On March 30, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the year ended December 31, 2019 (Press release, Soligenix, MAR 30, 2020, View Source [SID1234556004]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We are extremely pleased to have achieved positive top-line results in our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial that demonstrates SGX301’s potential to be an important new treatment for early stage cutaneous T-cell Lymphoma (CTCL). Having demonstrated statistical significance in the study’s primary endpoint, we will now look to report results from the extended treatment portion of the trial, which we anticipate announcing in June 2020. Following the positive recommendation received from the independent Data Monitoring Committee, we have successfully achieved our target of 260 patients randomized into the pivotal Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy; however, due to the uncertainty surrounding the coronavirus pandemic, we have decided to enroll approximately 25 additional patients into the study. We are taking this cautious approach in order to maintain the statistical integrity of the trial, by accounting for patients that may potentially drop out of the study before completing their protocol required study treatment and evaluation. Therefore, the study target to complete enrollment and provide top-line results is being revised from the second quarter of 2020 to the fourth quarter 2020; however, this will remain dependent on the medical and logistical challenges caused by the coronavirus showing a reasonable level of improvement in the relative near-term."

Dr. Schaber continued, "Under our Public Health Solutions business segment, we continue to progress our heat stable ricin vaccine, RiVax, with the support of a National Institute of Allergy and Infectious Disease contract award of up to $24.7 million. We are also excited to advance our work with University of Hawaiʻi at Mānoa (UH Mānoa) beyond filovirus vaccines (protecting against viruses such as Ebola and Marburg) to the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19. With over $7.5M in cash, not including our State and Federal funding, we anticipate having the cash resources sufficient to achieve multiple inflection points across our rare disease pipeline, including top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

Soligenix Recent Accomplishments

On March 23, 2020, the Company announced that it expanded its research collaboration with UH Mānoa to investigate potential coronavirus vaccines. The Company and UH Mānoa are expanding the technology platform, developed as part of their filovirus program, to assess compatibility with coronaviruses including SARS-CoV-2, the cause of COVID-19. The resulting vaccines have the potential to be broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised. To view this press release, please click here.

On March 19, 2020, the Company announced positive preliminary top-line results for its pivotal Phase 3 FLASH trial evaluating SGX301 (synthetic hypericin) in the treatment of CTCL. The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. To view this press release, please click here.

On February 13, 2020, the Company announced that its RiVax (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication had received "Fast Track" designation from the FDA. To view this press release, please click here.

On February 3, 2020, the Company announced that its ongoing collaboration with the UH Mānoa and Hawaii Biotech Inc. had resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines, in which the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus). To view this press release, please click here.

On February 3, 2020, the Company announced that the Japanese Patent Office had granted the patent titled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis." This allowance builds on similar intellectual property in the US, New Zealand, Australia and Singapore and patent applications pending in other jurisdictions worldwide. The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and add to composition of matter claims for dusquetide and related analogs that have been granted in the US and worldwide. To view this press release, please click here.

On January 14, 2020, the Company issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. To view this press release, please click here.

On December 18, 2019, the Company announced that it had received preliminary approval for a tax credit from the New Jersey Economic Development Authority’s (NJEDA) New Jersey Technology Business Tax Certificate Transfer program. As a result, the Company anticipates being able to transfer this credit and receive approximately $850,000 in net proceeds. To view this press release, please click here.

On December 3, 2019, the Company announced it had completed patient enrollment in its Phase 3 FLASH study for SGX301 in the treatment of CTCL. The study successfully enrolled 169 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent Data Monitoring Committee. To view this press release, please click here.
Financial Results – Year Ended December 31, 2019

Soligenix’s revenues for the year ended December 31, 2019 were $4.6 million as compared to $5.2 million for the year ended December 31, 2018. Revenues included payments on a contract in support of RiVax, in addition to the grants received to support the development of SGX301 for the treatment of CTCL and SGX942 for the treatment of oral mucositis in HNC.

Soligenix’s basic net loss was $9.4 million, or ($0.48) per share, for the year ended December 31, 2019, as compared to $8.9 million, or ($0.68) per share, for the year ended December 31, 2018.

Research and development expenses were $8.1 million as compared to $6.8 million for the years ended December 31, 2019 and 2018, respectively. The increase in research and development spending for the year ended December 31, 2019 was primarily attributable to the expansion of the Phase 3 clinical trial of SGX942 as well as the ongoing Phase 3 clinical trial of SGX301, compared to the same period in 2018.

General and administrative expenses were $3.4 million as compared to $3.0 million for the years ended December 31, 2019 and 2018, respectively.

As of December 31, 2019, the Company’s cash position was approximately $5.4 million.

On March 30, 2020 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune system recognition, reported successful completion of the safety lead in portion of the IT-01 KEYNOTE A10 study arm (NCT03058289) that is testing the combination of INT230-6, the Company’s lead investigational product, and Keytruda (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy (Press release, Intensity Therapeutics, MAR 30, 2020, https://intensitytherapeutics.com/intensity-therapeutics-reports-safety-results-from-first-cohort-of-the-keynote-a10-combination-clinical-trial-of-int230-6-and-keytruda/ [SID1234556003]).

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The cohort treated seven patients with different types of advanced cancers that were amenable to superficial injections including triple negative breast cancer (n=3) Merkel cell carcinoma, chordoma, desmoid tumor, and soft tissue sarcoma. Patients’s tumors were treated every two weeks for 5 doses with INT230-6 in combination with 200 mg of Keytruda every three weeks. All seven patients completed the 28 dose limiting toxicity (DLT) period with no DLT’s or drug related serious adverse events.The safety profile appears to be similar to INT 230-6 monotherapy. Following completion of the dosing of INT230-6, patients continue on Keytruda monotherapy for up to 2 years. Scans will be collected regularly on patients to evaluate the efficacy of the combination.

The study steering committee, which is comprised of the principal investigators, reviewed the safety data and approved dosing into deep tumors as well as initiating phase 2 studies. The KEYNOTE A10 phase 2 studies will enroll patients with pancreatic cancer, microsatellite stable colorectal cancer and cholangiocarcinoma, These cancers are typically immunologically cold and historically non responsive to immunotherapies. Intensity also plans a fourth phase 2 cohort to test the combination in squamous cell carcinoma patients who have already failed a PD1/PDL1 agent.

"The confirmation of safety in our first combination cohort marks an important milestone in our evaluation of INT230-6 dosed with Keytruda," commented Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "We are excited to begin enrolling patients with cancers that are difficult to treat and historically nonresponsive to PD1/PDL1 antibodies alone. Patients with these cancers have limited therapeutic options and are in desperate need of better treatments."

"INT230-6 has previously demonstrated tumor cell killing and immune system activitation resulting in tumor regression in non-injected tumors in patients with several different tumor types in the monotherapy portion of our ongoing Phase 1/2 study," said Ian B. Walters, MD, Chief Medical Officer of Intensity Therapeutics. "Considering the promising results INT230-6 has demonstrated as monotherapy and the encouraging safety observed thus far in combination with Keytruda, we look forward to moving into Phase 2, treating more patients with the combination and expanding upon our existing efficacy data. We believe our approach of releasing tumor antigens derived from the patient’s own tumors to enable an immune attack on the cancer can be further amplified by blocking a checkpoint signal with Keytruda."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer, resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity collaborative research, published in July 2019, showed that there was also strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.

On March 30, 2020 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported financial results for the fourth quarter ended December 31, 2019 and provided an update on recent operational and business progress (Press release, RAPT Therapeutics, MAR 30, 2020, View Source [SID1234556002])

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2019 was an especially productive year for RAPT with the completion of our initial public offering and the generation of encouraging early clinical data for our two lead immunology-based programs: FLX475 for the treatment of multiple cancers and RPT193 for the treatment of atopic dermatitis and other allergic inflammatory diseases," said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. "In addition, we partnered with Hanmi for FLX475 in Asia, a region with a high prevalence of ‘charged’ tumors, and we strengthened our balance sheet substantially with our follow-on offering in February 2020."

Dr. Wong continued, "For our ongoing Phase 1/2 study of FLX475, we continue to enroll and treat patients with multiple types of advanced cancer, though we are monitoring the impact of COVID-19 on our clinical trial sites both within and outside of the U.S. Because of the life-threatening nature of the cancers, we are working site by site to ensure that patients receive treatment and follow up as close to protocol-specified intervals as feasible. Our primary objective is patient safety and we will adapt to local circumstances as needed.

"For RPT193, we successfully completed the healthy volunteer portion of the study. We have made the decision to pause the enrollment of patients with atopic dermatitis in the Phase1b portion of our clinical study for RPT193 in an effort to support clinicians and healthcare facilities that are prioritizing the fight against COVID-19, while safeguarding the health and safety of patients and clinicians who would be involved in our trial. We intend to resume enrollment as soon as practical once we expect patients can be treated and followed up consistently under safer public health conditions."

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2019

Fourth Quarter Ended December 31, 2019

Net loss for the fourth quarter of 2019 was $13.2 million, compared to $9.4 million for the fourth quarter of 2018.

Research and development expenses for the fourth quarter of 2019 were $10.2 million, compared to $8.4 million for the same period in 2018. The increase was primarily due to clinical costs related to the advancement of RPT193 and FLX475 as well as the personnel costs associated with these studies offset by outsourced research and development and lab supplies.

General and administrative expenses for the fourth quarter of 2019 were $2.6 million, compared to $1.3 million for the same period in 2018. The increase was due to an increase in consulting costs as well as accounting and audit-related costs as well as other expenses associated with being a public company.

Full Year Ended December 31, 2019

Net loss for the year ended December 31, 2019 was $43.0 million, compared to $36.1 million for the same period in 2018.

Research and development expenses for the year ended December 31, 2019 were $34.9 million, compared to $31.8 million for the same period in 2018. The increase was primarily due to increases in costs relating to the clinical development of RPT193 and FLX475, facilities and personnel, offset by decreases in costs relating to lab supplies and outsourced research and development.

General and administrative expenses for the year ended December 31, 2019 were $8.7 million, compared to $5.2 million for the same period in 2018. The increase was primarily due to increases in professional service fees related to preparations for our initial public offering.

As of December 31, 2019, we had cash and cash equivalents of $77.4 million. In February 2020, we received net proceeds of approximately $69.7 million resulting from our follow-on public offering of 2,500,000 shares of common stock.

On March 30, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the year ended December 31, 2019 and provided a business update (Press release, Adamis Pharmaceuticals, MAR 30, 2020, View Source [SID1234556000]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "In light of the recent COVID-19 outbreak and overall economic outlook, we have attempted to determine the impact of the outbreak on our present and future operations, including the impact on our suppliers, manufacturers and commercial partners. The good news is that at the present time we have not seen a material impact of COVID-19 on demand for our products, and we have not yet seen any significant negative impact on our supply chain or distribution network. If the outbreak appreciably worsens and/or if governmental restrictions persist for a protracted period, that could of course affect our outlook."

"Having said that, the outbreak and governmental mandated social distancing and sheltering in place have caused some near-term impact and disruption to our employees and daily operations. For that reason, and to allow some time to gain additional visibility into the 2020 year, we have determined to postpone our regularly scheduled earnings conference call. My sincere hope is that we can have a more meaningful call in the future and provide a clearer picture of the remainder of 2020 and the outlook for the company."

"In the meantime, we remained focused on completing the additional work to allow us to supplement our NDA for our naloxone injection product (ZIMHI). We are actively addressing the issues the FDA raised in the Complete Response Letter we received late last year. We continue to believe ZIMHI can play an important role in combating the ongoing public health crisis of opioid overdose, and we look forward to the eventual approval of ZIMHI. SYMJEPI sales continue to be far lower than we ever expected. We are currently working with Sandoz to determine what needs to occur to accelerate its growth in the epinephrine market. Sales of pharmaceutical preparations through our US Compounding drug outsourcing facility had strong growth for 2019 versus the year prior."

Product Updates

SYMJEPI (epinephrine) Injection

On January 16, 2019, we announced that Sandoz had launched SYMJEPI (epinephrine) 0.3 mg Injection in the U.S. market, initially available in the institutional setting. On July 9, 2019, we announced the full launch (institutional and retail) by Sandoz of both dose forms of the SYMJEPI injection products.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories. On October 1, 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in both Australia and New Zealand.

ZIMHI (naloxone) Injection

On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. On December 19, 2019, Adamis provided an update indicating that it had provided responses to the comments included in the CRL and submitted them to the FDA along with a request for a meeting. On February 12, 2020, the Company had a Type A meeting with the FDA to discuss the company’s response to the CRL and the process and timeline for resubmission of the NDA to the FDA. At the meeting, Adamis obtained concurrence from the agency on the information required for resubmission of the NDA.

The company believes it can generate the additional data, and assuming successful testing, resubmit the NDA in the second quarter of 2020. The FDA expressed its intent to review the resubmission in a rapid and timely manner consistent with agency guidelines. The company continues to have discussions with potential commercial partners for ZIMHI.

Drug Outsourcing Facility

During the fourth quarter of 2019, the company’s wholly owned drug outsourcing facility, US Compounding (USC), continued to grow its revenues by approximately 13% in the fourth quarter compared to the same quarter in the prior year. For the year, USC increased revenues approximately 22% versus 2018. USC’s increase in revenues was due to the increase in sales of USC’s sterile pharmaceutical formulations resulting in part from an increase in production capacity in order to meet product demand and from increasing sales and marketing efforts.

2019 Financial Results

Adamis total revenues increased approximately 47%, from $15.1 million to $22.1 million, for the year ended December 31, 2018 and 2019, respectively. Total revenues increased by approximately 33%, to $5.5 million from $4.2 million fourth quarter of 2019 compared to the same period in 2018. The increase was primarily attributable to growth in sales of USC’s sterile pharmaceutical products and revenue relating to SYMJEPI.

Selling, general and administrative expenses ("SG&A") for the years ending December 31, 2019 and 2018 were approximately $25.3 million and $26.0 million, respectively, a decrease of approximately 3%. The decrease was primarily attributable to decreases of approximately $2.1 million in compensation expenses, occupancy costs, and other related expenses. These amounts were partially offset by an increase of approximately $1.4 million attributable to increases in consulting, legal, patent, insurance, PDUFA fees, marketing and selling expenses.

Research and development expenses were approximately $10.4 million and $18.8 million for the years ended December 31, 2019 and 2018, respectively, a decrease of approximately 45%. The decrease was primarily due to a decrease in development costs of our product candidates.

Cash and equivalents at the end of the year was approximately $8.8 million. In February, the Company increased its cash position by raising approximately $6.7 million before deducting the placement agent’s fees and other estimated offering expenses, in an equity financing transaction. The net loss for the year was approximately $29.3 million.

Targeted Milestones

●Increasing sales of SYMJEPI in the U.S.;
●Resubmission of New Drug Application for ZIMHI;
●FDA approval and commercial partner for ZIMHI;
●Following FDA approval, begin selling ZIMHI in the U.S.;
●Increasing sales and margins at US Compounding; and
●Completing a Phase III ulcer study in horses.

On March 27, 2020, Equillium, Inc. (the "Company", "we" or "us") reported that it has entered into a purchase agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, we may sell to Lincoln Park up to $15,000,000 of shares of our common stock, par value $0.0001 per share (the "Purchase Shares"), from time to time over the 36‑month term of the Purchase Agreement (Filing, 8-K, Equillium, MAR 27, 2020, View Source [SID1234555999]). Concurrently with the Purchase Agreement, we also entered into a registration rights agreement with Lincoln Park (the "Registration Rights Agreement") pursuant to which we agreed to take specified actions to register the shares of common stock that have been and may be issued to Lincoln Park under the Purchase Agreement for resale pursuant to a registration statement under the Securities Act of 1933, as amended (the "Securities Act").

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Following the satisfaction (or waiver by Lincoln Park) of certain conditions under the Purchase Agreement, we have the right, in our sole discretion, to present Lincoln Park with a purchase notice (a "Purchase Notice"), directing Lincoln Park to purchase up to 75,000 Purchase Shares per business day (a "Regular Purchase"), subject to a maximum commitment by Lincoln Park of $2,000,000 per Regular Purchase. The Purchase Agreement provides for a purchase price per Purchase Share equal to the lesser of: (i) the lowest sale price for our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) on the purchase date of such shares; and (ii) the average of the three lowest closing sale prices for our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) during the ten consecutive business days immediately preceding the purchase date of such shares.

In addition, on any date on which we submit a Purchase Notice to Lincoln Park, we also have the right, in our sole discretion, to present Lincoln Park with an accelerated purchase notice (an "Accelerated Purchase Notice") directing Lincoln Park to purchase shares of our common stock (an "Accelerated Purchase") equal to up to the lesser of: (i) three times the number of shares purchased pursuant to such Purchase Notice; and (ii) 30% of the aggregate shares of our common stock traded during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Accelerated Purchase date, the portion of the normal trading hours on the applicable Accelerated Purchase date prior to such time that any one of such thresholds is crossed (an "Accelerated Purchase Measurement Period"), provided that Lincoln Park will not be required to buy Purchase Shares pursuant to an Accelerated Purchase Notice that was received by Lincoln Park on any business day on which the closing sale price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) is below $1.00 per share. The purchase price per share for each such Accelerated Purchase will be equal to the lesser of: (y) 97% of the volume-weighted average price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date; and (z) the closing sale price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) on the applicable Accelerated Purchase date.

We may also direct Lincoln Park on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Purchase Agreement, to purchase shares of our common stock (an "Additional Accelerated Purchase") equal to up to the lesser of: (i) three times the number of shares purchased pursuant to the Regular Purchase made on such date; and (ii) 30% of the aggregate shares of our common stock traded on the Nasdaq Global Market (or any nationally recognized successor thereto) during a certain portion of the normal trading hours on the applicable Additional Accelerated Purchase date as determined in accordance with the Purchase Agreement (an "Additional Accelerated Purchase Measurement Period"), provided that the closing price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) on the business day immediately preceding such business day is not below $1.00. The purchase price per share for each such Additional Accelerated Purchase will be equal to the lesser of: (y) 97% of the volume-weighted average price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) during the applicable Additional Accelerated Purchase Measurement Period on the applicable Additional Accelerated Purchase date; and (z) the closing sale price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) on the applicable Additional Accelerated Purchase date.

The aggregate number of shares that we can sell to Lincoln Park under the Purchase Agreement may in no case exceed 3,523,717 shares of our common stock (which is equal to approximately 19.99% of the shares of our

common stock outstanding immediately prior to the execution of the Purchase Agreement (the "Exchange Cap"), unless: (i) we obtain stockholder approval to issue shares of our common stock above the Exchange Cap; or (ii) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds $2.6298 per share (which represents the closing price of our common stock on the Nasdaq Global Market immediately preceding the signing of the Purchase Agreement, plus an incremental amount) such that the transactions contemplated by the Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules; provided that at no time shall Lincoln Park (together with its affiliates) beneficially own more than 4.99% of our issued and outstanding common stock.

The Purchase Agreement contains customary representations, warranties, covenants, closing conditions and indemnification and termination provisions. Sales under the Purchase Agreement may commence only after certain conditions have been satisfied, which conditions include the registration statement covering the resale of the shares of our common stock issued or sold by us to Lincoln Park under the Purchase Agreement shall have been declared effective under the Securities Act by the Securities and Exchange Commission, the delivery to Lincoln Park of a final prospectus covering the shares of our common stock issued or sold by us to Lincoln Park under the Purchase Agreement, approval for listing on The Nasdaq Global Market of the shares of our common stock issued or sold by us to Lincoln Park under the Purchase Agreement, the issuance of 65,374 shares of our common stock to Lincoln Park as commitment shares to Lincoln Park, and the receipt by Lincoln Park of a customary opinion of counsel and other certificates and closing documents. The Purchase Agreement may be terminated by us at any time, at our sole discretion, without any cost or penalty. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of our common stock. While we have agreed to reimburse Lincoln Park for a limited portion of the fees it incurred in connection with the Purchase Agreement, we did not pay any additional amounts to reimburse or otherwise compensate Lincoln Park in connection with the transaction. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings (other than restrictions on our ability to enter into variable rate transactions described in the Purchase Agreement), rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. We may deliver Purchase Notices under the Purchase Agreement, subject to market conditions, and in light of our capital needs from time to time and under the limitations contained in the Purchase Agreement. Our net proceeds under the Purchase Agreement will depend on the frequency and prices at which we sell shares of our common stock to Lincoln Park. We expect that any proceeds we receive from such sales to Lincoln Park will be used for working capital and general corporate purposes.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement and, by its nature, is incomplete. Copies of the Purchase Agreement and the Registration Rights Agreement are filed as Exhibits 10.1 and 4.1 attached hereto, respectively. The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to such exhibits.

The Purchase Agreement and Registration Rights Agreement each contain customary representations and warranties, covenants and indemnification provisions that the parties made to, and solely for the benefit of, each other in the context of all of the terms and conditions of such agreements and in the context of the specific relationship between the parties thereto. The provisions of the Purchase Agreement and Registration Rights Agreement, including any representations and warranties contained therein, are not for the benefit of any party other than the parties thereto and are not intended as documents for investors and the public to obtain factual information about the current state of affairs of the parties thereto. Rather, investors and the public should look to other disclosures contained in our annual, quarterly and current reports we may file with the Securities and Exchange Commission.