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Instil Bio Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

On March 7, 2022 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its fourth quarter and year end 2021 financial results and provided a corporate update (Press release, Instil Bio, MAR 7, 2022, View Source [SID1234609601]).

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"I am pleased with our progress in establishing our operational capabilities and initiating a clinical study in our first year as a public company," said Bronson Crouch, Chief Executive Officer of Instil. "With the DELTA-1 Phase 2 trial of ITIL-168 underway and continued expansion of our manufacturing capabilities in both the United Kingdom and the United States, we continue to develop our platform to deliver cell therapies to patients. In 2022, we look forward to the opportunity to expand the targeted patient population for receiving our therapies in multiple indications with ITIL-168 and ITIL-306."

2021 Highlights and Anticipated Milestones:

Enrollment Ongoing in DELTA-1: Instil is enrolling patients in DELTA-1, a global Phase 2 clinical trial of ITIL-168 with registrational intent in patients with advanced melanoma whose disease has progressed following PD-1 inhibitor therapy and, if BRAF-mutated, targeted therapy. Instil expects top-line safety and efficacy data in 2023 which could potentially support BLA submission and a European Medicines Agency marketing authorization application (MAA) filing.

INDa Cleared for DELTA-2: Instil reported that in Q4 2021 the IND amendment was cleared for DELTA-2, a Phase 1 study of ITIL-168 in non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical cancer, and cutaneous squamous cell carcinoma (CSCC).

Readiness to Initiate Phase 1 Study of ITIL-306 in 2022: Instil remains on track to file an IND for a Phase 1 study of its first genetically engineered CoStAR-TIL, ITIL-306, in multiple solid tumor indications in H1 2022.

Presenting Pre-clinical Data on the CoStAR Platform: Instil expects to present further pre-clinical data on the CoStAR platform, including manufacturability and in vivo models of efficacy and safety, at an upcoming scientific conference in 2022. In November 2021, Instil presented posters highlighting pre-clinical data from the CoStAR platform demonstrating how CoStAR expression led to marked enhancement of effector function and proliferation of T cells and TILs in the studies. Further details can be found in the poster publications available on the publication section of the Company’s website.

Developing Novel CoStAR Constructs: Instil is developing novel, proprietary families of CoStAR constructs against new targets for solid tumors beyond the initial indications targeted for ITIL-306. Instil expects to select the next CoStAR candidate for IND-enabling studies in 2022.

Expansion of UK Manufacturing Facility Complete: Regulatory approval of the IMPACT manufacturing facility in Manchester, UK has been granted and clinical product manufacturing is ongoing. The opening of the IMPACT facility expands Instil’s clinical manufacturing capacity in Manchester, UK.

Validation of Tarzana Clinical Manufacturing Facility Ongoing: Validation of Instil’s clinical manufacturing facility in Tarzana, California is ongoing, with availability for clinical manufacturing expected in the first half of 2022. Upon readiness of the Tarzana clinical manufacturing facility, Instil expects to achieve manufacturing capacity of up to approximately 500 patient doses per year.
Fourth Quarter Full Year 2021 Financial and Operating Results:

As of December 31, 2021, we had $37.6 million in cash and cash equivalents and $416.5 million in marketable securities, compared to $241.7 million in cash and cash equivalents and no investments in marketable securities as of December 31, 2020. The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $42.6 million and $107.3 million for the fourth quarter and full year ended December 31, 2021, compared to $10.2 million and $19.4 million for the fourth quarter and full year ended December 31, 2020, respectively.

General and administrative expenses were $11.2 million and $48.3 million for the fourth quarter and full year ended December 31, 2021, compared to $7.2 million and $14.4 million for the fourth quarter and full year ended December 31, 2020, respectively

Scholar Rock Reports Full Year 2021 Financial Results and Highlights Business Progress

On March 7, 2022 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the full year ended December 31, 2021, and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Scholar Rock, MAR 7, 2022, View Source [SID1234609600]).

"We are excited by the momentum and engagement around our ongoing Phase 3 SAPPHIRE trial of apitegromab in spinal muscular atrophy, as well as our DRAGON Phase 1 trial of SRK-181 in solid tumors. These programs have significant potential to address unmet patient need in a differentiated way, as well as demonstrate the tremendous potential of Scholar Rock’s platform, which focuses on inhibiting the activation of latent growth factors," said Nagesh Mahanthappa, Interim Chief Executive Officer of Scholar Rock. "While we progress these clinical programs, we also continue to build upon our world-leading expertise in selectively targeting the activation mechanisms of the TGFβ-superfamily growth factors and advance our preclinical pipeline focused on diseases such as fibrosis and regulation of iron metabolism. We look forward to providing more details about these programs at scientific meetings and through publications in the coming months."

Company Updates and Upcoming Milestones

Apitegromab is a selective inhibitor of myostatin activation being developed as the potential first muscle-directed therapy for the treatment of spinal muscular atrophy (SMA).

Conducting SAPPHIRE Phase 3 Clinical Trial Evaluating Apitegromab in Patients with Non-Ambulatory Type 2 and 3 SMA. The randomized, double-blind, placebo-controlled Phase 3 clinical trial is evaluating apitegromab as add-on therapy for patients on either nusinersen or risdiplam. The study design plans for approximately 156 patients aged 2-12 years old with non-ambulatory Type 2 and 3 SMA to be enrolled in the main efficacy population. Patients will be randomized 1:1:1 to receive for 12 months either apitegromab 20 mg/kg, apitegromab 10 mg/kg, or placebo by intravenous (IV) infusion every 4 weeks in addition to background SMN treatment.
Data from TOPAZ Phase 2 Open Label Extension Trial Expected to be Presented by mid-2022. As of February 28, 2022, 55 of 57 patients remain enrolled in the long-term extension trial of apitegromab in Type 2 and Type 3 SMA.
SRK-181 is a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming primary resistance to and increasing the number of patients who may benefit from checkpoint inhibitor therapy.

Advancing Part B of the DRAGON Phase 1 POC Trial for SRK-181. Based on the safety and pharmacokinetic data from Part A of the DRAGON Phase 1 trial, Scholar Rock is conducting the Part B dose expansion portion of the trial, in which SRK-181 is dosed at 1500 mg every three weeks (Q3W) in patients receiving an approved anti-PD-(L)1 therapy dosed Q3W, or 1000 mg every two weeks (Q2W) in patients receiving an approved anti-PD-(L)1 therapy dosed Q2W. Part B consists of multiple proof-of-concept cohorts focused upon evaluating the ability of SRK-181 to overcome primary resistance to anti-PD-(L)1 therapy. Each cohort will enroll up to 40 patients with various solid tumors, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), and other solid tumors. The biomarker strategy in part B of DRAGON will explore early signs of SRK-181 activity, including target engagement and pathway modulation. This will include measuring effects on both circulating and tumor immune contexture, such as CD8+ T cell infiltration and reductions in myeloid-derived suppressor cell (MDSC) populations as well as analysis of TGFβ-related pathway signaling. Early efficacy and safety data are anticipated in 2022.
Full Year 2021 Financial Results

For the full year ended December 31, 2021, net loss was $131.8 million or $3.59 per share compared to a net loss of $86.5.0 million or $2.81 per share for the year ended December 31, 2020.

Revenue was $18.8 million for the year ended December 31, 2021 compared to $15.4 million for the year ended December 31, 2020. Revenue was related to the Gilead fibrosis-focused research collaboration, which concluded in December 2021.
Research and development expense was $108.5 million for the year ended December 31, 2021 compared to $74.1 million for the year ended December 31, 2020. The increase year-over-year was primarily attributable to planned spend associated with apitegromab development, including costs associated with clinical drug supply manufacturing and costs associated with our SAPPHIRE trial, as well as higher personnel-related costs.
General and administrative expense was $40.3 million for the year ended December 31, 2021 compared to $28.2 million for the year ended December 31, 2020. The increase year-over-year was primarily attributable to professional services and higher personnel-related costs, including filling key positions essential to progressing research, development and pre-commercial activities.
As of December 31, 2021, Scholar Rock had cash, cash equivalents, and marketable securities of approximately $253.0 million, which is expected to fund the Company’s operations into mid-2023. "Continued operational excellence is an important priority for us in 2022 as we advance several programs across the continuum of drug development. As we continue to progress our SMA program with our Phase 3 SAPPHIRE trial, we are also encouraged that so many of the patients who participated in the TOPAZ study are still opting to receive apitegromab. We look forward to obtaining further insights into longer-term treatment outcomes and sharing that data in the coming months. In our immuno-oncology program, the DRAGON study has entered Part B and could produce meaningful data later this year and our research colleagues are pushing forward on several fronts as we continue to generate exciting programs from our scientific platform," said Ted Myles, COO and CFO of Scholar Rock.

Targovax ASA and Agenus announce collaboration on mutant KRAS cancer vaccine adjuvanted with QS-21 STIMULON™

On March 7, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, and Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that they have entered into a clinical collaboration and supply agreement to combine Targovax’s TG mutant KRAS cancer vaccines with Agenus´s clinically validated and FDA approved QS-21 STIMULON adjuvant (Press release, Targovax, MAR 7, 2022, View Source [SID1234609599]).

The TG vaccines are peptide mixtures designed to elicit polyvalent immune responses against the most frequent mutations in the RAS gene family, which drive up to 30% of all cancers. TG01 has shown promise in phase 1/2 clinical trials, and Targovax has recently been awarded two prestigious research grants providing up to NOK 18m in funding to advance the TG program. Cancer vaccines require combination with an adjuvant in order to stimulate antigen processing and T-cell priming, and Targovax has selected QS-21 STIMULON as the adjuvant of choice for continued clinical development.

QS-21 STIMULON is a purified, natural saponin proprietary to Agenus. It has been widely studied in over 120 clinical trials and consistently demonstrated powerful antibody and cell-mediated immune responses as well as a favorable safety profile. QS-21 STIMULON is a critical component of multiple vaccines, including GSK’s FDA approved Shingrix shingles vaccine with protection exceeding 9 years, and the world’s first malaria vaccine Mosquirix.

Under the collaboration with Targovax, Agenus will supply QS-21 STIMULON and scientific support for up to three initial TG01 clinical trials in different cancer indications. If the clinical results meet certain pre-specified performance targets, the collaboration will be extended into an exclusive pivotal development and commercialization agreement where Agenus will be entitled to tiered double-digit royalties on future TG vaccine sales.

Dr. Garo H. Armen, Chief Executive Officer of Agenus Inc., said: "We look forward to collaborating with Targovax to extend the benefit of QS-21 STIMULON to new patient populations such as those harboring KRAS-mutated cancers. It highlights the broad applicability of our QS-21 STIMULON technology and could unlock a sizeable commercial opportunity in KRAS-mutated cancers."

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "QS-21 STIMULON is arguably the most clinically and commercially successful FDA approved adjuvant for protein- and peptide-based vaccines, and has proven highly effective in eliciting immune responses. We expect that this unique adjuvant will further enhance the efficacy of our TG01 and TG02 products, and see it as a critical component of our development strategy as we prepare to bring the TG vaccines back into the clinic in multiple mutant KRAS cancers."

Mission Therapeutics to participate in the 2022 Babraham Research Campus Signalling Event

On March 7, 2022 Mission Therapeutics ("Mission"), a drug discovery and development company focused on protein homeostasis by selectively inhibiting deubiquitylating enzymes (DUBs), reported that its VP of Translational Science, Dr Andy Pearce, will attend and present at the Babraham Research Campus Signalling Event on 9 March 2022 (Press release, Mission Therapeutics, MAR 7, 2022, View Source [SID1234609598]).

In his presentation, titled ‘Targeting Deubiquitinase Enzymes for Treatment of a Broad Spectrum of Diseases’, Andy will discuss the Company, discovery platform, cross disease interest, and data from its lead program, USP30. The presentation at 13.35 will include time for questions and Andy will be available for one-to-one meetings.

Mission Therapeutics has built a world-leading proprietary DUB platform for the discovery and development of first-in-class drugs that selectively target specific disease-associated DUBs. As the VP of Translational Science, Dr Pearce leads the Translational Science department and drug discovery projects. He previously led projects and research groups for over 15 years at Novartis and GSK.

The Signalling Event will focus on the range of R&D ongoing across the Babraham campus, as well as highlighting scientific services and capabilities available on site.

Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Results

On March 7, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and twelve months ended December 31, 2021 (Press release, Eagle Pharmaceuticals, MAR 7, 2022, View Source [SID1234609597]).

Business and Recent Highlights:

Announced the commercial availability of its novel product, 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 United States to treat nonsquamous non-small cell lung cancer and mesothelioma. Eagle received approval from the U.S. Food and Drug Administration ("FDA") in February 2020 of its new drug application ("NDA") for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company in December 2019. The agreement provided for a release of all claims by the parties and allows for an initial entry of PEMFEXY into the market (equivalent to approximately a three-week supply of ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022. The ALIMTA U.S. market totaled $1.2 billion for the 12 months ended December 31, 2021, as reported by Eli Lilly and Company
Commenced shipment of vasopressin on January 18, 2022 with 180 days of marketing exclusivity. Vasopressin, an A-rated generic alternative to Vasostrict, is indicated for use to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. U.S. sales of Vasostrict totaled $901.7 million for the 12 months ended December 31, 2021, as reported by Endo International plc.
AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group, ("AOP Health"), with whom Eagle entered into a licensing agreement in August 2021, has engaged with the FDA to obtain alignment on the content and format of the pre-clinical and clinical data required to support an NDA seeking approval of Landiolol, a novel therapeutic, for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. Based on the FDA’s responses to AOP Health’s communications, Eagle remains on track to support AOP Health’s NDA filing for Landiolol in the second quarter of 2022.
1 The Company’s expectations with respect to the first quarter of 2022 are based on its estimates and assumptions as of March 7, 2022 and are subject to substantial uncertainty. The Company’s first quarter of 2022 is ongoing and not complete, and the Company’s expectations with respect to revenues, earnings per share and adjusted non-GAAP earnings per share for the first quarter of 2022 are estimates. Actual revenue, earnings per share and adjusted non-GAAP earnings per share for the Company’s first quarter of 2022 are subject to completion of the quarter as well as financial closing procedures for the period, and the actual and reported financial results for the Company’s first quarter of 2022 may materially differ. As such, the Company’s expectations with respect to the first quarter of 2022 are inherently unpredictable and actual results and outcomes could differ materially for a variety of reasons, including the factors discussed below under "Forward-Looking Statements".

* Adjusted non-GAAP net income, adjusted non-GAAP earnings per share, adjusted non-GAAP R&D expense and adjusted non-GAAP SG&A expense are non-GAAP financial measures. For descriptions and reconciliations of these non-GAAP financial measures to their most comparable GAAP financial measures, please see below and the tables at the end of this press release.

Financial Highlights

Fourth Quarter 2021

Total revenue for Q4 2021 was $42.3 million, compared to $49.9 million in Q4 2020, primarily reflecting lower product sales of BELRAPZO and RYANODEX and lower royalty revenue of BENDEKA, partially offset by higher product sales of TREAKISYM.
Q4 2021 net loss was $6.2 million, or $(0.48) per basic and diluted share, compared to net income of $8.1 million, or $0.62 per basic and $0.60 per diluted share, in Q4 2020.
Q4 2021 adjusted non-GAAP net income* was $11.2 million, or $0.87 per basic and $0.85 per diluted share, compared to adjusted non-GAAP net income* of $12.8 million, or $0.98 per basic and $0.96 per diluted share, in Q4 2020.
Cash and cash equivalents were $97.7 million, net accounts receivable was $41.1 million, and debt was $26.0 million as of December 31, 2021.
Full Year 2021

Total revenue for the 12 months ended December 31, 2021 was $171.5 million, compared to $187.8 million in 2020. 2020 included a $5.0 million milestone payment from SymBio Pharmaceuticals Limited for regulatory approval of TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid bendamustine formulation.
Net loss for the 12 months ended December 31, 2021 was $8.6 million, or $(0.66) per basic and diluted share, compared to net income of $12.0 million, or $0.89 per basic and $0.87 per diluted share, in 2020.
Adjusted non-GAAP net income* for the 12 months ended December 31, 2021 was $34.4 million, or $2.64 per basic and $2.59 per diluted share, compared to $48.7 million, or $3.62 per basic and $3.54 per diluted share, in 2020.
From August 2016 through December 31, 2021, Eagle has repurchased $228.1 million of its common stock.
"With two important launches in early 2022, Eagle is off to a great start. The initial impressive revenue generated from vasopressin and PEMFEXY, each with significant periods of exclusivity, together with our royalties from bendamustine sales in Japan, position us to more than double our earnings this year. Based on early 2022 trends, we believe that our Q1 2022 earnings per share should approximate $4.00. Our pipeline is advancing as expected, and our balance sheet remains healthy. The period ahead will be exciting for us as we plan to deploy our cash to strengthen our product offerings and grow the company," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Q4 2021 BELRAPZO product sales were $5.5 million, compared to $10.2 million in Q4 2020.

Q4 2021 RYANODEX product sales were $6.1 million, compared to $7.9 million in Q4 2020.

Royalty revenue was $26.2 million in the fourth quarter of 2021, compared to $27.0 million in the fourth quarter of 2020. BENDEKA royalties were $24.2 million in the fourth quarter of 2021, compared to $27.0 million in the fourth quarter of 2020.

Gross margin was 71% during the fourth quarter of 2021, as compared to 75% in the fourth quarter of 2020. The decrease in gross margin for the fourth quarter of 2021 was driven by revenue mix.

R&D expense was $3.8 million for the fourth quarter of 2021, compared to $9.4 million for the fourth quarter of 2020. The decrease was primarily due to the non-recurrence of development cost on vasopressin and lower spend on RYANODEX related projects. Excluding stock-based compensation and other non-cash and non-recurring items, adjusted non-GAAP R&D expense* during the fourth quarter of 2021 was $2.6 million.

SG&A expenses in the fourth quarter of 2021 totaled $20.3 million compared to $18.2 million in the fourth quarter of 2020. This increase was primarily related to employee related costs and consulting costs partially offset by a decrease in stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, fourth quarter 2021 adjusted non-GAAP SG&A expense* was $14.6 million.

Net loss for the fourth quarter of 2021 was $6.2 million, or $(0.48) per basic and diluted share, compared to net income of $8.1 million, or $0.62 per basic and $0.60 per diluted share, in the fourth quarter of 2020, as a result of the factors discussed above.

Adjusted non-GAAP net income* for the fourth quarter of 2021 was $11.2 million, or $0.87 per basic and $0.85 per diluted share, compared to adjusted non-GAAP net income* of $12.8 million or $0.98 per basic and $0.96 per diluted share in the fourth quarter of 2020.

Full Year 2021 Financial Results

Product sales decreased by $7.3 million in the year ended December 31, 2021, primarily driven by decreases in product sales of Bendeka by $4.3 million, coupled with decreases in Belrapzo product sales of $3.8 million, due to price decreases and Ryanodex product sales by $3.0 million, due to volume decreases. The decreased sales were partially offset by increases in product sales of $3.9 million for TREAKISYM.

Gross margin was 75% in 2021, as compared to 76% in 2020. The decrease in gross margin in 2021 was driven by revenue mix.

R&D expense increased to $51.3 million in 2021, compared to $30.8 million in 2020, primarily reflecting a $10.0 million upfront payment related to our license agreement with Combioxin SA for CAL02, a $5.0 million upfront payment related to our licensing agreement with AOP Orphan for Landiolol, and increases of $2.3 million in development costs for vasopressin, $2.1 million in employee related costs, and $1.6 million related to PEMFEXY launch preparedness and regulatory costs. Excluding stock-based compensation and other non-cash and non-recurring items, adjusted non-GAAP R&D expense* in 2021 was $32.5 million.

SG&A expenses decreased by $3.3 million to $75.3 million in 2021, compared to $78.6 million in 2020. The decrease primarily reflects lower stock-compensation expense and the non-recurrence of expense related to Tyme Technologies, Inc. ("Tyme"), partially offset by increases in external legal fees and employee related costs. Excluding stock-based compensation and other non-cash and non-recurring items, adjusted non-GAAP SG&A expense* in 2021 was $54.9 million.

Net loss for the year ended December 31, 2021 was $8.6 million, or $(0.66) per basic and diluted share, as compared to net income of $12.0 million or $0.89 per basic and $0.87 per diluted share for the year ended December 31, 2020, as a result of the factors discussed above.

Adjusted non-GAAP net income* for the year ended December 31, 2021 was $34.4 million, or $2.64 per basic and $2.59 per diluted share, compared to adjusted non-GAAP net income* of $48.7 million, or $3.62 per basic and $3.54 per diluted share, for 2020.

First Quarter 2022 Expected Revenue and EPS1

Revenue for the first quarter 2022 is expected to be in the range of $120 million – $130 million.
Adjusted non-GAAP earnings per share* for the first quarter 2022 is expected to be in the range of $3.80 – $4.10.
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.
Liquidity

As of December 31, 2021, Eagle had $97.7 million in cash and cash equivalents plus $41.1 million in net accounts receivable, and $26.0 million in outstanding debt. Therefore, as of December 31, 2021, Eagle had net cash plus receivables of $112.8 million.

In the fourth quarter of 2021, Eagle purchased $8.6 million of its common stock as part of its current $160.0 million Share Repurchase Program. From August 2016 through December 31, 2021, Eagle has repurchased $228.1 million of its common stock.

Conference Call

As previously announced, Eagle management will host its fourth quarter 2021 conference call as follows:

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-0866 (US) or 402-220-0662 (International) and entering conference call ID EGRXQ421. The webcast will be archived for 30 days at the aforementioned URL.