On May 9, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported financial results for the first quarter of 2022 and provided an update on recent corporate highlights (Press release, Inhibrx, MAY 9, 2022, View Source [SID1234613924]).

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!

Recent Corporate Highlights

On February 22, 2022, Inhibrx announced that it had entered into an amendment to its Loan and Security Agreement with Oxford Finance LLC. The amendment provides for the funding of an additional $130.0 million in gross proceeds, $40.0 million of which was funded upon execution of the amendment on February 18, 2022, with the remaining $90.0 million to be funded in three separate tranches upon future milestone events.
On March 3, 2022, Inhibrx announced that the FDA granted orphan-drug designation for INBRX-101 for the treatment of alpha-1 antitrypsin deficiency, or AATD.
On April 5, 2022, Inhibrx announced that it will be presenting late-breaking data from INBRX-101 at the American Thoracic Society 2022 Conference taking place May 13-18, 2022.
On April 25, 2022, Inhibrx announced the formation of a Scientific Advisory Board, comprised of the top global experts in AATD, for INBRX-101.
Financial Results

Cash and Cash Equivalents. As of March 31, 2022, Inhibrx had cash and cash equivalents of $143.5 million, compared to $131.3 million as of December 31, 2021.
R&D Expense. Research and development expenses were $24.9 million during the first quarter of 2022, compared to $16.4 million during the first quarter of 2021. This overall increase was primarily due to an increase in work performed by Inhibrx’s contract development and manufacturing organization partners for the formulation and manufacturing of certain of its therapeutic candidates, as well as an increase in clinical trial expenses based on the initiation of a potentially registration-enabling Phase 2 trial in conventional chondrosarcoma and the progression of ongoing Phase 1 trials. Additionally, personnel-related costs increased during the first quarter of 2022 as compared to the same period in the prior year as a result of the continued expansion of Inhibrx.
G&A Expense. General and administrative expenses were $5.1 million during the first quarter of 2022, compared to $3.0 million during the first quarter of 2021. This overall increase was primarily driven by an increase of approximately $1.4 million in additional personnel-related costs, as well as marketing research expenses related to the initiation of our potential commercialization efforts for INBRX-101 and INBRX-109.
Net Loss. Net loss was $31.3 million during the first quarter of 2022, or $0.80 per share, compared to $19.3 million during the first quarter of 2021, or $0.51 per share.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

On May 9, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results for the first quarter ended March 31, 2022 (Press release, Mersana Therapeutics, MAY 9, 2022, View Source [SID1234613940]).

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!

"We believe that UpRi holds the potential to transform the treatment paradigm for patients with ovarian cancer. Our development strategy is designed to advance UpRi from platinum-resistant ovarian cancer with our potential UPLIFT data readout in 2023 into earlier lines of treatment with our UP-NEXT and UPGRADE trials," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "With a strengthened balance sheet and preparations to move XMT-1660 and XMT-2056 into the clinic in the near term, we look forward to delivering clinical data across all three of our platforms and building a leading ADC company."

Strategic Goals, Recent Developments and Anticipated Milestones

Build UpRi, a Dolaflexin ADC targeting NaPi2b, into a Foundational Medicine in Ovarian Cancer:
Presented Analysis Supporting UPLIFT Trial Dose: An analysis from nearly 100 patients in the expansion cohort of the Phase 1 Upifitamab Rilsodotin (UpRi) clinical trial based on a June 10, 2021 data cut was presented at the 2022 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer. This analysis supported the decision to select 36mg/m2 as the dose for UPLIFT, given the observed efficacy in both the evaluable and intent to treat populations, fewer adverse events (AEs) including Grade 3 or higher AEs, longer duration of treatment, and fewer discontinuations relative to the higher dose group.
Expecting to Complete Enrollment in UPLIFT Registration Trial in 3Q 2022: UPLIFT is enrolling up to 180 patients with platinum-resistant ovarian cancer, including approximately 100 patients with high NaPi2b expression. The trial’s primary endpoint will evaluate efficacy in the NaPi2b high population.
Advancing Toward Initiation of Patient Screening in UP-NEXT Trial in 2Q 2022: UP-NEXT is a Phase 3 clinical trial of UpRi as monotherapy maintenance following treatment with platinum doublets in recurrent platinum-sensitive ovarian cancer. This trial has the potential to serve as a post-approval confirmatory trial, supporting the expansion of UpRi into earlier lines of therapy.
Enrolling UPGRADE Combination Trial: UPGRADE, the company’s Phase 1/2 umbrella trial of UpRi in combination with other agents, is currently dose escalating UpRi in combination with carboplatin. Mersana expects to disclose interim data from this cohort in Q4 2022, with a primary focus on safety and tolerability. UPGRADE is intended to inform the further development of UpRi in combination with other therapies used in platinum-sensitive ovarian cancer.
Build Out Pipeline of Highly Impactful Cancer Medicines
Planning to Initiate Phase 1 Clinical Trial of XMT-1660 in Mid-2022: XMT-1660 is a B7-H4-directed Dolasynthen ADC with a precise and target-optimized drug-to-antibody ratio (DAR) of 6 and Mersana’s clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect. In April, the company presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that a single dose of XMT-1660 had anti-tumor activity in xenograft models of both triple-negative breast cancer and estrogen receptor positive breast cancer. The data presented also demonstrated that higher B7-H4 expression was associated with greater anti-tumor activity of XMT-1660, consistent with its targeted effect. In its Phase 1 clinical trial, the company expects to investigate XMT-1660 in B7-H4-expressing tumors such as breast, endometrial and ovarian cancers.
Planning to Initiate Phase 1 Clinical Trial of XMT-2056 in Mid-2022: XMT-2056, the company’s first Immunosynthen STING agonist ADC, targets a novel epitope of HER2 and is designed to offer a differentiated and complementary therapeutic approach to existing and emerging solid tumor treatments. In April, the company presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating that XMT-2056 had robust anti-tumor activity as a monotherapy in both high and low HER-2 expressing models. The data showed XMT-2056’s complementary mechanism of action also resulted in increased efficacy across a number of models in combination with trastuzumab, pertuzumab, anti-PD-1 and trastuzumab deruxtecan. In its Phase 1 clinical trial, the company expects to investigate XMT-2056 in HER2-expressing tumors such as breast, gastric and non-small-cell lung cancers.
Maintaining Pipeline Prioritization Discipline: Based on the lower prevalence of the NaPi2b biomarker in non-small cell lung cancer, the increasingly competitive nature of this indication and the company’s commitment to remain financially disciplined, Mersana has decided to discontinue the development of XMT-1592. Additionally, the company has decided to defer certain investments in its preclinical pipeline, including two of its earlier-stage candidates, XMT-2068 and XMT-2175.
Build Mersana with Strategic Partners:
Announced New Collaboration with Janssen: In February, the company announced a research collaboration and license agreement with Janssen Biotech, Inc. to discover novel ADCs for up to three targets by leveraging Mersana’s Dolasynthen platform and ADC expertise and Janssen’s antibodies. As part of the agreement, Mersana received a $40.0 million upfront payment and has the potential to receive more than $1.0 billion in total milestone payments and mid-single-digit to low-double-digit percentage royalties on future net sales.
First Quarter 2022 Financial Results

Net cash used in operating activities in the first quarter of 2022 was $8.0 million. Cash and cash equivalents as of March 31, 2022, were $230.1 million, compared to $177.9 million in cash and cash equivalents as of December 31, 2021. This increase reflects the receipt of the $40.0 million upfront payment from Janssen and proceeds from the sale of Mersana common stock through its at-the-market (ATM) equity offering program, partially offset by operating spend. The company expects that its available funds will be sufficient to support its operating plan commitments well into the second half of 2023.
Research and development (R&D) expenses for the first quarter of 2022 were $35.8 million, compared to $27.4 million for the same period in 2021. Included in first quarter 2022 R&D expenses was $2.9 million in non-cash stock-based compensation. The year-over-year increase in R&D expenses was primarily related to greater headcount, preparations for the clinical advancement of XMT-1660 and XMT-2056, and increased UpRi manufacturing and clinical costs.
General and administrative (G&A) expenses for the first quarter of 2022 were $12.8 million, compared to $7.2 million during the same period in 2021. Included in first quarter 2022 G&A expenses was $2.6 million in non-cash stock-based compensation. The year-over-year increase in G&A expenses was primarily related to an increase in consulting and professional fees, and increased headcount.
Net loss for the first quarter of 2022 was $47.3 million, or $0.59 per share, compared to a net loss of $34.7 million, or $0.50 per share, for the same period in 2021.
Conference Call Reminder
Mersana will host a conference call today at 8:00 a.m. ET to discuss its financial results for the first quarter of 2022 and business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 4289737. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for at least 90 days.

On May 9, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported that it plans to host a conference call on Monday, May 16, 2022, at 8:30 a.m. ET to discuss its financial results for the quarter ended March 31, 2022 and provide a corporate update (Press release, Synthetic Biologics, MAY 9, 2022, View Source/news-media/press-releases/detail/326/synthetic-biologics-to-host-conference-call-and-webcast-to [SID1234613956]).

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!

Individuals may participate in the live call via telephone by dialing (877) 451-6152 (domestic) or (201) 389-0879 (international) and using the conference ID: 13729717. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "News & Media" section of the company’s website, View Source, under "Events" or by clicking here, for 90 days after the call.

On May 9, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it has completed the divestiture of Sunosi (solriamfetol) in the U.S. to Axsome Therapeutics, Inc. (Nasdaq: AXSM) (Press release, Jazz Pharmaceuticals, MAY 9, 2022, View Source [SID1234613973]).

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!

Under the terms of the agreement, Jazz received an upfront payment of $53 million, and will receive a high single-digit royalty on Axsome’s U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome’s U.S. net sales of Sunosi in future indications. Subject to the satisfaction of conditions to closing, the ex-U.S. transaction is expected to close within 60 days.

"The divestiture of Sunosi enables us to sharpen our focus on the strategic areas where we see the most opportunity for sustainable growth and enhanced shareholder value," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "Looking forward, Jazz will continue to invest in our highest strategic priorities, driving the transformation of Jazz to an innovative, global biopharmaceutical leader, and delivering improved top- and bottom-line growth through operational excellence."

About Sunosi (solriamfetol)

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States.

Important Safety Information for Sunosi

SUNOSI (solriamfetol) is available in 75 mg and 150 mg tablets and is a federally controlled substance (C-IV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else, because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:

have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
have had a heart attack or a stroke
have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
What are the possible side effects of SUNOSI?

SUNOSI may cause serious side effects, including:

Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop any of these symptoms. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:

headache
decreased appetite
problems sleeping
nausea
anxiety
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.

On May 9, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three months ended March 31, 2022 (Press release, Eagle Pharmaceuticals, MAY 9, 2022, View Source [SID1234613876]).

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!

Business and Recent Highlights:

Achieved first quarter 2022 sales of $34.3 million for vasopressin, an A-rated generic alternative to Vasostrict, which the Company began shipping on January 18, 2022, with 180 days of marketing exclusivity. U.S. sales of Vasostrict totaled $901.7 million for the 12 months ended December 31, 2021, as reported by Endo International plc.
Achieved first quarter 2022 sales of $37.2 million of PEMFEXY (pemetrexed for injection), a branded alternative to ALIMTA. PEMFEXY is a ready-to-use liquid with a unique J-code and is approved in the U.S. to treat nonsquamous non-small cell lung cancer and mesothelioma. The ALIMTA U.S. market totaled $1.2 billion for the 12 months ended December 31, 2021, as reported by Eli Lilly and Company.
As previously announced, reached agreement on the proposed terms of a transfer of the entire issued and to be issued share capital of Acacia Pharma Group plc ("Acacia") to Eagle. The transaction is expected to close in June 2022, subject to satisfaction of closing conditions. The proposed transaction is expected to provide Eagle with two currently marketed, acute care, hospital products, both of which are new chemical entities ("NCEs") with strong patent protection:
BARHEMSYS, the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting, and
BYFAVO1 indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Remains on track to support NDA filing by AOP Health Group ("AOP Health"), with whom Eagle entered into a licensing agreement in August 2021, for landiolol, a beta-1 adrenergic blocker, later this month.
Expects to start phase 2b/3 clinical trial in CAL02 patients in Q3 2022 during pneumonia season.
Reached a settlement agreement with Hospira, Inc., related to BENDEKA (bendamustine hydrochloride). Eagle had asserted two Orange Book-listed patents against Hospira related to its NDA referencing BENDEKA. The settlement agreement provides that Hospira has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances.
Anticipates strong growth for 2022; key objective to pursue additional potential transactions to continue diversifying its commercial product portfolio and pipeline.
Financial Highlights

First Quarter 2022

Total revenue for Q1 2022 was $115.9 million, compared to $41.2 million in Q1 2021, primarily reflecting strong product sales of vasopressin and PEMFEXY.
Q1 2022 net income was $44.1 million, or $3.47 per basic and $3.41 per diluted share, compared to net loss of $0.4 million, or $0.03 per basic and diluted share, in Q1 2021.
Q1 2022 adjusted non-GAAP net income* was $52.2 million, or $4.10 per basic and $4.04 per diluted share, compared to adjusted non-GAAP net income of $3.2 million, or $0.24 per basic and diluted share, in Q1 2021.
Cash and cash equivalents were $69.5 million, net accounts receivable was $130.9 million, and debt was $24.0 million as of March 31, 2022. The Company had considerable cash outlays for the launch of vasopressin and PEMFEXY and repurchased $8.1 million of the Company stock in Q1 2022.
"The early momentum we saw at the beginning of 2022 has continued to build. We posted a great first quarter, reflecting the strong initial sales of vasopressin and PEMFEXY. We continue to strengthen our cash position, expect to acquire a company with two commercial assets, and significantly diversify our product portfolio," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "Looking ahead, we plan to put our cash and balance sheet to good use as we seek to further broaden our product offerings and pipeline and to expand our presence in the acute care and oncology spaces through potential acquisitions or licensing deals," concluded Tarriff.

First Quarter 2022 Financial Results

Total revenue for the three months ended March 31, 2022, was $115.9 million, as compared to $41.2 million for the three months ended March 31, 2021. A summary of total revenue by product is outlined below:

Gross margin was 76% during the first quarter of 2022, as compared to 74% in the first quarter of 2021. The increase in gross margin for the first quarter of 2022 was driven by the benefit of launch costs recognized in prior periods.

R&D expense was $6.1 million for the first quarter of 2022, compared to $14.3 million for the first quarter of 2021. The decrease was primarily due to the non-recurrence of development cost on vasopressin and lower spend on fulvestrant and RYANODEX related projects. Excluding stock-based compensation and other non-cash and non-recurring items, adjusted non-GAAP R&D expense* during the first quarter of 2022 was $5.4 million.

SG&A expenses in the first quarter of 2022 totaled $22.2 million compared to $19.9 million in the first quarter of 2021. This increase was primarily related to external legal spend for the anticipated acquisition of Acacia and sales and marketing costs for the launch of PEMFEXY partially offset by a decrease in stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2022 adjusted non-GAAP SG&A expense* was $16.6 million.

Net income for the first quarter of 2022 was $44.1 million, or $3.47 per basic and $3.41 per diluted share, compared to net loss of $0.4 million, or $0.03 per basic and diluted share, in the first quarter of 2021, as a result of the factors discussed above.

Adjusted non-GAAP net income* for the first quarter of 2022 was $52.2 million, or $4.10 per basic and $4.04 per diluted share, compared to adjusted non-GAAP net income* of $3.2 million, or $0.24 per basic and diluted share, in the first quarter of 2021.

2022 Full Year Expense Guidance

Adjusted non-GAAP R&D expense* is expected to be in the range of $46 million to $50 million, as compared to $32.5 million in 2021.
Adjusted non-GAAP SG&A expense* is expected to be in the range of $54 million to $58 million, as compared to $54.9 million in 2021.
The guidance excludes expense for operating Acacia in the event of successful acquisition.
Liquidity

As of March 31, 2022, Eagle had $69.5 million in cash and cash equivalents plus $130.9 million in net accounts receivable, and $24.0 million in outstanding debt. Therefore, as of March 31, 2022, Eagle had net cash plus receivables of $176.4 million.

In the first quarter of 2022, Eagle repurchased $8.1 million of its common stock as part of its current $160.0 million Share Repurchase Program. From August 2016 through March 31, 2022, Eagle has repurchased $236.1 million of its common stock.

Conference Call

As previously announced, Eagle management will host its first quarter 2022 conference call as follows:

Webcast (live and replay) www.eagleus.com, under the "Investor + News" section
A replay of the conference call will be available for one week after the call’s completion by dialing 888-562-2826 (US) or 402-220-7355 (International) and entering conference call ID EGRXQ122. The webcast will be archived for 30 days at the aforementioned URL.