On May 12, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the first quarter 2022 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAY 12, 2022, View Source [SID1234614370]).

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"I am pleased with the growing momentum in patient recruitment and enrollment after recent COVID-19-related delays at our sites," said Rick Fair, President and Chief Executive Officer. "We remain on track to report results from our ongoing BPX-601 and BPX-603 trials early next year. I appreciate our team’s and investigators’ hard work and commitment to execute to plan in 2022."
Program Highlights and Current Updates

BPX-601 GoCAR-T
•Enrollment in the Phase 1/2 dose escalation clinical trial in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC) is ongoing. The company expects to present a data update on BPX-601 in the first quarter of 2023.

BPX-603 GoCAR-T
•Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. The company expects to present a data update on BPX-603 in the first half of 2023.

Financial Results for the First Quarter 2022

R&D Expenses: Research and development expenses were $4.5 million for the first quarter 2022, compared to $6.5 million for the first quarter 2021. The decrease in R&D expenses for the first quarter 2022 was primarily due to reduced expenses related to rivo-cel activities, a discontinued development program.

G&A Expenses: General and administrative expenses were $1.5 million in the first quarter 2022 compared to $2.0 million for the comparable period in 2021. The decrease in G&A expenses for the first quarter 2022 compared to the first quarter 2021 was primarily due to reduced share-based compensation expense.

Loss from Operations: Bellicum reported a loss from operations of $5.9 million for the first quarter 2022, compared to $8.9 for the comparable period in 2021.

Net Income/Loss: Bellicum reported a net loss of $7.6 million for the first quarter 2022, compared to a net loss of $11.3 million for the first quarter 2021. The results included a loss from the change in fair value of warrant derivative liabilities of $1.6 million for the first quarter of 2022, which was primarily driven by an increase in our stock price over the first quarter of 2022.

Shares Outstanding: As of May 9, 2022, Bellicum had 8,609,661 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock is convertible into 10 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling
$41.3 million as of March 31, 2022, compared to $47.7 million as of December 31, 2021.

On May 12, 2022 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2022 (Press release, Applied Therapeutics, MAY 12, 2022, View Source [SID1234614385]).

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"We made significant progress in the first quarter across all three of our Phase 3 programs," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "We are pleased to have reached alignment with the FDA on Galactosemia, and are excited about the expected milestones in the year ahead."

Recent Highlights

Provided Regulatory Update on Galactosemia Program. In January 2022, the Company announced that the FDA would require clinical outcomes data for approval. Clinical outcomes are assessed in the pediatric clinical study every 6 months by a firewalled committee until the study reaches statistical significance. The Company met with the FDA in April 2022, and the FDA confirmed that the pediatric study as it is currently designed would support an NDA submission if statistical significance is reached. The 6-month clinical outcomes were assessed by the firewalled data monitoring committee, and it was determined that the safety/benefit profile supports continuing the study. The next committee evaluation will be following completion of the 12-month clinical outcomes assessments.

Presented Data on AT-007 Treatment in SORD Deficiency at the 2022 Annual Meeting of the Peripheral Nerve Society. In May 2022, the Company presented data highlighting the effect of AT-007 treatment on sorbitol levels. In a pilot study in patients with Sorbitol Dehydrogenase (SORD) Deficiency, sorbitol level correlated with disease severity, and AT-007 treatment substantially reduced sorbitol levels. In a Drosophila model of disease, elevated sorbitol resulted in neuronal damage and decline in mobility, and AT-007 treatment prevented the disease phenotype by inhibiting sorbitol production. Taken together, this data significantly advances the understanding of the disease and potential for treatment with AT-007.

Presented Data on Galactosemia Disease Progression at the 2022 43rd Annual Meeting of the Society for Inherited Metabolic Disorders. In April 2022, the Company presented data featuring baseline disease characteristics of 47 pediatric patients with Classic Galactosemia, illustrating the high burden of disease associated with Galactosemia, including neurological complications, due to high galactitol levels. In addition, data presented at the meeting illustrated that higher galactitol levels, but not higher Gal-1p levels, were associated with greater disease severity overall and on each of the four quadrants of central nervous system (CNS) function. Together, these data underscore the urgent need to bring a treatment to people living with Galactosemia.

Presented Data on Galactosemia Disease Progression at the 2022 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics. In March 2022, the Company presented data featuring the first therapeutic interventional clinical trial in pediatric patients with Classic Galactosemia, demonstrating that AT-007 significantly reduces toxic galactitol in ACTION-Galactosemia children.
Financial Results

Cash and cash equivalents and short-term investments totaled $55.7 million as of March 31, 2022, compared with $80.8 million at December 31, 2021.

Research and development expenses for the three months ended March 31, 2022 were $15.0 million, compared to $14.4 million for the three months ended March 31, 2021. The increase of $0.6 million was primarily due to an increase in clinical and pre-clinical expense of $5.1 million, primarily related to the progression of the SORD pivotal trial, progression of the AT-007 ACTION-Galactosemia long-term extension adult study, and progression of the AT-007 ACTION-Galactosemia Kids pediatric registrational study; an increase in personnel expenses of $0.8 million due to the increase in headcount in support of our clinical program pipeline; an increase in regulatory and other expenses of $0.2 million; an increase in stock-based compensation of $0.1 million due to new stock option and restricted stock grants; and offset by a decrease in drug manufacturing and formulation costs of $5.6 million primarily related to the completion and release of AT-001 and AT-007 drug product batches in the three months ended March 31, 2021.

General and administrative expenses were $8.1 million for the three months ended March 31, 2022, compared to $9.8 million for the three months ended March 31, 2021. The decrease of $1.7 million was due to a decrease in commercial expenses of $0.6 million related to a decrease in spend relating to commercial operations; a decrease in other expenses of $0.3 million relating to decreased costs of other office expenses; a decrease in stock-based compensation of $1.0 million relating to options being forfeited during the current period; a decrease in legal and professional fees of $0.2 million due to lower external legal fees; offset by an increase in personnel expenses of $0.2 million related to an increase in headcount; and an increase in insurance expenses of $0.1 million related to increased insurance costs.

Net loss for the first quarter of 2022 was $23.1 million, or $0.88 per basic and diluted common share, compared to a net loss of $24.2 million, or $1.00 per basic and diluted common share, for the first quarter 2021.

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 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver transformative therapies for rare cancers, reported two abstracts have been accepted into the program for the 2022 Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) (Press release, Sierra Oncology, MAY 12, 2022, View Source [SID1234614423]). An abstract presenting the full data from the pivotal phase 3 MOMENTUM study in myelofibrosis patients who are symptomatic and anemic has been selected for oral presentation. Additionally, a subset analysis from the trial evaluating safety and efficacy for patients with low platelet counts has been selected for poster presentation.

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"We are excited and honored to have the MOMENTUM data selected for an oral presentation at EHA (Free EHA Whitepaper) which demonstrates that momelotinib achieved statistically significant and clinically important efficacy across all prespecified primary and key secondary endpoints," said Barbara Klencke, MD, Chief Medical Officer of Sierra Oncology. "In addition, we are pleased to present the subset analysis in a poster presentation which indicates momelotinib may be safely administered and provide an improvement in symptoms, spleen and anemia in anemic myelofibrosis patients who present with low platelet counts. The data to be presented further expand upon the potential of momelotinib as a treatment option for myelofibrosis patients who are symptomatic and anemic."

Abstract: S195: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor

The primary and all key secondary results, as well as safety data, from the MOMENTUM pivotal Phase 3 trial of momelotinib will be presented in an oral presentation by Srdan Verstovsek, MD, PhD, co-Principal Investigator of the study. Topline results from the study were announced in January 2022. Key data to be presented include:

Primary Endpoint of Total Symptom Score (TSS) of >50%: 25% in the MMB arm vs. 9% in the control arm (p=0.0095)
Secondary Endpoint of Transfusion Independence (TI): 31% in the MMB arm vs. 20% in the control arm (one-sided p=0.0064; non-inferiority)
Secondary Endpoint of Splenic Response Rate (SRR) >35%: 23% in the MMB arm vs. 3% in the control arm (p=0.0006)
The rate of Grade 3 or worse adverse events in the randomized treatment period was 54% in the MMB arm and 65% in the control arm. Serious treatment emergent adverse events were 35% in the MMB arm and 40% in the control arm.
Mean baseline characteristics for all patients were TSS of 27, Hemoglobin (Hgb) of 8 g/dL and platelet count of 145 x 109/L
Presentation Details

Abstract: S195
Title: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor
Presenter: Srdan Verstovsek, MD, PhD, The University of Texas MD Anderson Cancer Center
Session Title: Treatments and Complications in MPN
Location: Hall Lehar 1-2
Date and Time: Saturday, June 11, 2022, 11:30 am – 12:45 pm CEST

Abstract: P1050: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]

Abstract P1050 will highlight an analysis of MOMENTUM patients with baseline platelet counts of <150 x 109/L on key symptom, anemia and spleen volume endpoints at 24 weeks. Results to be presented are consistent with the overall intent-to-treat analysis set. Momelotinib was superior to danazol for symptom responses, transfusion requirements and spleen responses, and showed a trend toward improved overall survival up to Week 24 was seen with momelotinib versus danazol [95% CI = 0.490 (0.195, 1.235)].

Presentation Details

Abstract: P1050
Title: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]
Presenter: Alessandro Vannucchi, MD, Center Research and Innovation for Myeloproliferative Neoplasms, AOU Careggi, University of Florence, Italy
Session Title: Poster Session
Date and Time: Friday, June 10, 2022, 4:30 – 5:45 pm CEST

On May 12, 2022 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the first quarter of 2022 (Press release, ChromaDex, MAY 12, 2022, View Source [SID1234614470]).

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First Quarter 2022 and Recent Highlights

Total net sales were $17.3 million, up 18% from the prior year quarter.
Tru Niagen net sales were $14.9 million, a 20% increase from the prior year quarter.
In April 2022, the ChromaDex External Research Program (CERP) achieved its 250th material transfer agreement since 2013, resulting in over 100 peer-reviewed preclinical and clinical studies, many including the study of Niagen and its impact on healthy aging.
Clinical study published in Cell Metabolism revealed NR as a potential neuroprotective therapy for Parkinson’s Disease (PD) patients, warranting further investigation in additional trials. Two additional studies are underway, including a 400 patient study at 1,000 milligrams per day, and a 20 patient study at 3,000 milligrams per day.
Launched new consumer product, Tru Niagen Immune, a first-of-its kind combination of immune-boosting nutrition with ChromaDex’s proprietary NAD+ boosting ingredient Niagen, beginning April 2022.
Granted additional U.S. continuation patent to protect the novel manufacturing process of NR and its various salt forms, which now cover NR Chloride, NR Malate, and NR Tartrate salts, through 2037.
"We delivered solid financial results in the first quarter, while strengthening our patent portfolio, and announcing dramatic new scientific research on Niagen(R)," said CEO, Rob Fried. "Following the quarter, we launched Tru Niagen(R) Immune and ramped up our new TV campaign to encouraging early results."

Results of operations for the three months ended March 31, 2022 compared to the prior year quarter

For the three months ended March 31, 2022 ("Q1 2022"), ChromaDex reported net sales of $17.3 million, up $2.6 million or 18% compared to the first quarter of 2021 ("Q1 2021"). The increase in Q1 2022 revenues was largely driven by growth in sales of Tru Niagen (primarily e-commerce) paired with slight growth in ingredient sales.

Gross margin percentage declined to 61.0% in Q1 2022 compared to 62.9% in Q1 2021 primarily due to business mix and increases in supply chain headcount to scale the business.

Operating expenses increased by $1.7 million to $18.3 million in Q1 2022, compared to $16.6 million in Q1 2021. The increase in operating expenses was driven by $2.0 million of higher selling and marketing expenses partially offset by a $0.6 million decrease in general and administrative expense. The increase in selling and marketing expenses are largely due to brand building activities, including new Tru Niagen television campaign.

The net loss for Q1 2022 was $7.7 million or $(0.11) per share compared to a net loss of $7.4 million or $(0.12) per share for Q1 2021. Adjusted EBITDA including legal expense, a non-GAAP measure, delivered a loss of $4.5 million for Q1 2022, a $1.2 million improvement from Q1 2021. Adjusted EBITDA excluding legal expense, a non-GAAP measure, was a loss of $2.1 million for Q1 2022. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA excluding legal expense to net loss, the most directly comparable GAAP measure.

For Q1 2022, the net cash outflow from operating activities was $7.2 million, compared to $5.4 million in Q1 2021 largely due to changes in working capital.

2022 Full Year Outlook

Looking forward, for the full year, the Company expects 15-20% revenue growth, driven by its global e-commerce business, as well as growth with existing and new strategic partners. The outlook does not include revenue upside from potential new partnerships in the pipeline. The outlook contemplates continued COVID-19 headwinds for international partners. The Company expects slightly better than 60% gross margin and a reduction in general and administrative expense of $5.0 to $6.0 million, as reported, for full year 2022, driven by lower legal expense. The Company expects to increase investments and resources to drive brand awareness and accelerate its research and development pipeline to capitalize on growth in the nicotinamide adenine dinucleotide (NAD+) market globally. Accordingly, the Company expects an increase in research and development expense of approximately $2.0 million. Selling and marketing expense is expected to be up in absolute dollars, but down slightly as a percentage of net sales, year-over-year.

Investor Conference Call

A live webcast will be held Thursday, May 12, 2022 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s first-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The toll-free dial-in information for this call is 1-888-330-2446 with Conference ID: 4126168.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on May 12, 2022 to 11:59 p.m. Eastern time on May 19, 2022. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

Important Note on Forward Looking Statements:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects," "anticipates," "intends" "estimates," "plans," "potential," "possible," "probable," "believes" "seeks," "may," "will," "should," "could," "predicts," "projects," "continue," "would" or the negative of such terms or other similar expressions. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the quotation from ChromaDex’s Chief Executive Officer, and statements related to the Company’s 2022 financial outlook including but not limited to revenue growth, gross margin, expenses, and investment plans. Other risks that contribute to the uncertain nature of the forward-looking statements include: the impact of the COVID-19 pandemic on our business and the global economy; our history of operating losses and need to obtain additional financing; the growth and profitability of our product sales; our ability to maintain sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; and the risks and uncertainties associated with our business and financial condition in general, described in our filings with the Securities and Exchange Commission (SEC), including, without limitation, our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q as filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.