Antengene Announces 2021 Full Year Financial Results and Provides Corporate Updates

On March 18, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported its financial results for the full year ended December 31, 2021 and provided corporate updates on key events and achievements since the start of 2021 (Press release, Antengene, MAR 18, 2022, View Source [SID1234610343]).

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"The last 15 months have been a time of significant achievements for Antengene," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "The company was founded to develop innovative cancer medicines to treat patients beyond borders, worldwide. We have delivered on our vision this year and significantly de-risked the Company. We accomplished this by securing our first regulatory approvals for our lead first-in-class/only-in-class product, XPOVIO (selinexor), across China and 3 Asia-Pacific countries, and making the transition to a commercial organization, and by significantly advancing our portfolio with potential first-in class/best-in-class clinical programs in China, Australia and the US."

Dr. Mei continued, "We also delivered on our mission of building a research-driven biopharmaceutical company that is developing transformational, best-in-class/first-in-class medicines for cancer, focusing on resistant or relapsing diseases with high unmet medical needs. Today, we have 8 programs in 18 clinical studies, including 5 registrational trials, utilizing our internal capabilities and platform and clinical development partnerships. We have built a team of over 350 employees across China, the US and APAC regions, and have built core capabilities in drug discovery, development, manufacturing and commercialization."

"Looking ahead," said Dr. Mei, "2022 is the fifth anniversary of Antengene’s founding and we believe it will be a landmark year for the Company. We expect to have regulatory approvals for selinexor in all 6 markets in Greater China and Asia Pacific markets where we have submitted new drug applications (NDAs). We are optimistic about the first launch of selinexor in Q2:22 in China, based on strong participation in the Named Patient Program (NPP) as well as the inclusion of selinexor in several important practice treatment guidelines. In addition, we expect to report data on at least 5 clinical programs and file 2 new investigational new drug (INDs), from in-house development programs."

In conclusion, Dr. Mei said "Looking forward, we believe our strong cash, bank balances and cash management products of RMB 2.370 billion, and revenue growth will continue to fund advancement of our programs and continue to deliver additional value for investors. Since cancer are diseases that knows no borders, we are devoted and passionate in advancing our programs to treat cancer patients beyond borders, worldwide. Antengene is optimistic about this year and the future based on the excellent work of our team and collaborators, all around the world, and we look forward to updating you on our progress as the year unfolds."

Overview of Antengene’s Products and Clinical Pipeline:

XPOVIO (selinexor) Commercial Approvals, Bridging Studies and Inclusion in Practice Treatment Guidelines: Antengene is strategically investing in XPOVIO (selinexor) and positioning the product for a successful commercial launch across the Asia-Pacific region based on solid registrational data and a growing body of studies to support product adoption and label expansions. In addition, Antengene has implemented a well-supported Named Patient Program, and built a highly experienced, well respected commercial team to position for market launch and revenue growth.

XPOVIO (selinexor) Approvals: We secured approvals for XPOVIO (selinexor), a first-in-class, oral selective inhibitor of nuclear export (SINE), in mainland China, Australia, South Korea and Singapore for hematological cancer indications including relapsed/refractory multiple myeloma (R/R MM), refractory diffuse large B-cell lymphoma (R/R DLBCL) for use as monotherapy and as part of established multi-drug regimen.
Further Selinexor Approvals in 2022: We expect further approvals in Hong Kong and Taiwan markets in 2022.
Named Patient Program: We provided selinexor to patients in mainland China and Hong Kong under the Named Patient Program which generated revenue of RMB28.5 million in 2021. This program provided Antengene with the opportunity to connect with key opinion leaders on selinexor, which will pave the way for an effective commercial launch of selinexor in China, planned to begin in Q2:22.
Selinexor Inclusion in Practice Treatment Guidelines: Use of selinexor was included in the Chinese Society of Clinical Oncology (CSCO) 2021 Diagnosis and Treatment Guidelines (CSCO Guidelines). This follows prior inclusion of multiple selinexor regimen into practice guidelines by major oncology networks, National Comprehensive Cancer Network (NCCN) in the U.S. and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in the EU.
Pivotal Selinexor Studies Presented at Major Medical Meetings: Positive results of the pivotal MARCH bridging study were reported at international medical meetings including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting in 2021. Results from the MARCH trial have confirmed the efficacy and manageable safety profile to be consistent with that observed in the STORM trial which supported selinexor’s accelerated approval by the U.S. Food and Drug Administration (FDA).
Pivotal Bridging Studies, BENCH and SEARCH are registrational trials in China: The BENCH study, which evaluates selinexor in combination with bortezomib and dexamethasone, for patients with R/R MM, will serve as the confirmatory trial to support selinexor’s conditional approval. The SEARCH study evaluates selinexor as monotherapy in patients with R/R DLBCL who have received at least 2 but no more than 5 prior treatment regimens. We expect to file sNDA for SEARCH and complete patient enrollment for the BENCH study in 2022.
Well-Prepared for Commercialization across China and Asia-Pacific Countries: Antengene has carefully invested in a commercial team of 170 with a proven track record of commercial success in China and APAC for a successful launch of XPOVIO (selinexor).
Business Development: focused on partnerships to facilitate clinical collaborations, in-license novel programs or enable access to novel platform/drug development technologies to complement and enrich our in-house capabilities.

ATG-037 (CD73 small molecule inhibitor): In May 2021, we entered into an exclusive, worldwide license agreement with Calithera Biosciences, Inc. for the development and commercialization of CB-708 (ATG-037), Calithera Biosciences, Inc.’s small molecule inhibitor of CD73. The Phase 1 STAMINA trial has secured HREC approval in Australia and is planned to begin enrollment in H1:22.
LegoChem Deal for New ADCs: In October 2021, we entered into a Research Collaboration and License Option Agreement with LegoChem Biosciences, Inc. ("LCB", KOSDAQ: 141080) for new antibody-drug conjugates (ADCs). Under this agreement, the two parties will jointly generate and evaluate ADC candidates using Antengene’s antibodies and LCB’s next generation ADC technology platform.
Bristol Myers Squibb Clinical Collaboration for ATG-017 (ERK1/2 inhibitor) and Opdivo (nivolumab): In December 2021, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety, pharmacokinetics and preliminary efficacy of ATG-017 in an open-label, Phase 1/2 combination trial with Bristol Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab) for patients with advanced solid tumors.
Clinical Program Poised to Deliver Multiple Data Readouts in 2022 and 2023 (originated in-house/through partners): The Antengene pipeline has been developed with a special focus on key mechanisms linked to relapsing/resistant disease including metabolic changes, genetic alterations, the tumor microenvironment and immune suppression/down-regulation. With a robust R&D portfolio, Antengene is well-positioned to evaluate proprietary combinations, further differentiating its programs.

Mid to Late-Stage Programs: (Antengene has certain Asia-Pacific rights): Antengene is exploring two members of the novel XPO1 family plus a novel mTOR cell growth inhibitor.

Selinexor (ATG-010, first-in-class XPO1 inhibitor): Antengene has developed a robust program to maximize the clinical utility for selinexor and the XPO1 class. The drug is being evaluated for new cancer indications, including maintenance treatment of endometrial cancer, and in combination with standard therapy for MM and DLBCL. The objective of these programs is to potentially improve response rates, maintain disease control, and expand the clinical utility of the drug.

Phase 2 MF-035 Myelofibrosis Trial designed to evaluate the safety and efficacy of selinexor in the treatment of patients with myelofibrosis in China (Global study).
Phase 2/3 XPORT-DLBCL-030 Trial designed to evaluate selinexor in combination with rituximab, gemcitabine, dexamethasone and platinum (SR-GDP) for patients with rr-DLBCL in China (Global study).
Phase 1b MATCH Trial designed to evaluate selinexor in combination with ATG-008 (onatasertib) for the treatment of R/R DLBCL (sponsored by Antengene).
Phase 1/2 SWATCH Trial designed to evaluate selinexor in combination with lenalidomide plus rituximab ("S-R2") for the treatment of relapsed/refractory indolent non-Hodgkin lymphoma ("rriNHL") (sponsored by Antengene).
Selinexor Data Presentations:

Phase 1b TOUCH Results: At the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2021), we published positive results from the open-label Phase 1b TOUCH trial of selinexor plus gemcitabine-oxaliplatin ("GemOx") for the treatment of Chinese patients with relapsed/refractory (R/R) T and NK-Cell lymphoma. The combination demonstrated an Overall Response Rate (ORR) of 46.2%, a Complete Response Rate (CRR) of 26.9% and a Duration of Response (DOR) of 3.1 months. ORR for peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and extranodal NK/T-cell lymphoma (ENKTL) subgroups reached 53.8% and 57.1%, CRR of 30.8% and 28.6%, and median Progression-Free Survival (PFS) of 4.4 months and 4.7 months, respectively (sponsored by Antengene).
Eltanexor (ATG-016, second generation XPO1 inhibitor): An expansive program to evaluate ATG-016 monotherapy in:

Phase 1/2 HATCH Trial in patients with high-risk myelodysplastic syndrome (MDS). Enrollment in China is underway (sponsored by Antengene).
Phase 1/2 REACH in patients with solid tumors. Enrollment in China is underway (sponsored by Antengene).
Phase 2 segment of the Solid Tumor/Hematologic Cancer trial. Enrollment in patients with high-risk MDS in China is underway (Global Study).
Eltanexor Data Presentations:

Phase 1/2 MDS Results: At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2021), Karyopharm published Phase 1/2 data with eltanexor in patients with MDS showing that single agent eltanexor was active in patients with high-risk, refractory disease. Of the 15 patients evaluable for efficacy, Karyopharm reported that 47% of patients achieved a bone marrow complete response and 33% had stable disease (SD) for a total disease control rate (DCR) of 80%.
Onatasertib (ATG-008, dual mTORC1/2 inhibitor) targets multiple key mTOR cell growth pathways. Data from the TORCH-2 Phase 1/2 solid-tumor dose-finding study in combination with PD-1 antibody was reviewed at Antengene’s 2021 R&D Day in November 2021. This promising signal warrants further exploration and Antengene will move rapidly to expand the study whilst exploring a potential accelerated regulatory path (sponsored by Antengene).

Early-Stage Clinical Programs (Antengene has global rights)

ATG-017 (ERK1/2 inhibitor) has potential synergy with checkpoint inhibitors and KRAS inhibitors. The Phase 1 ERASER dose escalation for the treatment of advanced solid tumors and hematologic malignancies is well advanced in Australia (sponsored by Antengene). Antengene will also be collaborating clinically with Bristol Myers Squibb in the ERASER study to evaluate ATG-017 in combination with Opdivo (nivolumab) in advanced solid tumors.
ATG-101 (PD-L1/4-1BB bispecific antibody) designed to block the binding of immunosuppressive PD-1/PD-L1 and activate immune effectors via 4-1BB co-stimulation. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also showed an excellent safety profile in GLP toxicology studies. The Phase 1 PROBE multicenter, dose-escalation clinical trial, in patients metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL), is ongoing in the US and Australia and the Investigative New Drug (IND) application has been approved in China.
ATG-037 (CD73 small molecule inhibitor) has the potential to reverse immunosuppression in the tumor microenvironment. Enrollment in the Phase 1 STAMINA trial, in patients with locally advanced or metastatic solid tumors, is planned to begin in Australia in H1: 22 (sponsored by Antengene).
Planning 2 INDs per Year (Antengene has global rights): Antengene has developed a vibrant, productive R&D team.

2022 IND Candidates: Antengene plans to submit an IND application for ATG-018 (ATR inhibitor) in H1:22. In addition, preclinical studies are also underway to support IND/CTA applications of ATG-022 (Claudin 18.2 antibody-drug conjugate) in 2022.
2023 Potential IND/CTA Filings: ATG-031 (CD24 antibody) and ATG-027 (B7H3/PD-L1 bispecific antibody)
Early Stage, IND Track Programs: ATG-032 (LILRB antibody) and ATG-041 (Axl-Mer inhibitor)
Corporate Updates: Corporate milestones related to development of critical research and development and manufacturing infrastructure to support biological and small molecule programs highlight Antengene’s transition to a fully-integrated biopharmaceutical company are exemplified by opening and development of two major manufacturing and R&D centers. These resources help Antengene stand out in the industry.

Antengene’s selection as a constituent stock in highlights the Company’s significant progress since its November, 2020 IPO.

Manufacturing Center in Shaoxing: In May 2021, the Company hosted an inauguration ceremony for our manufacturing center at the Binhai Life Science and Healthcare Industrial Zone in Shaoxing. Completion of the manufacturing center prepares for future production of oral medicines and provides Antengene with integrated capabilities in discovery, development, manufacturing, and commercialization. Antengene plans to initiate the manufacturing of selinexor at this site.
Agreement with Hangzhou Qiantang New Area Administrative Committee: In May 2021, we entered into a framework agreement with the Hangzhou Qiantang New Area Administrative Committee to build a drug discovery and manufacturing center for antibody biologics.
Selection in Major Stock Indexes: Antengene was selected as a constituent stock in three major, well-respected family market indexes, the Hang Seng Index Family, the FTSE Russell Index Family, and the MSCI Global Small Cap Indexes.
Financial Results

Cash, bank balances and cash management products: Cash, bank balances and cash management products at December 31, 2021 were RMB2,370.5 million as compared to RMB3,109.8 million at December 31, 2020.

Research and development costs: Research and development costs for the year ended December 31, 2021 were RMB405.0 million as compared to RMB347.7 million for the comparable period in 2020.

The increase relates to increased drug development expenses and expansion of R&D personnel.

Selling and distribution expenses: Selling and distribution expenses for 2021 were RMB67.9 million compared to RMB0.5 million for 2020.

The increase is primarily attributable to increased employee head count and professional fees related to preparations for the planned launch of our lead product, XPOVIO (selinexor) in 2022.

Administrative expenses: Administrative expenses for 2021 were RMB169.5 million compared to RMB154.2 million for 2020.

The increase is attributable to increased professional fees and headcount related to costs of operating as a public company and in support of commercial operations.

Press Release: Sanofi moves forward with EUROAPI listing on Euronext Paris

On March 18 2022 Today marks a major milestone for EUROAPI, a leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients* (API), as Sanofi’s Board of Directors reported, on March 17th, to submit to its shareholders the distribution of circa 58% of the share capital of EUROAPI. In addition to the previously proposed €3.33 cash dividend per Sanofi share, this additional extraordinary dividend, exclusively in kind, is subject to shareholders approval
at Sanofi’s May 3, 2022 Ordinary and Extraordinary Shareholders’ Meeting. If approved, the distribution will take place shortly after the listing of EUROAPI’s shares on the regulated market of Euronext Paris, subject to the approval of the French Autorité des Marchés Financiers (AMF) on EUROAPI’s French prospectus, which will be made available to the public ahead of Sanofi’s Shareholders’ Meeting. Through this transaction, Sanofi is giving its shareholders the opportunity to take part in the success of a leading player in the API market with strong ambitions to become a global champion on a growing and dynamic market, and due to be listed on the regulated market of Euronext Paris.

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In connection with the proposed spin-off, French Tech Souveraineté has agreed to purchase
12% in EUROAPI shares from Sanofi for up to €150 million, with the acquisition price to be determined based upon the thirty day volume weighted average trading price ("VWAP") of EUROAPI’s shares on Euronext Paris, starting on the first day of trading. As a result, French Tech Souveraineté will become a long-term reference shareholder of EUROAPI and will be represented by two non-executive members on EUROAPI’s Board of Directors, including Benjamin Paternot and another member to be determined. French Tech Souveraineté’s investment is subject to approval of the spin-off by Sanofi’s shareholders and other customary conditions.

Post transaction, Sanofi confirms that it will hold circa 30% of the share capital and voting rights of EUROAPI and will remain a long-term strategic partner, supporting EUROAPI’s growth ambitions as an independent company over the coming years. In addition to its highly diversified customer base of approximately 530 customers, EUROAPI benefits from a strong and long-term customer relationship with Sanofi, which represented nearly half of EUROAPI’s revenues in 2021.

In line with its "Play to Win" strategy aiming at simplifying its operations, Sanofi announced in February 2020 its ambition to create a new world leader in APIs to secure significant manufacturing and supply capacities that are critical for patients in Europe and beyond, in a context of increasing shortage of medicines essential to patient care. In 2021, Sanofi announced several critical steps in this journey with the unveiling of the creation of EUROAPI and the appointment of Karl Rotthier as its CEO in January, the appointment of Viviane Monges as Chair of the Supervisory Board in July and the finalization of the carve-out in December 2021.

Despite volatile market conditions, Sanofi has decided to move forward with the listing process of EUROAPI. As an independent stand-alone company, EUROAPI will be able to fully unlock its growth potential, offering the best alignment of strategy, value creation and financial objectives for all of Sanofi’s shareholders.

With a diversified technology portfolio, EUROAPI is positioned as the world’s leading manufacturer of small molecule API (including complex chemical synthesis molecules, biochemical molecules from fermentation and highly potent molecules). It was the world’s second largest manufacturer of APIs (including both small and large molecules such as peptides and oligonucleotides) in 2021 and number seven in the global CDMO (Contract Development and Manufacturing Organization) market in 20201.

EUROAPI develops, manufactures, markets and distributes APIs and intermediates used in the formulation of medicines for human and veterinary use, both from originators and generics, through its API Solutions business and CDMO activities.

Drawing on more than 150 years of experience in the growing API market, EUROAPI has a network of six production sites, all of which are located in Europe, and delivers around 200 APIs to approximately 530 customers in over 80 countries. The company will be able to rely on the expertise of around 3,350 employees and expects to achieve consolidated sales of around EUR 1 billion in the year ending December 31, 2022.

Further details regarding the specifics of the distribution, including the parity, and the timetable of the spin-off will be set forth in EUROAPI’s French prospectus.

Following the AMF’s approval of EUROAPI’s French prospectus, Sanofi and EUROAPI’s management teams will host a dedicated Capital Markets Day on April 1, 2022 at 1:30 pm CET to present EUROAPI’s business in greater detail (event registration details are available here).

*About Active Pharmaceutical Ingredients (APIs)
Active Pharmaceutical Ingredients (APIs) are the chemical or biological substances in a medicine that have a therapeutic effect. They are the essential molecules used in the composition and manufacture of any medicine.

Nymox Announces $5 Million Registered Direct Offering

On March 18, 2022 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported it has entered into definitive agreements with institutional and accredited investors for the purchase and sale of 3,030,304 common shares at a purchase price of $1.65 per share in a registered direct offering for gross proceeds of approximately $5 million before deducting placement agent fees and expenses (Press release, Nymox, MAR 18, 2022, View Source [SID1234610339]). The Company has also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 3,030,304 common shares. The warrants are exercisable immediately at an exercise price of $2.00 per share and will expire five (5) years from the date of an effective registration statement covering the shares underlying the warrants. The closing of the offering is expected to occur on or about March 22, 2022, subject to the satisfaction of customary closing conditions.

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Nymox intends to use the proceeds for general corporate purposes, including working capital.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering of the common shares (but not the warrants or the common shares underlying the warrants) is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-261571) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Nymox has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Nymox and such offering.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the common shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying common shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Janux Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results

On March 18, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update (Press release, Janux Therapeutics, MAR 18, 2022, View Source [SID1234610337]).

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"Janux made great strides in 2021 as we transitioned to a public company and advanced our pipeline of next generation immunotherapies utilizing our novel TRACTr and TRACIr platforms. We continue to build on this momentum by nominating a development candidate for our costimulatory bispecific program, the first development candidate discovered using our TRACIr platform," said David Campbell, Ph.D., President and CEO of Janux. "In 2022, we remain on-track to execute key milestones, including IND submissions for our PSMA-TRACTr and EGFR-TRACTr candidates, and we look forward to continuing to advance our additional pipeline programs in the year ahead."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

TRACTr product candidates advancing as planned. Janux’s lead TRACTr programs of next-generation T cell engagers remain on-track, with two Investigational New Drug (IND) applications expected in 2022.

In the first half of 2022, Janux expects to submit an IND for its PSMA-TRACTr candidate, targeting prostate-specific membrane antigen (PSMA), for the treatment of metastatic castration-resistant prostate cancer (mCPRC). cGMP manufacturing of drug substance and drug product has been completed.

In the second half of 2022, Janux expects to submit an IND application for its EGFR-TRACTr candidate, targeting epidermal growth factor receptor (EGFR), for the treatment of metastatic colorectal cancer (mCRC), squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC). cGMP manufacturing of drug substance has been completed.

In 2023, Janux expects to submit an IND application for its TROP2-TRACTr, targeting trophoblast cell surface antigen 2 (TROP2).

Nominated first TRACIr development candidate, a PD-L1xCD28 costimulatory bispecific for the treatment of solid tumors. Janux has successfully applied its TRACIr platform to

develop a costimulatory bispecific product candidate against programmed death-ligand 1 (PD-L1) and Cluster of Differentiation 28 (CD28) to further enhance the anti-tumor activity of T cells, which we believe has the potential to be used as a single-agent or in combination with our current TRACTr pipeline and other modalities. This is Janux’s first program derived from its TRACIr platform. In 2023, Janux expects to submit an IND application for this program.

Strengthened management team with appointment of Byron Robinson, Ph.D., J.D., as Chief Strategy Officer. Dr. Robinson brings 30 years of industry expertise and experience from key strategy roles at large pharma companies. Prior to joining Janux, Dr. Robinson served as Senior Vice President of Clinical Development Strategy and Innovation at Merck KGaA. In this role, he was responsible for generating strategic insights for internal and external innovation for the generation of the Clinical Oncology Franchise Strategy for all Merck KGaA oncology assets. In addition, he also served as the Senior Vice President Global Program Leader for the avelumab program, where he advanced BAVENCIO through late-stage development, including eleven registrational Phase 3 trials and more than 240 clinical trials.

FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS:

Cash and cash equivalents and short-term investments: As of December 31, 2021, Janux reported cash, cash equivalents and short-term investments of $375.0 million, compared to $7.8 million at December 31, 2020.

Research and development expenses: Research and development expenses were $11.2 million for the quarter and $26.2 million for the year ended December 31, 2021, compared to $1.0 million and $3.0 million for the same quarter and year in 2020.

General and administrative expenses: General and administrative expenses were $3.9 million for the quarter and $10.3 million for the year ended December 31, 2021, compared to $0.7 million and $1.8 million for the same quarter and year in 2020.

Net loss: Net loss was $13.4 million for the quarter and $32.7 million for the year ended December 31, 2021, compared to $1.7 million and $6.8 million for the same quarter and year in 2020.

Ichnos Sciences Presents Preclinical Data Package on First-in-class Oncology Treatment, ISB 1442, at IO360 Conference

On March 18, 2022 Ichnos Sciences Inc., a global biotechnology company developing innovative biologics in oncology, reported that preclinical data on ISB 1442, a first-in-class bispecific antibody for relapsed/refractory multiple myeloma and other CD38 positive hematologic malignancies, at the Immuno-Oncology 360 (IO360) conference (Press release, Ichnos Sciences, MAR 18, 2022, View Source [SID1234610336]). President and Chief Executive Officer of Ichnos, Cyril Konto, M.D., shared the data in a presentation titled "Beyond the T cell: Co-targeting CD38 and CD47 with a 2+1 Biparatopic Multispecific Antibody" during an afternoon session of the conference.

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In addition to presenting data for ISB 1442, Dr. Konto provided a description of Ichnos’ proprietary BEAT platform1 to meeting attendees. More specifically, he shared in vivo and in vitro study results showing the potency and anti-tumor effects of ISB 1442 relative to clinical benchmarks, daratumumab and agrolimab, and highlighted the flexibility of BEAT, which utilizes advanced heavy chain pairing and a common light chain, allows for modulation of the Fc functionality, and enables the exploration of the full design space.

The IO360 Conference is an annual gathering that convenes stakeholders from across the scientific and business communities, providing a forum to share the latest innovations in immuno-oncology. Ichnos was pleased to be a part of the agenda, which also included presentations by institutions such as John’s Hopkins University and several Fortune 100 pharmaceutical companies.

"Events such as IO360 are a great opportunity to learn about the latest in immuno-oncology and to exchange ideas with colleagues across the field," said Dr. Konto. "I am pleased to have had the opportunity to present data on ISB 1442, and Ichnos’ proprietary BEAT platform at the meeting."