On May 6, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the first quarter ended March 31, 2021 (Press release, Puma Biotechnology, MAY 6, 2021, View Source [SID1234579362]). Unless otherwise stated, all comparisons are for the first quarter of 2021 compared to the first quarter of 2020.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the first quarter of 2021 was $45.8 million, compared to $48.6 million in the first quarter of 2020.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $16.5 million, or $0.41 per basic share and $0.40 per diluted share, for the first quarter of 2021, compared to a net loss of $16.9 million, or $0.43 per share, for the first quarter of 2020.

Non-GAAP adjusted net income was $22.4 million, or $0.56 per basic share and $0.55 per diluted share for the first quarter of 2021, compared to non-GAAP adjusted net loss of $8.0 million, or $0.20 per share, for the first quarter of 2020. 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 provided by operating activities for the first quarter of 2021 was $15.7 million, compared to net cash used in operating activities of $11.5 million in the first quarter of 2020. At March 31, 2021, Puma had cash, cash equivalents and marketable securities of $109.1 million, compared to cash, cash equivalents and marketable securities of $93.4 million at December 31, 2020.

"During the first quarter, we continued to face the challenges brought about by the COVID-19 pandemic and the reduction in commercial access caused by it," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We are hopeful that with the progress made with vaccinations, commercial access will improve in 2021 which will greatly aid our commercial abilities. We continue to remain focused on and committed to providing support to patients battling cancer."

"In terms of clinical development, we are pleased that during the first quarter we were able to achieve the completion of enrollment in the randomized cohorts of the Phase II SUMMIT trial of neratinib for patients with hormone receptor-positive breast cancer that has a HER2 mutation. Enrollment in the other cohorts in SUMMIT continued as well, including for patients with EGFR exon 18 mutated non-small cell lung cancer and HER2 mutated cervical cancer. Additionally, our global partners continued to launch NERLYNX in several new countries during the first quarter and we look forward to launches in additional countries throughout 2021."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting top line data from the randomized cohort of the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation (2021); (ii) reporting Phase II data from the SUMMIT trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2-2021); (iii) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2-mutated

hormone receptor positive breast cancer and HER2-mutated cervical cancer (2021); (iv) reporting data from the Phase II TBCRC-022 trial of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2-2021); (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 (2021); and (vi) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries (2021)."

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, 2021, total revenue was $98.2 million, of which $45.8 million was net product revenue, $50.0 million was license revenue and $2.4 million was royalty revenue. The $50.0 million of license revenue in the first quarter of 2021 represents an upfront payment for providing our existing partner Pierre Fabre with development, manufacturing, and commercial rights to NERLYNX in Greater China. Total revenue was $51.2 million in the first quarter of 2020, of which $48.6 million was net product revenue, $2.0 million was license revenue, and $0.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $78.0 million for the first quarter of 2021, compared to $65.5 million for the first quarter of 2020.

Cost of Sales

Cost of sales was $29.6 million for the first quarter of 2021, of which $20.0 million represents a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China. Cost of sales was $9.1 million for the first quarter of 2020.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $28.2 million for the first quarter of 2021, compared to $30.9 million for the first quarter of 2020. The $2.7 million decrease resulted primarily from decreases in stock-based compensation expense of approximately $1.1 million, travel and meetings of approximately $1.4 million and other expenses of approximately $0.4 million, partially offset by an increase in professional fees of approximately $0.3 million.

Research and Development Expenses

Research and development expenses were $20.2 million for the first quarter of 2021, compared to $25.5 million for the first quarter of 2020. The $5.3 million decrease resulted primarily from decreases in clinical trial costs of approximately $2.7 million, stock-based compensation expense of approximately $2.0 million and consultant and contractor costs of approximately $0.6 million.

Total Other Expenses

Total other expenses were $3.7 million for the first quarter of 2021, compared to $2.6 million for the first quarter of 2020. The $1.1 million increase resulted primarily from decreases in interest income and other income of approximately $0.5 million, as well as an increase in interest expense of $0.5 million.

Conference Call

Puma Biotechnology will host a conference call to discuss its first quarter 2021 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 6, 2021. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (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 shortly after completion of the call and will be archived on Puma’s website for 90 days.

On May 6, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated therapeutics based on its Probody technology platform, reported first quarter 2021 financial results and provided a business update (Press release, CytomX Therapeutics, MAY 6, 2021, View Source [SID1234579360]).

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"Building on the sustained and focused performance by the CytomX team throughout 2020, we made excellent progress in the first quarter of 2021 with an ongoing emphasis on our two lead clinical product candidates, praluzatamab ravtansine (CX-2009) and CX-2029, both of which are in key Phase 2 studies addressing late-stage cancers with substantial unmet need," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We also continued to innovate with the unveiling of our work on conditionally activated cytokines that leverages the depth of our expertise in protein engineering, protease biology, and our understanding of the tumor microenvironment. Our leadership in the field of conditional activation and the versatility of our Probody technology platform position us for success in realizing our vision of transforming lives with safer, more effective therapies," added Dr. McCarthy.

Business Highlights and Recent Developments

Hosted a virtual investor event and webcast with industry experts John Lambert Ph.D., former chief scientific officer, ImmunoGen; Sara M. Tolaney, M.D., Dana-Farber Cancer Institute, Harvard Medical School; and Melissa L. Johnson, M.D., Sarah Cannon Research Institute, as well as company executives, to discuss CytomX’s Probody technology platform and the two lead product candidates, praluzatamab ravtansine (CX-2009) and CX-2029. An archived replay of the webcast can be accessed on the Events and Presentations section of CytomX’s website.
Began enrolling patients with human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer into a Phase 2 multi-cohort study evaluating our anti-CD166 conditionally activated antibody-drug conjugate (ADC), praluzatamab ravtansine (CX-2009) as monotherapy and, in patients with triple-negative breast cancer (TNBC), in combination with pacmilimab (CX-072), our conditionally activated anti-PD-L1 antibody.
Patient enrollment continued in the Phase 2 expansion study evaluating CX-2029, the anti-CD71 conditionally activated ADC in co-development with our partner AbbVie, as a single agent in four cohorts: squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastro-esophageal junction cancers, and diffuse large B-cell lymphoma.
Featured presentation at the Triple Negative Breast Cancer (TNBC) Drug Development Digital Summit 2021, by Alison L. Hannah, M.D., CytomX’s chief medical officer, titled "Clinical Development of Praluzatamab Ravtansine (CX-2009), a Conditionally Activated Probody Drug Conjugate (PDC) Targeted Against CD166 (ALCAM) in Patients with Advanced Breast Cancer." The oral presentation can be downloaded using this link.
Presented preclinical data highlighting an improved therapeutic window and potent anti-cancer activity for a conditionally activated interferon alpha-2b at the Cytokine-Based Cancer Immunotherapies Summit, demonstrating successful broadening of the Probody technology platform to cytokine modalities. The oral presentation can be downloaded using this link.
Our partner, Bristol Myers Squibb, expanded the scope of the Part 2b evaluation of BMS-986249, a Probody version of the CTLA-4-targeting antibody, ipilimumab, in combination with the anti-PD-1 antibody, nivolumab, with three new indications, advanced hepatocellular carcinoma, metastatic castration-resistant prostate cancer, and advanced TNBC. This combination is also being evaluated by Bristol Myers Squibb in a randomized study in patients with metastatic melanoma. Bristol Myers Squibb also continued to evaluate BMS-986288, a Probody version of non-fucosylated ipilimumab, as monotherapy or in combination with nivolumab in a Phase 1 clinical trial.
In collaboration with Amgen, investigational new drug application (IND)-enabling studies continued for CX-904, our conditional T-cell engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and CD3 on T cells.
IND-enabling studies for CX-2043, our third conditionally activated ADC directed against the epithelial cell adhesion molecule (EpCAM/Trop-1), were delayed as a result of recent supply chain interruptions. We no longer expect to submit an IND for CX-2043 in 2021.
Raised approximately $108 million from a follow-on public equity offering to support clinical and preclinical pipeline advancement and operations.
Anticipated 2021 Events

Initial data from the praluzatamab ravtansine (CX-2009) Phase 2 study in the fourth quarter of 2021.
Initial data from the CX-2029 Phase 2 expansion study in the fourth quarter of 2021.
IND submission for CX-904 in late 2021.
First Quarter 2021 Financial Results
Cash, cash equivalents and short-term investments totaled $393.8 million as of March 31, 2021, compared to $316.1 million as of December 31, 2020.

Revenue was $16.0 million for the three months ended March 31, 2021 compared to $49.6 million for the corresponding period in 2020. The decrease of $33.6 million was due to a $28.9 million decrease in revenue from AbbVie primarily related to the $40.0 million milestone payment earned in March 2020 associated with the CX-2029 project, a $10.0 million decrease in revenue from Bristol Myers Squibb for a milestone payment earned from the CTLA-4 program in February 2020, offset by an increase in revenue of $4.4 million from Astellas mainly driven by the full quarter recognition of the $80.0 million upfront payment related to the Collaboration and License Agreement with Astellas entered into in March 2020.

Research and development expenses decreased by $20.4 million during the three months ended March 31, 2021 to $22.4 million compared to $42.8 million for the corresponding period in 2020. The decrease was largely attributed to a decrease of $11.2 million in licensing expenses and a decrease of $8.5 million in laboratory contracts and services, decreased clinical trial spend and timing of manufacturing activities.

General and administrative expenses were essentially flat during the three months ended March 31, 2021 amounting to $9.2 million compared to $9.6 million for the corresponding period in 2020.

Conference Call & Webcast Information
CytomX management will host a conference call today at 5:00 p.m. ET (2:00 p.m. PT). Interested parties may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at www.cytomx.com or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) using the passcode 5397530. An archived replay of the webcast will be available on the Company’s website until May 13, 2021.

On May 6, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended March 31, 2021 and provided a corporate update (Press release, Athersys, MAY 6, 2021, View Source [SID1234579359]).

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"Since our recent call, we remain on track with respect to our operating plans," stated Mr. William (B.J.) Lehmann, Jr., Interim Chief Executive Officer of Athersys. "We look forward to important progress during the remaining course of the year, including expected top-line results from the TREASURE and ONE-BRIDGE studies in Japan."

"Additionally, we remain focused on important priorities for the year, which include advancing our MASTERS-2 study and other clinical programs, supporting our partner, Healios, as it prepares for important regulatory applications, and in further developing our commercial manufacturing processes and planning," added Mr. Lehmann.

Highlights of the first quarter of 2021 and recent events include:

Announcement by our Japanese partner, HEALIOS K.K. (Healios), of the completion of patient enrollment in the ONE-BRIDGE study evaluating the safety and efficacy of MultiStem (invimestrocel) cell therapy for the treatment of pneumonia-induced acute respiratory distress syndrome (ARDS) and COVID-induced ARDS;
Reached a cooperation agreement with Healios to resolve the legal matter between its CEO and Athersys Board member, Dr. Kagimoto, and the Company, and initiated negotiations to address open matters important to continued development, regulatory progress and successful commercialization in Japan following approval;
Recognized net loss of $26.5 million, or $0.13 net loss per share, for the quarter ended March 31, 2021; and
Ended the first quarter with $64.2 million of cash and cash equivalents.
"We believe that we are well positioned to advance our MultiStem programs over this year and further develop the capabilities important to longer term commercial success," concluded Mr. Lehmann.

First Quarter Results

There were no revenues for the three months ended March 31, 2021 and March 31, 2020, respectively. Our collaboration revenues currently fluctuate from period to period based on the delivery of goods and services under our arrangement with Healios.

Research and development expenses increased to $17.5 million for the three months ended March 31, 2021 from $12.1 million for the comparable period in 2020. The $5.4 million net increase is primarily associated with increases in clinical trial and manufacturing process development costs of $4.3 million, personnel costs of $0.7 million and stock compensation costs of $0.4 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.

General and administrative expenses increased to $8.8 million for the three months ended March 31, 2021 compared to $3.5 million in the comparable period in 2020. The $5.3 million increase was primarily related to legal expenses incurred in connection with the complaint filed by Dr. Kagimoto against the Company, its settlement, and the expenses associated with Dr. Van Bokkelen’s resignation and his separation letter agreement, including $2.3 million of non-cash stock compensation expense.

Net loss for the first quarter of 2021 was $26.5 million compared to a net loss of $15.6 million in the first quarter of 2020. The difference primarily results from the above variances.

During the three months ended March 31, 2021, net cash used in operating activities was $17.1 million compared to $12.1 million in the three months ended March 31, 2020. At March 31, 2021, we had $64.2 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.

Conference Call

William (B.J.) Lehmann, Jr., Interim Chief Executive Officer, Ivor Macleod, Chief Financial Officer, John Harrington, Executive Vice President and Chief Scientific Officer and Karen Hunady, Director of Corporate Communications and Investor Relations will host a conference call today to review the results as follows:

We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive the toll-free number, a direct entry passcode and a registrant ID.

On May 7th at 12:00 PM EDT, a replay of the event will be available on the webcast link at www.athersys.com under the investors’ section. Shareholders may also call in for on-demand listening on May 7th at 12:00 PM EDT until 11:59 PM Eastern Time on May 12, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 4548767.

On May 6, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended March 31, 2021 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, MAY 6, 2021, View Source [SID1234579358]).

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"We continue to enroll patients in our two proof-of-concept Phase 2 clinical studies for LX9211 in neuropathic pain and look forward to results from these studies by the end of the year," said Lonnel Coats, Lexicon’s president and chief executive officer. "We are also very pleased with the regulatory feedback received from the FDA on sotagliflozin in heart failure and we are moving expeditiously forward with a planned NDA filing in that indication this year."

First Quarter Highlights

LX9211

Patient enrollment continued in RELIEF-DPN-1, a Phase 2 clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. Enrollment is expected to total approximately 300 patients at approximately 40 clinical sites.
Patient enrollment continued in RELIEF-PHN 1, a Phase 2 clinical study of LX9211 for the treatment of post-herpetic neuralgia. Enrollment is expected to total approximately 74 patients at approximately 20 clinical sites.
Sotagliflozin

U.S. Food and Drug Administration (FDA) provided regulatory feedback that the results of the SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure.
2021 Anticipated Milestones and Events

NDA filing for sotagliflozin in heart failure.
Active efforts to secure strategic alliance for sotagliflozin in heart failure.
Phase 2 study results from RELIEF-DPN-1 for LX9211 in diabetic peripheral neuropathic pain.
Phase 2 study results from RELIEF-PHN-1 for LX9211 in post-herpetic neuralgia.
Additional publications for sotagliflozin and LX9211.
First Quarter 2021 Financial Highlights

Revenues: Revenues for the three months ended March 31, 2021 were negligible as compared to $8.0 million for the corresponding period in 2020, primarily due to the absence of product revenues as a result of the sale of XERMELO during the third quarter of 2020.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended March 31, 2021 decreased to $12.6 million from $55.2 million for the corresponding period in 2020, primarily due to decreases in external clinical development costs related to sotagliflozin resulting from the completion of clinical studies.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended March 31, 2021 decreased to $8.3 million from $14.7 million for the corresponding period in 2020, primarily due to lower salaries and benefit costs as a result of reductions in personnel in September 2020 and lower marketing expenses.

Net Loss: Net loss for the three months ended March 31, 2021 was $21.0 million, or $0.15 per share, as compared to a net loss of $66.6 million, or $0.63 per share, in the corresponding period in 2020. For the three months ended March 31, 2021 and 2020, net income included non-cash, stock-based compensation expense of $2.9 million and $4.4 million, respectively.

Cash and Investments: As of March 31, 2021, Lexicon had $141.4 million in cash and investments, as compared to $152.3 million as of December 31, 2020.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8456671. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.

On May 6, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the first quarter ended March 31, 2021 and provided an update on recent developments (Press release, IGM Biosciences, MAY 6, 2021, View Source [SID1234579357]).

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Pipeline Updates

IGM-2323

Recommended Phase 2 dose expected in 2021. IGM continues to advance the clinical development of IGM-2323, the Company’s IgM-based CD20 x CD3 bispecific antibody, for the treatment of non-Hodgkin’s lymphoma (NHL) and potentially other CD20-expressing hematologic malignancies, including chronic lymphocytic leukemia (CLL). IGM has cleared the titration dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs in the ongoing Phase 1 clinical trial of IGM-2323, and is currently enrolling patients in what is expected to be its top titration dose cohort, 50/1000 mgs. IGM is also currently enrolling patients in the expansion dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs. IGM expects to complete enrollment in the dose escalation portion of the Phase 1 clinical trial and select a recommended Phase 2 dose in 2021.
IGM-8444

Phase 1 data expected in the second half of 2021. IGM also continues to advance the clinical development of IGM-8444, the Company’s IgM Death Receptor 5 (DR5) agonist, for the treatment of a potentially broad range of solid tumors and hematologic malignancies. IGM has cleared its second dose escalation dose cohort, 1 mg/kg, in the ongoing Phase 1 trial, and is currently dosing patients in its third dose escalation cohort, 3 mg/kg, with every two week dosing. IGM has also begun dosing patients in its first combination with FOLFIRI dose cohort and its first weekly dosing cohort. IGM expects to report initial data from the dose escalation portion of the Phase 1 trial in the second half of 2021.
Clinical testing of birinapant in combination with IGM-8444 expected to begin this year. As previously announced, during the first quarter of 2021, IGM entered into an exclusive license agreement with Medivir AB, by which IGM received global, exclusive development and commercialization rights for birinapant. IGM remains on track to begin clinical testing of birinapant in combination with IGM-8444 this year.
IGM-7354

Investigational New Drug (IND) application expected to be filed this year. IGM also plans to file an IND application with the U.S. Food and Drug Administration (FDA) for IGM-7354, the Company’s IL‑15 x PD‑L1 bispecific IgM antibody, before the end of 2021 in order to begin clinical testing initially in solid tumors, followed by hematologic malignancies.
Corporate Updates

George Gauthier appointed to the newly created position of Chief Commercial Officer. Gauthier brings twenty years of experience in global commercial strategy, marketing and product development. Most recently, Mr. Gauthier was Vice President of Global Product Strategy for Breast and Gynecological Cancers at Genentech, where he led a global team in the creation and execution of commercial and product development strategies.
First Quarter 2021 Financial Results

Cash and Investments: Cash and investments as of March 31, 2021 were $331.7 million, compared to $366.3 million as of December 31, 2020.
Research and Development (R&D) Expenses: For the first quarter of 2021, R&D expenses were $23.6 million, compared to $14.6 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the first quarter of 2021, G&A expenses were $8.1 million, compared to $4.0 million for the same period in 2020.
Net Loss: For the first quarter of 2021, net loss was $31.6 million, or a loss of $0.95 per share, compared to a net loss of $17.6 million, or a loss of $0.58 per share, for the same period in 2020.
2021 Financial Guidance

IGM reiterates its previously issued financial guidance expecting full year GAAP operating expenses to be between $175 million and $185 million including estimated non-cash stock-based compensation expense of approximately $25 million. IGM expects to end 2021 with a balance of over $200 million in cash and investments.