On November 14, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, reported financial results for the three months ended September 30, 2024 (Press release, BioAffinity Technologies, NOV 14, 2024, View Source [SID1234648390]).

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Key Highlights

● Generated quarterly revenue of $2.4 million in the third quarter of 2024.
● More than 1,300% growth rate for CyPath Lung orders in first nine months of 2024 over full-year 2023.
● Number of physician offices signed increased by 75% compared to the second quarter of 2024, setting the stage for acceleration of CyPath Lung sales in the quarters ahead.
● In October 2024, CyPath Lung was added to the U.S. Federal Supply Schedule (FSS), a procurement system that provides the Veterans Health Administration and the Military Health System streamlined access to state-of-the-art healthcare products and services. Under the FSS contract, Veterans at high risk for lung cancer will have easy access to CyPath Lung through 1,380 government health care facilities. Approximately 8,000 Veterans are treated for lung cancer annually, according to the VA.
● Referrals and word-of-mouth from physicians, including key opinion leaders (KOLs), continues to be a key driver for expanding CyPath Lung in states beyond Texas; now receiving CyPath Lung orders from physicians in 11 states, up from eight in the second quarter of 2024. In addition to previously reported orders from Pennsylvania, New Jersey, North Carolina, Arizona, Michigan, California, and Ohio, physicians in Alabama, Louisiana and Illinois have also begun ordering CyPath Lung tests.
● Added new sales representative to target increasing opportunities in Texas.

● Continued to advance new product development initiatives in collaboration with Brooke Army Medical Center, the U.S Department of Defense’s largest military health organization, focusing on tests that use the Company’s artificial intelligence and flow cytometry platform for diagnosing COPD and a companion test with bronchoscopy.
● Economic study published in Journal of Health Economics and Outcomes Research, a peer-reviewed journal, concludes that adding CyPath Lung to the standard of care for Medicare patients with a positive lung cancer screening could have saved an average of $2,773 per patient for total cost savings of $379 million in 2022.
● Awarded a Certificate of Grant of Patent from the Japan Patent Office for the Company’s unique method using flow cytometry to predict the likelihood of lung disease, including the CyPath Lung diagnostic test for early-stage lung cancer.
● Appointed William Bauta, Ph.D., as Chief Science Officer following the retirement of Vivienne I. Rebel, M.D., Ph.D. Dr. Bauta joined bioAffinity in 2016 as Senior Vice President. Previously, he was Associate Director of science at Genzyme.
● Successfully closed a $2.7 million registered direct offering and concurrent private placement to fund continued growth.

Management Commentary

"We are pleased with the continued progress we achieved in the third quarter, highlighted by a 75% growth in the number of physician offices signing on to offer CyPath Lung. This significant expansion not only reflects the increasing recognition of our test’s value in early lung cancer detection but also lays a strong foundation for accelerating sales growth in the coming quarters," bioAffinity President and Chief Executive Officer Maria Zannes said. "With CyPath Lung now being used in 11 states and its recent addition to the U.S. Federal Supply Schedule, we are making meaningful strides in broadening access to this innovative diagnostic tool.

"Our focus remains on expanding our operations and strengthening our foothold in this rapidly growing market," Zannes continued. "Our strategic approach in Texas has resulted in a robust sales and support infrastructure that has us well-equipped to meet rising demand and accelerate our nationwide growth. As we look toward the future, we are confident that these efforts will not only fuel our success but also advance our mission to enhance patient outcomes through groundbreaking, noninvasive cancer diagnostics."

Third Quarter Financial Results

Revenue for the third quarter of 2024 was $2.4 million, compared with $298,000 revenue for the prior-year period. The majority of the year-over-year increase is through the acquisition of Precision Pathology Laboratory Services, LLC (PPLS). Revenue is primarily generated from patient service fees, including billing for CyPath Lung tests, with additional revenues generated from histology service fees and medical director fees.

Research and development expenses were $274,000 for the third quarter of 2024, compared with $330,000 for the comparable period in 2023. The decrease was primarily due to higher R&D laboratory supply and equipment costs following the acquisition of PPLS in the prior year period.

Clinical development expenses were $94,000 for the third quarter of 2024, compared with $106,000 for the third quarter of 2023. The decrease was primarily attributable to higher professional fees in the prior year period related to evaluating the clinical strategy for the Company’s Food and Drug Administration (FDA) pivotal CyPath Lung clinical trial.

Selling, general and administrative expenses were $2.4 million for the third quarter of 2024, compared with $2.0 million for the comparable period in 2023. The increase was primarily attributed to an increase in sales personnel and services to support the launch of CyPath Lung, together with acquired general and administrative costs from PPLS.

Net loss for the third quarter of 2024 was $2.0 million, or $0.16 per share, a $0.3 million improvement from a net loss of $2.3 million, or $0.26 per share, for the comparable period in 2023.

Cash and cash equivalents as of September 30, 2024, were $0.8 million, compared with $2.8 million as of December 31, 2023. Subsequent to the end of the third quarter of 2024, bioAffinity Technologies raised aggregate gross proceeds of $2.7 million in a registered direct offering and concurrent private placement closed on October 21, 2024.

On November 14, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported its intent to change the Company’s name to BeOne Medicines Ltd., confirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible (Press release, BeiGene, NOV 14, 2024, View Source [SID1234648389]).

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"Cancer, a leading cause of death worldwide, exacts an immense toll on individuals, families, and communities. No person, family, scientist, clinician, hospital, policy maker, company or country can or should face this devastating disease alone. We all must work together to win, which is why we are committed to playing a critical role and unifying the global community in the fight against cancer. Our focus is to not only bring innovative medicines to as many people as possible, but also to identify and address the challenges that impede access, making treatments more accessible and affordable," said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. "We have already helped more than 1.4 million patients, and with one of the most prolific oncology pipelines, this year we will bring more than 10 new potential medicines into the clinic. I look forward to our next chapter of growth as BeOne."

About Our Brand Evolution: BeOne Medicines

The proposed new name and logo illustrates our focus on coming together against cancer. Key attributes of the new logo design include:

"Be" represents the fundamental goal of any patient with cancer – simply to be free of disease;
"One" emphasizes our unity as a team and focus on bringing together patients, caregivers, scientists, healthcare providers, governments and industry with a shared mission to eliminate cancer together;
The word "Onc" spelled in red within "One" illustrates our redoubled commitment to oncology; and
The power button within the last "e" represents our always "on" approach in pursuing novel medicines that turn cancer "off" by disrupting key drivers of cancer cell growth and survival, harnessing the body’s immune system to attack tumors, and targeting specific biomarkers of cancer. The tilted angle of the button embodies our path which is not always straight-forward as we push the boundaries of science.
The new name is part of a broader strategic growth plan that has enabled the Company’s global oncology leadership since its inception in 2010. The Company recently reported $1 billion in quarterly total revenue driven by strong growth in product revenue in the U.S. and Europe. To support its expansive clinical portfolio and global growth, the Company opened its $800 million flagship clinical R&D and manufacturing facility at the Princeton West Innovation Campus in Hopewell, N.J. in July. Once the name is approved by shareholders, the company’s stock ticker on Nasdaq will change to "ONC".

The Company’s nearly 11,000 colleagues have advanced more than 20 molecules into the clinic and secured regulatory approvals across five continents. Its unique global research and development team, including clinical operations and development, is comprised of more than 3,600 colleagues conducting clinical trials across Europe, North and South America, Australia, and Asia in more than 45 countries. Its portfolio strategy emphasizes rapid generation of early-stage clinical proof-of-concept data enabled by its speed- and cost-advantaged ("Fast to Proof of Concept") approach to global clinical operations. The Company has solidified its leadership in hematology with BRUKINSA (zanubrutinib), which has the broadest label of any BTK inhibitor and, in the U.S., is the leader in new patient starts in both frontline and relapsed/refractory chronic lymphocytic leukemia in addition to all other approved B-cell malignancies. The Company is advancing this impactful therapy, which is approved in more than 70 markets, as the cornerstone of its hematology franchise as a monotherapy and as a backbone for potential best-in-class combinations with late-stage BCL2 inhibitor sonrotoclax and BTK degrader BGB-16673. In addition, the Company is focused on growing its leadership in solid tumors with its PD-1 inhibitor TEVIMBRA (tislelizumab) and by advancing potential best-in-class assets for breast, lung and gastrointestinal cancers across several modalities, including antibody drug conjugates, multi-specific antibodies, targeted protein degraders, and small molecule inhibitors.

On November 14, 2024 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the third quarter ended September 30, 2024, and highlighted recent Company progress (Press release, ArriVent Biopharma, NOV 14, 2024, View Source [SID1234648388]).

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"Our lead clinical program of firmonertinib in non-small cell lung cancer (NSCLC) is strongly advancing with encouraging potential to expand across EGFR mutant types. In September, we announced compelling monotherapy data for firmonertinib from our FURTHER study supporting rapid and robust anti-tumor activity across EGFR PACC mutations building on the strong activity observed in patients with EGFR exon 20 insertion mutations," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "Importantly, the high activity in tough to treat patients with central nervous system (CNS) metastases or compound mutations points to firmonertinib as a promising candidate for front-line patients with PACC mutations. Collectively, the broad activity in EGFR PACC mutations, the high responses in the CNS, and consistent, manageable safety profile across trials reinforces the promise firmonertinib holds to address unmet needs across the spectrum of EGFR mutant NSCLC."

Dr. Yao continued, "We expect several near-term catalysts for our firmonertinib program including initiating dose expansion for the combination study in classical EGFR mutant NSCLC with SHP2 inhibitor ICP-189 in the fourth quarter of the year, an update on the Phase 1b PACC study and plans for our potential registration study in the first half of 2025, and topline pivotal data from our global Phase 3 FURVENT study in front-line EGFR exon 20 mutant NSCLC in 2025. With our strong balance sheet and operating runway into 2026, we are well-positioned to execute across our near-term catalysts."

Third Quarter 2024 and Recent Highlights

Firmonertinib

● Positive proof-of-concept data in EGFR PACC mutant NSCLC. In September, ArriVent presented interim FURTHER Phase 1b clinical data for first-line firmonertinib monotherapy in patients with EGFR PACC mutant NSCLC during the Presidential Symposium at the 2024 annual World Conference on Lung Cancer and hosted a virtual webinar. In what we believe to be the first clinical dataset testing an EGFR inhibitor in a randomized defined population of EGFR PACC

mutant NSCLC, firmonertinib demonstrated robust systemic and CNS anti-tumor activity with a manageable safety profile consistent with previous trials.
Upcoming Milestones

● Dose expansion for SHP2 inhibitor combination. Initiation of dose expansion cohort for the ongoing Phase 1b trial evaluating firmonertinib in combination with SHP2 inhibitor ICP-189 by InnoCare in patients with classical EGFR mutations expected in the fourth quarter of 2024.
● EGFR PACC pivotal study plan. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in patients with EGFR PACC mutant NSCLC. ArriVent expects to provide an update on EGFR PACC plans in the first half of 2025.
● Selection of next-generation antibody drug conjugate (ADC) candidate. ArriVent and its partner, Aarvik Therapeutics, Inc., continue to make progress, including initiating CMC activities, on selecting a multi-target multivalent ADC candidate for the treatment of solid tumors in the ARR-002 program, and expect to complete selection of a candidate that will be advanced into IND enabling studies in late 2024 or early 2025.
● Top-line pivotal Phase 3 data in 2025. Firmonertinib is currently being studied as a monotherapy in the pivotal, global Phase 3 FURVENT trial (NCT05607550) evaluating firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations with topline data expected in 2025.
Third Quarter 2024 Financial Results

● As of September 30, 2024, the Company had cash and cash equivalents of $282.9 million, which is expected to fund operations into 2026. Net cash used in operations was $54.1 million and $40.9 million for the nine months ended September 30, 2024 and 2023, respectively.

● Research and development expenses were $58.9 million and $44.9 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in expense was primarily due to increased headcount and clinical expense related to firmonertinib.

● General and administrative expenses were $11.8 million and $6.6 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in expense was primarily due to expenses related to expanding the infrastructure necessary for operating as a public company.

● Net loss was $59.9 million and $48.1 million for the nine months ended September 30, 2024 and 2023, respectively.

On November 14, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that the Company has entered into a debt financing agreement with Hercules Capital, Inc. (NYSE: HTGC) for up to $50 million (Press release, Alector, NOV 14, 2024, View Source [SID1234648387]).

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"Alector is in a strong cash position with more than $457 million in cash and investments. This credit facility further enhances our financial strength and provides the Company with increased strategic and operational flexibility," said Marc Grasso, M.D., Chief Financial Officer of Alector. "We anticipate transformational data from both the AL002 INVOKE-2 Phase 2 trial and the latozinemab INFRONT-3 pivotal Phase 3 trial within our runway. This credit facility provides additional funding to advance our preclinical pipeline including our proprietary, versatile Alector Brain Carrier blood-brain barrier platform and programs."

Under the terms of the agreement, Alector drew an initial $10 million at closing. An additional $15 million is available at the Company’s request through June 30, 2026, with an additional $25 million available upon lender approval. The Company is under no obligation to draw funds in the future. The credit facility carries a low double-digit cost of capital.

"Hercules is pleased to enter into a strategic relationship with Alector as it advances its portfolio of assets aimed at treating neurodegenerative diseases," said Lake McGuire, Managing Director at Hercules Capital. "This capital commitment from Hercules seeks to help Alector deliver new therapeutic options to patients and further advance their novel and proprietary blood-brain barrier technology."

Alector’s cash, cash equivalents and investments were $457.2 million as of September 30, 2024. Excluding this $50 million credit facility, the Company believes that its current cash, cash equivalents and investments will be sufficient to fund its operations through 2026.

On November 14, 2024 Akari Therapeutics, Plc (Nasdaq: AKTX) reported the completion of the merger (the Merger) of Akari Therapeutics, Plc (the Company) and Peak Bio, Inc. (Peak Bio), creating an innovative biotechnology company with a broader focus in the advancement of multiple disease therapies (Press release, Akari Therapeutics, NOV 14, 2024, View Source [SID1234648381]). The combined entity will continue the two companies’ significant progress in the development of Antibody Drug Conjugates (ADCs) and advanced therapies for autoimmune and inflammatory diseases, including Geographic Atrophy (GA).

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"We have worked throughout this year to bring these two exciting companies together and are thrilled that we have finally completed the merger," said Samir Patel, MD, Akari’s Interim President & CEO. "Critically important, our post-merger, pro-forma financial statements, as released on Form 8-K, demonstrate shareholder equity sufficient to remedy our Nasdaq shareholder deficiency matter."

"We will immediately begin executing against the strategy we have announced for the combined entity, with specific focus on Antibody Drug Conjugate and Geographic Atrophy milestones over the next 12 months," continued Dr. Patel. "The combination of immediate capital provided by the PIPE financing and the available credit under the Equity Line of Credit (ELOC) will allow us to continue development on our lead assets, which have the potential to bring new treatment options to diseases with high unmet medical need."

"I am thrilled to be leading Akari into the future as the incoming Chairman," said Hoyoung Huh, MD, PhD, Chairman and Founder of Peak Bio. "We will fully leverage our current assets and programs to drive shareholder value, while aggressively seeking out new opportunities to bring forward therapies to alter the treatment paradigm in oncology, autoimmune and inflammatory diseases. I would also like to thank Akari’s outgoing Chairman, Dr Ray Prudo, for his dedicated service and continued support of the Company."

The Financing

The Company entered into a definitive agreement for a private placement financing with investors on November 13, 2024, pursuant to which the Company agreed to sell and issue an aggregate of 1,713,402 unregistered American Depository Shares (ADSs), each representing 2,000 of the Company’s ordinary shares, and Series C Warrants (the Warrants) to purchase up to 1,173,402 ADSs. The per unit price per ADS was $1.70 for all investors other than insiders and $2.385 for insiders, which is equal to the consolidated closing bid price of the ADSs on The Nasdaq Stock Market on November 12, 2024 plus $0.125. The warrants have a term of 3 years from the closing date of the private placement, have cashless exercise provisions and, other than those issued to insiders which are exercisable immediately upon issuance, are exercisable beginning on the date that is six months after the Closing Date. All warrants have an exercise price of $2.26 per ADS, which is equal to the Nasdaq official closing price of the Company’s ADSs on the Nasdaq Capital Market on November 12, 2024.

The Company expects the private placement to close shortly after the merger subject to the satisfaction of customary closing obligations.

Paulson Investment Company LLC acted as placement agent for the financing. Chardan acted as an advisor for the merger and the Company has retained Chardan for future financing.

The securities described above were offered and sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the Act) and Regulation D promulgated thereunder and have not been registered under the Act or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements.

The Equity Line of Credit

Additionally, on November 13, 2024, the Company entered into a term sheet for a $50m equity line of credit (ELOC) with White Lion Capital, LLC (White Lion). Under the ELOC, the Company would have the right, but not the obligation, to sell White Lion up to $50m of newly issued ADSs over a 3-year period, subject to conditions including the filing and effectiveness of a resale registration statement with the SEC covering the resale of ADSs sold to White Lion. Upon execution of the ELOC, sales of ADSs to White Lion under the ELOC would depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the ADSs and determinations by the Company as to the appropriate sources of funding and the Company’s operations.