On August 5, 2021 XOMA Corporation (Nasdaq: XOMA) reported its second quarter 2021 financial results and provided a recent operations update (Press release, Xoma, AUG 5, 2021, View Source [SID1234585912]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The events we have announced over the past four months reflect many more months of hard work by our team and our partners. On the acquisition side of our potential milestone and royalty asset business, we added Day One Biopharmaceuticals’ DAY101 (pan-RAF kinase inhibitor), Checkmate Pharmaceuticals’ vidotulimod (CMP-001), and Denovo Biopharma’s vosaroxin (topoisomerase II inhibitor) to our growing list of partner-funded assets. XOMA’s legacy technology license agreements resulted in the addition of three clinical-stage assets being developed by Affimed to our portfolio," stated Jim Neal, Chief Executive Officer of XOMA.

"Our asset partners also have had successes with assets in XOMA’s portfolio. In May, Janssen launched a Phase 3 study with cetrelimab (anti-PD-1 monoclonal antibody). In conjunction with the first NIS793 (anti-TGFβ monoclonal antibody) clinical data presentation at ASCO (Free ASCO Whitepaper) in June, Novartis announced its intention to begin a Phase 3 study with NIS793 later in 2021. Also at ASCO (Free ASCO Whitepaper), AVEO reported data from the ficlatuzumab Phase 2 study in head and neck squamous cell carcinoma and its desire to move ficlatuzumab into Phase 3 development. Last week, we were pleased to learn of two important designations granted by the FDA. NIS793 in combination with standard of care chemotherapy now has Orphan Drug Designation for the treatment of pancreatic cancer, and Day One Pharmaceuticals announced DAY101 has received Rare Pediatric Drug Designation for the treatment of pediatric low-grade glioma. Each of our license partners continues to invest significant resources to bring potential new therapies one step closer to physicians and patients.

"Today, we have a very strong balance sheet, which is debt free and paired with a lean expense structure. Our April offering of Series B Perpetual Preferred Stock, which pays an 8.375% dividend, raised an additional $40 million. At the end of the second quarter, we had $78.9 million in cash. In July, we paid dividends on both the XOMAP and XOMAO Perpetual Preferred Stocks.

"We look forward to continued progress by our team and by our partners," Mr. Neal concluded.

Financial Results
XOMA recorded total revenues of $0.9 million for the second quarter of 2021, compared to $0.4 million for the second quarter of 2020. The increase for the three months ended June 30, 2021, as compared to the same period in 2020, was primarily due to $0.5 million in revenue recognized in the second quarter of 2021 related to a milestone event under XOMA’s license agreement with Janssen.

Research and development expenses were $38,000 for both second quarters of 2021 and 2020.

General and administrative ("G&A") expenses were $3.9 million for the second quarter of 2021, compared to $3.6 million for the second quarter of 2020. The increase of $0.3 million for the three months ended June 30, 2021, as compared to the same period of 2020, was primarily due to a $0.3 million increase in salaries and related expenses.

In the second quarter of 2021, G&A expenses included $0.8 million in non-cash stock-based compensation expense, which was consistent with the second quarter of 2020. The Company’s net cash used in operations in the second quarter of 2021 was $4.0 million, as compared with $2.9 million during the second quarter of 2020.

In the second quarter of 2021, XOMA recorded $0.2 million in total interest expense, as compared to $0.5 million in the corresponding period of 2020. In June 2021, the Company repaid its outstanding debt obligations to Silicon Valley Bank and Novartis in full and recognized a $0.3 million non-cash loss on the extinguishment of debt.

For the quarters ended June 30, 2021 and 2020, XOMA recorded total other income of $1.3 million, and $0.1 million, respectively, reflecting the change in the fair value of equity securities.

Net loss for the second quarter of 2021 was $2.2 million, compared to net loss of $3.5 million for the second quarter of 2020.

On June 30, 2021, XOMA had cash of $78.9 million. The Company ended December 31, 2020, with cash of $84.2 million. On April 12, 2021, XOMA announced the closing of its Depositary Shares Offering and the exercise of the underwriters’ option, which resulted in approximately $38.0 million after deducting underwriting discounts and commissions, but before expenses. On April 15, 2021, the Company paid its first dividend on Series A Cumulative Perpetual Preferred (Nasdaq: XOMAP) in the amount of $0.71875 per share. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

On August 5, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the second quarter ended June 30, 2021 and year-to-date (Press release, Radius, AUG 5, 2021, View Source [SID1234585911]). In addition, the Company provided an update on components of the business.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Over the past 12 months we have focused on repositioning the business in a comprehensive manner," said Kelly Martin, Radius’ President and CEO. Martin continued, "within this effort three specific goals warrant being highlighted. They are, to become a cash flow positive company, to complete enrollment and execute our three ongoing pivotal trials in a high-quality manner, and opportunistically add assets that have the potential to enhance the Company’s value proposition. While there is still more to do, significant progress on all three of these objectives has been made to date."

Q2 and YTD FINANCIAL HIGHLIGHTS:

Total Net Revenue vs. prior year:
$52 million in Q2, 2021 vs. $50 million in Q2, 2020, +3% year-over-year
$108 million 1H, 2021 vs. $98 million 1H, 2020, +10% year-over-year
TYMLOS Net Revenue:
$52 million in Q2, 2021 vs. $50 million in Q2, 2020, +3% year-over-year
$97 million 1H, 2021 vs. $98 million 1H, 2020, -1% year-over-year
Total Company Adjusted EBITDA:
($6) million in Q2, 2021 vs. ($29) million in Q2, 2020
($11) million 1H, 2021 vs. ($55) million 1H, 2020
FY 2021 guidance: reiterate Adj. EBITDA of $10 million; while reducing TYMLOS revenue from $250 to $240 million
Liquidity position: $100 million of cash, cash equivalents and marketable securities as of 6/30/2021
ABALOPARATIDE COMMERCIAL UPDATE:

Patient growth continues in both quarter-over-quarter and year-over-year periods. Progress on business and market segment includes:

TYMLOS year-over-year new patient growth of 40+% in Q2, 2021 and 18% in 1H, 2021
Top 500 prescribers accounted for ~50% of new patients in Q2, 2021 vs. ~32% in Q1, 2021
In Q2, 2021, ~50% of our top 125 prescribers were orthopedic or spine-focused practices
New patient growth attributable to ortho/spine and bone health prescribers accelerated vs. prior quarter
As a reflection of the timing of new patient adds, we are reducing our FY 2021 TYMLOS net revenue guidance by $10 million. Given new patient growth during Q4, 2020 and 1H, 2021, we anticipate that the net revenue for TYMLOS in 2H, 2021 will be stronger than 1H, 2021.

The Company remains focused on making further progress in the commercial market space by concentrating resources, time, and effort on postmenopausal women with osteoporosis at high risk of fracture, including those with recent fractures.

ELACESTRANT UPDATE:

In partnership with the Menarini Group, progress continues to be made on the elacestrant asset and pivotal trial. The topline readout is still expected to occur in 2H, 2021 as previously communicated.

Importantly, there was a successful outcome in the completion of the bioequivalency study (BE study). This critical path item establishes equivalency between the clinical trial product and commercial product and is an important step forward on the progression of the asset.

Life cycle discussions and planning have been held with Menarini, and will continue to take place, regarding the possible therapeutic applications of elacestrant within the selective estrogen degrader (SERD) space.

RAD011 UPDATE:

As announced in a press release on July 23, Radius plans to initiate a seamless Phase 2/3 pivotal trial for patients with Prader-Willi Syndrome (PWS) in Q4, 2021 or early Q1, 2022. This trial will be global and incorporates feedback from the FDA, the KOL community as well as input from patient advocacy organizations.

Second Quarter 2021 Financial Results

Three Months Ended June 30, 2021

Net Loss
For the three months ended June 30, 2021, Radius reported a net loss of $16.8 million, or $0.35 per share, compared to a net loss of $43.9 million, or $0.95 per share, for the three months ended June 30, 2020.

For the three months ended June 30, 2021, non-GAAP adjusted net loss, was $10.5 million, or $0.22 per share, compared to non-GAAP adjusted net loss of $31.1 million, or $0.67 per share, for the three months ended June 30, 2020.

Revenue
For the three months ended June 30, 2021, TYMLOS net product revenues were $51.8 million compared to $50.1 million for the three months ended June 30, 2020.

Costs and Expenses
For the three months ended June 30, 2021, research and development expense was $27.0 million compared to $44.9 million for the three months ended June 30, 2020, a decrease of $17.9 million, or 40%. This decrease was primarily driven by a decrease of $10.6 million in abaloparatide-TD program cost, a $0.4 million decrease in occupancy and depreciation costs, a $4.6 million decrease in compensation expense, which is comprised of a $1.7 million decrease in compensation expense related to headcount and $2.9 million of billed reimbursable expenses, and a $8.8 million decrease in elacestrant program costs, which is comprised of a $6.6 million increase in gross program expenses offset by $15.4 million of billed reimbursable expenses. These decreases were offset by a $0.8 million increase in abaloparatide-SC program costs, a $3.6 million increase in RAD011 program costs, and a $2.1 million increase in professional fees and other expenses.

For the three months ended June 30, 2021, selling, general and administrative expenses were $32.1 million compared to $38.2 million for the three months ended June 30, 2020, a decrease of $6.1 million, or 16%. This decrease was primarily the result of a $2.6 million decrease in compensation cost, a $3.9 million decrease in professional support costs, and a $0.2 million decrease in occupancy and depreciation costs. These decreases were partially offset by a $0.5 million increase in travel and entertainment costs, and a $0.1 million increase in other operating costs.

Six Months Ended June 30, 2021

Net Loss
For the six months ended June 30, 2021, Radius reported a net loss of $32.6 million, or $0.69 per share, compared to a net loss of $81.5 million, or $1.76 per share, for the six months ended June 30, 2020.

For the six months ended June 30, 2021, non-GAAP adjusted net loss, was $19.0 million, or $0.40 per share, compared to non-GAAP adjusted net loss of $58.6 million, or $1.26 per share, for the six months ended June 30, 2020.

Revenue
For the six months ended June 30, 2021, TYMLOS net product revenues were $97.1 million compared to $98.0 million for the six months ended June 30, 2020.

For the six months ended June 30, 2021, license revenue was $11.0 million. No license revenue was recognized for the six months ended June 30, 2020.

Costs and Expenses
For the six months ended June 30, 2021, research and development expense was $58.4 million compared to $83.9 million for the six months ended June 30, 2020, a decrease of $25.5 million, or 30%. This decrease was primarily driven by a decrease of $14.0 million in abaloparatide-TD program cost, a $0.2 million decrease in RAD140 program costs, a $0.8 million decrease in occupancy and depreciation costs, a $9.3 million decrease in compensation expense, which is comprised of a $2.8 million decrease in compensation expense related to headcount and $6.5 million of billed reimbursable expenses, and a $16.4 million decrease in elacestrant program costs, which is comprised of a $9.6 million increase in gross program expenses offset by $26.0 million of billed reimbursable expenses. These decreases were offset by a $6.1 million increase in abaloparatide-SC program costs, a $3.6 million increase in RAD011 program costs, and a $5.8 million increase in professional fees and other expenses.

For the six months ended June 30, 2021, selling, general and administrative expenses were $66.2 million compared to $74.7 million for the six months ended June 30, 2020, a decrease of $8.4 million, or 11%. This decrease was primarily the result of a $2.0 million decrease in professional support costs, a $6.1 million decrease in compensation cost, and a $0.3 million decrease in other operating costs.

Webcast and Conference Call

In connection with today’s reporting of Second Quarter 2021 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, August 5, 2021, to review the commercial, research and development, and financial highlights and provide a Company update.

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

A replay of the conference call will be available on August 5 at 11:30 a.m. ET and the audio webcast of the call will be archived on the Company’s website for ninety days. To access the replay, dial (855) 859-2056 or (404) 537-3406 for International, using conference ID number 3659752. The live audio webcast of the call can be accessed from the Investors section of the Company’s website, View Source The full text of the announcement and financial results will also be available on the Company’s website.

On August 5, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the second quarter 2021, and provided an update on anticipated corporate milestones (Press release, Surface Oncology, AUG 5, 2021, View Source [SID1234585910]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter marked a major milestone for Surface, with SRF388 monotherapy eliciting the first-ever clinical response from a therapeutic targeting the IL-27 pathway. Generating evidence of monotherapy activity is a highly sought after, yet elusive, goal in immuno-oncology," said Rob Ross, M.D., chief executive officer. "Moreover, studies have confirmed the recommended Phase 2 dose for SRF617, and we are rapidly progressing this molecule forward in multiple combination approaches. We look forward to providing updates on the clinical progress of both programs in the coming months."

Recent Corporate Highlights:

On June 4, 2021, Surface presented preliminary data from the ongoing Phase 1 study of SRF388, an anti-IL-27 antibody, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. SRF388 demonstrated monotherapy activity by inducing a confirmed partial response in a heavily pretreated patient with non-small-cell lung cancer (NSCLC). It was well tolerated at all doses tested. With a recommended Phase 2 dose of 10 mg/kg every 4 weeks, Surface is currently enrolling Phase 2 monotherapy expansion cohorts for patients with renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC).

Surface also presented preliminary data from the ongoing Phase 1 study of SRF617, a CD39 inhibitor, during a webcast on June 4, 2021. SRF617 was well tolerated as a monotherapy, and the recommended Phase 2 dose of 1,400 mg has since been determined. Data from combination cohorts point to SRF617’s potential as a combination therapy, including an unconfirmed partial response in a patient with pancreatic cancer receiving second-line treatment with SRF617 in combination with gemcitabine/albumin-bound paclitaxel (Abraxane). Surface is currently enrolling Phase 1 combination cohorts for patients with gastric cancer and pancreatic cancer.

On June 4, 2021, Surface announced that it had entered into a clinical trial collaboration with Roche to evaluate SRF388 in combination with Roche’s atezolizumab and bevacizumab in patients with treatment-naïve HCC.

On July 8, 2021, Surface announced the appointment of Denice Torres to its board of directors. Ms. Torres has over 25 years of executive leadership experience in healthcare across the consumer, biopharmaceutical and medical device sectors.

Selected Anticipated Near-term Corporate Milestones:

Investigational New Drug (IND) filing for GSK4381562 formerly, SRF813, targeting the PVRIG checkpoint and partnered with GlaxoSmithKline, anticipated in 2H 2021.

Data update from Phase 1 study of SRF617 anticipated in late 2021.

Data update from Phase 1 study of SRF388 anticipated in early 2022.
Financial Results:

As of June 30, 2021, cash, cash equivalents and marketable securities were $164.3 million, compared to $175.1 million on December 31, 2020.

Research and development (R&D) expenses were $12.7 million for the second quarter ended June 30, 2021, compared to $9.5 million for the same period in 2020. This increase was primarily driven by progression in both our SRF617 and SRF388 Phase 1 clinical trials. R&D expenses included $0.9 million in stock-based compensation expense for the second quarter ended June 30, 2021.

General and administrative (G&A) expenses were $6.4 million for the second quarter ended June 30, 2021, compared to $5.0 million for the same period in 2020. This increase was primarily due to increases in personnel and facility related costs. G&A expenses included $1.4 million in stock-based compensation expense for the second quarter ended June 30, 2021.

For the second quarter ended June 30, 2021, net loss was $19.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.44. Net loss was $14.8 million for the same period in 2020, or basic and diluted net loss per share attributable to common stockholders of $0.44.

Financial Outlook:

Surface Oncology continues to project that current cash, cash equivalents and an anticipated near-term milestone from GSK are sufficient to fund the Company through 2023.

On August 5, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the second quarter ended June 30, 2021, and provided a corporate update (Press release, BioCryst Pharmaceuticals, AUG 5, 2021, View Source [SID1234585909]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"BioCryst is in an outstanding position, both near-term and long-term, with growing revenue from a strong ORLADEYO launch in the U.S., more approvals and launches of ORLADEYO around the globe and a pipeline in a molecule with our oral Factor D inhibitor, BCX9930, entering pivotal trials this year in the first of many indications," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

U.S. Launch

"The ORLADEYO launch is off to an excellent start because HAE patients want a safe and effective oral medicine to control their attacks and reduce their burden of therapy, and switching to ORLADEYO meets these needs for them," said Charlie Gayer, chief commercial officer of BioCryst.

ORLADEYO net revenue in the second quarter of 2021 was $28.5 million.

Patient switches continue to drive the launch with 60 percent of patients who were new to ORLADEYO in the second quarter switching from other prophylactic medicine to ORLADEYO and the remainder from acute-only treatment.

The number of physicians prescribing ORLADEYO grew by approximately 50 percent in second quarter.

The majority (approximately 70 percent) of HAE patients in the U.S. now have access to ORLADEYO through insurance policies.

Through the launch thus far, patient retention on therapy remains consistent with the one-year patient retention rate observed in the APeX-2 clinical trial.
ORLADEYO: Global Updates

On July 10, 2021, the company announced data presented at the European Academy of Allergy and Clinical Immunology Hybrid Congress 2021. HAE patients who were randomized to receive 150 mg of oral, once-daily ORLADEYO at the start of the APeX-2 trial had an 80 percent average reduction in their mean attack rate per month during weeks 25-96 of the trial, compared to baseline. Median attack rates also decreased from 2.7 attacks/month at baseline to 0.0 attacks per month in 16 of 17 months through the same period. ORLADEYO was generally well-tolerated during the treatment period with fewer drug-related adverse events reported in part 3 (weeks 49-96) as compared to part 1 (weeks 0-24) and part 2 (weeks 25-48). Eighty-one percent of the patients who entered part 3 completed the trial.

On June 16, 2021, the company announced that the Israeli Ministry of Health has accepted the regulatory submission of ORLADEYO for the prevention of recurrent attacks in patients with hereditary angioedema (HAE) 12 years and older. In addition, BioCryst entered into a distribution and supply agreement granting Neopharm Ltd., the exclusive rights to commercialize ORLADEYO in Israel.

On June 3, 2021, the company announced the launch of ORLADEYO in Germany.

On May 12, 2021, the company announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted marketing authorization for ORLADEYO for the routine prevention of HAE attacks in HAE patients 12 years and older.

On April 30, 2021, the company announced that the European Commission (EC) has approved ORLADEYO for the prevention of recurrent HAE attacks in HAE patients 12 years and older. The EC approval of ORLADEYO is applicable to all European Union member states plus Iceland, Norway and Liechtenstein.

On April 14, 2021, the company announced that the Japanese National Health Insurance System (NHI) approved the addition of ORLADEYO to the NHI drug price list on April 21, 2021. This triggered a $15 million milestone payment to BioCryst from Torii Pharmaceutical Co., Ltd., the company’s commercial partner in Japan, which BioCryst received and recognized in the second quarter.
Complement Oral Factor D Inhibitor Program – BCX9930

On June 15, 2021, the company announced the designs for REDEEM-1 and REDEEM-2, two upcoming pivotal trials with its oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 is a randomized, open-label, active, comparator-controlled comparison of the efficacy and safety of BCX9930 (500 mg bid) monotherapy in approximately 81 PNH patients with an inadequate response to a C5 inhibitor. REDEEM-2 is a randomized, placebo-controlled trial to evaluate the efficacy and safety of BCX9930 (500 mg bid) as monotherapy versus placebo in approximately 57 PNH patients not currently receiving complement inhibitor therapy. The primary endpoint for both trials is the change from baseline in hemoglobin, assessed at weeks 12 to 24 in REDEEM-1 and at week 12 in REDEEM-2. Trial site start-up activities are now underway at sites around the world and both pivotal trials are expected to begin enrolling patients in the second half of 2021.

In the second half of 2021, the company also plans to initiate a proof of concept trial of oral BCX9930 (500 mg bid) in renal complement-mediated diseases. The trial will be a basket study including cohorts of patients with C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy.
Additional Updates

On July 28, 2021, the company announced the appointment of Vincent Milano to the BioCryst board of directors.
Second Quarter 2021 Financial Results

For the three months ended June 30, 2021, total revenues were $50.0 million, compared to $2.9 million in the second quarter of 2020. The increase was primarily due to $28.5 million in ORLADEYO net revenue in the second quarter of 2021, the recognition of a $15 million milestone payment to BioCryst from Torii Pharmaceutical Co., Ltd., the company’s commercial partner in Japan, following approval and successful pricing negotiations in Japan, and $4.6 million for RAPIVAB (peramivir injection) stockpile sales to the government, all realized in the second quarter of 2021.

Research and development expenses for the second quarter of 2021 increased to $52.9 million from $27.5 million in the second quarter of 2020, primarily due to increased investment in the development of BCX9930 as well as other research, preclinical and development costs, offset by a reduction in spend on the ORLADEYO program following our commercial launch in December 2020.

Selling, general and administrative expenses for the second quarter of 2021 increased to $26.3 million, compared to $13.9 million in the second quarter of 2020. The increase was primarily due to increased investment to support the U.S. commercial launch of ORLADEYO and expanded international operations.

Interest expense was $13.5 million in the second quarter of 2021, compared to $2.9 million in the second quarter of 2020. The increase was due to service on the royalty and debt financings which were completed in December 2020. The interest payment-in-kind (PIK) option on the Athyrium term loan has been exercised and $3.9 million has been added to the $125 million principal in the second quarter of 2021, and $7.5M since issuance.

Net loss for the second quarter of 2021 was $43.2 million, or $0.24 per share, compared to a net loss of $38.6 million, or $0.24 per share, for the second quarter of 2020.

Cash, cash equivalents, restricted cash and investments totaled $222.8 million at June 30, 2021, compared to $191.6 million at June 30, 2020. Operating cash use for the second quarter of 2021 was $22.0 million.

Financial Outlook for 2021

In the launch period for ORLADEYO, the company is not providing specific revenue or operating expense guidance. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 9886913. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9886913.

On August 5, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, TCR2 Therapeutics, AUG 5, 2021, View Source [SID1234585908]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As we enter the second half of the year, we are approaching the conclusion of the Phase 1 portion of our gavo-cel clinical trial and selection of an RP2D. We look forward to presenting safety, efficacy and translational data from at least 17 patients, up to dose level 5, in an oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on September 17," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We believe that gavo-cel has the potential to significantly improve the standard of care for patients with treatment refractory mesothelin-expressing solid tumors. We are focused on identifying the RP2D before the end of 2021 to advance this program into Phase 2 where we can more definitively evaluate efficacy, including retreatment with gavo-cel and combinations with checkpoint inhibitors. We also remain committed to advancing our broad emerging pipeline, including new enhancements, allogeneic TRuC-T cells and new targets and look forward to showcasing these programs at our upcoming virtual R&D Day."

Recent Developments

Gavo-cel:

TCR2 announced today the Company plans to present new clinical data from the dose escalation portion of the Phase 1/2 clinical trial of gavo-cel in patients with treatment refractory mesothelin-expressing solid tumors as part of an oral presentation on September 17 at 14:20 CEST (8:20am EST) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 being held in-person from September 16-21, 2021. The presentation will include long-term follow-up from initial and new patients from the Phase 1 dose escalation, with data from additional non-mesothelioma patients, and will focus on safety, efficacy and translational data at dose levels 3 (1×108 cells/m2 with lymphodepletion), 4 (5×108 cells/m2 without lymphodepletion) and 5 (5×108 cells/m2 with lymphodepletion).
Corporate:

TCR2 announced today that it will host a virtual R&D Day on Wednesday, October 20, 2021 to showcase the broad emerging pipeline focusing on its enhancements, allogeneic strategies and new targets.
TCR2 announced the appointment of Peter Olagunju as its first Chief Technical Officer where he will oversee process development, manufacturing, quality control and technical operations for the Company’s TRuC-T cell programs and emerging pipeline. Previously, Mr. Olagunju was Senior Vice President of Technical Operations at FerGene, Inc. Before that, Mr. Olagunju was Vice President of Global Patient Operations at bluebird bio, Inc., where he held several roles of increasing responsibility and was the program lead and functional head of manufacturing supporting the European approval for ZYNTEGLO, a transformational gene therapy for Transfusion dependent Thalassemia.
Anticipated Milestones

TCR2 to highlight interim progress from the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors in an abstract at the 2021 World Conference on Lung Cancer.
TCR2 to highlight additional safety, efficacy and translational data from all patients receiving therapy up to dose level 5 (second and third gavo-cel doses) in the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial focused on mesothelin-expressing solid tumors in an oral presentation at the ESMO (Free ESMO Whitepaper) Congress 2021.
TCR2 to present an interim update from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in the second half of 2021.
TCR2 plans to file an IND for TC-510, the first enhanced TRuC-T cell (targeting mesothelin with a PD-1:CD28 switch), in the second half of 2021.
TCR2 plans to select a development candidate for its allogeneic program in the second half of 2021.
TCR2 to present preclinical data on its IL-15 enhancements program in the fourth quarter of 2021.
TCR2 to host virtual R&D Day focused on the broad emerging pipeline on October 20, 2021.
TCR2 anticipates production of clinical trial material from ElevateBio LLC and its manufacturing facility in Stevenage, UK, both in anticipation of demand from the Phase 2 expansion trial of gavo-cel, in 2022.
Financial Highlights

Cash Position: TCR2 ended the second quarter of 2021 with $317.3 million in cash, cash equivalents, and investments compared to $228.0 million as of December 31, 2020. Net cash used in operations was $15.0 million for the second quarter of 2021 compared to $16.0 million for the second quarter of 2020. TCR2 projects net cash use of $100-110 million for 2021, which includes tenant improvements to the Rockville facility. We expect cash on hand to support operations through 2023.

R&D Expenses: Research and development expenses were $18.6 million for the second quarter of 2021 compared to $12.9 million for the second quarter of 2020. The increase in R&D expenses was primarily due to an increase in headcount, additional lab facilities, and manufacturing facilities.

G&A Expenses: General and administrative expenses were $5.7 million for the second quarter of 2021 compared to $3.8 million for the second quarter of 2020. The increase in general and administrative expenses was primarily due to an increase in personnel costs and external professional fees.

Net Loss: Net loss was $24.3 million for the second quarter of 2021 compared to $16.2 million for the second quarter of 2020.
Adoption of New Lease Standard

During the second quarter of 2021, TCR2 adopted the new lease standard ASC 842 effective January 1, 2021. The lease standard requires companies to record right-of-use assets and lease liabilities for all leases. With the adoption of the new lease standard, the Company removed its facility in Rockville, MD as an asset under a built-to-suit lease in the amount of $41 million and removed the associated liabilities of $37 million. As of June 30, 2021, the Company’s right-of-use assets under operating leases, including the Rockville facility, were $30.6 million and operating lease liabilities were $27.6 million.

Upcoming Events

TCR2 Therapeutics management is scheduled to participate at the following upcoming conferences.

2021 Wedbush PacGrow Healthcare Conference: Robert Hofmeister, Ph.D., Chief Scientific Officer of TCR2 Therapeutics, will participate in a panel using a virtual platform on Tuesday, August 10, 2021 at 9:45am ET