On May 5, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the first quarter ended March 31, 2022 (Press release, Repare Therapeutics, MAY 5, 2022, View Source [SID1234613715]).

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"The first quarter was marked by significant progress in our RP-3500 program, including the comprehensive new dataset from the TRESR trial which was part of the featured oral presentation at the AACR (Free AACR Whitepaper) conference this year, and that the United States Adopted Names (USAN) council has adopted ‘camonsertib’ as the nonproprietary (generic) name in the United States, and the International Nonproprietary Names (INN) council has accepted ‘camonsertib’ as proposed INN for RP-3500," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "The findings continue to demonstrate camonsertib’s promising clinical benefit given as monotherapy in patients with solid tumors with multiple genotypes and potential best-in-class safety and tolerability profile for ATR inhibitors. Beyond ATM, encouraging data in other genotypes suggest further validation of our STEP2 platform to identify other synthetic lethalities as we expand TRESR and develop our pipeline of synthetic lethal candidates. We look forward to providing updates on the potential of camonsertib as monotherapy and initial data of camonsertib in combination with PARP inhibitors or gemcitabine expected in the second half of this year."

First Quarter 2022 Review and Operational Updates:

Announced updated clinical data from the ongoing Phase 1/2 TRESR (Treatment Enabled by SNIPRx) clinical trial of camonsertib, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors with specific synthetic-lethal genomic alterations including those in the ATM gene (Ataxia-Telangiectasia mutated kinase) at the 2022 AACR (Free AACR Whitepaper) Annual Meeting.
Updated data showed camonsertib monotherapy continues to appear safe and well tolerated. Expectedly, Grade 1-2 anemia was the most common treatment-related adverse event and was well controlled in patients. Only 24.2% of all patients in the 3 days on 4 days off schedule experienced Grade 3 anemia, and none experienced Grade 4 anemia.

Camonsertib monotherapy resulted in durable clinical benefit across tumor types and genomic alterations. Overall clinical benefit rate (CBR) for all patients was 43%, and 47% in patients after PARP inhibitor (PARPi) failure.

Promising results were observed particularly in patients with advanced ovarian cancer (n = 20). 90% of evaluated patients had prior PARPi failure, and 85% of evaluated patients were platinum resistant. In these patients, overall response (OR) was 25%, including one complete response (CR), three partial responses (PR) as determined by RECIST 1.1 criteria, and one durable and ongoing CA125 response. CBR was 75% and median progression-free survival (mPFS) was 35 weeks.

Clinical benefit was also observed in patients with tumors harboring BRCA1 and BRCA2 genomic alterations, as predicted by SNIPRx. In patients with BRCA1/2 mutated tumors (n = 37), ORR was 14% and included two patients with ovarian cancer, and one each with breast cancer, head and neck squamous cell carcinoma, and melanoma. CBR was 43% with a mPFS of 15 weeks in the BRCA1/2 population; in patients specifically with BRCA1 mutations, the CBR was 48%.

In patients with ATM loss-of-function (LOF) tumors (n = 34), ORR was 9% including one RECIST 1.1 confirmed/unconfirmed response, and two prostate specific antigen (cPSA) responses. CBR in patients with ATM LOF was 44%, with mPFS of 17 weeks.

New sequencing data demonstrated biallelic gene LOF, an emerging biomarker for synthetic lethal therapies, can potentially be leveraged to further enrich for patients most likely to benefit from camonsertib. CBR in patients with biallelic LOF was significantly higher (47%) compared to the CBR in patients with non-biallelic tumors (15%).

A poster presentation, titled "Circulating tumor DNA (ctDNA) determinants of improved outcomes in patients (pts) with advanced solid tumors receiving the ataxia telangiectasia and Rad3-related inhibitor (ATRi), RP-3500, in the phase 1/2a TRESR trial (NCT04497116)" (abstract #367586) will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual meeting in June.

Announced camonsertib dose selection Phase 1 monotherapy safety data from the Phase 1/2 TRESR Trial at the 2022 ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress
This comprehensive safety analysis from three monotherapy dosing schedules of camonsertib at therapeutic doses confirmed the acceptable tolerability of the recommended phase 2 dose (160mg 3 days on/4 days off).

Anemia was the most common reported toxicity with less than 25% of patients experiencing grade 3 toxicities.

A dose modification plan that includes 2 alternative dosing schedules was established to mitigate the on-target toxicity of anemia and maintain patients on a camonsertib dosing schedule that targets antitumor activity.

A nomogram, based on cycle 1 assessment of toxicities, is being prospectively evaluated to identify patients at increased risk of anemia and inform early intervention.

Announced publication of preclinical data in Nature demonstrating the potential of PKMYT1 inhibitor RP-6306 in tumors with CCNE1 amplification
In April 2022, the Company announced that preclinical data demonstrating inhibition of CCNE1-amplified tumor growth in vivo by selective inhibition of PKMYT1 using RP-6306, a first-in-class small molecule candidate targeting PKMYT1, were published in Nature.

SNIPRx, the Company’s proprietary, genome-wide, CRISPR-based screening approach, was used to uncover CCNE1 amplification as synthetic lethal to PKMYT1 inhibition. Data show PKMYT1 inhibition is a promising therapeutic target in CCNE1-amplified cancers.

Phase 1 clinical trials are currently evaluating RP-6306 as a monotherapy (MYTHIC) as well as in combination with gemcitabine (MAGNETIC) for the treatment of molecularly selected advanced solid tumors. The Company recently initiated an additional Phase 1 (MINOTAUR) clinical trial of RP-6306 in combination with FOLFIRI also for the treatment of molecularly selected advanced solid tumors.

Initiated patient enrollment in a new arm of its Phase 1 MYTHIC clinical trial designed to evaluate the safety and tolerability of RP-6306 in combination with camonsertib in patients with advanced solid tumors.
Appointed Philip Herman to Executive Leadership Team as EVP, Commercial & New Product Development
In January 2022, the Company appointed Philip Herman as EVP, Commercial & New Product Development. Mr. Herman was most recently Chief Commercial Officer of Y-mAbs Therapeutics and led the successful launch of DANYELZA (naxitamab).
First Quarter 2022 Financial Results:

Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of March 31, 2022 were $311.7 million.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $26.5 million and $16.5 million for the three months ended March 31, 2022 and 2021, respectively. The year-over-year increase in Net R&D expenses was primarily due to direct external costs related to the Company’s camonsertib and RP-6306 programs, and personnel related expenses, including share-based compensation.
General and administrative (G&A) expenses: G&A expenses were $8.8 million and $5.2 million for three months ended March 31, 2022 and 2021, respectively. The year-over-year increase in G&A expenses was primarily due to personnel related costs, including share-based compensation, as we scale the organization, and professional fees related to the Company’s transition from emerging growth company and smaller reporting company status at the end of 2021.
Net loss: Net loss was $34.8 million, or $0.83 per share in the three months ended March 31, 2022, and $21.4 million, or $0.58 per share in the three months ended March 31, 2021.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On May 5, 2022 Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon & Changjae Lee) reported its financial results for the first quarter of 2022 (separate basis) (Press release, Daewoong Pharmaceutical, MAY 5, 2022, View Source [SID1234613732]). In the first quarter, the separate sales and operating profit marked KRW 272.2 billion and KRW 26.8 billion, up 12.6% and 32.6% year-over-year, respectively . In the same quarter, the consolidated sales and operating profit marked KRW 298.4 billion and KRW 23 billion, up 10.7% and 2.2% y-o-y, respectively.

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Daewoong achieved record-high annual sales and operating profit in 2021 and again broke its record in the highest quarterly operating profit (separate basis) in the first quarter of this year. The sales growth of highly profitable ethical-the-counter (ETC) drugs and the increase in the export of Nabota were led by improvements in profitability, operating profit, and gross profit margin (GPM).

Sales of ETC drugs recorded KRW 197.6 billion, a 9% increase from KRW 181 billion y-o-y, leading to an increase in earnings. It is characterized by more than 20% growth compared to the same period of the previous year in highly profitable product lines such as an antiulcer drug Nexiad, a dyslipidemia drug Litorvazet, a gastric ulcer drug Axid, a hyperlipidemia drug Crezet, and an antithrombotic drug Cloart.

Sales of Nabota surged by 98% y-o-y, from KRW 15.4 billion to KRW 30.7 billion exports. In particular, its exports increased by 189% y-o-y, from KRW 7.9 billion to KRW 22.8 billion. For example, the exports to its U.S. sales partner Evolus amounted to KRW 18.3 billion, risen by three times y-o-y. Favorable exchange rates also supported the earnings. Nabota is expected to drive sales growth continuously, as Evolus is preparing to officially launch Nabota in Europe in the third quarter, and Nabota shows strong market presence in the countries where it has already been released.

Sales of over-the-counter (OTC) drugs recorded KRW 29.7 billion, a 12% increase from KRW 26.4 billion y-o-y. Due to the spread of COVID-19 and a surge in home treatment, the company’s representative cold medicine EZN6 grew by 77.3% y-o-y, and the quasi-drugs related to physical fatigue Urshot and a wet patch Easyderm also contributed to the growth. Sales of supplements also surged by 169% y-o-y, owing to its strategic reinforcement of the supplement portfolio for the liver, centered on the liver-specialized brand Ener Thistle, blood circulation, intestine, and vitamins, and focus on online sales channels.

"With export expansion of Nabota based on superior product power and quality, the highly profitable ETC product lines continued to grow, leading to another record-breaking highest quarterly operating profit," said Sengho Jeon, Daewoong Pharmaceutical CEO. "For the second quarter and the second half of this year, we are expected to achieve solid growth and increasing profitability, thanks to the expansion of Nabota’s overseas sales channels, the launch of highly profitable new products, such as Fexuclue tablets, a new drug for gastroesophageal reflux disease, and an increase in the gross profit margin."

On May 5, 2022 Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, reported that the Company has changed its name to Promontory Therapeutics Inc. ("Promontory") (Press release, Promontory Therapeutics, MAY 5, 2022, View Source [SID1234615801]). The new name reflects the Company’s growth and evolution, and its goal to become the leading company within oncology therapeutics advancing small molecule immunotherapies.

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"Our new corporate identity is aspirational, as we continue our growth and research and development efforts because we believe that small molecule immunotherapy has arrived, and that we are leaders within this area of cancer care," said Robert Fallon, Promontory President and Chief Executive Officer. "Through our internal work, coupled with our ongoing collaborations with global leaders in the field, we’ve developed unique insight into the development of highly-differentiated small molecule immunogenic agents, including our lead therapeutic candidate, PT-112."

Promontory is led by a strong management team, board of directors, and Scientific Advisory Board with in-depth industry knowledge. The company’s lead agent, PT-112, is a small molecule therapeutic agent that promotes immunogenic cell death (ICD), a rare form of cancer cell death based upon the release of damage associated molecular patterns (DAMPs), which engage specific pattern recognition receptors on dendritic cells that promote the adaptive anti-cancer immune response. PT-112’s highly potent induction of ICD has been validated in relevant cancer models and the drug is currently being studied in three Phase 2 trials for metastatic castration-resistant prostate cancer, thymoma and thymic carcinoma, and in combination with PD-L1 checkpoint inhibitor avelumab for non-small cell lung cancer.

To learn more about Promontory Therapeutics’ mission, as well as PT-112 visit promontorytx.com.

On May 5, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported it has dosed the first patient in a Phase 1/2 clinical trial of AU-007 for the treatment of solid tumors (Press release, Aulos Bioscience, MAY 5, 2022, View Source [SID1234613609]). AU-007 is a human monoclonal antibody computationally designed by Biolojic Design, with a highly differentiated approach to harnessing the power of interleukin-2 (IL-2) to eradicate solid tumors.

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"We are very pleased to begin patient dosing in our Phase 1/2 trial of AU-007, as it marks a significant milestone in our advancement to a clinical-stage company," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "This rapid progress speaks to the strength of our team at Aulos to collaborate efficiently and successfully move our first investigational therapy into the clinic. AU-007 has a mechanism of action completely distinct from anything ever tested in a human clinical trial, and we believe it addresses the key challenges associated with the therapeutic application of IL-2."

Currently approved therapy requires high doses of IL-2 that is associated with frequent and dangerous toxicities, including increased risk of pulmonary edema and capillary leakage. In preclinical studies, AU-007 has been shown to block IL-2 from binding to CD25 in trimeric receptors while preserving IL-2’s binding to dimeric CD122/CD132 receptors. This unique mechanism of action allows for anti-cancer activity from immune effector activation while preventing immunosuppressive T regulatory (Treg) cell expansion and vascular leakage driven by IL-2. Recently released preclinical data demonstrate significant tumor growth inhibition in murine models with AU-007, and complete MC38 colorectal tumor elimination when AU-007 is dosed in combination with checkpoint inhibitors.

The Phase 1/2 trial is a two-part, open label, first-in-human study currently enrolling patients in Australia. The study evaluates the safety, tolerability and immunogenicity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Phase 1 consists of three dose escalation arms that evaluate AU-007 either as a monotherapy, in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin administered once every two weeks. The Phase 2 portion of the trial evaluates a dosing regimen selected from dose escalation for expansion in specified tumor types to further define the safety and initial efficacy of AU-007. Initial data from the Phase 1 portion of the clinical trial is anticipated in late 2022.

To learn more about the clinical trial program, please visit ClinicalTrials.gov, using the identifier NCT05267626.

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On May 5, 2022 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the first quarter ended March 31, 2022. The Company also provided a general business update (Press release, Radius, MAY 5, 2022, View Source [SID1234613638]).

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Radius CEO Kelly Martin provided the following commentary covering a variety of topics:

"Failure to meet the prespecified primary endpoint in the long awaited abaloparatide transdermal system pivotal trial resulted in a swift and precipitous 50+% drop in the Radius share price during the month of December. Conversely, our convertible notes, as an indicator for the credit market assessment of the Radius balance sheet, cash flows and business fundamentals, were basically unchanged in price and value during that same period."

Martin added, "against this dislocation and backdrop, our approach is to ‘control what we can control’ and focus on advancing the Radius business on behalf of shareholders, creditors, patients and employees."

"To that end, we are working closely with our partner – the Menarini Group – on all aspects of elacestrant. Recent competitor trial failures in the SERD space may expand the potential commercial opportunity – and subsequent value – for the asset if approved. Our financial participation is realized through achievement of both milestones and royalties and, importantly, incorporates all indications, geographies and any combination therapies following the monotherapy data and potential approval. As announced in February, we will return 100% of the value generated by elacestrant to our capital providers – both creditors as well as shareholders."

"For RAD011, we are progressing this molecule in a deliberate and disciplined manner with a focus on specific genetically based and orphan neurological/behavioral diseases. Interest in the program – post the April R&D webcast – has been, and continues to be, noteworthy. Clear and specific patient need, little to no treatment options, pre-existing data and a concise regulatory path leading to single pivotal trial readouts in 2H 2024 underscore the characteristics of the opportunity."

"Lastly, for TYMLOS we are preparing for a potential US launch for the male indication, assisting our partners Paladin Labs in Canada and Teijin Pharma in Japan for launches in their respective countries. As per our previously stated goal to ‘expand the global footprint of the asset’ we expect to finalize up to three additional geographic/partner agreements over the coming months, and plan for up to four ex-US market launches in 2023. We have also completed all necessary steps for the EU re-submission and await that decision in 2H 2022."

In summary, Martin concluded, "as mentioned in our FY 2021 earnings in February, the recent market dislocation in biotechnology has been significant. We expect these challenges to continue throughout 2022. Within this environment, Radius continues to have the opportunity to differentiate itself by remaining active with the balance sheet and monitoring cash flow, managing the risk/reward dynamics of the three assets and, lastly, incorporating overall corporate timelines and potential business inflection points."

Q1 2022 FINANCIAL HIGHLIGHTS

Revenues

Total net revenues for the quarter were $43 million compared to $56 million in Q1 2021, which included $11 million in one-time payments received for abaloparatide approval in Japan and licensing in Canada
TYMLOS net product revenue was $43 million compared to $45 million in Q1 2021, down 5%. This modest decrease was expected in Q1 and was driven primarily by inventory destocking and seasonal payer dynamics
Patient Growth: average active patients on therapy increased by 4% compared to Q1 2021
Reiterate full year 2022 guidance of $232 million with 42% of net revenue estimated to come in 1H ($97 million) and 58% ($135 million) in 2H 2022. The Q1 net revenue is on track to meet the 1H guidance
Productivity and Headcount

Total headcount for the quarter was 258 compared to 294 in Q1 2021, down 12%; and down 31% compared to 376 in Q1 2020
Dramatic Productivity Improvements: TYMLOS net revenue per commercial employee was $374k in Q1 2022 compared to $283k in Q1 2021, up 32%; compared to Q1 2020, commercial productivity has improved by 66%
The Company continues to employ a ‘hybrid work environment’. Real estate footprint vs. 2020 has been reduced by nearly 85% and those associated infrastructure costs are down by ~65%
P&L

Net Loss of ($18.3) million in Q1 2022 vs ($15.7) million in Q1 2021
Adjusted EBITDA (Non-GAAP) loss of ($9.1) million Q1 2022 vs. ($4.6) million Q1 20211
Diluted EPS (GAAP): ($0.39) in Q1 2022 vs. ($0.34) in Q1 2021
Balance Sheet

$72 million of cash, cash equivalents and marketable securities as of March 31, 2022
Decrease in cash driven by change in net working capital ($19 million), annual bonus payouts, one-time reduction in force (RIF) payouts, and other one-time items
Mark Conley, Chief Financial Officer, commented, "Our first quarter TYMLOS net revenue is in line with our 1H 2022 net revenue guidance of $97 million and today we are reiterating our financial objectives for 2022, including TYMLOS net revenue of $232 million. Our total headcount has reduced further this quarter and our productivity has increased significantly, demonstrating efficient management of our cost structure, and increased operational efficiency."

Conley added, "We ended the quarter with $72 million in cash, driven by several one-time items. We expect cash on the balance sheet to increase as the year progresses."

Key Financial Objectives for 2022

Radius reiterates its financial objectives for 2022, as set out in its press release dated February 24, 2022, which included:

$232 million TYMLOS Net Revenue (42% estimated in 1H and 58% in 2H 2022)
($5) to $5 million Net Loss
$35 to $45 million Company Adjusted EBITDA (Non-GAAP)
ASSETS UPDATE

Elacestrant

Elacestrant is the first and currently only investigational oral SERD to show positive topline results in a pivotal trial as a monotherapy vs. standard of care (SoC) for the treatment of ER+HER2-advanced or metastatic breast cancer (mBC).

Recent competitor trial failures may broaden the opportunity for elacestrant
Differentiator of EMERALD from other SERD trials: two primary endpoints, all-comers and ESR1 mutant subgroup
Current focus: robust clinician engagement, life cycle and ‘go to market’ activity
Regulatory submissions: on track to file in the US in Q2 2022 with EU filing to follow the US filing
Life cycle management: Menarini Group is working to further develop elacestrant in the adjuvant setting, combination therapy, and metastatic breast cancer that has metastasized to the brain
RAD011

RAD011 is the Company’s investigational synthetic cannabidiol oral solution which has potential utilization in multiple neuro-endocrine, neurodevelopmental, or neuropsychiatric disease areas.

Initiating two single pivotal trials in Angelman syndrome (AS) (Q3) and Prader-Willi syndrome (PWS) (Q2)
SCOUT-015 study evaluating hyperphagia in PWS is open for recruitment and has begun patient screening in the US
Plans to follow AS and PWS trials with a Phase 2 infantile spasms (IS) trial evaluating spasm resolution
Dup15q syndrome: first company to receive Orphan Drug Designation; possible life cycle opportunity
Orphan Drug Designations have been granted for all four of the above indications in the US
On April 5, 2022, Radius hosted an R&D webcast dedicated to RAD011; a replay of the webcast and presentation is available on the Company’s website (View Source)
ABALOPARATIDE

TYMLOS in Male Indication

As previously reported on March 1, 2022, the Company filed a Supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for TYMLOS (abaloparatide) subcutaneous injection in men with osteoporosis at high risk for fracture.

10-month review process and, subject to approval, plan to launch in early Q1 2023
Estimated that 30% of all hip fractures occur in men and approximately 20% of men over the age of 50 will experience an osteoporosis-related fracture in their lifetime
The full data set from the ATOM Phase 3 study will be presented at the upcoming American Association of Clinical Endocrinology (AACE) Annual Meeting on May 12-14, 2022
TYMLOS Intellectual Property

On March 8, 2022, Radius announced the United States Patent and Trademark Office (USPTO) granted patent 11,255,842, which extends TYMLOS exclusivity to January 10, 2040
This adds to the Company’s four issued patents covering TYMLOS, which provide significant depth and breadth in protecting the commercial runway of the asset
Financial Results

Three Months Ended March 31, 2022

Net Loss
For the three months ended March 31, 2022, Radius reported a net loss of $18.3 million, or $0.39 per share, compared to a net loss of $15.7 million, or $0.34 per share, for the three months ended March 31, 2021.

For the three months ended March 31, 2022, Adjusted EBITDA (Non-GAAP), was ($9.1) million, or $0.19 per share, compared to Adjusted EBITDA (Non-GAAP) of ($4.6) million, or $0.10 per share, for the three months ended March 31, 2021.

Revenue
For the three months ended March 31, 2022, TYMLOS net product revenues were $43.0 million compared to $45.3 million for the three months ended March 31, 2021.

For the three months ended March 31, 2022, $0.2M in license revenue was recognized compared to $11.0 million recognized for the three months ended March 31, 2021.

Costs and Expenses
For the three months ended March 31, 2022, research and development expense was $22.7 million compared to $31.4 million for the three months ended March 31, 2021, a decrease of $8.7 million, or 28%. This decrease was primarily driven by a decrease of $7.3 million in abaloparatide-TD program costs, a $5.5 million decrease in abaloparatide-SC program costs, a $0.8 million decrease in professional fees driven by billed reimbursable consultant costs, and a $2.1 million decrease in elacestrant program costs, which is comprised of a $7.3 million decrease in gross program expenses as well as a $5.2 million increase in billed reimbursable expenses. These decreases were offset by a $6.1 million increase in RAD011 program costs, a $0.4 million increase in occupancy and depreciation costs, and a $0.4 million increase in compensation expense, which is comprised of a $1.0 million increase in compensation expense related to headcount offset by $0.5 million of billed reimbursable expenses.

For the three months ended March 31, 2022, selling, general and administrative expenses were $30.0 million compared to $34.1 million for the three months ended March 31, 2021, a decrease of $4.1 million, or 12%. This decrease was primarily the result of a $3.5 million decrease in professional support costs and a $1.2 million decrease in wages and employee benefit costs due to a decrease in headcount. These decreases were offset by a $1.4 million increase in occupancy and depreciation costs and other operating costs.

Webcast and Conference Call

In connection with today’s reporting of First Quarter 2022 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, May 5, 2022, to review financial results and provide a Company update.

Conference Call Information:
Date: May 5, 2022
Time: 8:30 a.m. ET
Domestic Dial-In Number: 1 (866) 323-7965
International Dial-In Number: 1 (346) 406-0961
Conference ID: 5844208
Webcast Link: View Source

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 May 5th at 11:30 a.m. ET. A live audio webcast of the call will be archived on the Company’s website for 12 months. To access the replay, dial (855) 859-2056 or (404) 537-3406 for International, using conference ID number 5844208. 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.

Use of Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), we use the following non-GAAP financial measures in this press release: Adjusted EBITDA and Adjusted EBITDA per share. The Company defines adjusted EBITDA as net income before interest, taxes, depreciation and amortization, adjusted for the impact of certain additional non-cash and other items that management does not consider in its evaluation of ongoing performance of the Company’s core operations. These items include stock-based compensation expense and other one-time expenses. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with Radius’ GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Radius’ operating performance and can enhance investors’ ability to identify operating trends in our business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Radius’ operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three months ended March 31, 2022 and 2021 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

This release includes forward-looking guidance for adjusted EBITDA. The Company is not able to provide, without unreasonable effort, a reconciliation of the guidance for adjusted EBITDA to the most directly comparable GAAP measure because the Company does not currently have sufficient data to accurately estimate the variables and individual adjustments included in the most directly comparable GAAP measure that would be necessary for such reconciliations, including (a) one-time items or other expenses that we do not believe are indicative of our ongoing operations. These adjustments are inherently variable and uncertain and depend on various factors that are beyond our control and as a result we are also unable to predict their probable significance. Therefore, because management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results in accordance with GAAP, it is unable to provide a reconciliation of the non-GAAP measures included in its 2022 guidance.