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.

On May 12, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the first quarter ended on March 31, 2022 (Press release, Scynexis, MAY 12, 2022, View Source [SID1234614404]).

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"Our Commercial organization is making solid progress toward bolstering prescription trends, and we are seeing the results of those concerted efforts," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We recently strengthened our balance sheet, which enables us to enhance our commercial efforts in VVC and continue our R&D activities into 2024, as we build a broad antifungal franchise for ibrexafungerp across multiple indications."

BREXAFEMME Commercial Update

BREXAFEMME delivered $0.7 million in net sales in first quarter 2022. According to IQVIA data, there were approximately 4,000 total prescriptions for BREXAFEMME written in Q1 2022. Total prescriptions have continued to grow in 2022 with 1,070 in January, 1,328 in February and 1,579 in March.
BREXAFEMME was prescribed by over 1,800 unique healthcare professionals (HCPs) in the first quarter, and 55% of these doctors expanded their use and prescribed the treatment to multiple patients during this period, up from 40% last quarter.
Commercial insurance coverage of BREXAFEMME continues to expand. As of April 2022, BREXAFEMME was covered by plans representing more than 93 million or 55% of commercially-insured lives.
Ibrexafungerp Clinical Updates

Reported positive results from the fourth interim analysis of the FURI and CARES trials highlighting oral ibrexafungerp’s potency against severe fungal infections. The recent interim analyses included 39 new cases from FURI and eight new cases from CARES who completed treatment during the 12 months since the prior interim analyses. In the combined analysis of 131 patients, 83.2% of patients demonstrated a clinical response to oral ibrexafungerp. Of the 131 FURI and CARES study cases analyzed to date, 61.1% achieved a complete or partial response, or clinical improvement; and 22.1% achieved stable disease, which is a favorable outcome in patients with severe progressive fungal infections.

Reported positive results from the pivotal Phase 3 CANDLE study of oral ibrexafungerp for prevention of rVVC. In this international trial of 260 patients with rVVC, defined as three or more episodes of vulvovaginal candidiasis (VVC) in the previous 12 months, patients initially received a three day regimen of fluconazole to treat their current infection, and responders were randomized in the prevention phase to receive either 300 mg ibrexafungerp BID or matching placebo one day a month, for six months. The study showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed or suspected, through Week 24 compared to 53.1% of placebo-treated patients (p=0.02). The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant (p=0.034). Ibrexafungerp was generally safe and well-tolerated. There were no serious drug-related adverse events, and no patients treated with ibrexafungerp discontinued therapy due to adverse events. The most commonly reported events were headaches and gastrointestinal events, which were mostly mild and generally consistent with the current BREXAFEMME label. SCYNEXIS plans to submit the results in a supplemental NDA to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022 and anticipates receiving approval by year-end.
SCYNEXIS initiated MARIO, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for invasive candidiasis (IC) in the hospital setting. Company anticipates enrolling the first patient by the end of Q2 2022.
Following the positive Phase 1 data with the IV formulation reported previously, SCYNEXIS has begun to scale up manufacturing to enable additional IV trials.
Ibrexafungerp Scientific Presentations and Publications

Presented several posters highlighting details from interim analyses of data from its ongoing Phase 3 FURI and CARES studies investigating the potential of ibrexafungerp as a treatment for invasive candidiasis (IC) and candidemia, including infections caused by Candida auris (C. auris). The posters were presented at the 32nd Annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held in Lisbon, Portugal April 23-26, 2022. Posters included:

An interim analysis of the CARES study of 18 enrolled patients with candidemia and other infections caused by Candida auris (C. auris) treated for a mean duration of 18 days, 78% of patients showed complete or partial response and 11% had stable disease.

An interim analysis with combined data of 49 patients with invasive candidiasis and candidemia from the ongoing Phase 3 FURI (n=39) and CARES (n=10) studies. Aggregate data from the two studies showed that of the patients treated with ibrexafungerp, 68% had complete or partial response and 14% had stable disease.

Data presented from an in vivo mouse model of mucormycosis found that ibrexafungerp monotherapy demonstrated in vivo efficacy in treating both Rhizopus delemar and Mucor circinelloides infections in mice, consistent with other antifungals currently used against mucormycosis. Additionally, the study found that when ibrexafungerp was combined with liposomal amphotericin B (LAMB) or posaconazole (POSA), synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone (p<0.05).

Reported new positive outcomes in patients with refractory vulvovaginal candidiasis (VVC) treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting held in San Diego May 6-8, 2022. Ibrexafungerp showed positive results in difficult-to-treat VVC patients with severe fungal infections who were either intolerant to standard antifungal therapy or experienced refractory infections despite treatment. Of the 14 patients in the FURI study with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee. Patients with VVC received 750 mg of oral ibrexafungerp (375 mg twice a day) every 72 hours for a total of three dosing days (Day 1, Day 4 and Day 7). In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing product label.
Corporate Developments

SCYNEXIS raised gross proceeds of $45 million gross ($42 million net) in an April 2022 public offering of common stock, pre-funded warrants, and warrants.
SCYNEXIS received $4.7 million in non-dilutive proceeds in February 2022 from the sale of New Jersey State net operating losses to a third party.
SCYNEXIS received an additional $5.0 million in non-dilutive proceeds in March 2022 from the third tranche of the previously reported Term Loan Agreement with Hercules Capital/SVB upon achieving positive results from the Phase 3 CANDLE study of ibrexafungerp for the prevention of recurrent yeast infections.
First Quarter 2022 Financial Results

BREXAFEMME generated net product revenue of $0.7 million in the first quarter of 2022. The product was approved for sale by the FDA in June 2021 and launched in September 2021.

Cost of product revenue was $100,000 in the first quarter of 2022.

Research and development expense for the first quarter of 2022 decreased to $5.7 million from $6.9 million versus the first quarter of 2021.

Selling, general & administrative (SG&A) expense for the first quarter of 2022 increased to $14.6 million from $6.7 million versus the first quarter of 2021. The increase was primarily driven by an increase in costs recognized to support the ongoing commercialization of BREXAFEMME.

Total other income was $9.6 million for the first quarter of 2022, versus total other expense of $2.0 million for the first quarter of 2021. During the first quarters of 2022 and 2021, SCYNEXIS recognized non-cash gains of $10.0 million and $1.3 million, respectively, on the fair value adjustment of the warrant liabilities and non-cash gains of $1.0 million and non-cash losses of $0.1 million, respectively, on the fair value adjustment of derivative liabilities.

Net loss for the first quarter of 2022, was $5.5 million, or $0.17 basic loss per share, compared to net loss of $4.7 million, or $0.18 basic loss per share for the first quarter of 2021.

Cash Balance

Cash and cash equivalents totaled approximately $95.2 million on March 31, 2022, compared to $104.5 million in cash and cash equivalents on December 31, 2021. Based upon its current operating plan, SCYNEXIS believes that its existing cash and cash equivalents, the net proceeds received from the April 2022 public offering, and the anticipated sales of BREXAFEMME will enable the Company to fund its operating requirements into Q1 2024.

Conference call and webcast details

Webcast: View Source;tp_key=e943d8c4f4

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration (FDA) granted ibrexafungerp Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On May 12, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-US) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Executive Officer, is scheduled to participate in a fireside chat at the 2022 RBC Capital Markets Global Healthcare Conference on Wednesday, May 18, 2022 at 8:30 am ET at the InterContinental New York Barclay hotel in New York City (Press release, Knight Therapeutics, MAY 12, 2022, View Source(TSX%3A%20GUD)%20(%22,30%20am%20ET%20at%20the [SID1234614403]).

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On May 12, 2022 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, reported its cash position as of March 31, 2022 and revenues for the first three months of 2022 (Press release, Genfit, MAY 12, 2022, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2022-financial-information [SID1234614401]).

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Cash position

As of March 31, 2022, the Company’s cash and cash equivalents amounted to €222.2 million compared with €108.9 million as of March 31, 2021 and €258.8 million as of December 31, 2021.

The increase in cash and cash equivalents between March 31, 2021 and March 31, 2022 takes into account the collaboration and license agreement signed with Ipsen in December 2021 which granted Ipsen an exclusive worldwide license to develop, manufacture and commercialize GENFIT’s investigational treatment elafibranor.1 As part of this licensing agreement, GENFIT received a non-refundable upfront payment of €120.0 million euros in December 2021, as well as €24.0 million in VAT collected on that amount. Furthermore, to underscore the long-term commitment represented by this partnership, Ipsen purchased newly issued GENFIT equity representing 8% post-issuance through a €28.0 million investment in GENFIT.

This increase also comprises three non-dilutive loans, which include two State-Guaranteed Loans from a pool of partner banks and Bpifrance respectively, as well as a subsidized loan from Bpifrance for an amount totaling €15.2 million euros.

The decrease in cash and cash equivalents between December 31, 2021 and March 31, 2022 notably includes the payment in January 2022 of the amount of €24.0 million representing the VAT collected on the initial upfront payment received from Ipsen in December 2021.

Revenues

Revenues for the first three months of 2022 amounted to €3. 895 million compared to €1 thousand for the same period in 2021.

The initial upfront payment from Ipsen in December 2021 was partially recognized as deferred revenue, amounting to €40.0 million as at the end of 2021, to be gradually recognized as revenue following the completion of the ELATIVE double-blind study, in accordance with the IFRS 15 norms. Revenues for the first three months of 2022 mainly came from the partial recognition of this amount corresponding to this period.

On May 11, 2022 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2022 and provided a business update (Press release, Savara, MAY 12, 2022, View Source [SID1234614400]).

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"As recently reported, we continue to steadily advance IMPALA-2, our pivotal Phase 3 clinical trial of molgramostim, a novel inhaled biologic," said Matt Pauls, Chair and CEO, Savara. "Despite the ongoing global unpredictability of COVID-19 and current geopolitical issues affecting Europe, we reaffirm our guidance of top line data by the end of 2Q 2024. With a cash position of ~$152M at the end of the first quarter of 2022, and a recent debt refinancing that reduced our cost of capital and strengthened our balance sheet, we believe that we are funded through 2025."

First Quarter Financial Results (Unaudited)

Savara’s net loss for the three months ended March 31, 2022 was $8.3 million, or $(0.05) per share, compared with a net loss of $10.2 million, or $(0.13) per share, for the three months ended March 31, 2021.

Research and development expenses decreased by $1.9 million, or 25.1%, to $5.7 million for the three months ended March 31, 2022 from $7.6 million for the three months ended March 31, 2021. The decrease was primarily attributable to an ~$2.5 million decrease in costs associated with the close-out and wind-down of activities related to the inhaled vancomycin development program. This decrease was partially offset by an ~$0.5 million increase in costs associated with the molgramostim development program for the treatment of aPAP. Molgramostim costs are related to the continued screening and enrollment of patients as well as Chemistry, Manufacturing, and Controls ("CMC") activities associated with the IMPALA-2 trial.

General and administrative expenses decreased by $0.4 million, or 15.3%, to $2.4 million for the three months ended March 31, 2022 from $2.8 million for the three months ended March 31, 2021. The decrease was primarily due to administrative and compensation costs associated with streamlining certain operational activities that were initiated during the third quarter of 2021.

As of March 31, 2022, the Company had cash, cash equivalents, and short-term investments of ~$152 million and debt of ~$25 million.