On November 8, 2022 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for its fiscal third quarter ended September 30, 2022 and recent business highlights (Press release, Coherus Biosciences, NOV 8, 2022, View Source [SID1234623391]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RECENT BUSINESS HIGHLIGHTS

CIMERLI (ranibizumab-eqrn), was approved in August 2022 by the U.S. Food and Drug Administration (FDA) as a biosimilar product interchangeable with Lucentis (ranibizumab injection), with 12 months of interchangeability exclusivity. Coherus launched CIMERLI on October 3, 2022.
CIMERLI achieved leading biosimilar market share within the first four weeks of launch, and 2023 net sales of CIMERLI are projected to exceed $100 million.
Toripalimab, a PD-1 inhibitor for the treatment of nasopharyngeal carcinoma, is under review by FDA, with a biologics license application (BLA) target action date of December 23, 2022. Thus far, travel restrictions related to the COVID-19 pandemic have hindered the FDA’s ability to complete inspections in China. Coherus and partner Junshi Biosciences are currently engaged in discussions with the FDA regarding opportunities to complete the inspections.
"We are pleased with the launch of our new revenue growth driver, CIMERLI, which builds on the success we demonstrated with UDENYCA, our first product, that also rapidly overtook a large, first-to-market competitor. This is the first of four product launches transforming Coherus into a multi-product company. In 2023, we plan to launch YUSIMRY, our FDA-approved Humira biosimilar, and upon FDA approval, toripalimab and our UDENYCA on-body injector presentation," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "Given projected topline growth from these launches and prudent expense management, we are targeting a return to profitability in 2024."

THIRD QUARTER 2022 FINANCIAL RESULTS

Net revenue, consisting primarily of net sales of UDENYCA, was $45.4 million and $82.5 million during the three months ended September 30, 2022 and 2021, respectively, and $165.7 million and $253.2 million during the nine months ended September 30, 2022 and 2021, respectively. The decline in both periods was primarily due to a decrease in the number of units of UDENYCA sold as well as a lower net realized price due to increased competition.

Cost of goods sold (COGS) was $35.2 million and $21.3 million during the three months ended September 30, 2022 and 2021, respectively, and $55.9 million and $45.5 million during the nine months ended September 30, 2022 and 2021, respectively, reflecting decreases in the number of units of UDENYCA sold as well as a reserve taken in the third quarter 2022 of $26.0 million against inventory at risk of expiration. COGS for the third quarter and first nine months of 2021 included the write-down of $5.2 million of inventory that did not meet Coherus’ acceptance criteria. UDENYCA COGS also includes a mid-single digit royalty on net sales payable through the first half of 2024.

Research and development (R&D) expense for the three months ended September 30, 2022 and 2021 was $45.8 million and $54.1 million, respectively. The decrease was driven by lower development costs, which was partially offset by higher compensation expense. For the nine months ended September 30, 2022 and 2021, R&D expense was $170.3 million and $312.3 million, respectively. The decrease was primarily due to the $136.0 million upfront license fee paid to Junshi Biosciences in 2021, which was partially offset by the $35.0 million option exercise fee for CHS-006 in the first quarter of 2022.

Selling, general and administrative (SG&A) expense was $44.8 million and $39.9 million during the three months ended September 30, 2022 and 2021, respectively, and $144.9 million and $119.7 million during the nine months ended September 30, 2022 and 2021, respectively. The increases were primarily driven by higher commercialization expenses in preparation for the commercial launch of CIMERLI in 2022 and multiple new product launches anticipated in 2023, including, of toripalimab, YUSIMRY, and the on-body injector presentation of UDENYCA.

Net loss for the third quarter of 2022 was $86.7 million, or $(1.11) per share on a basic and diluted basis, compared to a net loss of $38.5 million, or $(0.49) per share on a basic and diluted basis for the same period in 2021. Net loss for the first nine months of 2022 was $232.9 million, or $(3.00) per share on a basic and diluted basis, compared to a net loss of $241.4 million, or $(3.22) per share on a basic and diluted basis for the first nine months of 2021.

Non-GAAP net loss for the third quarter of 2022 was $74.4 million, or $(0.96) per share on a basic and diluted basis, compared to non-GAAP net loss of $26.6 million, or $(0.34) per share on a basic and diluted basis for the same period in 2021. Non-GAAP net loss for the first nine months of 2022 was $187.7 million, or $(2.42) per share on a basic and diluted basis, compared to non-GAAP net loss of $189.5 million, or $(2.53) per share on a basic and diluted basis for the first nine months of 2021. Beginning in the first quarter of 2022, the Company no longer regularly excludes upfront and milestone-based license fee payments from its non-GAAP financial information. To conform to this change, the prior period non-GAAP financial information has been recast to include upfront and milestone-based license fee payments. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash and cash equivalents were $286.8 million as of September 30, 2022, compared to $417.2 million at December 31, 2021.

2022 R&D and SG&A Expense Guidance

Coherus is revising the guidance range of combined 2022 R&D and SG&A expenses from $375 – $395 million to a range of $375 – $385 million. This guidance includes $55 million to $60 million of stock-based compensation expense and excludes the $35 million license fee paid in the first quarter of 2022 for CHS-006 as well as a potential $25 million milestone payable upon FDA approval of the toripalimab BLA for nasopharyngeal carcinoma. This financial guidance also excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

On November 8, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that members of the management team will participate at the following investor conferences (Press release, Neurocrine Biosciences, NOV 8, 2022, View Source [SID1234623390]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Kevin Gorman, Chief Executive Officer, Matt Abernethy, Chief Financial Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the Jefferies London Healthcare Conference at 1:30 p.m. Greenwich Mean Time (8:30 a.m. Eastern Time) on Tuesday, Nov. 15, 2022 in London.

Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the 5th Annual Evercore HealthCONx Virtual Conference at 12:35 p.m. Eastern Time on Thursday, Dec. 1, 2022.
The live presentations will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentations will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On November 8, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the patient’s own immune system to target and eradicate cancer, reported it intends to effect a 1-for-22 reverse split of its issued and outstanding common stock (Press release, OncoSec Medical, NOV 8, 2022, View Source [SID1234623389]). The reverse stock split will become effective on November 9, 2022 (the "Effective Date"), and the Company’s common stock is expected to begin trading on a split-adjusted basis when the market opens November 9, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The reverse stock split is primarily intended to bring the Company into compliance with the minimum bid price requirements for maintaining its listing on the Nasdaq Capital Market.

The Company’s Board of Directors approved the reverse stock split and the Company filed the Certificate of Change with the State of Nevada with the effective date of November 9, 2022. Approval of the reverse stock split by the Company’s stockholders was not required.

The Company’s common stock will continue to trade on Nasdaq Capital Markets under the symbol "ONCS". The new CUSIP for the common stock following the reverse stock split will be 68234L 405.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Stockholders who otherwise would be entitled to receive a fractional share will instead be entitled to receive the number of shares after rounding up to the next whole shares. Holders of the Company’s common stock held in book-entry form or through a bank, broker or other nominee do not need to take any action in connection with the reverse stock split. Stockholders of record will be receiving information from the Company’s transfer agent regarding their common stock ownership post- reverse stock split.

On November 8, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported its cash position as of September 30, 2022, and its revenues for the third quarter of 2022 (Press release, MaaT Pharma, NOV 8, 2022, View Source [SID1234623388]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cash position1

As of September 30, 2022, total cash and cash equivalents were EUR 40.3 million, as compared to EUR 38.4 million as of June 30, 2022, and EUR 43.3 million as of December 31, 2021. The net increase in cash over the third quarter of 2022 was EUR 1.9 million. This increase reflects:

Net financing inflows from receipt of funds of EUR 4.3 million in bank loans from CIC and Bpifrance.
Receipt of the R&D tax credit related to R&D expenditure for the full year 2021, totaling EUR 2.0 million
Financing of operations and ongoing development programs of EUR 4.4 million.
Revenues in Q3 20221

MaaT Pharma reported revenues[2] from its compassionate access program of EUR 0.4 million for the quarter ended September 30, 2022, and year to date revenues of EUR 0.9 million compared to EUR 0.2 million for same quarter in 2021 and EUR 0.6 million for the 9-months ended September 30, 2021.

Third quarter clinical and operational highlights

Clinical highlights

MaaT013, the lead MET drug candidate for hospital use in an acute setting:

Phase 3 open label, single arm trial (ARES) for the treatment of acute Graft-versus-Host Disease: in Q3 2022, in addition to France, Germany, Spain, Austria where the trial is ongoing, the Company received regulatory approvals in Belgium. An interim review of preliminary data after enrollment of half of the patients in the study is expected in the first half of 2023.
Randomized, placebo-controlled proof-of-concept Phase 2a trial (PICASSO), sponsored by AP-HP[3], evaluating MaaT013 in combination with immune checkpoint inhibitors for patients with metastatic melanoma, is ongoing. A first internal data review focusing on safety and some biomarker data is expected in the first half of 2023.
In the US, interactions with the U.S. Food and Drug Administration (FDA) remain active regarding MaaT013, for which US development is currently on clinical hold following an FDA communication received in August 2022 requiring additional information on the safety and efficacy of the Company’s "pooling" approach.
Pursuit of the Early Access Program in Europe in place since 2021 allowing patients to benefit from early access to the MaaT013 therapy, mainly for the treatment of acute Graft-vs-host-Disease. As of today, the Company has safely treated over 160 patients with MaaT013 in Europe.
On November 3, 2022, MaaT Pharma announced the release of an abstract, which was selected for an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting from December 10-13 in New-Orleans, Louisiana, U.S.A. The oral presentation will occur on December 10, 2022; 10:15am EST and will detail consolidated results from 81 patients with steroid-resistant, gastrointestinal, acute Graft-versus-Host-Disease (GI-aGvHD) treated with MaaT013 as salvage therapy, as part of the ongoing Early Access Program (EAP).
Link to abstract here.

MaaT033, the Company’s first MET for oral administration as adjunctive and maintenance treatment for patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT):

Preparations are ongoing for a pivotal Phase 2b trial to evaluate MaaT033’s safety and efficacy in improving overall survival and preventing complications in patients with blood cancers receiving allo-HSCT; based on current plans, the Company expects to initiate the study in Q4 2022.
On November 3rd, 2022, MaaT Pharma announced the release of an abstract, which was selected for a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting. Poster presentation will occur on December 11, 2022: 6:00pm – 8:00pm EST and will present detailed results from the Phase 1b clinical trial (CIMON) of MaaT033 in patients with acute myeloid leukemia.
Link to abstract here.

Operationalhighlight

On October 4th, 2022, MaaT Pharma appointed Dr. Nathalie Corvaïa as Chief Scientific Officer to oversee the Company’s non-clinical R&D strategies and its proprietary, AI-based MET drug design and development platform, gutPrint.

Upcoming scientific conferences participation

November 8-10, 2022 – 9th International Human Microbiome Consortium (IHMC) Congress – Kobe, Japan: Hervé Affagard, CEO and cofounder of MaaT Pharma, and Dr. Aurore Duquenoy, R&D specialist at MaaT Pharma will present three scientific posters at the conference.
Link to the Congress here.
November 9-11, 2022 – 21st Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #10 – Bordeaux, France: Dr. Emilie Plantamura, Head of Clinical Development at MaaT Pharma, Claire de Condé, Head of Clinical Operations at MaaT Pharma and Mélanie Tilte, Clinical Project Manager at MaaT Pharma will attend the congress and will be available for discussions at MaaT Pharma’s booth #10.
Link to the event here.
Upcoming investor conferences participation

November 14, 2022 – 7th annual conference LSX Inv€$tival Showcase – London, UK: Siân Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Carole Schwintner, Chief Technology Officer of MaaT Pharma will attend the investor event and participate in the European Lifestar Awards, where MaaT Pharma is a finalist for the IPO of the year category.
Additional information available on the LSX website.
November 15-17, 2022 – 13th Annual Jefferies London Healthcare Conference – London, UK: Siân Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Carole Schwintner, Chief Technology Officer of MaaT Pharma will attend the conference.
November 21, 2022 – Kepler Cheuvreux Life Sciences Day – Digital: Hervé Affagard, CEO and cofounder of MaaT Pharma will attend the event.
November 29, 2022 – Investir day – Paris, France: Siân Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Savita Bernal, Chief Business Officer of MaaT Pharma will attend the investor event.
Additional information available on the dedicated website here.
[1] Unaudited data
[2] Revenues correspond to compensation invoiced in relation to the compassionate access program, as approved by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM).
[3] AP-HP: Assistance Publique – Hôpitaux de Paris

On November 8, 2022 bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) reported that the Company will host a conference call and audio webcast on Monday, Nov. 14, 2022, at 8 a.m. ET to discuss its corporate and financial results for the third quarter of 2022 (Press release, BioAffinity Technologies, NOV 8, 2022, View Source [SID1234623385]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The audio webcast will be accessible via the Investor Relations section of the Company’s website, View Source An archive of the webcast will be available for 90 days.