On May 2, 2023 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results and provided a business update for the quarter ended March 31, 2023 (Press release, Dynavax Technologies, MAY 2, 2023, View Source [SID1234630838]).

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"We are excited to once again post record quarterly net product revenue for HEPLISAV-B, which exceeded our expectations. We are encouraged by the continued expansion of the total hepatitis B vaccination market, along with the continued market share gains of HEPLISAV-B, driven in part from the expanded ACIP recommendation for adult hepatitis B vaccination," said Ryan Spencer, Chief Executive Officer of Dynavax. "We expect these tailwinds driving HEPLISAV-B growth to further improve this year, while we also advance our clinical pipeline and continue to evaluate strategic opportunities to accelerate growth through disciplined use of our strong capital position."

BUSINESS UPDATES

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and Great Britain that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.

HEPLISAV-B achieved net product revenue of $43.5 million for the first quarter of 2023, an increase of 109% compared to $20.8 million for the first quarter of 2022.
HEPLISAV-B total market share increased to approximately 37%, compared to approximately 26% at the end of the first quarter of 2022.
HEPLISAV-B market share in Integrated Delivery Networks (IDNs) and Clinics increased to approximately 49%, compared to approximately 33% at the end of the first quarter of 2022.
HEPLISAV-B market share in the retail segment grew to 49% at the end of the first quarter of 2023, up from 28% at end of the first quarter of 2022.
Dynavax continues to see a positive impact on HEPLISAV-B revenue from the Centers for Disease Control and Prevention’s Advisory Committee of Immunization Practices (ACIP) universal recommendation for adult hepatitis B vaccination, which we believe has the potential to expand the market to over $800 million by 2027 with HEPLISAV-B well-positioned to achieve a majority market-share.
In February, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing Authorization in Great Britain for HEPLISAV-B.
In April, Dynavax submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for HEPLISAV-B vaccination of adults on hemodialysis.
Clinical Pipeline
Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

Tetanus, diphtheria and pertussis (Tdap) vaccine program:

The Company has completed a Phase 1 clinical trial evaluating its Tdap vaccine candidate adjuvanted with CpG 1018. Adult and adolescent safety data from the trial demonstrated that the Tdap vaccine candidate was well tolerated without observed safety concerns. Immunogenicity results in adults were consistent with the Company’s expectations and support its plan to continue advancement of this clinical program. These clinical results were presented at ID Week 2022.
Data from a non-human primate challenge study is anticipated in mid-2023.
The Company plans to initiate a human challenge study by the end of 2023.
Shingles vaccine program:

In January 2023, the Company reported top line results from the Phase 1 clinical trial designed to evaluate an investigational shingles vaccine, Z-1018, utilizing different regimens of CpG 1018 adjuvant.
An abstract featuring Phase 1 data results has been accepted for oral presentation at the National Foundation for Infectious Diseases’ online 2023 Annual Conference on Vaccinology Research on June 6, 2023.
Based on these initial data, the Company plans to initiate a Phase 1/2 study in early 2024 to evaluate various dose levels of glycoprotein E (gE) plus CpG 1018 adjuvant.
Plague vaccine candidate funded by the Defense Department (DoD):

Part 1 of the Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability in adults of a plague (rF1V) vaccine candidate adjuvanted with CpG 1018 was successfully completed in January 2023.
Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint and demonstrated a greater than two-fold increase in antibodies over the alum adjuvanted control arm after two doses.
The Company recently completed enrollment in Part 2 of the Phase 2 clinical trial, with top line data anticipated in 2024.
FIRST QUARTER 2023 FINANCIAL HIGHLIGHTS

Total Revenues and Product Revenue, Net.

Total revenues for the first quarter of 2023 were $46.9 million, compared to $114.0 million for the first quarter of 2022.
HEPLISAV-B vaccine product revenue, net was $43.5 million for the first quarter of 2023, compared to $20.8 million for the first quarter of 2022, representing year-over-year growth of 109%.
Other revenue was $3.5 million for the first quarter of 2023, compared to $1.7 million in the same period of 2022, primarily consisting of revenue related to the plague vaccine program in collaboration with and fully funded by the U.S. Department of Defense.
No CpG 1018 adjuvant product revenue was recorded in the first quarter of 2023, compared to $91.5 million in the first quarter of 2022, due to completion of all obligations and product delivery under the Company’s CpG 1018 adjuvant COVID-19 collaboration agreements as of December 31, 2022.
Cost of Sales – Product. Total cost of sales – product for the first quarter of 2023 decreased to $14.7 million, compared to $40.0 million in the first quarter of 2022. The decrease is due to no CpG 1018 adjuvant cost of sales – product for the first quarter of 2023 compared to $34.0 million in the first quarter of 2022. Cost of sales – product for HEPLISAV-B in the first quarter of 2023 increased to $14.7 million, compared to $6.0 million for the first quarter of 2022. The increase was due to higher sales volume driven by continued improvement in HEPLISAV-B market share and utilization, as well as certain one-time charges in connection with improvement projects, and an inspection-related expense, at the Düsseldorf manufacturing facility.

Research and Development Expenses (R&D). R&D expenses for the first quarter of 2023 increased to $13.6 million, compared to $11.1 million for the first quarter of 2022. The increase was primarily driven by continued investments in our product candidates utilizing CpG 1018 adjuvant through preclinical and clinical collaborations and additional discovery efforts.

Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the first quarter of 2023 increased to $36.5 million, compared to $32.2 million for the first quarter of 2022. The increase was primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial and marketing efforts to increase market share and maximize the ACIP’s universal recommendation.

Bad Debt Expense. During the first quarter of 2023, the Company recognized a bad debt expense of $12.3 million to reflect uncollectible receivables from its customer, Biological E, in connection with the CEPI Arrangement for Biological E supply of CORBEVAX to the Government of India. Among other factors, the credit profile of Biological E has been negatively impacted by its reliance on future cash collections from the Government of India, which have been significantly reduced and delayed in connection with decreased demand for CORBEVAX in India. In April 2023, Dynavax entered into an amendment with Biological E to resolve remaining outstanding payables from Biological E as well as an agreement with CEPI to fully forgive the corresponding advance payments associated with Biological E supply of CpG 1018.

Net loss. GAAP net loss was $24.3 million, or $0.19 per share (basic and diluted) in the first quarter of 2023, compared to GAAP net income of $32.9 million, or $0.26 per share (basic) and $0.22 per share (diluted) in the first quarter of 2022.

Cash and Marketable Securities. Cash, cash equivalents and marketable securities were $652.0 million as of March 31, 2023.

2023 FINANCIAL GUIDANCE

Full year 2023 financial guidance is reiterated and consists of the following expectations:

HEPLISAV-B net product revenue between approximately $165 – $185 million
Research and development expenses between approximately $55 – $70 million
Selling, general and administrative expenses between approximately $135 – $155 million
Conference Call and Webcast Information

Dynavax will host a conference call and live audio webcast on Tuesday, May 2, 2023, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).

On May 2, 2023 Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported first quarter 2023 financial results and business highlights (Press release, Biomea Fusion, MAY 2, 2023, View Source [SID1234630837]).

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"In 2023, we expect to continue to advance our clinical programs in diabetes and oncology and plan to report multiple data readouts throughout the remainder of the year, including late-breaking clinical data from COVALENT-111 at the upcoming American Diabetes Association, or ADA, Scientific Sessions," said Thomas Butler, CEO and Chairman of Biomea. "Loss of mass and function of beta cells is an underlying cause of type 2 diabetes. There is biological precedent, reinforced by our extensive preclinical data for BMF-219, that suggests inhibiting menin may enable the proliferation, preservation, and reactivation of healthy, functional beta cells capable of producing insulin, thereby leading to long-term glycemic control in patients with type 2 diabetes. We believe that none of the currently approved therapies for diabetes adequately addresses the beta cell mass and function loss. With its intended disease-modifying mechanism of action, BMF-219 could potentially represent a monumental shift for the treatment of patients with diabetes. The initial data we reported from COVALENT-111 in the first quarter of 2023 demonstrated that after just four weeks of treatment with BMF-219, the majority of patients in our lowest dose cohorts showed HbA1c improvements, with indications of potential longer-term disease modification and control. We are excited to report additional data from COVALENT-111 to the diabetes-focused scientific community at ADA in June."

First Quarter 2023 Clinical and Regulatory Highlights

DIABETES

COVALENT-111 (BMF-219 for Type 2 Diabetes)
BMF-219 is the first investigational menin inhibitor in clinical development for the treatment of type 2 diabetes patients.
Reported initial clinical data in March 2023 from the first two cohorts of the Phase II portion of COVALENT-111. As reported, 89% of patients enrolled in Cohort 3 (n=10 patients at 100 mg without food) achieved a reduction in HbA1c, 78% achieved ≥ 0.5% reduction in HbA1c and 56% achieved ≥ 1% reduction in HbA1c (median and mean reduction over the cohort: -1.0% and -0.81%, respectively). BMF-219 was well tolerated and demonstrated a favorable safety profile with no dose discontinuations.
Anticipated Upcoming Milestones:
Report further clinical updates from COVALENT-111 at ADA in June 2023.
ONCOLOGY

COVALENT-101 (BMF-219 for Genetically Defined Liquid Tumors)
BMF-219 is the first investigational menin inhibitor in clinical development to be evaluated as a therapeutic agent in hematologic malignancies outside of MLLr and NPM1 mutated AML/ALL patients, specifically in subsets of DLBCL, MM and CLL patients.
Continued site activation and patient enrollment across four liquid tumor cohorts including patients with AML/ALL, DLBCL, MM and CLL.
Anticipated Upcoming Milestones:
Report initial clinical data of AML/ALL patients (including those with MLLr rearrangement and NPM1 mutations) dosed in the COVALENT-101 study in the second quarter of 2023.
COVALENT-102 (BMF-219 for KRAS-Mutant Solid Tumors)
BMF-219 is the first investigational menin inhibitor in clinical development for the treatment of solid tumors. A targeted pan-KRAS inhibitor could have the potential to treat 25-35% of NSCLC, 35-45% of CRC, and approximately 90% of PDAC patients.
Dosed first patient in January 2023 in COVALENT-102, a study of BMF-219 as a monotherapy in patients with unresectable, locally advanced, or metastatic NSCLC, CRC or PDAC with an activating KRAS mutation.
Continued site activation and patient enrollment across all three solid tumor indications (NSCLC, CRC and PDAC with an activating KRAS mutation).
COVALENT-103 (BMF-500 for Acute Leukemias)
BMF-500 is a potential best-in-class oral covalent inhibitor of FLT3, designed and developed in-house, and the second investigational compound, discovered by Biomea’s FUSION System.
Demonstrated approximately 20-fold greater potency compared to Gilteritinib and more than 50-fold greater potency compared to the clinically investigated reversible menin/MLL inhibitors in acute myeloid leukemia (AML) cell lines, MV-4-11 and MOLM-13.
BMF-219 and BMF-500 preclinical combination shows greater than additive cell killing in acute leukemia cell lines and patient samples.
Anticipated Upcoming Milestones:
Initiate enrollment of BMF-500 in Phase I study (COVALENT-103) examining safety and efficacy in patients with relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with MLLr / NPM1 mutations.
FUSION SYSTEM DISCOVERY PLATFORM

Continued to advance third development candidate derived from Biomea’s proprietary FUSION System platform to discover novel covalently binding small molecules. Both BMF-219 and BMF-500 were discovered via the FUSION System, each within 18 months from target identification to IND candidate selection.
Anticipated Upcoming Milestones:
Provide update on third development candidate in the second quarter of 2023.
FIRST QUARTER 2023 FINANCIAL RESULTS

Cash, Cash Equivalents, Restricted Cash, and Investments: As of March 31, 2023, the Company had cash, cash equivalents, restricted cash, and investments of $86.7 million, compared to $113.4 million as of December 31, 2022, excluding gross proceeds of $172.5 million from a public offering of common stock in early April 2023.
Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $29.1 million for the three months ended March 31, 2023, compared to a net loss of $16.4 million for the same period in 2022.
Research and Development (R&D) Expenses: R&D expenses were $24.4 million for the three months ended March 31, 2023, compared to $11.4 million for the same period in 2022. The increase of $13.0 million was primarily due to an increase personnel-related costs as well as an increase in clinical and preclinical development costs, including manufacturing and external consulting, related to the Company’s product candidates, BMF-219 and BMF-500.
General and Administrative (G&A) Expenses: G&A expenses were $5.6 million for the three months ended March 31, 2023, compared to $5.1 million for the same period in 2022. The increase of $0.6 million was primarily due to higher personnel-related costs and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.

On May 2, 2023 CTI BioPharma Corp. (Nasdaq: CTIC), a commercial biopharmaceutical company focused on the development and commercialization of novel targeted therapies for blood-related cancers, reported that an authorized subcommittee of the Compensation Committee of its Board of Directors granted an equity award to a new employee as an equity inducement award outside of the Company’s Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employee’s acceptance of employment with the company (Press release, CTI BioPharma, MAY 2, 2023, View Source [SID1234630835]). The equity award was approved on May 1, 2023, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The employee received options to purchase 60,000 shares of CTI BioPharma common stock. The options will be issued upon the employee’s grant date (the "Grant Date"), and all stock options included within the equity inducement award will have an exercise price equal to the closing price of CTI BioPharma common stock on the Grant Date. One-fourth of the options will vest on each anniversary of the employee’s Grant Date, subject to the employee’s continued employment with CTI BioPharma on such vesting dates. The options have a ten-year term.

On May 2, 2023 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in fireside chats at the following investor conferences in May (Press release, CRISPR Therapeutics, MAY 2, 2023, View Source [SID1234630834]).

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Bank of America Securities 2023 Health Care Conference
Date: Tuesday, May 9, 2023
Time: 10:40 a.m. PT

JMP Securities Life Sciences Conference
Date: Monday, May 15, 2023
Time: 11:30 a.m. ET

A live webcast of the fireside chats will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following the presentation.

On May 2, 2023 ChromaDex Corp. (NASDAQ:CDXC) ("the Company") a global bioscience company dedicated to healthy aging, reported that it will hold a conference call on Wednesday, May 10, 2023 at 4:30 p.m. ET to discuss its financial results for the first quarter, which ended March 31, 2023 (Press release, ChromaDex, MAY 2, 2023, View Source [SID1234630833]). The financial results will be reported in a press release after the close of regular stock market trading hours on the same day as the conference call.

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Investor Conference Call:

ChromaDex management will host an investor conference call to discuss first quarter 2023 results and provide a general business update on Wednesday, May 10, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

Date: Wednesday, May 10, 2023
Time: 4:30 p.m. ET (1:30 p.m. PT)
Toll-free dial-in number: 1-888-330-2446
Conference ID: 4126168
Webcast link: ChromaDex First Quarter 2023 Earnings Conference Call

The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at www.chromadex.com.

A replay of the conference call will be available from 7:30 p.m. ET on May 10, 2023, to 11:59 p.m. ET on May 17, 2023.

Toll-free replay number: 1-800-770-2030
Replay ID: 4126168