On February 25, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the fourth quarter and year ended December 31, 2020 and provided a business update (Press release, Gossamer Bio, FEB 25, 2021, View Source [SID1234575624]).

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"The Gossamer team enters 2021 excited and focused on clinical trial execution," said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer. "Both seralutinib and GB004 are potentially paradigm shifting product candidates in indications of significant unmet patient need, and I am very proud of our team’s ongoing efforts to conduct our Phase 2 proof-of-concept studies for these programs despite the challenges of the pandemic."

Clinical-Stage Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for PAH

Enrollment ongoing in the TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline at week 24. Topline data from the TORREY study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Key opinion leader-led webcast and presentation regarding PAH and seralutinib (GB002) held on December 15, 2020 available through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)

Enrollment ongoing in the SHIFT-UC Study, a Phase 2 clinical trial in patients with active UC despite treatment with 5-ASAs. The primary endpoint is proportion of patients with clinical remission at week 12. Topline data from the SHIFT-UC study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Key opinion leader-led webcast and presentation regarding IBD and GB004 held on February 18, 2021 available through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com.
GB1275: Oral CD11b Modulator for Oncology Indications

Enrollment ongoing in a Phase 1 expansion cohort studying the recommended Phase 2 dose in KEYNOTE-A36, a Phase 1/2 clinical trial, including patients with gastric or esophageal cancer who have progressed after initial response to anti-PD-1 therapy and patients with advanced MSS colorectal cancer. Further Phase 1 data expected from this study in 2021.
GB001: Oral DP2 Antagonist for Eosinophilic Asthma

Gossamer engaged with the FDA and the EMA about the clinical development path in asthma, and based off those interactions, Gossamer believes that there is a viable clinical development path for GB001, or its backup molecule, in asthma. Gossamer does not currently plan to move forward with GB001, or its backup molecule, in further clinical trials without a partner.
Financial Results for Quarter and Full Year Ended December 31, 2020

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2020, were $512.6 million. As a result, we currently expect cash, cash equivalents and marketable securities, and access to our debt facility will be sufficient to fund operating and capital expenditures into the second half of 2023.
Research and Development (R&D) Expenses: For the quarter ended December 31, 2020, R&D expenses were $38.9 million compared to R&D expenses of $42.6 million for the same period in 2019. R&D expenses for the full year ended December 31, 2020, were $160.9 million compared to $143.4 million for the full year ended December 31, 2019. The increases were primarily due to an increase in expenses for GB004, seralutinib, GB1275 and preclinical programs.
In-Process Research and Development (IPR&D) Expenses: For the quarter ended December 31, 2020, IPR&D expenses were $5.3 million compared to $1.6 million for the same period in 2019. IPR&D expenses for the full year ended December 31, 2020, were $23.4 million compared to $3.6 million for the full year ended December 31, 2019. The increases were primarily attributable to a $15.0 million payment to Aerpio in connection with the amendment to the in-license agreement of GB004 in 2020 and a milestone payment of $5.0 million in connection with the initiation of the first Phase 2 clinical trial of seralutinib in 2020.
General and Administrative (G&A) Expenses: For the quarter ended December 31, 2020, G&A expenses were $15.9 million compared to $11.6 million for the same period in 2019. G&A expenses for the full year ended December 31, 2020, were $49.7 million compared to $39.1 million for the full year ended December 31, 2019. The increases were primarily attributable to an increase in stock-based compensation costs and an increase in personnel-related costs.
Net Loss: Net loss for the three months ended December 31, 2020, was $64.6 million, or $0.88 per share, compared to a net loss of $54.7 million, or $0.89 per share, for the same period in 2019. Net loss for the full year ended December 31, 2020, was $243.4 million, or $3.55 per share compared to a net loss of $180.3 million, or $3.29 per share, for the full year ended December 31, 2019.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 8:30 a.m. ET today, Thursday, February 25, to discuss its fourth quarter and full year 2020 financial results and provide a corporate update.

The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

On February 25, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Tracon Pharmaceuticals, FEB 25, 2021, View Source [SID1234575640]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We ended 2020 on a high note by enrolling the first patient in the ENVASARC pivotal trial within one year of licensing envafolimab and raising additional capital at market price that further extends our cash runway into the second half of 2022," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are focused on enrolling the ENVASARC trial expeditiously and expect the availability of interim data later this year, final data in 2022, and assuming positive clinical data and regulatory approval, to potentially commercialize envafolimab in 2023, in order to address a high unmet need for patients with UPS or MFS."

Recent Corporate Highlights

Envafolimab

As of February 5, 2021, TRACON had initiated 16 clinical sites and enrolled multiple patients at multiple sites in the pivotal ENVASARC trial of single agent envafolimab and envafolimab combined with Yervoy.

In January 2021, TRACON announced that its partners Alphamab Oncology and 3D Medicines received notification their New Drug Application for envafolimab, submitted in November 2020 in China, was granted priority review by the Center for Drug Evaluation of the National Medical Products Administration in the indication of MSI-H/dMMR cancer.

In December 2020, TRACON announced the dosing of the first patient in the pivotal ENVASARC trial.
TRC102

In November 2020, TRACON announced the publication of clinical data in the journal Cancer Cell, that provided molecular insight into TRC102’s mechanism of action and patient populations most likely to respond to treatment. The article, entitled, "Molecular Features of Cancers Exhibiting Exceptional Responses to Treatment," highlighted the clinical features and tumor biology of an exceptional responder patient treated with TRC102. TRC102 is a small molecule inhibitor of DNA base inhibitor repair being studied in Phase 1 and Phase 2 trials sponsored by the National Cancer Institute.
Corporate

In December 2020, TRACON announced financings of approximately $13.8 million in the aggregate with multiple new and existing healthcare focused institutional investors through registered direct offerings of its common stock. The financings were completed at market price, and TRACON expects the net proceeds will extend its cash runway into the second half of 2022.
Expected Key Upcoming Milestones

Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021.

Submit envafolimab response data to the FDA for orphan drug designation in sarcoma in 1H 2021.

Data presentation on TJ004309 Phase 1 results in 1H 2021.

Interim ENVASARC efficacy and safety data in 2H 2021.

Data presentation on TRC102 Phase 2 results in 2H 2021.

Request FDA breakthrough therapy designation for envafolimab in 2H 2021.

Decision on envafolimab NDA in China for MSI-H/dMMR cancer.
Fourth Quarter 2020 Financial Results

Cash, cash equivalents and short-term investments were $36.1 million at December 31, 2020, compared to $16.4 million at December 31, 2019. The Company expects that its current cash, cash equivalents and short-term investments will fund operations into the second half of 2022.

Research and development expenses for the fourth quarter of 2020 were $2.2 million, compared to $1.9 million for the fourth quarter of 2019.

General and administrative expenses for the fourth quarter of 2020 were $2.0 million, compared to $1.9 million for the fourth quarter of 2019.

Net loss for the fourth quarter of 2020 was $4.3 million, compared to $4.0 million for the fourth quarter of 2019.
Conference Call Details

Thursday, February 25, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 5681569
A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, as well as in a Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the US FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On February 25, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Nektar Therapeutics, FEB 25, 2021, View Source [SID1234575668]).

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Cash and investments in marketable securities at December 31, 2020 were approximately $1.2 billion as compared to $1.6 billion at December 31, 2019.

"This past year, Nektar made significant progress advancing our clinical pipeline of novel cytokine therapeutics," said Howard W. Robin, President and CEO of Nektar. "Our broad registrational program evaluating bempegaldesleukin (BEMPEG) plus nivolumab is progressing well with five registrational studies underway in melanoma, renal cell carcinoma and bladder cancer. We also recently added a sixth study to the registrational program to evaluate BEMPEG in combination with pembrolizumab in head and neck cancer and are pleased to be collaborating with Merck on the study. For our PROPEL study, we look forward to reporting the first data for BEMPEG plus pembrolizumab in patients with metastatic non-small cell lung cancer in the second half of 2021."

"For our second cytokine program, NKTR-255, we were very encouraged by the early signs of clinical activity that we recently reported at the SITC (Free SITC Whitepaper) 2020 meeting, and are now advancing two Phase 1 clinical studies in combination with ADCC antibodies, one in hematological malignancies and one in solid tumors," continued Mr. Robin. "Finally, our partner Eli Lilly is conducting a broad Phase 2 program for NKTR-358, our T regulatory cell IL-2 agent, with Phase 2 studies in both lupus and ulcerative colitis and plans to initiate additional Phase 2 studies in immune-mediated diseases over the next 12-18 months."

Summary of Financial Results

Revenue in the fourth quarter of 2020 was $23.5 million as compared to $33.9 million in the fourth quarter of 2019. Revenue for the year ended December 31, 2020 was $152.9 million as compared to $114.6 million in 2019 and was higher primarily due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb related to the start of two new registrational trials of bempegaldesleukin plus Opdivo (nivolumab) in adjuvant melanoma and muscle-invasive bladder cancer.

Total operating costs and expenses in the fourth quarter of 2020 were $134.2 million as compared to $143.5 million in the fourth quarter of 2019. Total operating costs and expenses for 2020 were $578.0 million as compared to $554.7 million in 2019. Total operating costs and expenses for full year 2020 increased as compared to 2019 primarily as a result of $45.2 million in impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program, partially offset by a decrease in R&D expense.

R&D expense in the fourth quarter of 2020 was $102.7 million as compared to $110.4 million for the fourth quarter of 2019. R&D expense for the year ended December 31, 2020 was $408.7 million as compared to $434.6 million in 2019. Excluding pre-commercial manufacturing costs for NKTR-181 incurred during 2019, research and development expense increased for the full year 2020 primarily due to the clinical development of bempegaldesleukin in five registrational trials.

G&A expense was $27.1 million in the fourth quarter of 2020 and $27.1 million in the fourth quarter of 2019. G&A expense for 2020 was $104.7 million as compared to $98.7 million in 2019.

Net loss for the fourth quarter of 2020 was $117.2 million or $0.65 basic and diluted loss per share as compared to a net loss of $112.2 million or $0.64 basic and diluted loss per share in the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $444.4 million or $2.49 basic and diluted loss per share as compared to net loss of $440.7 million or $2.52 basic and diluted loss per share in 2019.

2020 and Year-to-Date 2021 Business Highlights:

In February 2021, Nektar announced a clinical trial collaboration and supply agreement with Merck for a Phase 2/3 study of bempegaldesleukin, Nektar’s investigational IL-2 pathway agent, in combination with Merck’s KEYTRUDA (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1. The study is planned to start in the second half of 2021.
In February 2021, Nektar announced a financing and co-development collaboration with SFJ Pharmaceuticals for the development of bempegaldesleukin plus pembrolizumab in SCCHN. SFJ has agreed to fund up to $150 million to support the planned Phase 2/3 study and manage clinical trial operations for the study. In return, Nektar agrees to pay SFJ success-based annual milestone payments over a period of seven to eight years which are contingent upon receipt of certain U.S. regulatory approvals for specified indications for bempegaldesleukin, and will begin following completion of the SCCHN study, which is projected to be completed in 2024.
In December 2020, Nektar sold its royalties on future sales of ADYNOVATE and MOVANTIK to Healthcare Royalty Management, LLC in exchange for $150 million.
In December 2020, Nektar announced dosing of the first patient in its Phase 1/2 study of its IL-15 agonist, NKTR-255, in combination with cetuximab in patients with relapsed or refractory head and neck squamous cell carcinoma or colorectal cancer. The study may enroll up to 80 patients at approximately 15 investigator sites in the United States and European Union.
In December 2020, Nektar presented preclinical data for NKTR-255 at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting, underscoring the potential for NKTR-255 as an innovative immunotherapeutic agent in the treatment of multiple myeloma.
In November 2020, Nektar presented new data from its immuno-oncology pipeline at the virtual 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Updated clinical data from the PIVOT-02 study metastatic melanoma cohort showed that bempegaldesleukin with nivolumab resulted in a durable clinical benefit with median progression-free survival of 30.9 months. NKTR-255 showed biological activity in the first patients treated in the monotherapy dose-escalation phase of the ongoing Phase 1 study in multiple myeloma and non-Hodgkin’s lymphoma. In addition, new data showed that the combination of TLR agonist candidate, NKTR-262, plus bempegaldesleukin alters the tumor micro-environment through activation of both the innate and adaptive arms of the immune system.
In November 2020, Nektar presented new data from its NKTR-358 program at the American College of Rheumatology (ACR) virtual meeting. Data from the Phase 1b study in patients with mild to moderate systemic lupus erythematosus (SLE) showed that NKTR-358 produced a dose-dependent increase in expression of regulatory T cell (Treg) activation markers, providing a rationale for continued development in SLE and other inflammatory indications.
In October 2020, Nektar initiated a Phase 1b clinical study of bempegaldesleukin in adult patients with mild COVID-19 infection. The randomized, double-blind, placebo-controlled trial is designed to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic profile of bempegaldesleukin in adult patients with mild COVD-19.
In August 2020, Vaccibody AS and Nektar announced that the first patient had been dosed in the Phase 1/2a study evaluating bempegaldesleukin with VB10.NEO, Vaccibody’s personalized neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head and neck.
In June 2020, Nektar announced the presentation of results from the Phase 1b study evaluating multiple ascending doses of NKTR-358 at the Annual European Congress of Rheumatology (EULAR 2020) virtual meeting. The data showed that treatment with NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent expansion of regulatory T cells (Tregs) that was maintained over multiple administrations.
In May 2020, Nektar announced the publication of clinical data from its PIVOT-02 study evaluating bempegaldesleukin in combination with nivolumab in immunotherapy-naïve patients with advanced solid tumors, including melanoma, renal cell carcinoma (RCC) and non-small cell lung cancer. The data, published in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), showed that bempegaldesleukin plus nivolumab resulted in encouraging overall response rates across multiple tumor types, independent of baseline PD-L1 expression, with responses continuing to deepen over time.
In April 2020, Nektar repaid the principal and accrued interest of its senior notes totaling $254.8 million.
In February 2020, Nektar announced the publication of preclinical bempegaldesleukin data in two manuscripts in Nature Communications showing how bempegaldesleukin works synergistically with multiple immune-based therapies to enhance T-cell-mediated tumor control.
In January 2020, Nektar and Bristol-Myers Squibb announced a new joint development plan that expanded the ongoing registrational program for bempegaldesleukin plus Opdivo from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic RCC to include two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer. In addition, the expanded development plan includes a Phase 1/2 study to evaluate bempegaldesleukin plus nivolumab in combination with a tyrosine-kinase inhibitor in first-line RCC in order to support a future registrational trial.
In January 2020, Nektar made the strategic business decision to withdraw its New Drug Application (NDA) for NKTR-181, an investigational opioid medicine in development for chronic pain and make no further investment into the program.
Conference Call to Discuss Fourth Quarter and Year-End 2020 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, February 25, 2021.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through March 25, 2021.

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On February 25, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported its participation in the Cowen 41st Annual Healthcare Conference, which takes place March 1-4, 2021 (Press release, Agendia, FEB 25, 2021, View Source [SID1234575684]). Company management will be scheduling meetings with investors on Thursday, March 4. Meetings may be scheduled through Cowen.

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On February 25, 2021 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported that Joseph Oliveto, President and Chief Executive Officer, will present at the following investor conferences (Press release, Milestone Pharmaceuticals, FEB 25, 2021, View Source [SID1234575722]):

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The Cowen 41st Annual Health Care Conference’s panel on Cardiovascular Disease and Hospital Products on Thursday, March 4, 2021 at 1:30 p.m. Eastern Time.
The H.C. Wainwright Global Life Sciences Conference on Tuesday, March 9, 2021 on demand beginning at 7:00 a.m. Eastern Time.
The Oppenheimer 31st Annual Healthcare Conference on Tuesday, March 16, 2021 at 10:00 a.m. Eastern Time.
A replay of the pre-recorded H.C. Wainwright presentation and live webcast Oppenheimer presentation can be accessed in the News & Events section of Milestone’s website at www.milestonepharma.com. An archived replay of the webcasts will be available on the same website for approximately 90 days following the presentations.