On January 26, 2022 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported financial results for the third quarter of fiscal year 2021 and other corporate updates (Press release, Myovant Sciences, JAN 26, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-financial-results-third-quarter [SID1234607408]).

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"Our third fiscal quarter 2021 financial results reflect the continued strong momentum for the ORGOVYX and MYFEMBREE launches. ORGOVYX volume grew 40% sequentially, reflecting steadily increasing patient and clinician demand for its differentiated clinical profile compared to other androgen deprivation therapy alternatives. By December 2021, MYFEMBREE had captured 45% new-to-brand prescription share among GnRH antagonist therapies FDA-approved for the treatment of uterine fibroids, significant progress only six months following launch. This notable performance for both brands reaffirms our belief that ORGOVYX and MYFEMBREE have the potential to become standard of care therapies in advanced prostate cancer and uterine fibroids, respectively, and represent significant commercial opportunities over time," said David Marek, Chief Executive Officer of Myovant Sciences, Inc.

Mr. Marek added, "We anticipate 2022 will be a significant growth year with several important milestones that will support our mission of redefining care and position Myovant for long-term success. In addition to executing commercially, we look forward to submitting for FDA review the results of the LIBERTY randomized withdrawal study in women with uterine fibroids, completing the two-year SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain, and potentially launching MYFEMBREE in endometriosis in the U.S. pending FDA approval, while also expanding our pipeline by advancing relugolix lifecycle opportunities and pursuing business development."

Third Fiscal Quarter 2021 and Recent Corporate Updates

ORGOVYX (relugolix 120 mg)

Third fiscal quarter 2021 net product revenues for ORGOVYX in the U.S. were $24.4 million, reflecting 40% sequential volume growth compared to second fiscal quarter 2021, partially offset by a lower net price due to higher gross-to-net discounts. There were no material changes in inventory for ORGOVYX over the course of third fiscal quarter 2021.
Over 1,800 treatment centers prescribed ORGOVYX to approximately 11,000 patients on free and commercial drug, from launch through December 2021, excluding patients utilizing product samples. The cumulative number of estimated patients initiating ORGOVYX therapy has continued to increase steadily in each successive month since launch.
As of January 2022, Myovant achieved 81% commercial coverage and 99% Medicare Part D coverage for ORGOVYX. Myovant continues to engage with key commercial and Part D payers to maintain coverage as well as to potentially expand coverage with payers yet to make a coverage decision.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Third fiscal quarter 2021 net product revenues for MYFEMBREE in the U.S. were $2.4 million. There were no material changes in inventory for MYFEMBREE over the course of third fiscal quarter 2021.
New-to-brand prescription share among gonadotropin-releasing hormone (GnRH) antagonists approved by the U.S. Food and Drug Administration (FDA) for the treatment of uterine fibroids was 45% in December 2021 compared to 20% in September 2021, reflecting steadily increasing demand for the differentiated clinical profile of MYFEMBREE while growing the class.
Approximately 1,400 patients have been treated with MYFEMBREE from launch through November 2021, including patients on commercial drug and free drug programs, excluding patients utilizing product samples.
From launch through December 2021, over 800 unique providers had prescribed MYFEMBREE, of which 58% had not previously prescribed a GnRH antagonist FDA-approved for the treatment of uterine fibroids.
As of January 2022, Myovant achieved 83% commercial coverage for MYFEMBREE. Myovant continues to engage with key commercial payers to maintain coverage as well as to potentially expand coverage with payers yet to make a coverage decision.
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Since regulatory approvals for RYEQO by the European Commission (EC) in July 2021 and Medicines and Healthcare products Regulatory Agency in August 2021, Gedeon Richter (Richter), Myovant’s commercialization partner in certain other international markets, has launched RYEQO in 12 countries.
Third fiscal quarter 2021 net product revenues for RYEQO were $2.4 million, composed of $2.3 million related to product supply to Richter and $0.1 million royalties on net sales of RYEQO in Richter’s Territory.
Ex-U.S. Rights to Relugolix in Oncology

Myovant is continuing to assess partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in oncology. Myovant’s goal is to reach agreement with a partner by the anticipated EC approval of relugolix for prostate cancer, expected in mid-calendar year 2022.
Board of Director Appointment

Effective on November 5, 2021, Dr. Nancy Valente, M.D. was appointed by Myovant’s Board as an independent director following Ms. Kathleen Sebelius’ retirement from Myovant’s Board. Dr. Valente also became a member of the Audit Committee and the Chair of the Nominating and Corporate Governance Committee of Myovant’s Board.
Expected Upcoming Milestones

FDA submission of the Phase 3 LIBERTY randomized withdrawal study results for MYFEMBREE in women with uterine fibroids is expected in the first quarter of calendar year 2022.
Two-year data from the SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain is expected in the first quarter of calendar year 2022.
FDA decision for the MYFEMBREE sNDA seeking approval for the management of moderate to severe pain associated with endometriosis is expected by its May 6, 2022 target action date. FDA approval of MYFEMBREE for this indication would trigger a $100.0 million regulatory milestone payment from Pfizer. If approved by May 6, 2022, Myovant and Pfizer expect to launch MYFEMBREE in the U.S. for this indication in May 2022. If approved, this indication would utilize the same dosage, formulation, administration, and branding as MYFEMBREE, which was previously approved by the FDA in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids.
EC decision on the advanced prostate cancer Marketing Authorisation Application is expected in mid-calendar year 2022.
European Medicines Agency regulatory submission for RYEQO for the treatment of women with endometriosis-associated pain is expected in calendar year 2022. Richter will be the sponsor.
Third Fiscal Quarter 2021 Financial Summary

Total revenues for the three months ended December 31, 2021 were $54.4 million compared to $1.4 million for the three months ended December 31, 2020.

Product revenue, net from sales of ORGOVYX and MYFEMBREE in the U.S. for the three months ended December 31, 2021 were $24.4 million and $2.4 million, respectively. For the three months ended December 31, 2021 product revenue, net also includes revenues related to product supply to Richter of $2.3 million, as well as royalties on net sales of RYEQO in Richter’s Territory of $0.1 million. There was no such revenue recorded in the comparable prior year period.
Pfizer collaboration revenue for the three months ended December 31, 2021 was $25.2 million, reflecting the partial recognition of the upfront payment Myovant received from Pfizer upon entering into the Pfizer Collaboration and License Agreement in December 2020 and of the regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in May 2021. Pfizer collaboration revenue in the three months ended December 31, 2020 was $1.4 million, reflecting the partial recognition of the upfront payment received from Pfizer.
Cost of product revenue for the three months ended December 31, 2021 was $4.2 million related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. There were no such amounts recognized in the comparable prior year period.

Collaboration expense to Pfizer for the three months ended December 31, 2021, was $12.1 million, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S., pursuant to the Pfizer Collaboration and License Agreement. There were no such amounts recognized in the comparable prior year period.

Research and development (R&D) expenses for the three months ended December 31, 2021, were $25.7 million compared to $30.5 million for the comparable prior year period. The decrease in R&D expenses primarily reflects a reduction in clinical study costs as a result of the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies, as well as higher cost sharing with Pfizer for certain R&D expenses.

Selling, general and administrative (SG&A) expenses for the three months ended December 31, 2021, were $72.1 million compared to $49.2 million for the comparable prior year period. The increase was primarily due to higher expenses to support the ORGOVYX and MYFEMBREE U.S. launches, including higher personnel-related costs primarily due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology and women’s health sales forces.

Interest expense was $3.5 million for the three months ended December 31, 2021, compared to $2.6 million for the comparable prior year period. The increase in interest expense was primarily driven by the higher balance under Myovant’s loan agreement with Sumitomo Dainippon Pharma (Sumitomo Dainippon Pharma Loan Agreement) and $0.6 million of accretion of the financing component of the cost share advance from Pfizer.

Foreign exchange gain for the three months ended December 31, 2020 was $5.9 million, primarily the result of the impact of fluctuations in the foreign currency exchange rate between the Swiss franc and the U.S. dollar on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement. As a result of a change in the functional currency of Myovant’s wholly-owned subsidiary in Switzerland, Myovant Sciences GmbH, from the Swiss franc to the U.S. dollar in December 2020, Myovant is no longer exposed to significant foreign currency gains or losses.

Net loss for the three months ended December 31, 2021 was $63.4 million compared to $73.8 million for the comparable prior year period. On a per common share basis, net loss was $0.68 and $0.82 for the three months ended December 31, 2021 and 2020, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $569.1 million as of December 31, 2021, and consisted of $527.8 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, January 26, 2022, to discuss financial results for its third fiscal quarter ended December 31, 2021 and corporate updates. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S. The webcast will be archived on Myovant’s investor relations website following the call.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. ORGOVYX (relugolix 120 mg) was approved in the U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix (120 mg) is also under regulatory review in Europe for men with advanced prostate cancer. MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months, and by the European Commission and the Medicines and Healthcare products Regulatory Agency in July 2021 and August 2021, respectively, as RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted Myovant’s supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of May 6, 2022. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.

On January 26, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that it has entered into a long term strategic agreement with FUJIFILM Diosynth Biotechnologies (FDB), a subsidiary of FUJIFILM Corporation (Fujifilm) under which Fujifilm will acquire Atara’s T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California for USD 100 million upfront, retaining current manufacturing and quality staff at the site (Press release, Atara Biotherapeutics, JAN 26, 2022, View Source [SID1234607405]).

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The parties will also enter a long-term supply agreement, which could extend to ten years. Following completion of the transaction, FDB, a leading contract development and manufacturing organization (CDMO) in advanced therapies, will provide Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its maturing and promising pipeline, including tabelecleucel (tab-cel), under regulatory review in Europe for EBV+ PTLD, ATA188 for multiple sclerosis, and allogeneic CAR T therapies, ATA3271 and ATA3219. FDB will also expand use of the Thousand Oaks site and leverage its talented staff to manufacture a broader portfolio of cell therapies. Atara will retain its expertise, staff, and capabilities in manufacturing process science to continue to innovate in initial manufacturing and scale up for allogeneic cell therapies.

"FUJIFILM Diosynth Biotechnologies is a highly respected, quality-focused, industry-leading manufacturing and development organization that shares our pioneering culture and belief that allogeneic cell therapies will transform the future of medicine," said Pascal Touchon, President and CEO of Atara. "We are incredibly proud of our world-class ATOM staff and facility and believe that this strategic partnership will meet our long-term manufacturing needs. Our team has developed processes for our products, scaled them up, and built inventory for clinical trials and the potential commercial launch of tab-cel. We believe that now is the right time for a strategic relationship with FDB to provide us with expert manufacturing capabilities, as needed. Accordingly, we will further focus capital resources on the development and commercialization of our pipeline of potentially transformative therapeutics for serious diseases."

Atara expects to report cash, cash equivalents and short-term investments of $371.1 million as of December 31, 2021. This information is preliminary, has not been audited, and is subject to change upon the audit of the company’s financial statements for the year ended December 31, 2021.

Under the terms of the deal, Atara will receive USD 100 million at closing and Fujifilm plans to offer positions to approximately 140 current highly skilled manufacturing and quality staff at the site. The agreement is expected to reduce Atara’s planned operating expenses over the multiyear period. Upon closing, the upfront consideration, along with the reduction in operating expenses, in addition to Atara’s existing cash, cash equivalents and short-term investments is expected to fund Atara’s planned operations into Q4 2023, beyond the anticipated completion of the randomized, placebo-controlled Phase 2 study of ATA188, the Company’s investigational off-the-shelf T-cell candidate that has the potential to reverse disability in progressive multiple sclerosis.

Atara retains the recently established Thousand Oaks-based Atara Research Center (ARC), which is fully operational and will house Atara’s Pre-Clinical, Translational Sciences, Manufacturing Process Sciences, and Analytical Development teams to further drive innovation by leveraging the Company’s unique and differentiated allogeneic cell therapy platform. Atara will also retain a talented technical operations team to manage external manufacturing, quality, logistics and supply.

"We are thrilled that through this acquisition we will add approximately 140 talented staff from Atara’s cell therapy manufacturing facility to the FUJIFILM Diosynth Biotechnologies family. The collective expertise of the team will further support our efforts as a world-class CDMO," added Martin Meeson, chief executive officer, FUJIFILM Diosynth Biotechnologies. "We also look forward to adding the facility to FUJIFILM Diosynth Biotechnologies’ existing global footprint and to bolster the expansion of our advanced therapies CDMO business."

ATOM is a 90,000 ft cutting edge T-cell therapy manufacturing facility fully qualified to support clinical and commercial production and designed with the flexibility to expand to support various production requirements and capacities. The closing of the transaction, subject to expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, is expected to occur in April 2022.

Evercore Group LLC is acting as strategic advisor to Atara and Gibson Dunn & Crutcher LLP is acting as its legal counsel.

Atara Conference Call

In connection with this announcement, Atara will host a webcast and conference call today at 4pm PST / 7pm EST. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID: 13726583. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of www.atarabio.com. An archived replay will be available on the Company’s website for 30 days.

On January 26, 2022 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported that the Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") has notified the Company that it has been granted an additional 180 calendar day period, through July 23, 2022, to evidence compliance with the US$1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market (Press release, AEterna Zentaris, JAN 26, 2022, View Source [SID1234607404]).

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If at any time before July 23, 2022, the bid price for the Company’s common shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days (and generally not more than 20 consecutive business days, in Nasdaq’s discretion), it is expected that Nasdaq would provide formal notice that the Company has regained compliance with the bid price requirement.

In the event the Company does not evidence compliance with the minimum bid price requirement during the 180-day grace period, it is expected that Nasdaq would notify the Company that its shares are subject to delisting. At such time, the Company may appeal such determination to a Nasdaq Hearings Panel (the "Panel’) and it is expected that the Company’s securities would continue to be listed and available to trade on Nasdaq at least pending the completion of the appeal process. There can be no assurance that any such appeal would be successful or that the Company would be able to evidence compliance with the terms of any extension that may be granted by the Panel.

The Nasdaq notification letter does not impact the Company’s compliance or listing status on the Toronto Stock Exchange.

On January 26, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the publication of new preclinical immunotherapy data for novel, potentially solid tumor- and therapeutic combination-agnostic radioenhancer NBTXR3 in the Journal of Nanobiotechnology (Press release, Nanobiotix, JAN 26, 2022, View Source [SID1234607403]).

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The Nanobiotix preclinical program aims both to provide a deeper understanding of the NBTXR3 mechanism of action and to discover new pathways for the radioenhancer to potentially improve treatment outcomes for patients. Given preclinical and early clinical data suggesting a potential immune priming effect triggered by radiotherapy (RT)-activated NBTXR3 and the medical unmet need for patients with primary or secondary resistance to immune checkpoint inhibitors, Nanobiotix and The University of Texas MD Anderson Cancer Center are exploring several therapeutic combinations involving checkpoint inhibitors, radiotherapy, and NBTXR3.

"We believe that we have only scratched the surface of opportunity for NBTXR3 as a potentially-ideal combination agent with immune checkpoint inhibitors," said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. "As the industry continues to advance development of these powerful immunotherapy agents, we feel there is an urgent need for novel combinations that can help improve efficacy for naïve patients and overcome resistance for non-responders. Our view is that the results presented in this new publication add to the growing body of data suggesting therapeutic potential for NBTXR3 in combination with immune checkpoint inhibitors, and we look forward to further investigation in the lab and in the clinic."

Following previously reported positive preclinical data on the addition of NBTXR3 to a combination of radiotherapy and anti-PD-1 in anti-PD-1 sensitive and resistant lung cancer models, this evaluation investigated the addition of NBTXR3 to a combination of radiotherapy, anti-PD-1, and anti-CTLA-4 in an anti-PD-1 resistant model. Mice were inoculated with metastatic lung cancer cells in their right (primary tumor) and left (secondary tumor) legs. They were then treated with various combinations of anti-PD-1, anti-CTLA-4, NBTXR3, and radiotherapy in an effort to isolate the effect of adding NBTXR3, modifying the RT protocol, or both. Mice surviving after 178 days were rechallenged with tumor cells and monitored for tumor growth.

The evaluation showed that both modifications to RT protocol and the addition of NBTXR3 improved outcomes of combination therapy, and that the cohorts in which NBTXR3 was included in the regimen outperformed all others. Of note, the cohort treated with NBTXR3 and modified RT together showed that the therapy had significant antitumor effects against both primary and secondary tumors, improving the mouse survival rate from 0% to 50%. None of the re-challenged survivor mice developed tumors, and they had higher percentages of memory T cells versus control, suggesting the induction of long-term antitumor immune memory. The authors concluded that NBTXR3 in combination with radioimmunotherapy significantly improved anti-PD-1 resistant lung tumor control in mice by promoting antitumor immune response.

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy either naïve or resistant to prior PD-1 (either primary or secondary as per SITC (Free SITC Whitepaper) criteria).

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies.

On January 26, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported that Rick Fair, President and CEO, will participate in the B. Riley Securities 2022 Virtual Oncology Conference (Press release, Bellicum Pharmaceuticals, JAN 26, 2022, View Source [SID1234607402]). A corporate presentation is scheduled for Thursday, January 27, 2022 at 4 p.m. ET / 1 p.m. PT.

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A live webcast of the presentation will be available from the Investor Relations section of the company website at Events & Presentations – Bellicum with a replay available shortly after the live event.