On May 5, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the first quarter ended March 31, 2022 (Press release, Puma Biotechnology, MAY 5, 2022, View Source [SID1234613714]). Unless otherwise stated, all comparisons are for the first quarter of 2022 compared to the first quarter of 2021.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2022 was $40.7 million, compared to product revenue, net of $45.8 million in the first quarter of 2021.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net loss of $3.4 million, or $0.08 per basic and diluted share, for the first quarter of 2022, compared to net income of $16.5 million, or $0.41 per basic share and $0.40 per diluted share, for the first quarter of 2021.

Non-GAAP adjusted net loss was $0.3 million, or $0.01 per basic and diluted share, for the first quarter of 2022, compared to non-GAAP adjusted net income of $22.4 million, or $0.56 per basic share and $0.55 per diluted share, for the first quarter of 2021. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2022 was $26.9 million, compared to $15.7 million provided by operating activities in the first quarter of 2021. At March 31, 2022, Puma had cash, cash equivalents and marketable securities of $73.9 million, compared to cash, cash equivalents and marketable securities of $82.1 million at December 31, 2021.

"2021 was an important year for Puma as we made operational changes to maximize the efficiency of the Puma team and the environment with which we operate," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We remain committed to increasing awareness of and access to NERLYNX as an option to reduce the risk of recurrence for patients battling HER2-positive breast cancer; the inclusion of NERLYNX in the updated NCCN guidelines is an important step to expanding the awareness and utilization of neratinib for high-risk patients."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in HER2-mutated HR-positive breast cancer (H1 2022); (ii) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in HER2-mutated biliary tract cancer (H1 2022); (iii) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2 2022); (iv) conducting a pre-NDA meeting with the FDA to discuss the potential for an accelerated approval pathway of neratinib in HER2-mutated HR-positive breast cancer (H2 2022); (v) conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2022); (vi) reporting Phase II TBCRC-022 trial data from Cohort 4B and 4C of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2 2022); and (vii) reporting Phase II data from the SUMMIT trial of neratinib in cervical cancer patients with HER2 mutations (H2 2022)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the first quarter ended March 31, 2022, total revenue was $45.7 million, of which $40.7 million was net product revenue and $5.0 million was royalty revenue. This compares to total revenue of $98.2 million in the first quarter of 2021, of which $45.8 million was net product revenue, $50.0 million was license revenue and $2.4 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $46.4 million for the first quarter of 2022, compared to $78.0 million for the first quarter of 2021.

Cost of Sales

Cost of sales was $10.8 million for the first quarter of 2022, compared to $29.6 million for the first quarter of 2021. Cost of sales in the first quarter of 2021 included $20.0 million for a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China, partially offset by higher royalties due on increased non-U.S partner sales.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $20.4 million for the first quarter of 2022, compared to $28.2 million for the first quarter of 2021. The $7.8 million decrease resulted primarily from decreases of approximately $3.1 million in professional fees and expenses, primarily related to a decrease in consulting costs for marketing and commercialization support; $2.9 million in payroll and related costs due to reduced headcount; and $1.4 million in stock-based compensation also due to reduced headcount.

Research and Development Expenses

Research and development expenses were $15.2 million for the first quarter of 2022, compared to $20.2 million for the first quarter of 2021. The $5.0 million decrease resulted primarily from decreases of $2.5 million in internal R&D costs related primarily to reduced payroll costs; $1.3 million in stock-based compensation due to the impact of headcount reductions in 2021; $0.7 million in consultants and contractors due to the close of the CONTROL study and the winding down of the SUMMIT study; and $0.5 million in clinical trial expenses due to reduced study costs as noted above.

Total Other Income (Expenses)

Total other expenses were $2.7 million for the first quarter of 2022, compared to total other expenses of $3.7 million for the first quarter of 2021. The $1.0 million decrease in other expenses resulted primarily from lower interest expense on the milestone installment payments to Pfizer as well as lower costs related to our outstanding debt.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2022 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 5, 2022. The call may be accessed by dialing (866) 682-6100 (domestic) or (862) 298-0702 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On May 5, 2022 -Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the second quarter of fiscal 2022 ended March 31, 2022 (Press release, Twist Bioscience, MAY 5, 2022, View Source [SID1234613713]).

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"We’re building momentum through the first half of fiscal 2022, with another consecutive quarter of record revenue and orders," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We continued to deliver a wide range of products to our customers through the Omicron surge, while bolstering our balance sheet to reduce downside risk in this unpredictable market."

"Twist Biopharma added 5 new partnerships and 15 programs, with Twist Boston (Abveris) actively working on 81 programs today. For data storage, we are building important relationships with key industry associations and are debugging our integrated CMOS chip for production capacity now, both critical for the introduction of our storage solutions," continued Dr. Leproust.

"We remain committed to managing our cash burn in our drive toward adjusted EBITDA break even for the core business, which we expect to occur when we reach $300 million in revenue for SynBio and NGS," added Jim Thorburn, CFO of Twist.

FISCAL 2022 SECOND QUARTER FINANCIAL RESULTS

Orders: Total orders received for the second quarter of fiscal 2022 were $55.0 million compared to $41.7 million for the same period of fiscal 2021.
Revenue: Total revenues for the second quarter of fiscal 2022 were $48.1 million compared to $31.2 million for the same period of fiscal 2021.
Cost of Revenues: Cost of revenues for the second quarter of fiscal 2022 was $29.7 million compared to $19.0 million for the same period of fiscal 2021.
Research and Development Expenses: Research and development expenses for the second quarter of fiscal 2022 were $31.2 million compared to $15.8 million for the same period of fiscal 2021.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of fiscal 2022 were $54.0 million compared to $34.4 million for the same period of fiscal 2021.
Net Loss: Net loss attributable to common stockholders for the second quarter of fiscal 2022 was $60.7 million, or $1.13 per share, compared to $37.9 million, or $0.78 per share, for the same period of fiscal 2021.
Cash Position: As of March 31, 2022, the company had $604.4 million in cash, cash equivalents and investments.
Recent Highlights:

SynBio and NGS

Shipped products to approximately 2,000 customers in the second quarter of fiscal 2022, versus approximately 1,700 in the second quarter of fiscal 2021.
Shipped approximately 124,000 genes during the second quarter of fiscal 2022, compared with approximately 90,000 in the second quarter of fiscal 2021.
Entered into four-year supply agreement with Ginkgo Bioworks, which includes a $58 million minimum in all product purchases over the lifetime of the contract with Ginkgo having the option to access significantly more products from Twist.
Launched Twist High Throughput Antibody Production, a gene-to-antibody production platform that enables customers to turn digital DNA sequences into purified IgG antibodies for therapeutic discovery and screening applications.
Launched encapsulated synthetic RNA positive controls for SARS-CoV-2 that can be shipped and stored at room temperature to enable Twist to serve customers in regions that do not have an effective cold chain system or easy access to ultra-cold storage and may also allow the use of the controls in point of care settings.
Partnered with C2i Genomics to develop whole-genome cancer reference materials to be used to provide diagnostic labs with the ability to better validate and monitor the quality of whole-genome cancer screening and minimal residual disease (MRD) products.
Created a replicon tool with Eleven Therapeutics to be used to study viral genome replication and antiviral drug screening for SARS-CoV-2 as well as vaccine and therapeutic development.
BioPharma and DNA Data Storage

Signed an agreement with Kriya to discover and optimize novel antibodies to be used with Kriya’s gene therapy technology platform in oncology applications.
Signed a collaboration with MediSix Therapeutics to discover novel antibodies to be developed as T-cell therapies.
Announced that the DNA Data Storage Alliance, of which Twist is a founding member, has grown to more than 50 members.
Joined the Storage Networking Industry Association (SNIA) as a voting member.
Became a part of the Digital Preservation Coalition’s (DPC) Supporter Program.
Corporate

Raised $269.8 million in net proceeds in an upsized underwritten public offering of common stock.
Updated Fiscal 2022 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2022. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2022, Twist provided the following updated financial guidance:

Revenue is now expected to be in the range of $191 million – $199 million
SynBio revenue including Ginkgo Bioworks is expected to be in the range of $71 million to $73 million
NGS revenue is estimated to be in the range of $94 million to $96 million
Biopharma revenue is estimated to be approximately $26 million to $30 million
Gross margin is expected to be 37% for fiscal 2022 which reflects the impact of expected costs associated with ramping our Wilsonville, Oregon "Factory of the Future" facility to bring it online; excluding these expected costs, gross margin would be 42% to 44%
Operating expenses including R&D and SG&A are expected to be approximately $335 million for the year
Net loss is expected to be approximately $260 to $265 million, reflecting the impact of the Abveris acquisition in stock-based compensation and includes:
R&D is expected to be approximately $130 million
Approximately $40 million for DNA data storage
Stock-based compensation is expected to be approximately $85 million
Depreciation is expected to be $13 million
Capital expenditures are expected to be $90-$100 million, including building out the "Factory of the Future"
Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 4:30 p.m. Eastern Time today to discuss its financial results and provide an update on the company’s business. The call can be accessed by dialing (866) 688-0947 (domestic) or (409) 217-8781 (international) and refer to the conference ID 7377195. A telephonic replay of the conference call will be available beginning approximately four hours after the call through May 12, 2022 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 7377195. The webcast replay will be available for two weeks. If a participant will be listen-only, they are encouraged to listen via the webcast on Twist’s investor page.

On May 5, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported its first quarter 2022 financial results for the period ended March 31, 2022 (Press release, Merrimack, MAY 5, 2022, View Source [SID1234613712]).

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"During the first quarter of 2022 we continued to see reductions in our operating expenses and were able to close the sale of an additional preclinical asset" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We continue to be focused on maintaining cash balances that will allow us to be in a position to receive milestone payments from Ipsen and Elevation if the programs that we have licensed to them continue to progress."

First Quarter 2022 Financial Results

Merrimack reported a net loss of $132 thousand for the first quarter ended March 31, 2022, or $0.01 per basic and diluted share on a fully diluted basis, compared to a net loss of $696 thousand, or $0.05 per basic and diluted share on a fully diluted basis, for the same period in 2021.

Merrimack reported a gain on the sale of assets for the first quarter ended March 31, 2022, of $445 thousand, attributable to the sale of certain of our preclinical programs, compared to $50 thousand for the same period in 2021.

General and administrative expenses for the first quarter ended March 31, 2022, were $577 thousand, compared to $746 thousand for the same period in 2021.

As of March 31, 2022, Merrimack had cash and cash equivalents and investments of $14.3 million, compared to $14.2 million as of December 31, 2021.

As of March 31, 2022, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On April 27, 2022, Ipsen released to the public an update on its sales performance for the first quarter of 2022. At the same time, Ipsen publicly indicated that a data readout from its ongoing Phase 3 trial of ONIVYDE as a treatment of second line small cell lung cancer would be provided in the second half of 2022. In addition, Ipsen reported that it is continuing to study ONIVYDE in Phase III clinical trials in first line pancreatic ductal adenocarcinoma, with a data readout expected in 2023.

Elevation Oncology

– On April 27, 2022 Elevation Oncology announced that initial data from its Phase 2 CRESTONE Study of Seribantumab has been selected for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 7, 2022.

On May 5, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the first quarter ended March 31, 2022 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, MAY 5, 2022, View Source [SID1234613711]).

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"In the first quarter, we began enrollment in the Phase 2 expansion cohorts with CYT-0851 monotherapy and continued enrolling in the Phase 1 combination study. Our R&D Day in April highlighted the exceptional work of our discovery research team that has provided us with a greater understanding of the mechanism of action for CYT-0851, potentially expanding the opportunity of the drug into new tumor types," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "I am proud of the entire Cyteir team and look forward to delivering on key data reporting milestones in the second half of the year."

First Quarter 2022 Accomplishments

Advanced CYT-0851 Clinical Program

Progress continues to advance CYT-0851 in monotherapy and combination clinical studies. Enrollment is ongoing in six disease-specific Phase 2 expansion cohorts with monotherapy in hematologic malignancies and solid tumors. Completion of stage 1 of this study is expected before the end of 2022. Enrollment is also ongoing in a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: (1) rituximab plus bendamustine; (2) gemcitabine; and (3) capecitabine, in both hematologic malignancies and solid tumors. Initial safety data from this combination study is expected before the end of 2022.
A poster with updated data from the Phase 1 dose-escalation portion of the first-in-human Phase 1/2 trial of CYT-0851 will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5, 2022.
Continued to Advance Our Synthetically Lethal Preclinical Pipeline

Cyteir continues to advance two previously reported discovery projects focused on identifying inhibitors of DNA damage repair. The first of these undisclosed targets (Target 2) plays a key role in Non-Homologous End Joining (NHEJ) and the second (Target 3) in Microhomology-Mediated End Joining (MMEJ) DNA repair pathways. Both undisclosed target projects are currently in lead generation, and we anticipate reaching the drug candidate nomination stage in 2023.
Cyteir expects to complete IND-enabling studies for CYT-1853 in the first half of 2022, and if the data supports an overall risk-benefit improvement and differentiation from CYT-0851, Cyteir plans to file an IND application with the FDA before the end of 2022.
CYT-0851 Mechanism of Action Due to Inhibition of Monocarboxylate Transporters, Essential Proteins in Cancer Metabolism

Based on molecular, bioinformatic, and biochemical characterization research that has been done at Cyteir to elucidate the mechanism of action of CYT-0851, management believes that the observed effects of CYT-0851 on the viability of cancer cells are due to inhibition of monocarboxylate transporter (MCT) activity and the subsequent disruption of lactate transport. Monocarboxylate transporters are essential proteins in cancer metabolism making MCTs an attractive target for cancer therapy. Based on the newly identified mechanism of action, the patient selection biomarker discovery strategy has been modified while all aspects of the trial design remain appropriate and unchanged. This new understanding of the mechanism of action of CYT-0851 could potentially accelerate development of a biomarker and allow for expansion into additional opportunities in other tumor types. The initial results from the work on our biomarker were presented in a virtual R&D Day in April.
First Quarter 2022 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of March 31, 2022 were $177.4 million, which are expected to fund planned operations into 2024.

Research and development (R&D) expenses: R&D expenses were $10.1 million for the first quarter of 2022 versus $5.6 million for the same period in 2021. The year-over-year increase in R&D spending in the comparative periods was due primarily to increased research activity, clinical trial expenses, and headcount, including the ongoing of Phase 1 and Phase 2 studies for CYT-0851.

General and administrative (G&A) expenses: G&A expenses were $4.0 million for the first quarter of 2022 compared to $1.7 million for the same period in 2021. The year-over-year increase in G&A expenses in the comparative periods was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company.

Net loss: Net loss was $14.1 million, or $0.40 per share, in the first quarter of 2022 compared to $7.3 million, or $3.40 per share, for the same period in 2021.

On May 15, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported partner Compass Therapeutics reported positive interim ES104 (also known as CTX-009) Phase 2 data in combination with paclitaxel in patients with biliary tract cancers (BTC) (Press release, Elpiscience, MAY 5, 2022, View Source [SID1234613705]). ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization.

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In the study, ES104 demonstrated:

42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmation
Anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with a PR or stable disease (SD) out of 24 enrolled patients
Well-tolerated and preliminary safety profile consistent with prior studies
The Phase 2 study in patients with BTC is currently being conducted at four leading medical centers in Korea and Compass Therapeutics plans to open additional sites in the United States. In China, Elpiscience is currently enrolling patients in a ES104 Phase 1/2 study for the treatment of unresectable locally advanced or metastatic colorectal cancer (CRC). ES104 is currently the only clinical-stage bispecific antibody targeting VEGF and DLL4 in China.

"We are encouraged by the impressive interim Phase 2 data in BTC patients from our partner," said Steve Chin, Chief Medical Officer of Elpiscience. "ES104 in combination with paclitaxel showed a high ORR including responses in all four BTC subtypes and good overall tolerability consistent with prior studies. We believe in the clinical strategy to simultaneously target VEGF and DLL4 and look forward to our study findings in advanced CRC patients."

For more information on the Phase 1/2 clinical study in patients with unresectable locally advanced or metastatic CRC, refer to Clinicaltrials.gov identifier NCT05167448.

About ES104

ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of ES104 show that blocking both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Partial responses to ES104 as monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. ES104 has completed a Phase 1 monotherapy dose-escalation and expansion study (NCT03292783). Phase 1b and Phase 2 clinical studies (NCT04492033) in combination with chemotherapy are ongoing. Elpiscience licensed ES104 greater China rights from Compass Therapeutics in January 2021 and is conducting Phase 1/2 study in China for treatment in patients with unresectable locally advanced or metastatic colorectal cancer.