appointed Khalil Barrage, Managing Director at Invus, as a new director for three years. The shareholders also renewed the term of office of GammaX Corporate Advisory, represented by Jacques Mallet, for an additional 3-year term. Danielle Guyot-Caparros, whose third term of office expired at this General Meeting, did not wish to renew her mandate.
As a result of these changes, the Board of Directors has now eight members, out of which four are independent.

Delisting from Copenhagen’s First North Market

The Company has applied for and received, by letter dated August 29, approval from Nasdaq in Copenhagen for the Onxeo shares to be withdrawn from trading on the Nasdaq First North Growth market. In accordance with Nasdaq regulations, the Danish Onxeo shares will remain tradable on the Nasdaq First North Growth market, subject to the availability of counterparties, for a period until November 8, 2022. The company maintains its primary listing on Euronext Growth Paris.
OUTLOOK

The Company continues to pursue its strategy based on the development of its therapeutic innovations up to proof of concept in humans, with the following projected activities:

AsiDNA

Initiation of patient enrolment in a U.S. Phase 1b/2 clinical trial;
First results (part 1b) of the REVOCAN study expected from the study sponsor, Gustave Roussy;
Continuation of the Children study (phase 1b/2) conducted by the European ITCC consortium, with the support of the Institut Curie.
OX400

Optimization of the most promising OX400 compound;
Preclinical proof of concept in vitro and in vivo in combination with immunotherapies;
Development of the translational and regulatory plan for entry into the clinic in 2023.
platON

Continued evaluation and optimization of new compounds.
The 2022 half-year financial report is available on the Company’s website.

On September 13, 2022 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company pioneering the development of monoclonal antibodies targeting various cancer types, reported the completion of the Fourth Cohort in dosing patients in the Company’s Phase I trial to evaluate Pritumumab ("PTB") as a treatment for Brain Cancer, including Primary and metastatic Brain Tumors (Press release, Nascent Biotech, SEP 13, 2022, View Source [SID1234619502]).

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After reviewing data gathered from the four completed cohorts, this milestone will allow the trial to advance to a fifth and final cohort. Patient enrollment continues for Phase I and interested parties may review trial requirements at www.clinicaltrials.gov under the search term ‘Pritumumab’.

Following completion of dosing of the Fifth Cohort, the Phase I trial will be complete, and the Company will prepare data for submission to the FDA in preparation for Phase 2 clinical research.

"Having completed four cohorts, we are enthusiastic about moving to our fifth and likely final cohort in the Phase I trial," noted Nascent CEO, Sean Carrick. "The data received so far has been very encouraging. We will continue to perform PK studies on the fourth and fifth cohorts to support an upcoming data submission to the FDA."

PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy and seek out only cancer cells without damaging healthy cells.