On March 30, 2020 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy based therapies, reported financial results for the fourth quarter and full year of 2019 and provided an update on strategic and operational developments (Press release, EDAP TMS, MAR 30, 2020, View Source [SID1234556047]).

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Marc Oczachowski, EDAP’s Chief Executive Officer, said: "We are proud of our team for a very successful year in 2019, which was our first full year of U.S. FDA approval for Focal One, our latest generation high Intensity Focused Ultrasound (HIFU) robotic device for the targeted ablation of prostate tissue. During the year, we placed Focal One devices at many highly regarded healthcare institutions, including Mayo Clinic, Houston Methodist Hospital, University of California at Irvine Medical Center and University of Chicago Medicine, among others. We ended the year with a strong sales pipeline and good momentum both in the U.S. and worldwide.

"As far as financial results, we grew our company sales by 14.5% year-over-year, which was driven by HIFU sales growth of 28%. We expanded our gross margins to a record 46.8%, which represents an increase of 362 basis points in 2019 as higher margin HIFU sales led to higher profitability. The Company has now been profitable for five consecutive quarters, and we have a strong balance sheet with EUR 20.9 million in cash. We are looking forward to the commencement of U.S. reimbursement for Focal One in 2021, which has the potential to be a significant catalyst for further adoption.

"The COVID-19 virus represents a major new challenge for all of us, and we are proactively taking measures across all areas of our business. Our number one priority is the health and safety of our employees and to ensure uninterrupted service to our existing customers. Due to this ongoing pandemic, we anticipate the likelihood of an impact to our near-term revenue as procedures are delayed and the sales cycle for new installations becomes elongated. However, we are pleased with the momentum with which we entered 2020, and we believe we have the resources to successfully navigate this crisis."

"Finally, we are announcing today that Philippe Chauveau is stepping down from his role as Chairman of the Board but will continue to serve as a Director until June of this year, as part of a long-established transition plan. Philippe’s insights have been invaluable since joining our Board in 1997," Mr. Oczachowski concluded.

EDAP’s Chief Executive Officer, Marc Oczachowski, has been selected by the Board to replace Mr. Chauveau as Chairman. Mr. Oczachowski has worked at EDAP in various roles of increasing responsibility since 1997, becoming Chief Operating Officer in November 2004 and Chief Executive Officer in March 2007. He has served as a Director on EDAP’s Board since 2017.

"I am humbled that my fellow directors have nominated me to assume the role of Chairman, and I remain steadfast in my commitment to maintain our position as a leading global innovator in the use of therapeutic ultrasound," Mr. Oczachowski commented.

Full Year 2019 Results

Total revenue for the full year of 2019 was EUR 44.9 million (USD 50.2 million), a 14.6% increase compared to EUR 39.2 million (USD 46.2 million) for the full year of 2018.

Total revenue in the HIFU business for the full year of 2019 was EUR 14.1 million (USD 15.8 million), a 28.1% increase compared to EUR 11.0 million (USD 13.0 million) for the full year of 2018.

For the full year of 2019, total revenue for the UDS division was EUR 30.8 million (USD 34.4 million), a 9.3% increase compared to EUR 28.1 million (USD 33.2 million) during the year-ago period.

Gross profit for the full year of 2019 was EUR 21.0 million (USD 23.5 million), compared to EUR 16.9 million (USD 19.9 million) for the year-ago period. Gross profit margin on net sales was 46.8% for the full year 2019 compared to 43.2% for the full year 2018.

Operating expenses were EUR 18.8 million (USD 21.0 million) for the full year of 2019, compared to EUR 18.2 million (USD 21.5 million) for the same period in 2018.

Operating profit for the full year of 2019 was EUR 2.2 million (USD 2.5 million), compared to an operating loss of EUR 1.3 million (USD 1.5 million) in the full year of 2018.

Net income for the full year of 2019 was EUR 1.5 million (USD 1.7 million), or earnings of EUR 0.05 per diluted share, as compared to a net loss of EUR 0.3 million (USD 0.4 million), or a loss of EUR 0.01 per diluted share in the year-ago period.

As of December 31, 2019, cash and cash equivalents were EUR 20.9 million (USD 23.4 million).

Fourth Quarter 2019 Results

Total revenue for the fourth quarter 2019 was EUR 12.0 million (USD 13.3 million), a 9.8% decrease compared to EUR 13.3 million (USD 15.1 million) for the fourth quarter of 2018.

Total revenue in the HIFU business for the fourth quarter 2019 was EUR 2.9 million (USD 3.2 million), a 33.1% decrease compared to EUR 4.3 million (USD 4.9 million) for the fourth quarter of 2018. The year-over-year decline was due to two Focal One units sold during the fourth quarter of 2019 compared to four Focal One units sold in the year ago period.

For the three months ended December 31, 2019, total revenue for the UDS division was EUR 9.1 million (USD 10.1 million), a 1.6% increase compared to EUR 8.9 million (USD 10.2 million) during the year-ago period.

Gross profit for the fourth quarter 2019 was EUR 5.1 million (USD 5.7 million), compared to EUR 6.0 million (USD 6.8 million) for the year-ago period. Gross profit margin on net sales was 43.0% in the fourth quarter of 2019, compared to 45.0% in the year-ago period. The decline in gross profit year-over-year was due to in part to lower sales in HIFU business as compared ot the year-ago period.

Operating expenses were EUR 5.1 million (USD 5.6 million) for the fourth quarter of 2019, compared to EUR 5.1 million (USD 5.8 million) for the same period in 2018.

Operating profit for the fourth quarter 2019 was EUR 0.1 million (USD 0.1 million), compared to EUR 0.8 million (USD 1.0 million) in the fourth quarter of 2018.

Net loss for the fourth quarter 2019 was EUR 1.0 million (USD 1.1 million), or EUR (0.03) per diluted share, as compared to net income of EUR 1.0 million (USD 1.2 million), or EUR 0.04 per diluted share in the year-ago period.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Tuesday, March 31, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Tuesday, March 31, 2020 @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13700921
Webcast: View Source

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On March 30, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported the achievement of a clinical milestone in conjunction with the CX-2029 program, triggering a $40 million payment from AbbVie to CytomX (Press release, CytomX Therapeutics, MAR 30, 2020, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-milestone-achievement-abbvie-cd71" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-milestone-achievement-abbvie-cd71" rel="nofollow">View Source [SID1234556046]). The company also provided an update on its lead wholly owned clinical programs.

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"CytomX has made excellent progress during 2020, including the establishment of a major new strategic alliance with Astellas, the initiation of a randomized Phase 2 study by our partner, Bristol Myers Squibb, evaluating the anti-CTLA-4 Probody, BMS-986249, in front line melanoma, and today the achievement of a significant clinical and financial milestone within our AbbVie alliance. This progress underscores the increasing validation of our Probody platform and illustrates how our partnering strategy continues to contribute meaningfully to the advancement of our pipeline," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "From our position of strength, against the pressures that the COVID-19 pandemic backdrop is placing on the healthcare system and clinical trial enrollment across the biopharma sector, we are today announcing steps to reprioritize our clinical portfolio and optimize resource allocation with the goal of maximizing long-term value. These steps will afford an increased emphasis on our work on undruggable targets such as CD166 and CD71 and the continued advancement of additional potential first-in-class programs towards future IND filings."

Achievement of $40 Million Phase 1 Dose Escalation Milestone in CX-2029 AbbVie Partnership

In April 2016, AbbVie and CytomX entered into a Co-Development and Licensing Agreement under which the two companies are co-developing CX-2029, a Probody drug conjugate against CD71. CD71, also known as the transferrin receptor 1 ("TfR1"), is a cell surface protein essential for iron uptake in dividing cells. CD71 is highly expressed in a number of solid and hematologic cancers and has attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells. CD71 has high potential as an anti-cancer target but is widely considered undruggable due to its presence on most dividing healthy cells. CX-2029 is designed to potentially create a therapeutic window for this novel target.

Under the agreement, CytomX is responsible for clinical development up to initial clinical proof of concept. AbbVie will lead late-stage clinical development and global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the United States. The $40 million milestone announced today was reached by CytomX through the achievement of pre-specified criteria for the dose escalation phase of the ongoing Phase 1/2 clinical trial, PROCLAIM-CX-2029 (NCT003543813). CytomX and AbbVie are finalizing plans for the advancement of CX-2029 to Phase 2 expansion cohorts in select tumor types. Preliminary clinical data from the Phase 1 dose escalation phase of PROCLAIM-CX-2029 is expected to be presented in 2020.

"We are encouraged by the progress of CX-2029 in the dose escalation studies executed by CytomX and look forward to seeing the data emerge from the expansion cohort phase," said Mohit Trikha, Ph.D., vice president and head of oncology early development and Bay Area Site Head, AbbVie.

Clinical Pipeline Update

CytomX is conducting multiple clinical trials worldwide and is committed to protecting the safety of its study participants and the physicians and staff that operate these clinical studies.

In assessing the evolving COVID-19 pandemic, and the emerging challenges for clinical trial execution within our studies and across the industry, CytomX has made the decision to temporarily pause new patient enrollment and new site activation in the PROCLAIM-CX-2009-001 study evaluating the CD166-targeting Probody drug conjugate CX-2009. This study includes the Phase 2 expansion study evaluating CX-2009 as monotherapy in patients with hormone receptor (ER, PR) positive, HER2 negative breast cancer. CytomX continues to closely monitor emerging Health Authority guidance and IRB/Ethics Committee recommendations. CytomX intends to resume the CX-2009 clinical program as soon as practicable.

CytomX has also made the strategic decision to terminate the PROCLAIM-CX-072-002 study (NCT03993379) evaluating the anti-PD-L1 Probody CX-072 in combination with Yervoy (ipilimumab) in melanoma. This decision comes following a re-evaluation of the evolving clinical, competitive and commercial landscapes in immuno-oncology, taken together with impact of the COVID-19 pandemic. This decision allows for resources to be redirected towards CytomX’s potential first-in-class assets, including a combination of CX-072 and CX-2009, and to the generation of additional clinical candidates for advancement to IND filing and clinical trials.

Teleconference Scheduled Today at 6:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 6:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 7169589. An archive of the webcast will be available on the CytomX website from March 30, 2020, until April 6, 2020.

On March 30, 2020,Trovagene, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC (the "Purchaser"), pursuant to which the Company agreed to offer, issue and sell to the Purchaser, (i) in a registered direct offering, an aggregate of (a) 800,000 shares (the "Shares") of common stock, par value $0.0001 per share ("Common Stock") and (b) Series I pre-funded warrants (the "Series I Pre-Funded Warrants") to purchase up to 131,967 shares (the "Series I Warrant Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), which will be exercisable immediately upon issuance for a period of five years after the date of issuance, and (ii) in a concurrent private placement, Series J warrants (the "Series J Warrants") to purchase up to 931,967 shares (the "Series J Warrant Shares") of Common Stock, for aggregate gross proceeds to the Company of approximately $1.0 million, before deducting estimated offering expenses payable by the Company (Filing, 8-K, Trovagene, MAR 30, 2020, View Source [SID1234556043]).

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The combined purchase price for each Share, together with one Series J Warrant, is $1.073 per Share/Series J Warrant. Each Series J Warrant shall be exercisable beginning on the six-month anniversary of the date of issuance and for a period of five years after such date (or five-and-a-half years after the issuance date), at an exercise price of $0.948 per Series J Warrant Share. The exercise price of the Series J Warrants and the shares of the Company’s Common Stock issuable upon the exercise of the Series J Warrants (the "Series J Warrant Shares") will be subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Series J Warrants.

The aggregate exercise price of the Series I Pre-Funded Warrants ($1.073 per Series I Warrant Share), except for a nominal exercise price of $0.01 per Series I Warrant Share, will be pre-funded to the Company on the date of issuance of the Series I Pre-Funded Warrants and, consequently, no additional consideration (other than the nominal exercise price of $0.01 per Series I Warrant Share) shall be required to be paid by the holder to effect any exercise of the Series I Pre-Funded Warrants. The Company shall not be required to return or refund any portion of such pre-paid aggregate exercise price of the Series I Pre-Funded Warrants for any reason, including in the event such Series I Pre-Funded Warrants shall not have been exercised prior to expiration. Each of the Series I Pre-Funded Warrants and the Series J Warrants may be exercised on a "cashless" basis under certain circumstances set forth in the warrants.

The Shares, Series I Pre-Funded Warrants and the Series I Warrant Shares issuable upon exercise of the Series I Pre-Funded Warrants are being offered by the Company pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on June 25, 2019, and was declared effective on July 1, 2019 (File No. 333-232321) (the "Registration Statement").

The Series J Warrants and the Series J Warrant Shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and are instead being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

Per the terms of the Purchase Agreement, the Company has agreed to certain restrictions on future stock offerings, including that during the 60-day period following the closing, the Company will not issue (or enter into any agreement to issue) any shares of Common Stock or Common Stock equivalents, subject to certain exceptions.

The closing of the offering described above is subject to satisfaction of specified customary closing conditions.

The foregoing summaries of the offerings, the securities to be issued in connection therewith, the Purchase Agreement, the Series I Pre-Funded Warrants and Series J Warrants do not purport to be complete and are qualified in their entirety by reference to the definitive transaction documents. Copies of the form of Purchase Agreement, the Form of Series I Pre-Funded Warrant and the Form of Series J Warrant are attached hereto as Exhibits 10.1, 10.2 and 10.3, respectively, and are incorporated herein by reference.

On March 30, 2020 Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, reported that Hunter Smith, the Company’s Chief Financial Officer, has been named to the additional role of Interim Chief Executive Officer, effective immediately (Press release, Rhythm Pharmaceuticals, MAR 30, 2020, View Source [SID1234556041]). Mr. Smith succeeds Keith Gottesdiener, M.D. whose planned departure was announced by the Company in January 2020. Dr. Gottesdiener stepped down from his roles as CEO, President and member of the Board of Directors following the Company’s completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

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"On behalf of the Board, I am pleased that Hunter and the Rhythm management team will continue their excellent stewardship of the Company and dedication to transforming the care of people living with rare genetic disorders of obesity while we continue our search for a permanent CEO," said David Meeker, M.D., Chairman of the Board of Directors. "With Murray Stewart, Chief Medical Officer, leading our clinical development and regulatory strategy and Nithya Desikan, Chief Commercial Officer, and her team making tremendous strides in community building, we believe that Rhythm is well positioned to change the paradigm for rare genetic obesity."

As previously disclosed, the Company’s Board of Directors has formed a search committee and retained an executive search firm to assist in identifying Dr. Gottesdiener’s permanent successor. The Board has made significant progress in the search process and is considering a number of highly qualified candidates.

"I look forward to working closely with the Board, Murray and Nithya, our colleagues on the management team, and the entire Rhythm team to advance setmelanotide," Mr. Smith said. "We are committed to working with patients and the community to build greater awareness and understanding of rare genetic disorders of obesity so we can maximize our impact and transform the care of people living with these conditions."

COVID-19 and Business Continuity
To help protect the health and safety of the patients, caregivers and healthcare professionals involved in its ongoing clinical trials of setmelanotide, as well as its employees, in response to the novel coronavirus (COVID-19) pandemic, Rhythm has implemented a number of precautionary clinical and operational measures to protect patient well-being and ensure consistent and appropriate clinical trial conduct.

With many clinical trial sites already closing down in response to COVID-19-related country- and state-level guidelines and more closures expected, Rhythm and study investigators and staff remain focused on the safety, treatment and monitoring of patients currently enrolled in these trials. Rhythm has introduced measures to ensure patients in ongoing clinical trials continue to be monitored as scheduled and receive their study drug.

Mr. Smith continued, "We are acutely aware of the unprecedented crisis unfolding across the globe as a result of the COVID-19 pandemic. Over the past several weeks, we have put measures in place to protect the health and safety of patients and staff participating in our clinical trials, as well as our employees and their families, and to seek to ensure that our ongoing studies can continue with minimal interruption."

POMC Deficiency Obesity and LEPR Deficiency Obesity
Today, Rhythm announced that it has completed its rolling submission of an NDA to the FDA for setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity. The FDA typically has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Rhythm has requested priority review for the application which, if granted, could provide a target FDA review period of six months from the application filing date. Rhythm continues to anticipate that it will submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second quarter of 2020. At this time, Rhythm is continuing its regular interactions with the FDA and EMA and based on current information, the Company does not anticipate COVID-19 to materially affect its timelines.

Ongoing Clinical Trials of Setmelanotide
Rhythm continues to expect to meet disclosed timelines for reporting data from its pivotal Phase 3 trial in Bardet-Biedl Syndrome (BBS) and Alström Syndrome and Phase 2 Basket Study. The Company anticipates announcing topline data in the fourth quarter of 2020 or early in the first quarter of 2021 from the Phase 3 BBS and Alström syndrome trial, which completed enrollment in December 2019. Rhythm also anticipates announcing additional data in high-impact heterozygous (HET) obesity and additional data from one or more of its other ongoing indications in 2020, based on current enrollment levels in the Phase 2 Basket Study.

Rhythm currently believes there will be no disruption of clinical supply of setmelanotide. The Company’s contract manufacturers have indicated that they have appropriate plans and procedures in place to ensure uninterrupted future supply of clinical and commercial-grade setmelanotide, subject to potential limitations on their operations due to COVID-19.

Corporate Operations

Consistent with guidelines from the Centers for Disease Control (CDC) and the Commonwealth of Massachusetts, Rhythm has also implemented measures to help keep the Company’s employees, families, and local communities healthy and safe. All employees are working remotely and all business travel has been restricted.

On March 30 2020 I-Mab (the "Company")(Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, reported a strategic partnership with Kalbe Genexine Biologics ("KG Bio"), a joint venture of Kalbe Farma Tbk ("Kalbe"), and Genexine, Inc. ("Genexine") (Press release, I-Mab Biopharma, MAR 30, 2020, View Source [SID1234556023]). Under the terms of the agreement, KG Bio will receive a right of first negotiation for an exclusive license for the commercialization of two I-Mab discovered product candidates: TJD5, a highly differentiated anti-CD73 antibody in Phase 1 development for advanced solid tumors, and an I-Mab product candidate to be agreed upon by both parties.

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With the agreement, KG Bio will have a right of first negotiation for exclusive rights to commercialize these two product candidates in the ASEAN (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) and MENA (Algeria, Bahrain, Djibouti, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Malta, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates, Palestine, and Yemen) regions, as well as Sri Lanka.

"This partnership recognizes the potential of our internally-discovered anti-CD73 antibody TJD5 in immuno-oncology, and its clear clinical differentiation related to a novel epitope of CD73," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "We are pleased to enter into this strategic partnership with the Kalbe corporate family, which is a leader in commercializing innovative therapies in Southeast Asia and other key strategic markets and deepen our relationship with Genexine. We believe this partnership will expand the commercialization potential of TJD5 and other candidates in our portfolio."

"I-Mab has a highly innovative and globally competitive pipeline epitomized by products with best-in-class potential such as TJD5. With this novel partnership KG Bio will further strengthen its immuno-oncology portfolio. We are determined to maximize the potential of these products by leveraging our commercial capabilities and presence in the ASEAN, Middle East and North Africa (MENA) regions as well as Sri Lanka, where demand for breakthrough therapies is growing significantly." commented Sie Djohan, President Director of KG Bio.

If and when I-Mab and KG Bio enter into the definitive licensing agreement for TJD5, I-Mab would be eligible to receive from KG Bio an aggregate amount of up to approximately $340 million, including an upfront payment and subsequent payments conditional upon achieving certain development

and commercial milestones. KG Bio would pay I-Mab tiered royalties in the low to mid-teen percentages on net sales from the ASEAN and MENA regions, as well as Sri Lanka.

About TJD5

TJD5 is a differentiated, humanized monoclonal antibody against CD73. CD73 is expressed in tumors and plays a critical role in suppressing immune cells in tumor micro-environment. By binding to a novel epitope and inhibiting CD73, TJD5 is believed to reshape the immuno-suppressive tumor micro-environment and increase T-cell anti-tumor activity. When combined with a PD-L1 antibody in vivo, TJD5 achieved better anti-tumor efficacy. TJD5 is currently being evaluated in a Phase 1, dose-escalation clinical trial in patients with advanced solid tumors in the United States.

About Kalbe Genexine Biologics (KG Bio)

KG Bio is a joint venture between Kalbe Farma of Indonesia and Genexine of South Korea. KG bio is focused on clinical development and the commercialization of novel biologics and monoclonal antibodies in ASEAN, Asia Pacific and MENA. Through innovative technological platform that ensures affordable and high-quality products, KG Bio aims to provide innovative biologic and immuno-oncology products, and better solutions in treating human diseases.