On May 12, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it will present Phase 1 study results from its lead program, ST101, during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 in Chicago, IL (Press release, Sapience Therapeutics, MAY 12, 2022, View Source [SID1234614409]).

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Details of the poster presentation are as follows:

Abstract Number: 3014
Title: Efficacy proof-of-concept from a phase 1 study of a novel therapeutic peptide, ST101, targeting the oncogenic transcription factor C/EBPβ in patients with refractory solid tumors
Session Title/Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Type: Poster Discussion Session

Abstracts and full session details, when available, can be accessed through the ASCO (Free ASCO Whitepaper) meeting planner: Abstracts | ASCO (Free ASCO Whitepaper) Annual Meeting

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: a Phase 1 dose escalation/regimen exploration phase and a Phase 2 expansion phase. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On May 12, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading Pan-American (ex-US) specialty pharmaceutical company, reported financial results for its first quarter ended March 31, 2022 (Press release, Knight Therapeutics, MAY 12, 2022, View Source [SID1234614408]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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Q1 2022 Highlights

Financials

Revenues were $63,807, an increase of $17,738 or 39% over the same period in prior year.
Gross margin of $32,477 or 51% compared to $20,580 or 45% in the same period in prior year.
Adjusted EBITDA1 was $13,312, an increase of $7,732 or 139% over the same period in prior year.
Net loss on financial assets measured at fair value through profit or loss of $16,363, of which $16,281 was unrealized.
Net loss was $18,811, compared to net income of $3,558 in the same period in prior year.
Cash inflow from operations was $12,879, compared to a cash inflow from operations of $17,207 in the same period in prior year.
Corporate Developments

Purchased 1,734,305 common shares through Knight’s Normal Course Issuer Bid ("NCIB") at an average price of $5.29 for an aggregate cash consideration of $9,183.
Hired Leopoldo Bosano as VP Manufacturing and Operations.
Products

Launched Lenvima (lenvatinib) and Rembre (dasatinib) in Colombia in February 2022.
Launched Halaven (eribulin mesylate) in Colombia in March 2022.
Subsequent Events

Entered into an exclusive license, distribution and supply agreement with Helsinn Healthcare SA for AKYNZEO oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI oral/IV (palonosetron) in Canada.
Shareholders re-elected Jonathan Ross Goodman, Samira Sakhia, James C. Gale, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
Purchased an additional 893,414 common shares through NCIB for an aggregate cash consideration of $4,760.
"I am excited to report that in the first quarter of 2022 Knight’s revenues increased by $17,738 or 39%. In addition to the acquisition of Exelon, we had revenue growth across all our therapeutic areas driven by market penetration of our key promoted brands and an increase in patient treatments due to reduced COVID-19 restrictions. On the business development front, we entered into an exclusive license, distribution and supply agreements with Helsinn in our key territories", said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc. "As we look to the balance of 2022, we will continue to execute on revenue and EBITDA growth as well as adding new products through business development."

Revenues: For the quarter ended March 31, 2022, excluding the impact of hyperinflation, revenues increased by $17,752 or 39% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation is explained as following:

An increase in revenues of $7,059 driven by the acquisition of Exelon.
The remainder of the increase is driven by the growth and market penetration of our key promoted brands as well as an increase in patient treatments as our markets reduce COVID-19 restrictions.
Gross margin: For the quarter ended March 31, 2022, gross margin increased from 45% to 51% explained by a change in product mix as well as the acquisition of Exelon and related revenues recorded as a net profit transfer.

Selling and marketing: For the quarter ended March 31, 2022, selling and marketing expenses increased by $2,077 or 27% driven by an increase in certain variable costs such as logistics fees, compensation as well as an increase in selling and marketing activities related to key promoted products and Exelon.

General and administrative: For the quarter ended March 31, 2022, general and administrative expenses increased by $1,750 or 25% driven by increase in compensation and certain consulting and professional fees.

Amortization of intangible assets: For the quarter ended March 31, 2022, amortization of intangible assets increased by $5,986 due to the acquisition of Exelon.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter ended March 31, 2022, interest income was $1,480, a decrease of 26% or $518, compared to the same period in prior year due to a lower average cash and marketable securities balances and loan balance.

Interest expense: For the quarter ended March 31, 2022, interest expense was $1,111, an increase of $451 or 68%, compared to the same period in prior year due to higher interest rates.

Adjusted EBITDA: For the quarter ended March 31, 2022, adjusted EBITDA increased by $7,732 or 139%. The growth in adjusted EBITDA is driven by an increase in gross margin of $11,897, offset by an increase in operating expenses.

Net loss or income: For the quarter ended March 31, 2022, net loss was $18,811 compared to net income of $3,558 for the same period in prior year. The variance mainly resulted from the above-mentioned items and (1) a net loss on the revaluation of financial assets measured at fair value through profit or loss of $16,363 versus a net gain of $9,473 in the same period in prior year, mainly due to unrealized losses and gains on revaluation of the strategic fund investments, offset by (2) an income tax recovery of $3,501 due to the recognition of certain deferred tax assets compared to an income tax expense of $869 in the same period in prior period.

Cash, cash equivalents and marketable securities: As at March 31, 2022, Knight had $156,396 in cash, cash equivalents and marketable securities, an increase of $6,894 or 5% as compared to December 31, 2021. The variance is primarily due to cash inflows from operating activities, offset by the shares repurchased through NCIB.

Financial assets: As at March 31, 2022, financial assets were at $169,392, a decrease of $23,051 or 12%, as compared to the prior year, mainly due to negative mark-to-market adjustments of $16,660 driven mainly by the decline in the share prices of the publicly-traded equities of our strategic fund investments. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

Bank Loans: As at March 31, 2022, bank loans were at $41,025, an increase of $5,098 or 14% as compared to the prior period, due to appreciation of the Brazilian Real and Colombian Peso versus Canadian Dollar.

Product Updates

Knight obtained regulatory approval and launched Lenvima, Halaven and Rembre in Colombia during the first quarter of 2022. Lenvima, the orally available multiple receptor tyrosine kinase inhibitor developed by Eisai, is indicated for the treatment of radioiodine refractory differentiated thyroid cancer ("RR-DTC") and unresectable hepatocellular carcinoma ("u-HCC") and was launched in February 2022. Halaven injection is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatments for advanced cancer. Previous treatment should have included anthracyclines and a taxane in either the adjuvant or metastatic setting, unless these treatments were not suitable. Halaven is also used to treat patients with advanced or metastatic liposarcoma that cannot be surgically removed and who have already been treated with an anthracycline, unless deemed unsuitable. Knight launched Halaven in Colombia in March 2022. In addition, Rembre is indicated for treatment of chronic myeloid leukemia with positive Philadelphia chromosome (Ph+) and was launched in February 2022.

Subsequent to the quarter Knight entered into an exclusive license, distribution and supply agreement with Helsinn Healthcare SA for AKYNZEO oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI oral/IV (palonosetron) in Canada. AKYNZEO oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. ALOXI solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

NCIB

For the three-month period ended March 31, 2022, the Company purchased 1,734,305 common shares at an average price of $5.29 for an aggregate cash consideration of $9,183 of which $2,520 remains to be settled as at March 31, 2022. Subsequent to quarter-end up to May 10, 2022, the Company purchased an additional 893,414 common shares at an average purchase price of $5.33 for an aggregate cash consideration of $4,760.

Financial Outlook Update

Knight provides guidance on revenues1 on a non-GAAP basis. This is due to both the difficulty in predicting Argentinian inflation rates and its IAS 29 impact.

For fiscal 2022, Knight has updated its guidance and expects to generate $260 to $270 million in revenue, an increase of $5 million on the upper end of the range. The guidance is based on a number of assumptions, including but not limited to the following:

no revenues for business development transactions not completed as at May 11, 2022
discontinuation of certain distribution agreements
Exelon marketing authorization transfer to Knight in May 2022 in Colombia and in June 2022 in Brazil
recording revenue related to Akynzeo and Aloxi following transition period from Helsinn’s current licensees
no interruptions in supply whether due to global supply chain disruptions or general manufacturing issues
no new generic entrants on our key pharmaceutical brands
no unforeseen changes to government mandated pricing regulations
successful commercial execution on product listing arrangements with HMOs, insurers, key accounts, and public payers
successful execution and uptake of newly launched products
no significant restrictions or economic shut down due to the COVID-19 pandemic
foreign currency exchange rates remaining within forecasted ranges

Should any of the assumptions differ, the financial outlook and the actual results may vary materially. Refer to the risks and assumptions referred to in the Forward-Looking Statements section of this news release for further details.

_____________________________
1 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to the definitions in section "Non-GAAP measures" for additional details

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its first quarter ended March 31, 2022, today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

On May 12, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the first quarter for the period ended March 31, 2022 (Press release, Navidea Biopharmaceuticals, MAY 12, 2022, View Source [SID1234614407]).

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First Quarter 2022 Highlights and Subsequent Events

Continued enrollment into the Company’s NAV3-33 Phase 3 trial in rheumatoid arthritis ("RA") titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis."
Announced positive preliminary results from the Company’s ongoing NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Two non-overlapping classes that align with the fibroid and non-fibroid histological pathotypes were identified, supporting the hypothesis that these classes can be identified by Tc99m tilmanocept imaging.
Received regulatory approval for Lymphoaim in India.
Filed two new provisional patent applications. Both are related to new methods to maximize target-tissue uptake and reduce off-target binding. These have important implications for pipeline applications.
Received Notices of Allowed Claims for patent applications in the United States, Israel, Australia, and Japan.
Closed on a $1.5 million bridge loan from the Company’s Vice Chair of the Board of Directors, John K. Scott, Jr.
Adopted a plan designed to protect the Company’s net operating loss and tax credit carryforwards.
Continued to work on financing for the Company. We have engaged with multiple investment banks and options are being pursued.
Settled litigation with Platinum-Montaur Life Sciences LLC.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. The NAV3-33 Phase 3 and NAV3-32 Phase 2b trials continue to enroll. We are pleased with the preliminary positive results from the NAV3-32 study that thus far support our hypothesis that we can distinguish between fibroid and non-fibroid pathotypes of RA with a single scan." Dr. Rosol continued, "Concurrent with all of this, we continue to make progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."

Financial Results

Total net revenues for the first quarter of 2022 were $0, compared to $124,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debts previously written off in 2015 coupled with recognition of license revenue related to transitional sales in Europe in 2021.
Research and development expenses for the first quarters of both 2022 and 2021 were $1.2 million. Decreases in Manocept diagnostic and Tc99m tilmanocept development costs and decreased regulatory consulting expenses were offset by increased Manocept therapeutic development costs, employee compensation including fringe benefits and incentive-based awards, and recruiting expenses.
Selling, general and administrative expenses for the first quarter of 2022 were $1.8 million, compared to $2.2 million in the same period in 2021. Decreases in employee compensation including fringe benefits and incentive-based awards, legal and professional services, general office expenses, travel, franchise taxes and investor relations costs were offset by increased director fees, losses on the abandonment of certain intellectual property and increased insurance costs.
Navidea’s net loss attributable to common stockholders for the first quarter of 2022 was $3.0 million, or $0.10 per share, compared to $3.0 million, or $0.11 per share, for the same period in 2021.
Navidea ended the first quarter of 2022 with $1.2 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On May 12, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, and Helsinn Healthcare SA ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track record of commercial execution, reported that Knight, through one of its wholly-owned subsidiaries, and Helsinn have entered into an exclusive license, distribution and supply agreement for AKYNZEO oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI oral/IV (palonosetron) in Canada (the "Products") (Press release, Knight Therapeutics, MAY 12, 2022, View Source;Distribution–and-Supply-Agreement-for-Akynzeo174–and-Aloxi174–5-12-2022 [SID1234614406]). According to IQVIA, sales of AKYNZEO in Canada and Brazil were approximately $7 million in 2021.

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Under the terms of the agreement, Knight shall have the exclusive right to distribute, promote, market and sell the Products in the licensed territories. Knight will begin commercial activities following a transition period from Helsinn’s current licensees.

"We are very excited to enter into this agreement with Helsinn for AKYNZEO in Canada, Brazil and other selected Latin American countries, and ALOXI in Canada," said Samira Sakhia, President and CEO of Knight. "These products are highly synergistic with our oncology portfolio and commercial footprint, and we look forward to widening access to these therapies in our target markets. AKYNZEO and ALOXI are leading, guideline-recommended1,2,3 antiemetics that help to prevent one of the most common side effects of chemotherapy."

"AKYNZEO and ALOXI form a key part of Helsinn’s commercial engine of supportive cancer care products," said Giorgio Calderari, Helsinn CEO. "Knight has a unique footprint with strong capabilities across Canada and Latin America, and we look forward to collaborating with them as they work to ensure patients in these geographies have access to these important medicines."

The financial terms of the transaction were not disclosed.

About Akynzeo

AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. AKYNZEO oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

About Aloxi

ALOXI is a second generation 5-HT3 receptor antagonist with high receptor binding affinity and a duration of action up to 5 days after chemotherapy administration4,5. ALOXI solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

References
1 Roila F. et al. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. MASCC/ESMO Antiemetic Guideline 2016 V.1.4 last update July 2019. Available at: View Source;
2 Hesketh J. et al. J Clin Oncol. 2020 Aug 20;38(24):2782-2797. doi: 10.1200/JCO.20.01296. Epub 2020 Jul 13;
3 NCCN: National Comprehensive Cancer Network; NCCN Clinical Practice Guidelines in Oncology; Version 2.2022. Available at: www.nccn.org
4 Rojas C, Slusher BS. Eur J Pharmacol 2012;684(1-3):1-7; 6;
5 Navari RM and Aapro M. N Engl J Med 2016;374:1356-67.

On May 12, 2022 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three months ended March 31, 2022 and provided a corporate update (Press release, Altimmune, MAY 12, 2022, View Source [SID1234614405]).

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"We continue to advance the development of pemvidutide, our GLP-1/Glucagon dual receptor agonist and look forward to reporting both weight loss and liver fat reduction data from multiple ongoing clinical trials later this year," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "Based on a greater than 10% weight loss after only 12 weeks of treatment, we believe that pemvidutide has the potential to deliver weight loss comparable to the results of bariatric surgery in people with obesity. In addition, we believe that pemvidutide will have a highly differentiated product profile compared to other products in development—no dose titration, faster weight loss, and robust reductions in lipids. If achieved, we believe these features would translate into greater ease of administration, improved adherence to therapy, and greater potential for cardiovascular benefit."

Recent Highlights and Anticipated Milestones:

Pemvidutide1 (ALT-801)

Enrollment ongoing in 48-week Phase 2 MOMENTUM trial of pemvidutide in obesity

This Phase 2 trial is being conducted at approximately 25 sites in the U.S., with Dr. Lou Aronne, Professor of Clinical Medicine, Weill Cornell Medical College, a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator.
The trial is expected to enroll approximately 320 non-diabetic subjects with either obesity or overweight. Subjects are being randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks.
The primary endpoint is the relative (percent) change in body weight at 48 weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.
Dosing has commenced and an interim analysis is planned to assess changes in body weight after 24 weeks of treatment, with an expected readout in Q4 2022.
Enrollment completed in 12-week Phase 1b nonalcoholic fatty liver disease (NAFLD) trial

This Phase 1b trial is being conducted in the U.S., with Dr. Stephen A. Harrison, Director, Pinnacle Research and University of Oxford, serving as Principal Investigator.
The trial is comprised of non-diabetic and diabetic subjects randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 12 weeks.
The primary efficacy readouts are liver fat reduction and weight loss at day 85 (12 weeks).
Data readout expected in Q3 2022.
Enrollment ongoing in Phase 1b NAFLD extension trial
This 12-week extension trial allows subjects who have completed the 12-week Phase 1b NAFLD trial to receive a total of 24 weeks of treatment, with an expected data readout on weight loss at 24 weeks in Q4 2022.
Enrollment ongoing in Phase 1b trial of diabetic subjects with obesity and overweight
This 12-week trial will expand on findings from our first-in-human trial in subjects with obesity and overweight, in whom decreased insulin resistance and maintenance of glucose control were observed, including subjects with pre-diabetes.
1 proposed INN

Upcoming presentations summarizing data from the Phase 1 trial of pemvidutide at international Scientific Meetings

May 27, 2022: Global NASH Congress, London UK –The Emerging Weight Loss Therapeutics and Implications for the NASH Treatment Paradigm. Oral presentation by Scott Harris, M.D., Chief Medical Officer, Altimmune.
June 6, 2022: American Diabetes Association (ADA) Scientific Sessions, New Orleans, LA –Pemvidutide (ALT-801), a Balanced (1:1) GLP-1/Glucagon Dual Receptor Agonist, Induces Rapid and Marked Weight Loss without the Need for Dose Titration in People with Overweight/Obesity. Oral presentation by Samuel Klein, M.D., William H. Danforth Professor of Medicine and Nutritional Science, Washington University School of Medicine.
June 25, 2022: EASL International Liver Congress, London, UK –Pemvidutide (ALT-801), a novel GLP-1/glucagon dual receptor agonist, induces significant reductions in major lipid classes implicated in the pathogenesis of NASH and other conditions. Oral presentation by Stephen Harrison, M.D. Medical Director, Pinnacle Research and University of Oxford.
HepTcell

Enrollment continuing in the Phase 2 clinical trial in chronic hepatitis B, with data readout expected H1 2023
Readouts are expected to include virological markers of hepatitis B infection and functional cure.
Financial Results for the Three Months Ended March 31, 2022

Altimmune had cash, cash equivalents and restricted cash totaling $180.0 million at March 31, 2022.
Revenue was minimal for the three months ended March 31, 2022 compared to $0.8 million in the same period in 2021. The change in revenue quarter over quarter was primarily due to the discontinuation of development activities for the T-COVID and NasoShield programs.
Research and development expenses were $15.1 million for the three months ended March 31, 2022, compared to $11.9 million in the same period in 2021. The expenses for the quarter ended March 31, 2022 included $10.8 million in direct costs related to development activities for pemvidutide and $2.5 million in direct costs related to development activities for HepTcell.
General and administrative expenses were $4.4 million for the three months ended March 31, 2022, compared to $3.8 million in the same period in 2021. The change was primarily attributable to increased stock compensation expense.
Net loss for the three months ended March 31, 2022 was $19.4 million, or $0.44 net loss per share, compared to $14.9 million in the same period in 2021, or $0.38 net loss per share.
2022 operating expense guidance will be provided on the conference call.
Conference Call Information:

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and NASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. By combining GLP-1 and glucagon activity in a single peptide, pemvidutide has the potential to achieve weight loss comparable to the results of bariatric surgery. Pemvidutide incorporates the EuPortTM domain, a proprietary technology that increases its serum half-life for weekly dosing while slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability. In a 12-week Phase 1 clinical trial, pemvidutide-treated subjects demonstrated striking reductions in body weight, liver fat and serum lipids commonly associated with cardiovascular disease.

About HepTcell

HepTcell is a novel, investigational, immunotherapeutic comprised of nine synthetic peptides representing conserved hepatitis B (HBV) sequences formulated with IC31, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.