On August 9, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and six months ended June 30, 2022 (Press release, Eagle Pharmaceuticals, AUG 9, 2022, View Source [SID1234617946]).

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Business and Recent Highlights:

Completed the acquisition of Acacia on June 9, 2022, providing Eagle with two currently marketed, acute care, hospital products, both of which are new chemical entities ("NCEs") with strong patent protection:
BARHEMSYS4 is the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting despite prophylaxis5
BYFAVO6 for injection is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, with an estimated total addressable market in procedural sedation of more than $0.4 billion per year7 in the U.S.
Combined addressable market is an estimated $3.1 billion per year8
Projected annual peak sales of $275 million9 in the United States
Acquired an equity stake in, with an option to purchase, Enalare, adding a portfolio of novel NCEs with strong intellectual property protection, from the mid-2030s into the 2040s, including composition of matter patents. Enalare’s lead compound, ENA-001 is an investigational, one-of-a-kind NCE being developed as an agnostic respiratory stimulant for multiple patient populations experiencing acute respiratory depression. The initial targeted indications include: post-operative respiratory depression, the most advanced development program; community drug overdose; and Apnea of Prematurity, a common condition in preterm infants. The Company believes this acquisition strengthens Eagle’s position as a diversified pharmaceutical company and a leader in hospital/anesthesia.
Supported AOP’s submission of new drug application ("NDA") for landiolol, an ultra-selective Beta-1 Adrenergic Blocker, seeking approval for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. FDA decision with respect to approval is expected mid-2023, and enrollment of the study of pediatric patients with supraventricular tachycardia is underway in Europe.
Appointed pharmaceutical industry veteran, Debra M. Hussain, as Senior Vice President, Head of Commercial.
Financial Highlights

Second Quarter 2022

Total revenue for Q2 2022 was $74.1 million, compared to $48.1 million in Q2 2021, primarily reflecting product sales of vasopressin and PEMFEXY.
Q2 2022 net loss was $(9.5) million, or $(0.74) per basic and diluted share, compared to net income of $3.6 million, or $0.28 per basic and $0.27 diluted share, in Q2 2021.
Q2 2022 adjusted non-GAAP net income was $20.3 million, or $1.58 per basic and $1.56 per diluted share, compared to adjusted non-GAAP net income of $12.4 million, or $0.95 per basic and $0.93 diluted share, in Q2 2021.
Cash and cash equivalents were $36.6 million, net accounts receivable was $85.9 million, and debt was $50.0 million, as of June 30, 2022.
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4 View Source
5 FDA labels for other recommended treatments do not include treatment after failed prophylaxis.
6 View Source
7 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.
8 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.
9 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.

"Our 2022 results to date are bearing out the vision that we have been articulating for Eagle for some time. It’s only midyear, and we have already turned in the best earnings performance in the history of our company. Our first-half earnings per share are more than twice our full-year 2021 numbers. As we look to sustain and accelerate this growth, we continue to support our commercial launches and broaden our portfolio through acquisitions, such as Acacia and the potential to acquire Enalare, both of which enhance our position in hospitals and critical care," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"The addition of BARHEMSYS and BYFAVO, the planned launch of landiolol next year, if approved, CAL02, and now our investment in Enalare, puts us well on our way to becoming a diverse pharmaceutical company. We are pleased that we have delivered on our previously stated aspirations and believe we are well positioned to use 2022 as a springboard for further growth," concluded Tarriff.

Second Quarter 2022 Financial Results

Total revenue for the three months ended June 30, 2022 was 74.1 million, as compared to $48.1 million for the three months ended June 30, 2021.

Q2 2022 PEMFEXY product sales were $16.5 million and vasopressin product sales were $11.3 million.

Q2 2022 RYANODEX product sales were $8.8 million, compared to $7.9 million in the second quarter of 2021.

Q2 2022 BELRAPZO product sales were $8.1 million, compared to $7.6 million in the second quarter of 2021.

Royalty revenue was $24.9 million in the second quarter of 2022, compared to $28.5 million in the second quarter of 2021. BENDEKA royalties were $23.0 million in the second quarter of 2022, compared to $27.8 million in the second quarter of 2021.

A summary of total revenue is outlined below:

Gross margin was 68% during the second quarter of 2022, as compared to 78% in the second quarter of 2021. The decrease in gross margin was driven by revenue mix, primarily the launch of PEMFEXY and vasopressin.

R&D expense was $11.4 million for the second quarter of 2022, compared to $9.9 million for the second quarter of 2021. The increase was primarily due to clinical expense for fulvestrant and spend on CAL02. Excluding stock-based compensation and other non-cash and non-recurring items, adjusted non-GAAP R&D expense during the second quarter of 2022 was $10.8 million.

SG&A expenses in the second quarter of 2022 totaled $36.8 million compared to $16.6 million in the second quarter of 2021. This increase was primarily related to external legal spend for the acquisition of Acacia, severance costs, and sales and marketing expenses associated with the launch of PEMFEXY. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2022 adjusted non-GAAP SG&A expense was $15.2 million.

Net loss for the second quarter of 2022 was $(9.5) million, or $(0.74) per basic and diluted share, compared to net income of $3.6 million, or $0.28 per basic and $0.27 per diluted share, in the second quarter of 2021, as a result of the factors discussed above.

Adjusted non-GAAP net income for the second quarter of 2022 was $20.3 million, or $1.58 per basic and $1.56 per diluted share, compared to adjusted non-GAAP net income of $12.4 million, or $0.95 per basic and $0.93 diluted share, in the second quarter of 2021.

2022 Full Year Expense Guidance

Adjusted non-GAAP R&D expense for the full year 2022 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 for the full year 2022 is expected to be in the range of $62 million to $66 million, as compared to $54.9 million in 2021.
Liquidity

As of June 30, 2022, Eagle had $36.6 million in cash and cash equivalents and $85.9 million in net accounts receivable, and $50.0 million in outstanding debt. Therefore, as of June 30, 2022, Eagle had cash plus net receivables of $122.5 million.

Conference Call

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

A replay of the conference call will be available for two weeks after the call’s completion by dialing 800-938-0997 (U.S.) or 402-220-1541 (International) and entering conference call ID EGRXQ222. The webcast will be archived for 30 days at the aforementioned URL.

On August 9, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported financial results for the second quarter of 2022 (Press release, Agenus, AUG 9, 2022, View Source [SID1234617945]).

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"Agenus’ presentation of botensilimab/balstilimab combination data in MSS colorectal cancer at ESMO (Free ESMO Whitepaper) GI was received with great enthusiasm by many thought leaders and clinicians in the fields of GI cancers and immuno-oncology," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "Treatment-resistant MSS CRC patients lack effective options, with the standard of care offering only a 1-2% response rate and an expected median survival ranging from 6 to 7 months. Our results could potentially change the treatment paradigm and offer hope to a significant number of patients with limited options. We are working closely with regulators and advisors to expedite botensilimab’s development in pursuit of global registrations across multiple cancers."

Botensilimab/balstilimab data to drive rapid enrollment in randomized trials

Combination delivered 24% overall response rate (ORR) and 73% disease control rate (DCR) in 41 heavily pretreated MSS CRC patients at ESMO (Free ESMO Whitepaper) GI.
Treated population verified to be unlikely to respond – low mutational burden, no prior IO responses, largely PD-L1 negative.
Safety profile manageable, with no grade 4 or 5 toxicities and no hypophysitis.
Strong enthusiasm generated amongst many leading oncologists, given strong data and high unmet need.
Agenus initiating Phase 2 randomized trials in MSS colorectal cancer, melanoma, and pancreatic cancer later this year.
Clinical-stage pipeline continues to advance

Company to present additional Phase 1b botensilimab expansion cohort data with longer follow-up at a major medical conference later this year.
Dosing underway in Phase 1 study to evaluate AGEN1571 as a monotherapy and in combination with botensilimab and/or balstilimab in participants with advanced solid tumors.
Enrollment continues in Agenus directed trials, such as a combination study involving AGEN2373 (CD137 agonist) and botensilimab.
Company ends Q2 in a strong financial position

$238 million in net cash and short-term investments reflects prudent prioritization of key programs along with capital management strategy.
$25 million of QS-21 STIMULON sales-based milestone achieved, payments to be received in the second half of 2022 based on royalties owed on Shingrix sales1.
Additional potential milestone payments and business development or financing activities may significantly enhance cash position.
Second Quarter 2022 Financial Results

We ended our second quarter 2022 with a cash and short-term investment balance of $238 million as compared to $263 million and $307 million on March 31, 2022, and December 31, 2021, respectively.

We recognized revenue of $21 million for the second quarter ended June 30, 2022, which represents an increase of $10 million from the $11 million reported for the same period in 2021. Revenue for the six months ended June 30, 2022, was $47 million, an increase of $25 million from the same period in 2021. Amounts include revenue under our collaboration agreements, in 2022 milestones earned, and revenue related to non-cash royalties earned. Non-cash royalties represent royalties from Shingrix sales which are passed to HCR under our royalty purchase agreement.

For the second quarter ended June 30, 2022, our cash used in operations was $43 million compared to $56 million for the same period in 2021. Our net loss for the quarter ended June 30, 2022, was $49 million or $0.17 per share compared a net loss of $84 million or $0.37 per share for the quarter ended June 30, 2021. Non-cash operating expenses for the second quarter ended June 30, 2022, were $19 million compared to $30 million for the second quarter of 2021.

Our cash used in operations for the six months ended June 30, 2022, was $96 million with a net loss of $100 million or $0.35 per share compared to cash used in operations of $98 million and a net loss for the same period in 2021 of $138 million or $0.65 per share.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

On August 9, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the second quarter ended June 30, 2022 and provided a business update (Press release, Gossamer Bio, AUG 9, 2022, View Source [SID1234617944]).

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"Everyone at Gossamer is looking forward to the upcoming TORREY Phase 2 results, as we actively prepare for seralutinib’s next steps in clinical development," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer.

"Our strong financial position, bolstered by our recent private placement, has enabled us to accelerate investment into a registrational Phase 3 program for seralutinib. Despite existing treatments that improve symptoms of the disease, PAH remains a progressive illness, with a heavy burden on patients and caregivers. Seralutinib is one of the few therapies in development with the potential to directly address the pathology of the underlying disease, underscoring the need to accelerate seralutinib’s registrational Phase 3 program."

Product Candidate Updates

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

Ongoing TORREY Study is a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance from baseline at week 24.
Topline data from the Phase 2 TORREY Study are expected in the second half of November or first half of December.
Ahead of these data, Gossamer has commenced investment in operational activities to enable the commencement of a registrational PAH Phase 3 clinical program in the third quarter of 2023.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL) and other Rare CNS Malignancies

First patient dosed in Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies.
Results from open-label Phase 1b/2 STAR CNS to be presented at relevant medical conferences, as data become available.
Corporate Updates

On July 15, the Company sold 16.6 million shares of its common stock to a select group of institutional and accredited investors in a private placement, raising approximately $120 million in gross proceeds.
Financial Results for Quarter Ended June 30, 2022

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2022, were $222.2 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second quarter of 2024.
Research and Development (R&D) Expenses: For the quarter ended June 30, 2022, R&D expenses were $42.6 million, compared to $44.3 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the quarter ended June 30, 2022, G&A expenses were $11.3 million, compared to $11.3 million for the same period in 2021.
Net Loss: Net loss for the quarter ended June 30, 2022, was $56.5 million, or $0.74 per share, compared to a net loss of $59.8 million, or $0.80 per share, for the same period in 2021.

On August 9, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported that it has entered into a securities purchase agreement to sell in a private placement to a group of new and existing institutional investors, led by Deep Track Capital, LP and including participation from Great Point Partners, Broadfin Holdings, LLC and other leading healthcare investors, 16,129,032 shares of its common stock at an offering price of $3.10 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 8,548,387 shares of common stock at a purchase price of $3.0999 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Heron Therapeutics, AUG 9, 2022, View Source [SID1234617943]). Gross proceeds of the private placement are expected to be approximately $76.5 million, before deducting placement agent fees and other expenses. The private placement is expected to close on or about August 11, 2022, subject to the satisfaction of customary closing conditions.

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Heron intends to use the net proceeds from the proposed private placement to support its acute care and oncology care commercial franchises, including accelerating the adoption of ZYNRELEF and preparing for the anticipated launch of HTX-019 for the prevention of postoperative nausea and vomiting ("PONV") ahead of the September PDUFA date, and for working capital and general corporate purposes.

Cantor Fitzgerald & Co. is acting as sole placement agent.

The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any states’ securities laws and may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Heron has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in this private placement (the "Resale Shares").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the Resale Shares under the resale registration statement will only be by means of a prospectus.

On August 9, 2022 PMV Pharmaceuticals, Inc. ("PMV Pharma" Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, PMV Pharma, AUG 9, 2022, View Source [SID1234617942]).

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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

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"The highlight of the second quarter was the oral presentation at ASCO (Free ASCO Whitepaper) of positive initial data from the ongoing PYNNACLE study of PC14586, our investigational first-in-class p53 Y220C reactivator, in patients with solid tumors," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "The data provide clinical proof of concept for PC14586 as monotherapy, with meaningful clinical activity observed across multiple tumor types."

Corporate Highlights:

Initial data from the dose-escalation portion of the Phase 1/2 PYNNACLE study were featured in an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) annual meeting. Enrollment is ongoing to support the determination of a recommended Phase 2 dose.
PMV Pharma announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada) to evaluate the combination of PC14586 with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. The combination trial is anticipated to begin in Q4 2022.
Appointed Marc Fellous, M.D. as Vice President, Clinical Development and Medical Affairs. Prior to joining PMV Pharma, Dr. Fellous was Global Medical Affairs Head on larotrectinib, the first tumor-agnostic drug approved in the U.S. and Europe, and selitrectinib programs at Bayer. He held leadership roles at Bayer and Roche for more than 13 years, contributing to the strategy and launch of multiple successful oncology products. Dr. Fellous completed his doctorate in general medicine at the University Paris V along with a specialized master’s degree in medical management from ESCP-Europe Business School.
Continued progress on the Company’s research pipeline of its Wild-Type p53-Induced Phosphatase 1 (WIP1) inhibitor and p53 mutant programs.
Second Quarter 2022 Financial Results

As of June 30, 2022, PMV Pharma had $277.4 million in cash, cash equivalents, and marketable securities, compared to $339.0 million as of June 30, 2021. Net cash used in operations was $31.7 million for the six months ended June 30, 2022, compared to $22.1 million for the six months ended June 30, 2021.
Net loss for the six months ended June 30, 2022, was $35.7 million compared to $24.5 million for the quarter ended June 30, 2021.
Research and development (R&D) expenses were $23.3 million for the six months ended June 30, 2022 compared to $15.2 million for the six months ended June 30, 2021. The increase in R&D expenses was primarily due to increased headcount and clinical trial expenses associated with advancing our lead product candidate, PC14586, through the Phase 1/2 clinical trial.
General and administrative (G&A) expenses were $13.2 million for the six months ended June 30, 2022, compared to $9.6 million for the six months ended June 30, 2021. The increase in G&A expenses was primarily due to costs relating to operating as a public company.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).