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.

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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]).

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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]).

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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.

On November 8, 2022 Nuvectis Pharma, Inc (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the third quarter of 2022 and provided an update on recent business progress (Press release, Nuvectis Pharma, NOV 8, 2022, View Source [SID1234623383]).

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"In the third quarter of 2022, we continued to advance both of our pipeline products, NXP800 and NXP900, toward the next phase in their respective development programs. The NXP800 Phase 1a dose-escalation study is proceeding as planned, with the start of the Phase 1b expansion phase expected in Q1 2023. The recently reported positive preclinical data in an ARID1a-mutated gastric carcinoma model provides another possible development opportunity for NXP800, as ARID1a is mutated in approximately 20-25% of the roughly 26,000 new cases reported in the US annually," commented Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, "We believe that NXP900 is uniquely positioned to become the first SRC/YES1 kinase inhibitor for the treatment of certain solid tumors. In this regard, the recent discovery of increased sensitivity to NXP900 in cancer cells harboring alterations in the HIPPO signaling pathway is very important, as it provides additional potential criteria for patient selection. We anticipate completing the NXP900 IND-enabling studies by the end of this year and to submit an IND or an equivalent application in Q1 2023." Mr. Bentsur concluded, "We continue to operate efficiently with an expected cash runway into the second half of 2024."

Third Quarter Highlights

NXP800

•The Phase 1a dose escalation portion of the Phase 1 clinical program of NXP800 is ongoing, and the Phase 1b dose expansion study is expected to begin in Q1 2023.
•Positive preclinical data in a xenograft model of ARID1a-mutated gastric cancer provides another possible development opportunity for NXP800. According to the American Cancer Society, approximately 26,000 new cases of gastric cancer are expected in 2022, of which approximately 25% will carry an ARID1a mutation.
•Biomarker data supporting the clinical development of NXP800 were presented at the 2022 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) ("ENA") Symposium.

NXP900

•NXP900 preclinical data was presented at the 2022 ENA Symposium. The presentation provided new data on the differential activity profile of NXP900 versus dasatinib, and on the increased sensitivity to NXP900 in cancer cells harboring alterations in the HIPPO signaling pathway.

Third Quarter 2022 Financial Results

Cash, cash equivalents, and short-term investments were $23.6 million as of September 30, 2022, compared to $5.7 million as of December 31, 2021. The increase of $17.9 million was primarily a result of the Company’s initial public offering in February 2022 and the private placement in July 2022.

The Company’s net loss was $5.9 million for the three months ended September 30, 2022, compared to $4.7 million for the three months ended September 30, 2021, an increase of $1.2 million. Net loss for the third quarter of 2022 included $0.5 million in non-cash expenses and $3.4 million in one-time expenses, primarily related to milestone and fee payments in connection with the NXP800 and NXP900 license agreements.

Research and development expenses were $4.5 million for the three months ended September 30, 2022, compared to $4.2 million for the three months ended September 30, 2021, an increase of $0.4 million. The increase in research and development expenses is primarily attributed to one-time expenses related to milestone and fee payments in connection with the license agreements, and an increase in preclinical and clinical development costs. Research and development expenses for the third quarter of 2022 included $0.3 million in non-cash expenses.

General and administrative expenses were $1.4 million for the three months ended September 30, 2022, compared to $0.5 million for the three months ended September 30, 2021, an increase of $0.9 million. The increase in general and administrative expenses is primarily attributed to the 2022 initial public offering. General and administrative expenses for the third quarter of 2022 also included $0.2 million in non-cash expenses.

On November 8, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported a presentation outlining the design of its ongoing breast cancer vaccine trial on December 7, 2022, at the 2022 San Antonio Breast Cancer Symposium (Press release, Anixa Biosciences, NOV 8, 2022, View Source [SID1234623380]).

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This Symposium takes place December 6-10, 2022 in San Antonio, TX, and is designed to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease, to an international audience of academic and private physicians and researchers. The scientific program consists of formal lectures by experts in clinical and basic research, selected slide and poster presentations, forums, and case discussions.

Presentation details can be found below:

About Anixa Bioscience’s Breast Cancer Vaccine
Anixa’s breast cancer vaccine, currently in Phase 1 trials, takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by Dr. Vincent Tuohy, Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences. Dr. Tuohy will receive a portion of commercialization revenues received by Cleveland Clinic for this technology and also holds personal equity in Anixa.