On August 9, 2022 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported financial results for the quarter ended June 30, 2022 (Press release, Lumos Pharma, AUG 9, 2022, View Source [SID1234618011]).

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!

"During our second quarter of 2022 we continued to execute on our clinical programs evaluating orally administered LUM-201 in PGHD and are delighted to reaffirm our commitment to announcing interim data for our OraGrowtH210 and OraGrowtH212 Trials by the end of this year," said Rick Hawkins, Chairman and CEO of Lumos Pharma. "Additionally, we continue to be pleased with our enrollment trends and now expect to release primary outcome data from both OraGrowtH Trials in the second half of 2023. We also continue to support our collaboration with Mass General on an investigator-initiated trial evaluating LUM-201 in NAFLD, which is now prescreening subjects. We look forward to advancing these programs and to the release of interim data from our OraGrowtH Trials later this year."

Recent Highlights

Interim analyses for Phase 2 OraGrowtH210 and PK/PD OraGrowtH212 Trials by end of 2022. Both the OraGrowtH210 and OraGrowtH212 Trials in subjects with idiopathic, Predictive Enrichment Marker-(PEM)-positive Pediatric Growth Hormone Deficiency (PGHD) are progressing well, and we confirm our plan to conduct interim analyses in Q4. We believe the interim data should provide an early indication of efficacy and safety of oral LUM-201 versus standard of care daily recombinant human growth hormone (rhGH) injections in idiopathic PGHD. In addition, we are progressing toward full enrollment of both trials, enabling a readout of our primary outcome data on 80 subjects from the OraGrowtH210 Trial in the second half of 2023. The OraGrowtH212 Trial has recently been extended to follow subjects to near adult height. The primary outcome data for this trial on up to 24 subjects is now expected in the second half of 2023, concurrent with the OraGrowtH210 Trial. Our trials are being conducted in the idiopathic subset of the PGHD population, and prior studies demonstrate a slower growth trajectory on rhGH in this subset. Therefore, the appropriate yardstick for growth on LUM-201 in the OraGrowtH210 Trial is the growth on rhGH in the control arm of this trial, not the growth in other trials that typically enroll more severely growth hormone deficient subjects. Baseline characteristics will determine whether we combine the annualized height velocity (AHV) data from both trial datasets at the interim and final analyses.

Prescreening continues in Massachusetts General Investigator-Initiated Trial evaluating LUM-201 in NAFLD. As previously announced, we entered into a clinical collaboration with Dr. Laura Dichtel and Massachusetts General Hospital to explore the potential of LUM-201 in Nonalcoholic Fatty Liver Disease (NAFLD) in an investigator sponsored pilot study. Prescreening in the trial is ongoing, and we expect this trial to begin enrollment in the near future. While we remain focused on our core LUM-201 program in PGHD, we are pleased to support Mass General’s exploration of LUM-201’s potential in this indication, a condition estimated to be prevalent in approximately 25% of adults worldwide. NAFLD can often advance to the more serious liver disease non-alcoholic steatohepatitis (NASH) with fibrosis, and NASH-associated liver failure is one of the leading causes of liver transplants in the United States.
Financial Results for the Quarter Ended June 30, 2022

Cash Position – Lumos Pharma ended the quarter on June 30, 2022 with cash and cash equivalents totaling $79.5 million compared to $94.8 million on December 31, 2021. The Company expects an average cash use of approximately $8.5 to $9.5 million per quarter through 2022. Cash on hand as of June 30, 2022 is expected to support operations into the second quarter of 2024, inclusive of the primary outcome data readout from OraGrowtH210 and OraGrowtH212 Trials anticipated in the second half of 2023.
R&D Expenses – Research and development expenses were $4.6 million for the quarter ended June 30, 2022, an increase compared to $4.1 million for the same period in 2021, primarily due to an increase of $0.3 million in personnel and stock option expense and $0.3 million in legal and consulting expenses, offset by a decrease of $0.1 million in clinical trial and contract manufacturing expenses.
G&A Expenses – General and administrative expenses were $3.7 million for the quarter ended June 30, 2022, a decrease as compared to $4.6 million for the same period in 2021, primarily due to decreases of $0.6 million in personnel-related expenses, $0.4 million in stock compensation expenses and $0.3 million in legal and other expenses, offset by an increase of $0.3 million in royalty expenses.
Net Loss – The net loss for the quarter ended June 30, 2022 was $7.8 million compared to net loss of $8.7 million for the same period in 2021.
Lumos Pharma ended the second quarter 2022 with 8,377,567 shares outstanding.
Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical programs. There will also be a question-and-answer session following management’s prepared remarks.

Access to the live conference call is available five minutes prior to the start of the call by dialing (833) 634-2295 (U.S.) or (412) 902-4176 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at View Source in the "Investors & Media" section under "Events and Presentations" or through this link: View Source;To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (international) and using the passcode 1602592. The replay will be available for two weeks from the date of the call.

About Lumos Pharma’s Clinical Trials

Phase 2 OraGrowtH210 Trial of Oral LUM-201 in PGHD

The OraGrowtH210 Trial is a multi-site, global trial evaluating orally administered LUM-201 at three dose levels (0.8, 1.6, 3.2 mg/kg/day) against a standard dose of injectable rhGH in approximately 80 subjects diagnosed with idiopathic (moderate) PGHD, which is less severe than organic PGHD. The objective of this trial is to identify the optimal dose of LUM-201 to be used in a Phase 3 registration trial, based on annualized height velocity from a 6-month dataset, and to prospectively confirm the preliminary validation of our Predictive Enrichment Marker (PEM) strategy. The interim analysis will evaluate the safety and annualized height velocity of the three dose levels of LUM-201 against a standard dose (0.24 mg/kg/week, dosed daily) of injectable recombinant human growth hormone (rhGH) in a minimum of 40 subjects at six months on therapy. The complete set of 6-month, primary outcome data for 80 patients is anticipated in the second half of 2023. Subjects will be dosed for a total of 24 months.

OraGrowtH212 Trial Evaluating PK/PD and Pulsatility of Oral LUM-201 in PGHD

The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of oral LUM-201 in up to 24 PGHD subjects at two dose levels, 1.6 and 3.2 mg/kg/day. The primary objective of the OraGrowtH212 Trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone from LUM-201 therapy, contributes to its efficacy in PGHD. The primary endpoint for this trial is six months of PK/PD (pulsatility) and height velocity data in up to 24 subjects. Subjects will be allowed to remain on treatment until they reach a bone age of 14 for females and 16 for males reflecting near-adult height. Primary data readout in up to 24 patients is anticipated in the second half of 2023.

Switch Study, OraGrowtH213 Trial, Evaluating LUM-201 in OraGrowtH210 Subjects Previously on rhGH

The OraGrowtH213 Trial is an open-label, multi-center, Phase 2 study evaluating the growth effects and safety of LUM-201 following 12 months of daily rhGH in up to 20 idiopathic PGHD patients who have completed the OraGrowtH210 Trial. Subjects will be administered LUM-201 at a dose level of 3.2 mg/kg/day for up to 12 months.

Lumos Pharma Collaboration with Massachusetts General Hospital Evaluating LUM-201 in NAFLD

Lumos Pharma has entered a collaboration with Massachusetts General Hospital (MGH) to evaluate LUM-201 in patients with nonalcoholic fatty liver disease (NAFLD). GH is a critical stimulator of lipolysis, and shows anti-inflammatory effects, and preclinical data suggest that amplifying GH secretion has the potential to reduce hepatic steatosis and prevent NAFLD progression. Interestingly, enhancing the natural pulsatile release of GH has been shown clinically in short-term studies to be more efficacious in inducing lipolysis than continuous infusions of GH.  This MGH investigator-initiated trial is a single-site, 6-month, open-label pilot study of daily oral LUM-201 in adults with NAFLD. The trial will evaluate a dose of 25 mg/day of LUM-201 in 10 subjects with NAFLD and relative IGF-1 deficiency. The primary endpoints will be to determine the reduction in liver lipid content, inflammation, and fibrosis in these subjects administered LUM-201 compared to each subject’s baseline.

On August 9, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a biotherapeutics company dedicated to changing the treatment paradigm for patients with devastating diseases, reported that it has raised aggregate proceeds of up to approximately $115.4 million, net of transaction fees, through the sale of shares of its Founded Entity, Karuna Therapeutics ("Karuna," Nasdaq: KRTX), comprising a sale of 125,000 Karuna shares in on-market transactions and expected completion of call options covering up to 477,100 Karuna shares (collectively, the "Transaction") (Press release, PureTech Health, AUG 9, 2022, View Source [SID1234617994]). PureTech intends to use the proceeds from the Transaction to further the advancement and growth of the Company and will update its cash runway guidance in its half-yearly results for the six months ended June 30, 2022, to be announced on August 25, 2022.

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!

Following the Transaction and presuming the exercise of all call options written by the Company, PureTech will have generated an aggregate total of approximately $681.1 million in sales of Karuna equity since Karuna’s initial public offering. PureTech will continue to hold 1,054,464 shares of Karuna common stock, which is equal to approximately 3.5% of Karuna’s outstanding shares as of August 3, 2022, with a market value of approximately $254.3 million as of market close on August 8, 2022.

Additionally, as the founder of Karuna and co-inventor of the KarXT program, PureTech also has a right to royalty payments of 3% of net sales of any commercialized product as well as 20% of sublicense income covered by the license agreement. The license agreement covers the KarXT program in key territories including the United States, European Union, and Japan. PureTech is also eligible to receive certain milestone payments upon the achievement of regulatory approvals.

The Transaction constitutes a class 2 transaction for the purposes of the UK Financial Conduct Authority’s Listing Rules.

On August 9, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the second quarter ended June 30, 2022 (Press release, Idera Pharmaceuticals, AUG 9, 2022, View Source [SID1234617992]).

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!

Second Quarter Financial Results
Our cash position as of June 30, 2022 was $24.5 million. Based on our current operating plan, we anticipate that our current cash and cash equivalents will fund our operations through the one-year period subsequent to the August 9, 2022 filing date of the Quarterly Report Form 10-Q.

Research and development expenses for the three months ended June 30, 2022 totaled $2.7 million, compared to $3.9 million for the same period in 2021. General and administrative expense for the three months ended June 30, 2022 totaled $2.7 million, compared to $2.5 million for the same period in 2021. Restructuring costs for the three months ended June 30, 2021 totaled approximately $1.2 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such costs were incurred during the three months ended June 30, 2022.

As a result of the factors above, net loss applicable to common stockholders for the three months ended June 30, 2022 was $5.3 million or $0.10 per basic and diluted share compared to net loss applicable to common stockholders of $7.6 million or $0.15 per basic and diluted share for 2021.

On August 9, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported its financial and operating results for the second quarter ended June 30, 2022 and provided an update on its full year 2022 financial guidance and recent corporate activities (Press release, Halozyme, AUG 9, 2022, View Source [SID1234617991]).

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

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

                  Schedule Your 30 min Free Demo!

"As we report our strong second quarter results and execute our plans to continue to deliver sustained high growth, I have never been more excited about the future and potential of Halozyme. We see strong ENHANZE momentum with our Wave 2 products DARZALEX SC and Phesgo and with recent positive Phase III study results for efgartigimod SC and Tecentriq SC, two of our four Wave 3 launch products with the potential for launch 2023-2025. As planned, we project at least six Phase 2 or Phase 3 study starts in 2022," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The acquisition of Antares Pharma enhances our revenue growth and durability, adding a commercialized, broadly licensable autoinjector platform and two innovative commercial products in the large and growing testosterone replacement therapy market."

Recent Partner Highlights:

In August 2022, Roche announced that the Phase III IMscin001 study evaluating a subcutaneous (SC) formulation of Tecentriq (atezolizumab) with ENHANZE met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with advanced or metastatic non-small cell lung cancer for whom prior platinum therapy has failed. The safety profile of the SC formulation was consistent with IV Tecentriq.
In July 2022, Takeda announced positive topline results from pivotal Phase 3 trial evaluating HYQVIA (Immunoglobulin infusion 10% (Human) with rHuPH20), for maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
In June 2022, Bristol Myers Squibb nominated an undisclosed target resulting in a $5 million milestone payment.
In June 2022, ViiV initiated enrollment of a Phase 1 single dose escalation study in subjects with HIV to evaluate pharmacokinetics, safety and tolerability of long-acting cabotegravir administered subcutaneously with ENHANZE.
In June 2022, argenx initiated a Phase 2 study evaluating efgartigimod with ENHANZE in subjects with bullous pemphigoid.
In May 2022, Chugai initiated a Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and safety of targeted antibody administered subcutaneously with ENHANZE.
In April 2022, Roche initiated a Phase 3 study evaluating OCREVUS (ocrelizumab) with ENHANZE in subjects with multiple sclerosis.
Recent Corporate Highlights:

In May 2022, we completed the acquisition of Antares Pharma, Inc. resulting in an expansion of our commercial portfolio of proprietary and partnered products and the potential for future growth through new partnership agreements.
In June 2022, we announced the commercial launch of TLANDO, an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.
In June 2022, we completed the $150 million Accelerated Stock Repurchase that was initiated in December of 2021, resulting in the total repurchase of 3.9 million shares at an average price of $38.51 per share.
Second Quarter Financial Highlights

Revenue for the second quarter was $152.4 million compared to $136.5 million for the second quarter of 2021. The 12% year-over-year increase was driven by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab) and the addition of product sales as a result of the Antares Pharma acquisition, partially offset by a decrease in revenues under collaborative agreements due to a $40 million upfront payment associated with entering into the ViiV collaboration in the prior year period. Revenue for the quarter included $85.3 million in royalties, an increase of 86% compared to $45.8 million in the prior year period.
Cost of sales for the second quarter was $33.9 million, compared to $23.0 million for the second quarter of 2021. The year-over-year increase was driven by an increase in product sales as a result of the Antares Pharma acquisition.
Amortization of intangibles expense in the second quarter was $11.4 million, an increase from no expense in the second quarter of 2021 due to the Antares Pharma acquisition, in which we acquired intangible assets that are amortized over a useful life related to the auto injector technology platform, XYOSTED and TLANDO.
Research and development expenses for the second quarter were $15.5 million, compared to $8.1 million for the second quarter of 2021. The increase is primarily due to planned investments in ENHANZE and one-time compensation costs related to the Antares Pharma acquisition.
Selling, general and administrative expenses for the second quarter were $57.5 million, compared to $12.3 million for the second quarter of 2021. The increase was primarily due to one-time transaction and compensation costs related to the Antares Pharma acquisition and an increase in compensation expense related to the ongoing combined workforce.
Operating Income in the second quarter of 2022 was $34.1 million, compared to an operating income of $93.0 million in the second quarter of 2021.
Net Income: On a GAAP basis in the second quarter of 2022, net income was $22.7 million, compared with net income of $91.5 million in the second quarter of 2021. Non-GAAP net income was $75.7 million in the second quarter of 2022, compared with non-GAAP net income of $97.8 million in the second quarter of 2021.1 The Company notes that 2022 is the first year in which Halozyme will record income tax expense as part of its income statement.
Earnings per Share: On a GAAP basis in the second quarter of 2022, diluted earnings per share was $0.16, compared with $0.62 in the second quarter of 2021. On a non-GAAP basis diluted earnings per share was $0.53, compared with diluted earnings per share of $0.66 in the second quarter of 2021.1
Cash, cash equivalents and marketable securities were $209.4 million on June 30, 2022, compared to $740.9 million on December 31, 2021.
Financial Outlook for 2022

The Company is raising its financial guidance for 2022 which was last provided on May 10, 2022, as a result of the recent close of the Antares Pharma transaction and strong year-to-date results. For the full year 2022, the Company expects:

Total revenue of $655 million to $685 million, an increase from our prior guidance range of $530 million to $560 million, representing growth of 48% to 55% over 2021 total revenue primarily driven by projected revenue contribution from the Antares business of $115 million to $125 million. The Company expects revenue from royalties to increase greater than 65% over revenue from royalties in 2021 to approximately $340 million to $350 million.
Operating income of $240 million to $265 million, a decrease from our prior guidance range of $350 million to $380 million, representing a decline of 4% to 13% over 2021 operating income. Our 2022 guidance includes one-time transaction costs related to the Antares Pharma acquisition, including amortization of intangible assets, as well as an incremental $20 million operating expense investment to maximize ENHANZE and to extend royalty revenue durability.
GAAP net income of $170 million to $195 million, a decrease from our prior guidance range of $270 million to $295 million; and non-GAAP net income of $295 million to $320 million, an increase from our prior guidance range of $290 million to $315 million.1 The Company notes that 2022 will be the first full fiscal year in which Halozyme will record income tax expense as part of its income statement.
GAAP diluted earnings per share of $1.20 to $1.35, a decrease from our prior guidance of $1.90 to $2.05, due to acquisition related costs in 2022.
Non-GAAP diluted earnings per share are expected to be $2.10 to $2.25, an increase from our prior guidance range of $2.05 to $2.20,1 reflective of the projected accretion from the Antares Pharma acquisition.
The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the second quarter ended June 30, 2022 today, Tuesday, August 9, 2022 at 4:30 p.m. ET/1:30 p.m. PT. The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the "Investors" section of www.halozyme.com.

On August 9, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company"), and Enalare Therapeutics Inc ("Enalare") reported an agreement for Eagle to make an equity investment of $25 million in Enalare, a clinical-stage privately held biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening acute respiratory and critical care conditions (Press release, Eagle Pharmaceuticals, AUG 9, 2022, View Source [SID1234617990]). The investment also includes an exclusive option for Eagle to acquire all remaining issued and outstanding Enalare stock upon the achievement of development milestones as set forth in the agreement.

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

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

                  Schedule Your 30 min Free Demo!

As part of the transaction, Eagle will invest up to approximately $55 million, which is expected to occur over the next two years subject to the achievement by Enalare of certain milestones on an agreed upon timeline. The investment consists of an upfront investment of $25 million, $12.5 million now and $12.5 to be paid in six months, and two potential follow-on equity investments of $15 million each contingent upon (i) the commencement of the ENA-001 Phase 2 clinical trial, and (ii) the ENA-001 Phase 2 clinical trial reaching 50% enrollment. Eagle and Enalare have also entered into an agreement providing Eagle the option to acquire the all remaining Enalare shares for an aggregate purchase price ranging from $100-$175 million plus royalty rights ranging from 9%-12% on all future global net sales of any Enalare product, paid to the ex-Eagle holders of Enalare shares at the time of acquisition.

The transaction is expected to provide Eagle with products protected by intellectual property rights, including composition of matter patents, which potentially provide patent term into the mid-2030s to the early 2040s. The Company believes these products have the potential to address significant unmet medical needs for millions of patients worldwide suffering from acute respiratory depression, including those in the hospital post-operative care setting, those experiencing community drug overdose, and preterm infants suffering a common condition known as Apnea of Prematurity.

Enalare’s lead compound, ENA-001, is an investigational, one-of-a-kind NCE designed as an agnostic respiratory stimulant.
It has been shown to be well tolerated in restoring breathing drive and responsiveness in five Phase 1 human studies.
Recent topline results of Enalare’s Phase 1 Study 108 indicate that ENA-001 successfully achieved the study’s primary endpoint. It was shown to be safe and well-tolerated and was able to reverse propofol-induced dampening of ventilatory responsiveness in the population studied.
Enalare is planning to initiate a Phase 2 clinical study for use in this patient population in the near term.
Approval for post-operative respiratory depression expected in 2026, and community drug overdose thereafter.
ENA-001 is also being developed in an Intramuscular ("IM") Formulation in partnership with the Biomedical Advanced Research and Development Authority ("BARDA") (contract number 75A50121C00044) for the potential use in patients experiencing drug overdose in a community setting and as a potential medical countermeasure for mass casualty events. This effort is also supported via a grant from the National Institute on Drug Abuse (NIDA: award number R44DA057133), a division of the National Institutes of Health. Enalare is planning to complete the required preclinical activities with the IM formulation in the near term and to begin human clinical studies in the first half of next year.
In addition, Enalare is developing ENA-001 for the treatment of Apnea of Prematurity ("AoP"), a condition commonly affecting infants born preterm in which they experience shallow or intermittent stoppage of breathing. Persistent AoP can cause near- and long- term neurological development risks to the infant. ENA-001 has received Rare Pediatric Disease designation from the U.S. Food and Drug Administration ("FDA") in the treatment of AoP, which potentially provides for a priority review voucher if the product is approved for this indication. Enalare is currently executing an animal proof-of-concept study with ENA-001 in the treatment of AoP and expects to further pursue orphan drug designation and initiate human clinical trials.
"By adding Enalare’s highly differentiated and complementary NCE to our portfolio, we immediately expand Eagle’s long-term growth possibilities. We believe ENA-001 has enormous potential to address important unmet medical needs. It is an agnostic respiratory stimulant with what we view as compelling clinical and health economic value propositions. It is also an ideal fit within our current hospital critical care portfolio, comprised of four approved and two investigational products. BARHEMSYS, the only proven antiemetic for the treatment of post-operative nausea and vomiting ("PONV"), BYFAVO5, the first new drug approved for procedural sedation in decades, RYANODEX, and vasopressin are all in market. If approved, landiolol, an ultra-short acting cardio-selective IV beta-blocker, and CAL02, a first-in-class anti-infective agent to treat severe bacterial pneumonia will join our currently approved products to create a formidable hospital/anesthesia product portfolio," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"We plan to leverage our strong balance sheet and usher ENA-001 toward a potential 2026 launch. This is a great opportunity for Eagle and one that furthers our transformation into a diversified, branded pharmaceutical company with long-duration assets in acute care," concluded Tarriff.

"This partnership is an exciting step forward in the development of ENA-001 and for the millions of patients worldwide that can benefit from such a novel agnostic respiratory stimulant," stated Herm Cukier, President and CEO of Enalare Therapeutics. "Our partnership with Eagle provides us access to capital and a robust infrastructure and commercial platform to develop and potentially launch our product. Without added headcount or expense, Eagle will be able to rely on our experienced and highly regarded team as we move onto Phase 2 and 3 trials, which we believe will successfully demonstrate ENA-001’s ability to improve patient respiratory capacity. We look forward to a close and productive working relationship and supporting Eagle in the successful development of Enalare’s products," concluded Cukier.

________________________
5 View Source

Transaction Rationale

Enalare’s intellectual property with potential patent duration through the mid 2030s to early 2040s offers Eagle access to complementary and diversified revenue streams;
Eagle believes there is a compelling commercial opportunity for Enalare’s lead drug candidate, ENA-001:
Agnostic respiratory stimulant with first-in-class mechanism of action;
Studied in more than 100 human subjects to date;
Differentiated product that significantly expands long-term sales potential and durability of Eagle’s hospital business;
Synergistic fit with Eagle’s current and expanding portfolio of hospital products, with overlap of customer channel and decision makers;
Timing of launch, if approved, aligns with anticipated Eagle commercial capacity;
Provides the opportunity for strategic expansion into adjacent therapeutic and customer channels.
About ENA-001

ENA-001 is an investigational new chemical entity ("NCE") being developed by Enalare for multiple potential indications, including the prevention and treatment of post-operative respiratory depression. With its novel mechanism-of-action and based on findings to date, it could potentially improve the lives of those impacted by several life-threatening conditions including community drug overdose, post-operative respiratory depression, and apnea of prematurity. If approved, ENA-001 would offer new treatment options for physicians, emergency responders, and caregivers addressing acute respiratory depression across multiple patient populations in multiple settings.