On February 28, 2023 Theratechnologies Inc. ("Theratechnologies", the "Company", or "we") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has entered into a first amendment to its credit agreement dated July 20, 2022 (the "Credit Facility") with certain funds and accounts for which Marathon Asset Management, L.P. acts as investment manager (collectively, "Marathon") (Press release, Theratechnologies, FEB 28, 2023, View Source [SID1234627928]).

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The Company and Marathon agreed to amend the terms of the Credit Facility by removing the condition related to the submission to the FDA of its human factors validation study ("HFS") related to EGRIFTA SV in order to access a US$20 million second tranche of the Credit Facility, and by allowing the inclusion of a going concern note in the auditor’s report to shareholders for the fiscal year ended November 30, 2022 without triggering an event of default.

The amendment was entered into in consideration of the issuance of an aggregate of 5,000,000 common share purchase warrants (the "Warrants") to Marathon. Each Warrant entitles the holder thereof to purchase one common share of the Company at a price of US$ 1.45 per share (the "Exercise Price") until February 27, 2030. The Exercise Price of the Warrants was calculated based on the volume weighted average price of the Company’s common shares on the Nasdaq over the 30 trading days for the Company’s common shares immediately preceding the date of issuance of the Warrants, plus a 50% premium. The exercise of the Warrants may be made by paying the Exercise Price in cash or by way of a cashless exercise. The Warrants are not listed. They are transferable only to affiliates of Marathon or to other potential lenders under the terms of the Credit Facility and their affiliates. The Company has relied on the exemption of Section 602.1 of the Toronto Stock Exchange Company Manual to proceed with the issuance of the Warrants.

The Company’s access to the second tranche of US$20 million remains subject to compliance with all of the other conditions set forth in the Credit Facility, including achieving net revenues of at least US$75,000,000 in the preceding 12 months prior to the disbursement of the second tranche and the absence of any event of default under the Credit Facility. The Credit Facility provides that the second tranche must be used to repay all of the outstanding US$27.5 million convertible notes of the Company due June 30, 2023.

"We are very pleased that Marathon accepted to amend the Credit Facility to allow us to access the second tranche without requiring the filing to the FDA of the HFS related to EGRIFTA SV. Having reached this agreement with Marathon at this stage speaks to the very good work the team has made thus far on the advancement of the HFS", said Paul Lévesque, President and CEO, Theratechnologies.

As previously announced, the FDA required the Company to conduct a HFS following our submission to the FDA in March 2021 of a change being effected ("CBE") supplement to the Instructions For Use ("IFU") included in the EGRIFTA SV product labeling after we received complaints from patients relating to the reconstitution of EGRIFTA SV. The Company implemented the changes to its IFU per the timelines set forth in the regulation. The FDA subsequently responded to our CBE supplement with a complete response letter asking us to carry out a HFS to ensure that patients reconstitute EGRIFTA SV in the proper manner. We have until September 15, 2023, to resubmit a CBE supplement in response to the letter issued by the FDA. The first part of the HFS, the formative study, has now been completed and the Company filed its proposed HFS protocol with the FDA for its review prior to initiating the summative study. The Corporation has not yet received a response from the FDA on its proposed HFS protocol.

On February 28, 2023 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that the company requested Fast Track designation to US Food & Drug Administration (FDA) for its first-in-class anti-PAUF monoclonal antibody ‘PBP1510 (INN-ulenistamab)’ for pancreatic cancer treatment (Press release, Prestige BioPharma, FEB 28, 2023, View Source [SID1234627927]). FDA will review the request and decide within sixty days. In June 2022, the company was granted approval for phase 1/2a clinical trial of PBP1510 in the US by FDA. The company plans to further expedite the development through FDA’s approach

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PBP1510 has been recognized as a promising new drug for pancreatic cancer treatment. The drug targets and neutralizes PAUF (Pancreatic Adenocarcinoma Up-regulated Factor), a protein that plays a critical role in tumor growth and rapid progression of pancreatic cancer. In 2020, PBP1510 was granted Orphan Drug designation by the US FDA, the European Medicines Agency (EMA), and Korea Ministry of Food and Drug Safety. In addition, the company has applied for patent for the first-in-class antibody in 24 countries, which has been successfully registered in 10 countries as of now including the US, Korea, and Singapore

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. To receive Fast Track designation, it must be determined that a drug treats or prevents a serious condition with no current therapy or show some advantage over available therapy in a serious condition. Pancreatic cancer has the highest mortality rate among major cancers and is the third leading cause of cancer-related death in the US. The company aims to pave the express way for PBP1510 by seeking close consultation and support from FDA through Fast Track designation

Upon receiving Fast Track designation, the company will have more frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval. In addition, it can have more frequent written communication from FDA on such matters as the design of the proposed clinical trials and use of biomarkers. These benefits lead to higher efficiency and stability in development. Moreover, the company is eligible for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed which is the usual case

Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: "We are making all round efforts to ensure the success of our first-in-class antibody PBP1510 through patent registration, clinical studies and development, and preparation for market authorization and commercialization. In addition to the Fast Track designation request, we also plan to request for FDA’s Breakthrough Therapy designation for PBP1510, as soon as we confirm preliminary clinical evidence on significant endpoint, to secure intensive guidance on efficient drug development program and organizational commitment involving senior managers."

On February 28, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in the brain cancer space, reported that the Company has completed and closed its Phase I clinical trial evaluating safety and tolerance for Pritumumab ("PTB") as a treatment for Primary and Metastatic Brain Cancers (Press release, Nascent Biotech, FEB 28, 2023, View Source [SID1234627926]). Previous announcements shared the end of the enrollment and dosing period of the Phase I trial.

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Nascent will continue to collect and evaluate the Clinical data from the Phase I trial as it prepares to submit results to the U.S. FDA for Phase II consideration.

Completing the Phase I trial is a major milestone and Nascent is excited to move toward finalizing plans for Phase II research. Phase I reinforced the companies’ determination and excitement around this unique monoclonal antibody treatment approach and Phase I has shown that it can be given safely at high doses. This is a new pathway toward attacking one of the defining health challenges we face, with longer-term implications that transcend the brain cancer market. We look forward to the opportunity to see our unique R&D platform become a game changer for patients suffering from brain cancer.

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.

On February 28, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported to advise the successful conclusion of its recent equity financing round (Press release, Kazia Therapeutics, FEB 28, 2023, View Source [SID1234627924]).

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Key Points

AU$ 4.5 million raised from existing sophisticated and institutional investors, as announced to ASX on 16 January 2023

AU$ 2.606 million raised from existing shareholders via Share Purchase Plan (SPP), which closed on 24 February 2023

Total gross proceeds of AU$ 7,106,000 will be applied (after application of expenses) to Kazia’s R&D pipeline, which comprises two assets in nine clinical trials

Multiple inflection points expected in CY2023, with potential to substantially revalue both paxalisib and EVT801 development candidates

Cash inflows provide runway to 4Q CY2023, on current cashflow forecast.

"We are grateful for the emphatic support of our shareholders," commented Iain Ross, Chairman of the Board at Kazia Therapeutics. "The proceeds of this financing will help the company to deliver a number of key read-outs during CY2023, which we expect to materially advance the development of our two assets, and in particular to position paxalisib for its further development and ultimate commercialization."

Shares subscribed for under the institutional placement have been issued, as per the company’s announcement of 28 February 2023. Shares subscribed for under the SPP will be issued on 3 March, as previously announced to ASX.

On February 28, 2023 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, reported its cash position as of December 31, 2022 and revenues for 2022 (Press release, Genfit, FEB 28, 2023, View Source [SID1234627923]).

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Financials

As of December 31, 2022, the Company’s cash, cash equivalents and current financial instruments amounted to €140.2 million compared with €258.8 million as of December 31, 2021. As of September 30, 2022, cash, cash equivalents and current financial instruments totaled €163.6 million.

The decrease in cash, cash equivalents and current financial instruments between September 30, 2022 and December 31, 2022 notably includes the payment of CHF2.4 million (€2.4 million) representing a net cash adjustment made at year end in accordance with the Versantis AG share purchase agreement, and related acquisition costs totaling €1.7 million.

The decrease in cash, cash equivalents and current financial instruments between December 31, 2021 and September 30, 2022 includes the payment of €24.0 million in January 2022 representing the VAT collected on the initial upfront payment received from Ipsen in December 2021, the disbursement of employee participation in the profits of GENFIT SA in May 2022 for a total of €0.6 million for the financial year 2021, and the initial consideration of CHF40.0 million (€41.9 million) for the acquisition of Versantis AG on September 29, 2022.

Revenues

Revenues for 2022 amounted to €20.2 million compared to €80.1 million for the same period in 2021.3

Of the €20.2 million in revenues for 2022, €15.9 million is attributable to the partial recognition of the €40.0 million deferred income described below. €1.0 million in revenue was generated from the services rendered by GENFIT to Ipsen in accordance with the Transition Services Agreement signed in 2022, which essentially outlines

1 Of the cash, cash equivalents and current financial instruments amount noted above as of December 31, 2022, there is a €4.5 million current financial instrument whose term is 180 days

2 Unaudited financial information under IFRS

3 Revenues as recognized under IFRS 15

the scope of services to facilitate the transition of some activities related to the Phase 3 clinical trial evaluating elafibranor in Primary Biliary Cholangitis. €3.3 million was recognized as revenue in 2022 in accordance with the Inventory Purchase Agreement signed with Ipsen, pursuant to which Ipsen purchased inventory of elafibranor active pharmaceutical ingredient and drug product during the second half of 2022 with the prospect of transferring the conduct of the ELATIVE study to Ipsen

Revenues for 2021 mainly resulted from the receipt of the €120 million upfront payment from Ipsen, out of which €80 million was recognized as 2021 revenue, and €40 million deducted as deferred revenue. The remainder will be gradually recognized as revenue following the completion of the ELATIVE double-blind study, in accordance with IFRS 15 and the terms of the strategic licensing and collaboration agreement with Ipsen on December 17, 2021

Upcoming topline data readout for the Phase 3 ELATIVETM study

Topline data for our Phase 3 global trial ELATIVE evaluating elafibranor in patients with Primary Biliary Cholangitis is expected to be announced in the second quarter 2023

Upcoming financial communications

The Company will release its full-year 2022 financial results on April 13, 2023. The 2022 Universal Registration Document, the 2022 Annual Financial Report (included in the 2022 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2023.